chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered an expired dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date 27-MAY-2023) for prophylaxis.   On 27-OCT-2023, the patient received the 1st dose of Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 The pharmacist reported a patient was administered an expired dose of Shingrix which led to expired vaccine used. The reporter consented to follow up.
Red puffed swelling at shot site. Tender to touch, and also warm to the touch. Starting to get itchy, also tingles when getting goosebumps.
immediately after the vaccination, for both doses, there was a significant sensation of pressure in chest that lasted approximately 3-5 minutes, then went away.; No other side effects other than a sore arm; This is a spontaneous report from a non-contactable consumer,  A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on 20Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and experienced significant sensation of pressure in the chest that lasted approximately 3-5 minutes, then went away. On 20Apr2021 immediately after the vaccination, the patient experienced a significant sensation of pressure in the chest that lasted approximately 3-5 minutes, then went away. There were no other side effects other than a sore arm. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant sensation of pressure in the chest that lasted approximately 3-5 minutes was recovered on 20Apr2021, while the event sore arm was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Received shot on the 5th. - Friday On Saturday I started noticing my heart rate increased and my BP was up. Then it seem to go away. Then Sunday while at church I felt like it was acting up. By Sunday evening my BP and heart rate were jumping all over. The highest was BP 196/91 with a heart rate of 130. Like I said it was going up and down. I considered calling 911 but a nurse suggested I just monitor it as they would not do anything at the hospital but monitor me.  On Monday I stayed in contact with my cardiologist and these symptoms lasted till Wednesday morning. Since then everything has been great. I know they say the second dose is worse when it comes to reaction and part of me DOES not want to get the second dose. I have a Defibrillator / pacemaker and am starting to question the real need of this shot. Thank you
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced lung swelling and pain on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
RECURRENT FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 09-APR-2021, the subject experienced recurrent fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent fever. This report was non-serious.
Tested positive for COVID-19 virus after all three doses of the vaccination. Received antibodies infusion on 11/24/2021.
covid, 2months after 2nd vaccine May2021; covid, 2months after 2nd vaccine May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 14:00 as dose 1, single (Lot number: EZ9266), in left arm and on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OSA", start date: 01Jan2012, stop date: 01Jan2020, notes: Illness/AE: OSA Mild with CPAP occasional use, Pertinent Details: Borderline; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Illness/AE: Urethral Fascia sling repeat removal, Pertinent Details: Sling Broken in muscle; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019; "CPAP", start date: 01Jan2012, stop date: 01Jan2020; "vaginal atrophy" (ongoing); "Asthma" (ongoing); "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "covid, 2months after 2nd vaccine May2021". Clinical course: The patient had Covids, 2 months after 2nd vaccine May2021 the approximately every 6 month from May2021 until Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Pt recv vax on 4/8/99; on 4/9/99 pt exp progressive facial & throat swelling-angioedema
Patient's mother reports a trip to the ER within 24 hours of vaccination due to soft ball like bump at the injection site. This bump is swollen, red, and hot to the touch. Pt also had fever. She was given antibiotics, and MD said it was infection secondary to the immunization. Culture still pending. What type of infection not known.
Pt recv vax on 10/8/97; immediately post vax pt exp asthmatic episode, rash of upper body/ face; tx=Albuterol (3), Benadryl
Per mom, baby has pink splotchy rash to neck and chest after rec vaccines 9-15098.
05/29/2005-Urticaria over the face, trunk and abdomen. Lasted until 06/02/05. Seen in ER, given Benadryl liquid PO PRN. 06/02/05- Mom reported mild diarrhea.
Immediately following vaccine became very weak, faint, nauseous, clammy / sweaty. Concerned I was going to pass out and it felt like a severe panic attack. This lasted about 30 minutes - it subsided and I felt normal again about 1 hour after injection.  About 8 hours after vaccine began to get muscle / joint aches and fatigue. This progressed into chills / low grade fever overnight. The next day I felt extremely fatigued and chilled, was unable to work and look at screens for extended period of time. Chills subsided the following evening and were replaced by headache.   The following day (day 2 after vaccine) was still foggy and fatigued but did not feel actively ill. Fog began to lift by that evening (48 hours post-vaccine) and now feel normal again.
Feeling like drugged; feel sick; Feeling unwell; Feel very tired and very weak; I could not drive; I feel terrible; Joint pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 63-year old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included schizoaffective disorder bipolar type from an unknown date and unknown if ongoing Schizo-affective Bipolar  disorder 1  Diagnosis date: have it for "30" (not clarified) years, think from 1993 or 1994 , diabetes mellitus from Apr1998 to an unknown date Verbatim: Diabetes type 2 , hypothyroidism from an unknown date and unknown if ongoing. Low Thyroid    Diagnosis date may be in September 1999. The patient's concomitant medications were not reported. The patient experienced feeling like drugged; feel sick on an unspecified date with outcome of unknown, feeling unwell causing malaise on an unspecified date with outcome of unknown, feel very tired and very weak, could not drive; feels terrible causing asthenia on an unspecified date with outcome of unknown and joint pain causing arthralgia on an unspecified date with outcome of unknown.  No follow-up attempts are possible; No further information expected .
I did not have an adverse reaction to the vaccine. In 12/2022, I was diagnosed with non-Hodgkin's lymphoma. I am in treatment now.
Pt was administered both Proquad and Varicella vaccines on 8/14/23 .  Provider ordered both vaccines. The MA did not catch that Varicella is in the Proquad vaccine.  MA contacted Merck on 8/24/23 to report and gather data regarding double varicella vaccine. Parent was contacted  8/24/23 about double vaccination with Varicella vaccine and given the information provided by Merck.  Per Merck, "the risk for an adverse event might increase when extra doses are administered at an earlier time than the recommended interval for certain vaccine." Parent reported on 8/24/23 the child was 'wiped out' for a couple of days after receiving the vaccines.  No injection site reactions. No fevers.  No rashes on the body.
Severe shoulder and under arm pain. It is difficult to use it or get dressed with out pain.  I wii see my Doctor on December 3rd to address issue.
Could not sleep at night because of pain; Itching in the afternoon; Swelling last night; Pain in the area of injection/if she touches it there is no pain, but only the sensation; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep at night because of pain), VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. N/A, N/A and N/A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia and Cataracts.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced INSOMNIA (Could not sleep at night because of pain), VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation). On 23-Aug-2021, VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation) had resolved. At the time of the report, INSOMNIA (Could not sleep at night because of pain) outcome was unknown.            Concomitant medications were not provided.  Treatment medication was not provided.
24 hours post vaccine I broke out in hives all over my arms and legs. Responded to Benadryl and Zyrtec. 24 hours later I broke out again in hives all over my arms and legs and Benadryl and Zyrtec once again relieved the symptoms. 24 hours later I again broke out in hives, which responded to Benadryl. I have no allergies and have never had an allergic reaction in my life. I have eaten nothing new nor been exposed to anything new - my routine has been the same since before the vaccine.  I did not have an allergic reaction immediately following the vaccine. The reaction is only cutaneous with no difficulty breathing but has happened for 3 days in a row.
03/08/2021: Baseball size bright red circle at site of injection. Severe pain from the 2nd day that lasted 1 week. Swelling (A lump) at the injection site. Extremely itchy since 03/4/2021 and itchy currently
This case was reported by a consumer, via Merck, and described the occurrence of shingles in a 52-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medications include Levoxyl, Singulair, Zoloft and Advair.  On an unspecified date the subject received an unspecified dose of Flu vaccine.  One week after vaccination with Flu vaccine, the subject experienced shingles.  The subject reported that she believes that the flu vaccine caused her shingles.  The subject sought medical attention and had an "office visit".  At the time of reporting the outcome of the event was unspecified.
This spontaneous report was received from a female consumer referring to her 18 year old. The mother of the patient called to question the probability of any adverse effect for her son, who had received a fourth dose of GARDASIL, after already having the third and final dose. A misuse was also reported within this same case, for the same patient, due to the fact that this patient received the first two doses at the recommended times and the third dose two months after the second. No adverse effect was reported with the misuse. The third dose of GARDASIL was received in November 2012 and the fourth dose was received in August 2013. Additional information is not expected.
Cough; Vomiting/throwing up; Nausea; Fever of 101; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 66-year-old female patient (reporters wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date of vaccine was not provided), via an unspecified route of administration, on Friday morning 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date in Jul2021, the patient had experienced vomiting, nausea, fever of 101 and headache. On 24Jul2021, (Saturday) she also experienced a cough. Reporter wanted to know if this was typical after first dose. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in Jul2021. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Information has been received from a consumer concerning a 60 or 70 year old female who was vaccinated SC once with a 0.65 ml dose of Zostavax (Oka/Merck). The reporter stated that "her friend told her that she had heard of another person who died after receiving Zostavax (Oka/Merck)." The reporter stated that it was unknown whether the death was related to vaccination, and the reporter noted that she did not have complete adverse information. Additional information is not expected.
Information has been received from a nurse concerning a 35 year old female with allergy to nortriptyline and no pertinent medical history who on 03-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX (lot # 662662/0979X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed swelling, redness and tenderness at the injection site. The patient was recovering from swelling, redness and tenderness at the injection site. No lab tests were performed. The patient called the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 2 patients. This is 2nd of 2 reports. An 11-12 year-old patient (child) patient of an unspecified ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose into the thigh muscle on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was administered TRUMENBA into the thigh muscle instead of the deltoid because the patient had less muscle mass, and experienced a larger local reactions compared to the older children given TRUMENBA in the deltoid with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017266468 same reporter, different patient, same drug/events.
body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159/110; chills; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left shoulder/deltoid left on 20Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing hypertensive diagnosed four years ago. Concomitant medications the medication that she took for her blood pressure. The patient took first dose Covid 19 vaccine two days ago. She started feeling chills on 20Jan2021 and body aches on 21Jan2021. The patient stated two days ago that she had heart palpitations that speeded up to 159/110 all day on 20Jan2021. She was a hypertensive person and her blood pressure will go up. She was told there would be risks. She wanted to know if she should take the second dose on 10Feb. Wanted to know if something will happen to her if she took it. The chills lasted only two hours. The body aches stopped at 5PM. She had heart palpitations with activity and only lasted for 24 hours. The patient had none while laying down. No treatment was received. Outcome of the event chills was recovered on 20Jan2021, of the events body aches and heart palpitations that speeded up to 159/110 was recovered on 21Jan2021.   Information on the lot/batch number has been requested.
Awoke at 0400 c/o headache, weakness, and severe chills.  Temperature not taken because skin felt cool.  Mother called this Am reporting s/s.  Encouraged to take temperature. Reported to be 101.8 at 1130am, headache,weakness remain.  Client took 1000mg of Tylenol during the night and again at 1130am.
patient got the J and J COVID Vaccine today at our clinic.  While patient was waiting her 15 minutes before she could leave she started to feel light-headed.  She flagged us over when we got to her she became unresponsive.  We laid her on the ground, elevated her feet and within 30 seconds she aroused without any deficits.  She remained with us for another 30 minutes with any further complaints and was OK to go home
Information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning an 18 year old female who on 18-SEP-2007 was vaccinated with GARDASIL vaccine (yeast) IM in her left deltoid (lot number 1061U). The patient received her injection on 18-SEP-2007 at 10:59 am. The patient called at 5:39 pm and stated the injection site itched, bumps appeared going down her arm that itched, she had swelling and pain at the injection site and she ran a slight fever. The patient took diphenhydramine hydrochloride (Benadryl) 50 mg po and the symptoms resolved (2007, exact date not reported). Additional information is not expected.
Sore arm at injection site. Muscle ache, headache, chills. Started approximately twelve hours post injection. It's now 11:30am and feeling somewhat better (no chills although other symptoms persist to lesser extent). Had similar but more severe symptoms after first dose administered in Oct, 2018.
The patient tested positive for COVID on 7/15/2021 after being exposed to family member(s) that were also positive. He came to the hospital on 7/19/2021 with symptoms of shortness of breath, hypoxia, and dyspnea.
Information has been as received from a nurse concerning a patient of unknown age and gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown date that was after 22-AUG-2013, the patient was vaccinated with PNEUMOVAX 23 (lot# 0492AE, expiration date 22-AUG-2013) (strength, dose, frequency and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported. Additional information is not expected because no consent was given for the follow-up.
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's illness at vaccination was otitis media. The pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 9 lbs and 2.5 oz. The patient had 2 sisters. Concomitant therapies included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion did not occur as a result of digital data logger)) (Product storage error) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event).The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513: US-009507513-2206USA007524:
Hives one hour after immunization. No breathing difficulty. Next day, swelling in area of injection with erythema.