chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered the fluzone quad (prefilled) that expired in june 2023 with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who administered the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] that expired in june 2023 with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of a 0.5 ml of suspect Suspension for injection of INFLUENZA QUADRIVAL A-B VACCINE (prefilled) (strength: standard) (lot UT7744JA, expiry date: 30-Jun-2023) via intramuscular route in the left arm as prophylactic vaccination (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Numbness on the right side of the face after 8 minutes. it lasted for 10 minutes before it subsided and then it happened again  ten minutes later. I have felt the after effects on the side of my face since then. My teeth hurt and after effects of numbness.  Also, 102 temp two days after injection and very painful  arm on the injection side.
patient received a third dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient received a third dose of Menveo). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter consented to follow up.  The reporter reported that a patient received a third dose of Menveo, which led to extra dose administered.
In February 2021 I had a weekend of right flank pain that I did not seek medical care for and the pain spontaneously resolved over a few days.  I was admitted to a local Medical Center in late October 2021 after a scheduled primary care visit showed a hypertensive crisis and the ensuing inpatient workup showed I had no coagulopathy and no findings of a COVID infection (acute or prior).  A CT angiogram done 11/2021 showed the acute bilateral renal artery branch thromboses, acute ischemic areas in both kidneys and old infarcts in the right kidney.  I was treated by Internal Medicine, Vascular Surgery, and Nephrology and I believe Hematology was consulted as well.  I was found to have thromboses of branches of the right renal artery (areas of old infarct) and severe hypertension (220/110's) and additional thromboses of  branches of the right and left renal arteries.   I now take 2 antihypertensive medications (Losartan and Nifedipine) which I had previously did not)  and Eloquis for anti thrombotic treatment for an unknown timeframe.  After evaluation and consultation and literature search my physicians informed me that they believed that the thromboses were from the vaccine as no other cause was identified, and the mRNA vaccines are known to have this as a risk.
Progress Notes Healthcare Provider Cosign Needed Expand AllCollapse All        Subjective Patient is a 56 y.o. female who was seen at healthcare facility today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and hot. Patient has a history of multiple sclerosis and complained of a weakness in her legs that she experiences during her flares. She does mention having to be on 2L oxygen at times when she has a flare. O2 is 100% at rest today. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling.   This provider was notified of patient reaction and she was then assessed.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and increased weakness.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches       Previous Reactions: Denies reactions to prior vaccines    Objective    Vitals Vitals:   03/24/21 1202 03/24/21 1219 03/24/21 1232 BP: (!) 155/92 (!) 145/78 136/76 Pulse: 86 79 80 SpO2: 100% 100% 100%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling of lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: Water and lying patient in trendelenburg position. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)
Patient was having seizure symptoms within 10 mins of receiving his first dose of the COVID-19 Pfizer vaccination. 911 was called immediately and while the EMS was arriving to the scene patient was starting to feel better. There was no reports of any signs of trouble breathing. EMS arrived on the scene and assessed the patient. Patient refused to go to the hospital with the EMS and reports to be feeling fine. Recommendations to follow up with a physician was advised.
Pt had first flu shot on 10/13/18. Second flu shot was given to pt on 10/18/18.
Pt reports last night noticing redness, swelling to L upper arm today 12/22/02 L deltoid is very swollen, red and warm 4x4 area of swelling and redness present-administered Benadryl 50mg po apply heat and f/u this week.
Patient was given her 1st dose of VARIVAX on 8/13/13 in the left thigh and the next morning about 3:00 AM the mother noticed a rash at the injection site and the other thigh (i.e. right) which patient was scratching.
Weakness; Fatigue; Chills; Bones and muscles hurting to the point he couldn't get out of bed; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, RABEPRAZOLE SODIUM (ACIPHEX) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). On 24-Jan-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 3 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK, Every 3 hours. On 31-Jan-2021, PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) took 3-4 months to recover.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021 contains non-significant information. Patient demographic was updated.
Patient complaint of nausea 2 minutes after Moderna  Vaccine 2 dose.
pt recvd vax; exp shortness of breath & pressure on chest -> 5 hrs; swelling of eyelids->48 hrs;pt states used to be allergic to eggs;presently eat eggs but has mult allergies;
My arm got very sore later in the day and continued for a couple days. Shortly after my elbow and forearm area started hurting. It?s still bothering me.
Client remained in office 30 Minutes post vaccine feeling well without complaints of dysnea. Client states that as she was driving home, she felt her throat itching and felt her throat closing up.  She had liquid Zyrtec in her car she took it and felt better several minutes later. Did not notify anyone of this event.  She also stated that she does carry an epipen but did not use it because she did not want to go to the hospital. she also mentioned that she has a peanut allergy-but did not write it down-She can react to aerosolized egg and peanuts. She mentioned this respiratory event, when I followed up with her regarding another issue the next day.
My 15 minutes ended at 12:22p. About a couple of minutes I started feeling effect. First I felt dizzy, then like I was going to pass out so I sat down.  Afterwards, I went to another office because our lobby was full and I didn't want to draw attention to myself.  My coworker was watching me.  My head and hands both became clammy.  Then my coworker said my eyes were really red.  Then she said my face turning red.  She grab one of the workers and they took my blood pressure.  I had gone to a surgeon the day before and my blood pressure there was 92/68.  During 3/31, my blood pressure was like 113/98.  Then they took my temperature and I had a fever.  I didn't have trouble breathing or chest pain but they brought me to a healthcare facility.  There they watched me for about an hour and a half and gave me an EPI pen.   My symptoms of headache, nausea, chills, fever, muscle aches, inability to sleep for more than 30 min have continued since 3/31 minus a few hours on 4/7.  The most constant symptoms are headache, nausea, chills and then the other symptoms come and go.  For example today, I have headache, nausea, chills and then I spiked a fever even though I am taking Advil and Tylenol to help with the headache.  Also today, in addition to feeling hot, my palms of my hands are hot.  Last Thurs and Sat in addition to the headache, nausea, chills I was fatigued to the point where I slept 14 hours on Thurs and 16 hours on Sat.  Another symptom that I have is on my injection arm.  Occasionally it will hurt from my middle finger to my collar bone.
Oral thrush; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left arm, on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Patient's relevant medical history was reported as no. Patient did not have COVID prior to vaccination. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; and an unspecified BP med;  all these as other medications in two weeks. Patient did not have any other vaccines in 4 weeks. The patient historically took first dose of BNT162B2 (lot number: Ek9231) intramuscular on the left arm, at age 63 years, on 19Jan2021 at 08:30 AM for COVID-19 immunisation. Patient previously took paracetamol,  tramadol hydrochloride (ULTRACET) on an unspecified date and had known allergies. The patient experienced oral thrush on 15Feb2021. AE treatment was an antifungal mouth wash. Facility type vaccine was at a hospital. COVID was not tested post-vaccination. The outcome of the event was recovering at the time of reporting.   Follow-up attempts completed. Information about lot/batch number cannot be obtained. No further information expected.
Itchy Sensation Near the Injection Site; Discomfort near injection site; Swelling near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort near injection site), VACCINATION SITE SWELLING (Swelling near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation Near the Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort near injection site) and VACCINATION SITE SWELLING (Swelling near Injection Site). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation Near the Injection Site). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort near injection site), VACCINATION SITE SWELLING (Swelling near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation Near the Injection Site) had not 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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
I had a sore arm for about 3 days after the initial injection. However one week later the injection sight turned red and developed a rectangular rash. It had a bump and was hot to the touch. The whole arm hurt and my arm pit and right side felt swollen and sore. Then it started to itch. Friday night, March 05, it was so painful that I couldn?t sleep most of the night and this was after taking Tylenol and Benadryl.   This started on Thursday March 04 and went on for 4 days.  I went to a Primary care on March 05 and saw a nurse practitioner.  She looked at the arm and said it was cellulitis, which can occur after an injection or giving blood.  She prescribed antibiotics and I asked for Benadryl for the itching.  She said I could take Tylenol for the pain.
Breakthrough case admission after 3 vaccines Pfizer 5/12/21 Lot# Ew0083; ' Pfizer 6/1/21 Lot# Ew0191;  Pfizer 11/16/21 Lot# FF2590
Very faint, small areas of macular eruptions over his upper trunk: injection site appears indurated, but no signs of obvious cellulitis. Benadryl given for itching or discomfort PRN Temp 99.2 degrees
After booster shot of Moderna: headache, muscle pain, fever ,SWELLING LIPS(I received a filler on lips 2 months ago before the booster shot).  The third day I am taking claritin, I plan to visit a doctor or go to urgent care, because after 3 days there is no improvement
Severe burning in back, toes and eyes.   Severe body pain.  Vomiting
expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given to patient) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     The patient's past medical history included Lattice degeneration of retina and Peptic ulcer. Concurrent medical conditions included Coronary artery disease, Diabetes, Hypertension and Hearing loss.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2022 at 10:05 AM, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 04-Mar-2022 at 10:05 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   The patient received a dose of the Moderna COVID-19 vaccine from a vial that was past 12 hours of first puncture. The vial was punctured on 3MAR2022 at 9:15 AM and the dose was administered on 4MAR2022 at 10:05 AM.  No treatment information was provided.
Headache; Muscle Pain; Exhaustion; Nausea; This Spontaneous report from contactable other health care professional (patient).   A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9269 and expiry date was not reported) via an unspecified route of administration, on an unspecified date (at the age of 42-year-old) a dose number unknown, single of COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient had not received any other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. On 12Feb2021 patient experienced Headache, Muscle Pain, Exhaustion, Nausea. Patient had not received any treatment for the events reported. outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
w/in 48hr of vax pt devel an inj site rxn described as cellulitis;pt was treated w/DPH & recovered; this is 1 of 3 pt from this site to devel an inj site rxn p/vax;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a health professional regarding multiple unspecified patients of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L030868, expiry: 09-JUN-2018), (incorrect product storage). No concomitant medications were reported. The improper storage temperature was 31.9 degrees Fahrenheit for a time frame of 23 hours and 30 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Flu-like chills, fever over 101 F, weakness, cough, racing heart.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little pain in arm after second shot". Additional information: She got the first shot and had no problems. The second shot she had a little pain in her arm. 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) : US-PFIZER INC-202101796320 Same patient and drug, different event separated in time.
This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot#EW0181), via an unspecified route of administration, on Jun 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient stated 2 days before the day of report, he developed a pretty severe arm ache in his left shoulder and in his upper arm that radiates to his hands. He also added he experienced injection pain, two and a half weeks before. He wanted to know if this was a side effect of the vaccine. The patient had a really sore shoulder and it kind of radiated down his arm (pain). This was actually bad enough that he went to the ER that morning. He thought it was just some really tight muscle. They gave him a unspecified muscle relaxant, which just was not working. So, he is just curious if there has been any reported very sore shoulders as much as over 2 weeks after the initial injection. The patient did not think this was a side effect of the vaccine. His second dose due on Jul 7, 2021. Therapeutic measures were taken as a result of the events; with outcome of unknown. No follow-up attempts possible. No further information expected.
itching, redness Narrative: redness and itching at vaccination injection site visit 1 week after injection. symptoms lasted 24 hours
Mom reports child has pea-size "knot" on (Lt) leg at injection site. Denies redness or warmth to touch. Afebrile. Mom states it was first noticed sometime last week, but she doesn't recall when.
This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative. A 28-year-old female patient received TRUMENBA, (Lot number and expiration date were not reported), with route of administration, on the left arm on 26Jul2018 at a single dose for immunization; and MENACTRA, (Lot number and expiration date were not reported), with route of administration unspecified, on 26Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2018, the patient had site reactions of hot, swollen and red; could not move arm; and received meningococcal group b rlp2086 at 28 years old. The outcome of the events was unknown.
Red, raised, fluid-filled spots on chest, back, face, hands, hair. Very itchy; elevated temperature. Duration 2 days.
Patient stated that she had" a red 4 inch lump that was hot feverish that is painful" she also said her shoulder was in pain. I told her to contact her physician if the pain doesn't go away
(R) thigh 3 cm erythema, slightly indurated. Conservative tx (cool packs, TYLENOL PRN). F/U instructs for need to return to clinic. Area marked with skin scribe.
muscle sore at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After first dose of vaccine the patient experienced muscle sore at injection site on 25Feb2021. The outcome of the event was unknown.  Information about batch/lot number is requested.  Follow-up attempts are completed. No further information is expected.