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chrisvoncsefalvay

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vaers-outcomes

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On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel

0No event

Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. Concomitant products included CARVEDILOL for an unknown indication. On 13-Apr-2022 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 1:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no No. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient did not have any known allergies. Patient was not COVID-19 positive withing last month. On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet. No Treatment information was reported.

0No event

This spontaneous report as received from a nurse refers to an 8 months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dos and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.

0No event

No adverse reaction. Flumist vaccine was administered at 21 months instead of 24 months of age.

0No event

2 days after vaccination, patient spiked a temperature of 104 and had a febrile seizure. She stopped breathing and had to be brought by ambulance to ER. Was treated and spent 1 night in hospital.

2ER_VISIT, HOSPITAL

myocarditis; feeling pain in my body/ pain all over her body; My ribs pain me; can't sleep; sick; I can't hardly use my arms/ I almost lose my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling pain in my body/ pain all over her body"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "My ribs pain me"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I can't hardly use my arms/ I almost lose my legs". The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: myocarditis in my heart; Positron emission tomogram: find it in my heart. Clinical course: The caller requested information on what to do with myocarditis that happened after receiving the Pfizer Biontech COVId-19 vaccine. Patient got two shots of the Pfizer vaccine and she got one shot of the booster. Every time she went to the ER like she got a heart attack I never get one. Patient had been going on feeling pain in her body. Her ribs pain her. Every real pain just pain. Really can't sleep(?). They did MRI in her heart and they find the myocarditis in her heart they did a PET scan and they found it in her heart. The myocarditis almost killed her. Pfizer should tell people you can get that. She almost lost my life. (Unintelligible) When she took the first vaccination she could walk, the second one she creep. She almost lost her legs. When she took the booster she was so sick. Patient could not hardly use her arms. The caller proceeded to complain about the pamphlet not being sent with the vaccine so people who get it know what could potentially happen to them. Caller mentions that on Tik Tok and you tube are people complaining about adverse events of the vaccine and how they got sick from it. Caller got 2 vaccines and booster, had myocarditis, calling to have that reported. She had myocarditis, in heart, got from Pfizer. She stated, the only thing she called for was to report and saw what she can do for it. Has disease on her body, germs and, pain all over her body. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272054 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300272055 same patient/vaccine, different vaccine dose/event;

1ER_VISIT

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (hcp). This hcp reported the same events for 2 patients. This is the first of two reports. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 21Dec2020 at a single dose on left deltoid for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient reported to have received the vaccine 3 weeks ago and was scheduled to receive the vaccine yesterday (11Jan2021) but tested positive last Saturday 09Jan2021. He mentioned that he had subsequent symptoms of COVID on 01Jan2021. He and his significant other (S/O) got tested last 05Jan2021. He got a negative result while his S/O got a positive result. He had symptoms throughout the week until he confirmed positive last Saturday. As of this report, he is still in quarantine and is experiencing residual congestion and tiredness. He asked when he should schedule to receive the vaccine. The patient underwent lab tests and procedures which included COVID-19 test: negative on 05Jan2021, and then positive on 09Jan2021. The patient has not recovered from the events.; Sender's Comments: Based on the available information, a causal relationship between event positive "COVID-19 test with symptoms" (coded to coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021030850 same drug/events/reporter, different patients

0No event

arm hurts; felt poorly more than the first time; chill, bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Previously administered products included for Flu: Flu shot (Seemed to have trouble breathing and didn't reported anything like that. Like congested.). Past adverse reactions to the above products included Unwell with Flu shot. On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills). At the time of the report, PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) had resolved. No concomitant medications reported No treatment medications reported. This case was linked to MOD-2021-314548 (Patient Link).

0No event

Onset of shingles 2 weeks post-vaccine

0No event

Dizziness; Mild headache; Body aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-213958 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

0No event

Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes open.

1ER_VISIT

FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS.

0No event

Expired covid vaccine give on 9/1/22- Vaccine expired 8/31/22

0No event

Profound joint pain, diffuse.

1ER_VISIT

Patient had two ED visits 3/9/21 and 3/11/21, then presented to the ED on 3/28/21 where he was subsequently hospitalized with severe sepsis.

2ER_VISIT, HOSPITAL

Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; This is a spontaneous report from a contactable consumer (patient). An 82-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) administered in right arm via an unknown route of administration on 14Feb2021 at 09:45 am as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications in two weeks included Esomeprazole (ESOMEPRAZOLE), Simvastatin (SIMVASTATIN), Ramipril (RAMIPRIL), Amlodipine (AMLODIPINE). Prior vaccination, patient was not diagnosed with covid. On 18Feb2021 at 15:30 pm, the patient experienced severe cramp, left leg at least 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting about 1 hr. cramps lasted approximately 3-5 minutes each time. The outcome of the events was unknown. No other vaccine was received in four weeks. Post vaccination, the patient was not tested for covid. The patient had known allergies only to Typhus vaccine many years ago.

0No event

pt recvd vax & approx 2-3 hrs p/vax pt became red in color, sweating & limp; pt was rushed to MD; MD reported pt to act as though "drugged"; no fever w/color pink to red; observed x 2 hrs in office;

1ER_VISIT

I had a sore throat and a lot of congestion in my nose and the back of my throat. Then I took a home COVID-19 home test on 12/07/2022 and it was positive. I called the doctor and they called in a prescription for PAXLOVID for me. I did have to treat diarrhea after starting the medication. After I started to take the medication, my symptoms improved within 2-3 days. I have completely recovered with no lingering symptoms.

0No event

Headache Tiredness Dizziness Nausea Vertigo at night during bedtime. It would wake me up. The room would be spinning. By morning, I was still dizzy, but I was able to function. After 2nd vaccine, I have had SEVERE vertigo 2 weeks after the 2nd injection that has caused me to miss work. My primary care doctor called in Meclizine. I also spoke with a vestibular physical therapist who instructed me on the Epley maneuver. I had 2 days of severe spinning then 6 days of mild spinning and dizziness then a return of severe spinning. I am on day 12 of these symptoms.

0No event

I had awful migraines that did NOT improve with Tylenol or Ibprophen. My migraines had an aura to them on the 1/1/2021. I was also nauseous and had a difficult time keeping food down. I was also very tired and slept longer than I normally do. I had my vaccine done on 12/30/2020 and the symptoms did not occur until 1/01/2021. An hour or so after the injection, my arm started to become sore. It was very sore until 1/3/2021. They lasted until 1/3/2021. Now I feel fine.

0No event

Her ankle and hip joints pain started to worsen/Experiencing joint pain after first and second; A part of her hips started to hurt and went away; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 84-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date (age at vaccination: 84-year-old) as single dose for covid-19 immunization. Vaccination Facility: Hospital. Vaccine Administered at Military Facility: No. Medical history included ongoing arthritis, ongoing Dermographism Had since her 30s, ongoing cardiac disorder, ongoing thyroid disorder, ongoing Fibromyalgia Had since her 30s. Concomitant medication included atenolol (ATENOLOL), amlodipine besilate (NORVASC), furosemide (LASIX [FUROSEMIDE]), potassium (POTASSIUM), all taken for cardiac disorder from an unspecified start date and ongoing, levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing, cimetidine (TAGAMET [CIMETIDINE]) taken for mechanical urticaria from an unspecified start date and ongoing, Historical Vaccine included received flu shot and Got so sick and sick for over a year (Will never get flu shot again.) at the age 18 or 19 years. loratadine (CLARITIN [LORATADINE]) taken for mechanical urticaria from an unspecified start date and ongoing, prednisone (PREDNISONE) taken for rheumatoid arthritis from an unspecified start date and ongoing, paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing. It was reported that patient wanted to know if the joint pain she experienced is something caused by the Pfizer BioNTech Covid-19 Vaccine or caused by her history of arthritis and fibromyalgia. She experienced the worsened joint pain a few days after getting her 2nd shot of the Pfizer BioNTech Covid-19 Vaccine last 24May2021 and the pain persists until now. Also reported her ankle and hip joints pain started to worsen after the second shot of the vaccine last 14May2021. During the first shot, a part of her hips started to hurt and went away, on the following day another part of the hip started to hurt and went away again. She wanted to know how long her joint pain would last. She was quite displeased that she is unable to obtain medical recommendation as to managing her joint pain and how long the worsening would last. Upon date 24May2021 it was reported that stated after the first shot, she had joint pain, but it went away. Second shot was more pronounced pain. She has arthritis and fibromyalgia. Pain happened shortly after the shot. Today the pain is worse. Day before pain was not so bad. It is off and on. Caller states she doesn't want to worry. Caller states that her husband said that the person had trouble giving her second shot. She moved the needle around. Arm hurts a little bit. Getting better. She did not even feel the first shot. She did not even know that she had gotten it when it was already done. She then explains that this is getting better. She confirms her arm was hurting a little before the second shot because she had already had the first shot in that arm. It is worse with the second. With the first shot, she had hardly any problems at all. This is why she is hoping second shot is not a problem for her. Therapeutic measures were taken as a result of events with Tylenol for pain. Patient was not visited physician office or Emergency Room. The outcome for the event her ankle and hip joints pain started to worsen/experiencing joint pain after first and second was not resolved and for event a part of her hips started to hurt and went away outcome was resolved on 2021. Information on the lot/batch number has been requested.

0No event

Diagnosed Thyroid dysfunction. Diagnosed with hypothyroidism. With many symptoms. (Weak, Dizzy, Short of Breath, racing heart, Feeling faint, Insomnia, General feeling of Unwellness, Feeling very sick and ill. Heart Dull Ache Pressure 7-8 severity 1-10 scale). moderate to severe Aches and pains in joints. Blurry vision. Now taking Levothyroxine 50mcg. Diagnosed High Blood Pressure. Rapid pulse rate. Now taking Irbesartan 150mg

1ER_VISIT

softness when touched; light pain when arm is raised; some swelling on injectioin site (right arm); This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 42B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included ROSUVASTATIN, AMLODIPINE and LOSARTAN for Blood pressure high, INSULIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication. On 08-Apr-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient used ice pack to treat the adverse event. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received on 08-07-2021 - Events outcome updated.

0No event

This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 27-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:

0No event

Patient received his Covid19 Jannsen vaccine April 8, 2021 and came in June 28th, 2021 and insisted on getting the first of the 2 dose series Covid19 Moderna vaccine. The patient pleaded that he needed to protect himself against the Delta variant. Patient received the Moderna vaccine. I was asked to report this to Moderna vaers.

0No event

Visit to ER--EPIPEN given for future use.

0No event

2nd shot put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unwell (Verbatim: 2nd shot put me down). The outcome of the unwell was recovered/resolved (duration 72 hrs). It was unknown if the reporter considered the unwell to be related to Shingles vaccine. It was unknown if the company considered the unwell to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the second shot put him/her down for 72 hours, but it was not worse than actual shingles. The follow-up could not be possible as no contact details were available.

0No event

Nausea; headache; tiredness; very strong muscle pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included autonomic seizures, hypothyroidism and migraines. Concomitant medications included levetiracetam (KEPPRA), lamotrigine(LAMICTAL ER), rizatriptan benzoate (MAXALT), levothyroxine(MANUFACTURER UNKNOWN) and paracetamol(TYLENOL), all from unknown dates and for unknown indications. The patient had allergies to tramadol, naproxen, ibuprofen and prozac. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 13:00, the patient experienced nausea, very strong muscle pain at injection site, headache and tiredness. The patient did not receive any treatments for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, very strong muscle pain at injection site, headache and tiredness was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

0No event

7 days after receiving 4 month vaccines, including ROTATEQ, he began with vomiting, bloody stools. (+) Intussusception/Malrotation, required surgery to correct.

2ER_VISIT, HOSPITAL

Red rash from armpit to wrist, swelling, extreme tenderness.

0No event

Also noticed increase in sense of smell persistent after both vaccine doses; Vomiting; Diarrhea; Cold Sweats; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported, expiry date: not reported), via an unspecified route of administration, administered in Arm Right on 08Feb2021 14:00 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included metformin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported,expiry date: not reported) via an unspecified route of administration on 18Jan2021 14:00 as dose 1, single for covid-19 immunisation and noticed increase in sense of smell persistent. Patient had no known allergies. No COVID prior vaccination and no COVID tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 19:30, the patient experienced vomiting, diarrhoea, cold sweats, disoriented and also noticed increase in sense of smell persistent. No treatment was given for the events. The outcome of the events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021154724 same patient/reporter, different AE/second dose

0No event

Dizziness and loss of hearing about 1 month. Observed for 20 minutes.

0No event

pt recv vax;3 days later inject site rxn characterized by redness, swelling & tenderness at inject site;addtl info revealed pt had induration at inject site;

1ER_VISIT

Error: Improper Storage (ex. temp./location)-

0No event

(06/08/2021) Flu like symptoms including weakness possible fatigue, not confirmed for CovID, lasted 2 weeks and occasional cough even now. Only stay at home and flu protocol for treatment. No prescriptions or such.

0No event

pt recvd vax & was fussy p/vax; later noted to be gasping for breath w/significant nasal congestion; poss unresponsive for 5 mins; t101.4;

1ER_VISIT

HIGH FEVER WITH NORMAL CBC,PARENT REPORTED 106 DEGREE FEVER THE NIGHT VACCINE WERE GIVEN

0No event

my arm still kills; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis. On 8th July 2020, the patient received Bexsero. In July 2020, less than a week after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. The primary reporter was an agent from GSK. The patient received Bexsero shot 6 days ago and reported arm still kills. The reporter asked was there something wrong because nothing showed up in and arm should have stop hurting. The reporter did not consent to follow up. Read internal comments for more information.

0No event

loss of vision; Retinal Vein or Artery Occlusion; Retinal Vein or Artery Occlusion; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 78 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for immunisation; influenza vaccine (INFLUENZA), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing); "CKD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant), RETINAL VEIN OCCLUSION (hospitalization, disability, medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Retinal Vein or Artery Occlusion"; BLINDNESS (hospitalization, disability, medically significant) with onset 25Sep2023, outcome "not recovered", described as "loss of vision". The patient was hospitalized for blindness, retinal artery occlusion, retinal vein occlusion (hospitalization duration: 5 days). The events "loss of vision" and "retinal vein or artery occlusion" required emergency room visit. Clinical course: On 25Sep2023, the patient suffered sudden onset of retinal vein or artery occlusion in left eye which resulted in loss of vision in that eye. The adverse events resulted in an emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient did not receive any other vaccines within four weeks prior to the vaccines. The patient did not receive any other medications within two weeks to the vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. It was unknown if therapeutic measures were taken as a result of blindness, retinal artery occlusion, retinal vein occlusion. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.

2ER_VISIT, HOSPITAL

MBR presented with localized rash on (R) lateral chest and shoulder R/T smallpox vaccine rec'd 11 AUG 07. Reported minor itching and mild tenderness of area with palpation. Also stated he had painful lymph nodes, (R) axillary area.

1ER_VISIT

VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT

0No event

patient came in today and showed right arm there was a red rash all around the area and down the upper arm a little. patient said had been sore and itchy and burning after injection and she rubbed her arm alot didnt know if that made it worse. I told patient to have it looked at by md

0No event

This spontaneous report was received from a medical assistant concerning a 64-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.

0No event

This initial spontaneous report was received on 26-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-SEP-2010, the patient was inoculated (by an unspecified person) at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, he was treated (by an unspecified healthcare professional) at a dermatology office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.

0No event

Patient administered Covid Johnson & Johnson vaccine at Pharmacy. Patient c/o swelling to the left arm, dizziness, throat itching, body aches, coughing at night, chills and sweats since receiving the vaccine. Patient states she took Benadryl without relief. Patient seen by provider at a Community Health Center and prescribed Clindamycin HCl 300 mg capsules and instructed to follow up with PCP in 2 weeks for cellulitis.

0No event

Patient also received 2nd Moderna on 4/20/21 no lot number available; event occurred after 2nd vaccine; breakthrough case admission

4HOSPITAL

headache, fatigue, fever, chills, Lasted for 6 days

0No event

Redness, pain, swelling and itching.

1ER_VISIT

On 5/13/00, the pt developed generalized fatigue and weakness, progressing to weakness and numbness in upper and lower extremities. Continued increasing muscle weakness with difficulty walking on 5/16/00. Sought medical advise on 5/17/00. Admitted to hospital and dxed with Guillain-Barre Syndrome based on spinal tap results and nerve conduction studies. Treated with immunoglobulins. Follow up 07/27/2000: "Patient final diagnosis Gullian-Barre Syndrome; was diagnosed by neurologist. Patient experienced other illnesses within 4 weeks before onset of GBS syndrome; Patient experienced or has other previous illness or medical condition before the onset of GBS symdrome such as Ulceration Colitis in 1992, no flareups within past year. Patient received influenza vaccinations previously."

4HOSPITAL

Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.

0No event

Severe fatigue and soreness.

0No event

Pt co cramping ( menstrual sx like) tingling sensation on L fingers, severe pelvic pain. Felt like going to the bathroom, chills, severe menstrual cramping. 3:45 Sx resolved within one hour.

0No event

Patient had syncope episode after administering 4th injection (PREVNAR 13) in LT IM. Infant initially cried then slumped forward. Nurse took child from parent's arms, notified provider. Approximate episode lasted 8-10 sec. Infant was examined by provider afterwards and monitored.

0No event

Muscle and joint ache, fatigue when I woke up day after receiving second dose. Muscle & joint aches reduced after morning run / workout, though symptoms persisted at a lower level throughout that day. Felt fine by second day after vaccination.

0No event

Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection arm, swollen axillary lymph node in injection arm, swollen bump at injection site.

0No event

Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles as a result from pt's zoster vaccine live (ZOSTAVAX) use and was treated by a healthcare provider for shingles. The outcome of the event was not reported. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies.

4HOSPITAL

*SWELLING UNDER LEFT ARM BETWEEN SHOULDER AND ELBOW - MIGRATED TO ELBOW IN FOLLOWING DAYS - WENT AWAY AFTER A COUPLE OF WEEKS

0No event

Dose given 3 days past BUD. Consulted with CDC and Pfizer. There was no adverse event as experienced by patient - only the administration timing.

0No event

pt recvd vax 1430 & devel fever to 103 @ 1800, fever of 104.9 @ 1930;2000, had gen tonic sz lasting 3-4mins;brought to ER treated w/APAP/Ibuprofen completely recovered;

1ER_VISIT

After getting the shot, felt lightheaded, pulse raced, sweating, flushing of face. Since getting the shot I have developed allergies to everything including smells, sunlight, foods previously tolerated, heat, etc. I have now been diagnosed by a specialist with MCAS.

1ER_VISIT

Raised, reddened welt that is increasing in diameter on right arm. Warm to touch. Afebrile. Keflex started on January 15, 2015.

1ER_VISIT

Pt recd vaccines yesterday. Has fever today of 102F.

0No event

After 72 hours, terrible Migraine and cluster headaches started 24 hours a day non- stop since 2nd vaccine. With Dizziness, nausea & pain in stomach, left upper chest pains off & on, and high blood pressure(never had before)

0No event

c/o itching, hives, left arm swelling, warmth (L) hand swelling lip edema, sore throat. Methylpred 125 IM / Benadryl 50IM Ibuprofen 600mg PO.

0No event

Vaccine stored in an unapproved storage unit

0No event

Appendicitis that needed an appendectomy nearly 3 weeks after 2nd dose

2ER_VISIT, HOSPITAL

Ten days post vax, this child experienced a purpuric rash on her stomach and front portion of her thighs. She was given a 100 mg dose of ibuprofen. The pt remained afebrile and the rash was not itchy. On 06/15, the rash began to turn brown "resembling a purpuric rash." She saw physician for work up all of which were nml. The pt recovered. No further information is available.

1ER_VISIT

The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 20 September 2013. A medical assistant only administered the DTaP-IPV portion of PENTACEL. It was a vaccine underdose. No adverse event was reported. List of documents held by sender: none.

0No event

hospitalized with covid; fully vaccinated with 2 boosters

4HOSPITAL

Could be tendon pain; Short of breath when wasn't before; Sneezing; Teary eyes; Could be allergies; Chest anxiety feeling of; Pain goes into the shoulder too (left arm); Left arm is painful and everything hurts in that arm (left arm); Headaches for 2-3 days, never had before; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Could be tendon pain), DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes) and HYPERSENSITIVITY (Could be allergies) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma since 2000. Concomitant products included NETARSUDIL MESILATE (RHOPRESSA), BIMATOPROST (LUMIGAN), DORZOLAMIDE and TIMOLOL for Glaucoma. On 27-Mar-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021 at 5:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced TENDON PAIN (Could be tendon pain), DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes), HYPERSENSITIVITY (Could be allergies), CHEST DISCOMFORT (Chest anxiety feeling of), ARTHRALGIA (Pain goes into the shoulder too (left arm)), MYALGIA (Left arm is painful and everything hurts in that arm (left arm)) and HEADACHE (Headaches for 2-3 days, never had before). The patient was treated with IBUPROFEN (IBUPROFEN MAX) in May 2021 for Adverse event, at a dose of UNK UNK, bid. At the time of the report, TENDON PAIN (Could be tendon pain) and ARTHRALGIA (Pain goes into the shoulder too (left arm)) had not resolved, DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes), HYPERSENSITIVITY (Could be allergies), CHEST DISCOMFORT (Chest anxiety feeling of), MYALGIA (Left arm is painful and everything hurts in that arm (left arm)) and HEADACHE (Headaches for 2-3 days, never had before) outcome was unknown and CHILLS (Chills) had resolved. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains significant information-Patient demographics, therapy details of suspect product updated and outcome of the event Pain goes into the shoulder too (left arm) updated to not resolved.,

0No event

Error: Improper Storage (temperature)-

0No event

Fatigue, Headache, Chills, Nausea, joint pain began on Friday Jan. 1, 2021 symptoms started about 0800. All symptoms have continued through today Jan. 4, 2021. Taking tylenol 500mg for headache Symptoms lasted for 4 days

0No event

patient complained of tingling extremities (legs, hands and feet). She also complained of feeling slightly faint and dizzy. she did not pass out. She did not have shortness of breath or palpitations. She also felt weak. We had the patient lay down and elevate legs/feet. about 15 minutes after that she was feeling back to her normal self.

0No event

Fever, chills, nausea, and fatigue. Kept waking up during the night being hot or cold. The next day mild fever and chills, but still feeling fatigued.

0No event

gave 0.5 ml instead of 0.25 ml

0No event

This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates (either 17-SEP-2015 or 18-SEP-2015) the patients wre vaccinated with improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017; Lot # L014415, expiration date 25-JUL-2016; Lot # L013429, expiration date 21-JUL-2017) (dose and route of administration were not reported). No adverse effects or product quality complaint were reported. This is one of the three cases reported by the same source. Additional informtaion has been requested.

0No event

Feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 26th January 2021, the patient received the 1st dose of Shingles vaccine. On 27th January 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine in the afternoon of day before reporting date. The patient felt like crap now.

0No event

about a week after the second vaccine I had some arm pain and neck pain the neck and shoulder pain was and is still so bad I did go to my provider and they put me on muscle relaxers and 800 ibuprofen the pain is still there and sometimes very unbearable

0No event

Narrative: COVID infection, severe COVID pneumonia requiring hospitalization in a fully vaccinated individual

2ER_VISIT, HOSPITAL

Swelling and redness at injection site (Right deltoid muscle). Fever of 101 F. Treatment: Loratadine: 10 mg by mouth daily and Prednisone 45 mg by mouth daily.

0No event

Patient was under the age of 18 years when vaccinated

0No event

Patient with extreme nausea and vomiting that started soon after receiving the Moderna vaccine. Patient with loss of consciousness, diaphoresis and garbled speech during a foley catheter exchange thought to be from dehydration. Patient was admitted to Hospital for observation for 2 days

4HOSPITAL

second dose which has been given with 3 months apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HEPATITIS A VACCINE (HAVRIX). In January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15th Apr 2022 Reporter's Comments: The registered pharmacist reported that a patient received in January 2022 a second dose of Havrix which was given with 3 months apart instead of 6 months. The reporter consented to follow up. Additional Supportive Information: The patient received havrix 2nd dose earlier than recommended which led to shortening of vaccination schedule.

0No event

4th dose of HPV given in error.

0No event

pt started to get a fever around 10 pm that same evening that he had the vaccine, temp peaked at 4 am to 103.6 . pt reported feeling fine 8 am on 6/3/19

0No event

I received the vaccine around 1400 and about 20 minutes later I started itching and wheezing and having stridor, my throat and neck visibly swelled and I had hives on my chin, neck, chest, armpits, and arms that started spreading from my scalp to my toes, and I had mid sternal chest pain and was dizzy and cold. I took 4 doses of my albuterol inhaler on the way to the ED, received IV SOLUMEDROL, BENADRYL and PEPCID at first and 500ml bolus of saline, then received VESTARIL and PEPCID prescriptions for the following week. I was diagnosed with anaphylaxis and systemic skin reaction and the MD in the emergency department believes it was an additive in the vaccine this year. The CDC stated the only change was the addition of gentamicin. I was not sick at the time, and am not symptomatic with my asthma as a baseline. I rarely use my rescue albuterol inhaler, maybe twice a month. Over a week later, I am still wheezing, using my inhaler more frequently and reactive to temperature and allergic stimuli, I have not returned back to my baseline. I have asthma and anaphylaxis as my only medical history. I am allergic to KEFLEX, codeine, SINGULAIR and red wine products (which causes the anaphylaxis previously). I have never had a reaction to any other vaccinations. I have my flu shot yearly for the past six years with no reactions or symptoms. Thank you and let me know if I can provide any more information . I hope by doing this I can prevent it from happening to someone else.

1ER_VISIT

Headache, Chills, Body Aches, Fatigue, Soreness, Nausea

0No event

I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.

0No event

Pt. recieved DTAP and CHICKENPOX in L leg area on 6 Feb. 07. The area is warm to touch and appr. softball size. no c/o pain with pt. Pt does c/o itching. Pt was seen by provider and given instructions for what to look for in future and to return if condition worsens.

1ER_VISIT

Intense pain and then fainting with some jolting, lost bladder control. Chills, headache, nausea, intense stomach pain the next night.

0No event

HPV-4 was given to a patient instead of PPSV23.

0No event

Patient did not have any side affects or symptoms.

0No event

heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

0No event

pain began 1 day after receiving an influenza vaccination in his left shoulder; severe point tenderness at the deltoid muscle, generalized tenderness about the left glenohumeral joint; mild acromioclavicular joint osteoarthritis; osseous edema; Tearing of the posterosuperior and posterior glenoid labrum with a large paralabral cyst was noted; labral tear; negatively impact his daily life at work and when trying to sleep; shoulder injury related to vaccine administration; 3-month history of left shoulder pain; Initial information received on 03-Oct-2022 by physicianregarding an unsolicited valid serious case issued from a literature article: This case involves a 49 years old male patient who experienced shoulder injury related to vaccine administration (SIRVA) while receiving vaccine influenza quadrival A-B vaccine [fluzone quadrivalent] (latency: 1 day). On an unknown date, the patient received a 0.5 mL dose of injectable influenza, quadrivalent, preservative-free (11V4; Fluzone Quadrivalent, Sanofi Pasteur), with the site of injection documented as within the left deltoid. A pharmacist at a large retail pharmacy administered the vaccine as part of the Immunization Program. On an unknown date, the patient presented with a 3-month history of left shoulder pain (arthralgia). He reported that the pain (pain) began 1 day after receiving an influenza vaccination in his left shoulder. The patient's initial pain was significant for several days, improved slightly without resolving, and then progressively worsened during the next 2 months, prompting presentation to the emergency department (ED). He reported the occasional "giving out" of his left arm when crawling on all fours, as was sometimes necessary in his occupation as a heating, ventilation, and air-conditioning technician. The pain was worst with overhead movements, quantified by the patient as 6 of 10 in severity, and negatively impacted his sleep. The patient denied any associated neck pain, shoulder swelling, or redness. The patient endorsed a history of chronic left shoulder pain with certain overhead activities that he had had for several years but that was tolerable; however, his presenting symptoms were different in quality and severity. Physical examination findings on initial presentation were positive for severe point tenderness at the deltoid muscle, generalized tenderness about the left glenohumeral joint (tenderness), and diffuse pain with cross-chest abduction. Range of motion was full. Radiographs of the left shoulder obtained in the ED demonstrated mild acromioclavicular joint osteoarthritis (osteoarthritis) with otherwise no significant abnormality. The patient was discharged from the ED with prescriptions for naproxen 500 mg oral tablets and topical diclofenac-sodium 1% gel, as well as outpatient referral to orthopedic surgery. When the patient was seen in the orthopedic surgery clinic, he reported that the medications prescribed upon ED discharge had not improved his symptoms at all, and his symptoms were worse. He rated his pain as 8 of 10 in severity. Noncontrast magnetic resonance imaging (MRI) of the left shoulder demonstrated osseous edema (bone marrow oedema) within the posterolateral proximal humerus and humeral greater tuberosity at the level of the infraspinatus tendon insertion. Soft tissue edema was also seen within the teres minor tendinous insertion and subscapularis musculotendinous junction. Tearing of the posterosuperior and posterior glenoid labrum with a large paralabral cyst (synovial cyst) was noted. The initial MRI report listed metastatic disease as a differential diagnosis for the osseous findings, so whole-body bone scan was recommended to evaluate for additional regions of abnormal bone marrow. Technetium-99m- methyl diphosphonate whole-body bone scan obtained approximately 2 weeks following the initial orthopedic surgery consultation was negative for any asymmetric or abnormal uptake suspicious for malignancy. At a follow-up visit with orthopedic surgery following the shoulder MRI and bone scan, 4 months from the date of his influenza vaccination, the patient endorsed continued pain. Although he did not quantify the severity of the pain at this visit, he said it had continued to progress since the previous visit. The patient reported that his shoulder pain was never tolerable enough for him to participate in the physical therapy that was prescribed at the initial orthopedic surgery clinic visit. SIRVA was diagnosed based on the onset of symptoms relative to the influenza vaccination and the imaging findings. The team of treating physicians felt that the patient's longstanding, less-severe shoulder pain was attributable to the labral tear (cartilage injury) seen on MRI and potentially related to overuse or repetitive motion, given the patient's profession and no apparent history of inciting trauma. A therapeutic injection of 40 mg triamcinolone acetonide was administered via posterior approach into the subacromial bursa with the intent of providing symptom relief. Six months following the therapeutic shoulder injection, the patient reported no significant improvement in his symptoms that continued to negatively impact his daily life at work and when trying to sleep (loss of personal independence in daily activities). Action taken with vaccine influenza quadrival A-B vaccine: Not applicable for the event Shoulder injury related to vaccine administration. Corrective treatment: Naproxen, diclofenac sodium, triamcinolone acetonide for the event Shoulder injury related to vaccine administration. Outcome: Not Recovered/ not resolved for the event Shoulder injury related to vaccine administration. Seriousness: Hospitalization, disability for the event Shoulder injury related to vaccine administration. Reporter causality: Related for the event Shoulder injury related to vaccine administration. Based upon the reported information, the role of vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 10-OCT-2022: This case involves a 49 years old male patient who experienced shoulder injury related to vaccine administration (SIRVA) while receiving vaccine influenza quadrival A-B vaccine [fluzone quadrivalent]. Based on information received, the causal role of VACCINE cannot be excluded in the occurrence of the event due to compatible temporal relationship of ADR to the VACCINE. However, information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case.

4HOSPITAL

This spontaneous report as received from a Licensed Practical Nurse refers to a 13 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:

0No event

This spontaneous report has been received from a pharmacist via company representative referring to a female patient of unknown age. On approximately 24-Oct-2015 (reported as about a month ago) the patient was vaccinated with ZOSTAVAX (route and lot# not reported), 1 vial at unspecified time. The pharmacist learned in an unspecified way (either phone call or a visit back to the pharmacy by the patient,) that the patient started experiencing pain at an unspecified time, on the day the ZOSTAVAX was administered. The patient reported that she was having pain in the unspecified arm that she received the vaccine. The patient was still in pain at the time of reporting (24-NOV-2015). The causality was not reported. Additional information has been requested.

0No event

rt arm bright red, 4inches in diameter inj site slightly raised 1/2inch; very painful, sore mass, malaise, +1 edema

0No event

Information has been received from a consumer concerning her daughter who was vaccinated with the third dose of GARDASIL. Subsequently the patient experienced mononucleosis. the patient sought unspecified medical attention. No further information is available

1ER_VISIT

Fever; Chills; I couldn't Sleep; This is a spontaneous report received from a contactable consumer (Patietn). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), Solution for injection, via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:00 (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal. Patient historic vaccine included first dose of BNT162B0 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot: Not reported), Solution for injection, via unspecified route of administration, via unknown route on an unspecified date as single dose for COVID-19 immunization. On 23Feb2021, the patient experienced fever, chills and couldn't sleep. The patient underwent lab tests and procedures which included body temperature: 103, 102 and 101 on 23Feb2021. It was reported that, yesterday she received her second dosage of Pfizer vaccine. First one was okay for her, it was a little arm pain, but yesterday was terrible for her. She got the shot at 11 O'clock at the daytime, she was fine she was able to work. She worked from 3 to 11 but when she came at night like 11 in the evening, she came home took her shower yesterday started to chill and whole night she couldn't sleep. She had fever 103; 102; 101 and she couldn't even sleep. Her complaint was chills and fever whole night today. At that moment, at the night time she didn't take anything (did not take any treatment) she took a shower thought it is going to help her. The events were recovered on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.

0No event

VACCINE WAS INEFFECTIVE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter indicated that the patient felt vaccine was ineffective (dose number in series 1) and stated she did not have anything left to boost- referring to the level of protection that remained from Janssen vaccine. On 01-NOV-2021, the patient additionally received Moderna vaccine (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported for prophylactic vaccination. It was unknown if the patient had any adverse events after Moderna vaccine (dose number in series 2). The reporter stated that she heard the vaccine was only good for 2 months and was concerned about patient for the level of protection against COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was ineffective was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214573. This case, from the same reporter is linked to 20220160825.; Sender's Comments: V0: 20220160740-covid-19 vaccine ad26.cov2.s- Vaccine was ineffective. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

0No event