chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 103 for several days, swollen and deep red arm from injection site all the way down, extreme weakness headaches broke out in hives from my sculp all the way to my toes, trouble breathing. I took ibuprofen and Tylenol, OTC cold meds and pretty much just suffered for a good 7 days after both shots.
GENERALLY FEELING AWFUL; BODY ACHES; SOME CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced generally feeling awful, body aches, and some chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, some chills and generally feeling awful was not reported. This report was non-serious.
This spontaneous report was received from a certified medical assistant and refers to 12 patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored (temperature: 34 F for a total time of 65 hours) doses of ROTATEQ (lot# reported as L033543, expiration date: 30-MAY-2017) orally, dose was not reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number FX77G, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced allergic reaction to a GlaxoSmithKline Flu vaccine.
Fussiness & fever to 103, inc to 104 w/cont crying @ 7PM 13AUG; adm to hosp 14AUG w/t106.1, szs; hosp 1 wk w/congestive heart failure;
Information has been received from a consumer concerning a 4 year old female with an allergy to penicillin and no pertinent medical history reported who in June 2002 was vaccinated SC with the first dose of MMR (dosage not reported). There were no concomitant medications reported. On an unspecified date in 2002, at 2 years of age the patient developed Asperger's syndrome. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the Asperger's syndrome. Upon internal review, the Asperger's syndrome was considered to be an other important medical event (OMIC). Additional information is not expected.
68yo lady admitted with acute on chronic hypoxic and hypercapnic respiratory failure admitted yesterday with worsening SOB after a couple of recent hospitalizations for H. Influenzae PNA c/b bacteremia and psoas abscess that required drainage and abx therapy beginning on 1/20 to 3/1. She tested positive for COVID-19 on admission.
Patient vaccinated 4/19/2021.  Patient became immobile 4/30/2021.  Patient died 5/9/2021.
Slight fever and swelling at injection site w/in 3 days of vaccination. More swelling and spreading redness by 3/6/12.
4 hrs p/vax had sz like activity where stiffened up, arched back, twitched arms x 30 sec; then was listless & afraid to be on back; mom has 2 other children & have had no problems;
Patient experienced swelling and soreness around injection site. It started 2 days after injection was given. Recommended ice, naproxen, and BENADRYL as treatment. I examined the area 1 week after injection. It was slightly improved but still red and swollen.
This case was reported by the mother of a consumer and described the occurrence of fever in an infant male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Rotavirus vaccine. A physician or other health care professional has not verified this report. There were no concurrent medications. On 25 March 2011, the subject inadvertently received an extra dose of PEDIARIX and an extra dose of unspecified rotavirus vaccine. It was additionally reported that the subject had received an extra dose of unspecified rotavirus vaccine at 5 months of age. Four total doses of each PEDIARIX and rotavirus vaccine had been administered to the subject. Rotavirus vaccine at 3, 4, 5 and 6 months and PEDIARIX in November 2010, December 2010, February 2011 and again on the day of reporting, 25 March 2011. The mother additionally reported that her son experienced fever following every vaccine administered. No specific details were provided. At the time of reporting the outcome of the events was unspecified. No additional events were reported. The mother stated that she believed her son was supposed to have gotten Hib and pneumococcal vaccine on 25 March 2011, but he did not. Follow-up information was received via physician who reported that the mother of the subject denied any adverse reaction. The subject "had a tiny subcutaneous bump on the site of injection which disappeared in two days".
Patient was informed afternoon of 09/04/2017 that they noticed her face / cheek swelling. Patient called Pharmacy staff 09/05/2017 approximately 1 pm informing staff pharmacist, her face has swollen significantly. She was advised to take BENADRYL. Patient called approximately an hour later and I spoke to her advising her to take BENADRYL, take her body temperature. I asked her if she was having difficulty breathing. The patient replied no and sounded very alert and coherent. I informed her I would call her 6 hours later and ask of her condition. I spoke to patient approximately 6 hours later. She informed me she was doing much better and her swelling improved with only 1 BENADRYL. I informed her the proper dose for allergic reactions was two capsules 2-3 times daily. I informed this was a sedating dose. I asked her to take two capsules tonight and if she woke up next morning completely cured to take another dose to be safe. If her conditioned worsened to call us or her doctor.
Pt had redness and swelling at injection site. Went to local emergency room for evaluation. Discharged with no treatment necessary. Plans to follow up with own doctor.
Prolonged crying >6 hours, fever to 102.6 and vomiting.
Face, neck and upper chest was red, swollen, itchy and hot for over a week.  This happened with both doses 1 and 2, but not with my booster.
Pt rec'd 1st COVID Vaccine (Pfizer) on 4/07/2021. Reports he had symptoms of fever / chills on 4/8 - then developed  loss of smell and a stuffy nose. Had  COVID test 4/12 and it was positive.
Contracted COVID-19 virus after being fully vaccinated. I had to get the antibiotic infusion.
Pt recv vax on 12/2/98; on same day pt exp red/ hot/ swelling of Rt Leg vax site; tx=Tylenol, rest, ice
Before administering vaccine patient asked to lay down for shots for fear of needles. After giving vaccines patient sat up looked i felt fine, stood up and proceeded to walk out of room. I was talking w/ patients sister when she hit wall /side down but stared conscious she was dizzy stayed for 15min drank juice and felt fine upon leaving clinic.
Broke out in huge hives 36 hours after vx. Called an ER and was encouraged to take Benedryl. Took for a few days and it helped a little. Called her Dr. and was prescribed Prednison
The day after taking the second dose, my hands started getting numb and asthma started. I had to call my Pulmonologist and when I was in the office I couldn't move or breathe. The doctor took me to the hospital, I was in intensive care for one week, I could not move from the neck down. I came out of intensive care. I was in hospital for a week, then I was in rehabilitation center for almost a month. I was discharged and taking therapy and I still have sequela. Currently I use a cane.
I feel like I'm fighting a cold, mild sore throat, fatigue, anxious, some diarrhea, nausea.  It started after my flu shot 9/20 and is continuing after my covid booster 9/24.  I had the same reaction for 2 weeks  after my 1st covid shot 2/23/21.  I'm taking antihistamines and 4 mg ondansetron for the nausea.
Pt. was given varicella vaccine on 3/22/99.Pt. developed chickenpox on 12/6/99.
Patient rec'd flu vaccine on 3/11/16. At apt on 3/31/16 patient reported left arm pain since vaccination. Pt was instructed to use warm compress.
head cold; nose congestion; This is a spontaneous report from a contactable consumer (patient) and Pfizer sponsored programmer. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Apr2021 at single dose for COVID-19 immunisation at the age of 47-year-old. Medical history and concomitant medications were unknown. The patient experienced head cold in the last two days. The patient had nose congestion. The patient had no fever, aches, no loss of smell or taste, and nothing in her throat. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Patient came in for second COVID-19 Pfizer Biontech vaccine on 5/21/21. Patient stated 5 days after receiving the first dose, he experienced severe chest pain for 2.5 days and experienced chest tightness and was in pain. Patient did not seek any medical attention and the pain went away after 2.5 days. We have not seen reports of this adverse event, therefore, did not provide the second dose of the vaccine and recommended the patient to follow-up with their PCP before receiving the second dose.
ACUTE PERICARDITIS, UNSPECIFIED  7/16/2022 &  9/18/2022  --  RECURRENCE OF SAME SYMPTOMS
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX QUADRIVALENT. In September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The case was one of the 7 cases reported for adverse events experienced by the 7 patients vaccinated with FLUARIX QUADRIVALENT, at the same facility. This case is regarding the patient who experienced more than usual redness and swelling at injection site. The cases reported for other 6 patients were US2015137455 and US2015137458 (anaphylactic shock), and US2015137461, US2015137462, US2015137463 (redness and swelling at injection site) and US2015137460 (full body rash). There were many employees were vaccinated at the same facility with the FLUARIX QUADRIVALENT, among them 7 patients experienced events.
This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 19-year-old female patient who received MENVEO (batch number AMVA036A, expiry date 1st October 2019) for prophylaxis. On 11th December 2018, the patient received the 1st dose of MENVEO (intramuscular). In December 2018, less than a week after receiving MENVEO, the patient experienced injection site cellulitis. The patient was treated with doxycycline. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to MENVEO. Additional details were reported as follows: This case was reported by the risk Manager of University. The patient received MENVEO on the left deltoid. On 17th December 2018, the patient was seen by a physician due to cellulitis in the deltoid. The physician had prescribed doxycycline 100mg twice daily for 10 days. On Thursday, the patient was called back with an update. The patient required an emergency room visit. The contact details of the physician was provided.
A nurse reported the occurrence of Zoster type rash in an 11 y.o. male who was vaccinated with Hep B vaccine Recombinant (Engerix-B) for prophylaxis. The reporter submitted this report directly to VAERS. There were no relevant past medical history or concurrent medications. On 10/9/02, the subject received his first injection of Engerix-B (10 mcg) in the left deltoid (lot # ENG5286A). Approximately 24 hrs later on 10/10/02 the subject developed a rash on both arms along a dermatome, which was characterized by 9 or 10 eruptions varying from blisters to crusting. The child had no fever or rash on the chest or abdomen or any other part of the body. As of 10/11/02, the event persisted.
Given wrong immunizations. Gave KINRIX & MMR which were drawn for sister. Patient received PEDIARIX, KINRIX & MMR. Patient family notified & reassured. Dr. spoke with HD.
This spontaneous report as received from a pharmacy technician refers to an unspecified group of patients (demographic data not provided). The patients were vaccinated with ZOSTAVAX on an unknown date, after exposed to 43.1 F for 29 hours on 03-MAR-2014. No adverse event was reported. This report is linked with case MARRS # 1405USA004199 (the same report link). Additional information has been requested.
A physician reported a pt received vaccine on 8/8/00, approximately 1 hr post vaccine she developed a fever of 102F and a flat irregular rash on her trunk, the pt also felt ill and weak. Pt recovered.
pt recvd vax 25MAY93 & exp severe cramping & heaviness in both legs; pt was hospitalized; addtl details will be requested;
Patient developed Tinnitus after receiving Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Patient developed Tinnitus after receiving Moderna booster) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient developed Tinnitus after receiving Moderna booster). At the time of the report, TINNITUS (Patient developed Tinnitus after receiving Moderna booster) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient age was reported as approximately 60 years. Concomitant product information was not provided. It was reported that patient received Moderna booster dose. Treatment information was not provided.
A 76 year old male patient received 4 instillations of Tice BCG for bladder cancer, administered at weekly (and occasionally longer) intervals, with the first instillation given on 12/20/2002.  Since almost immediately after receiving the first instillation, he began experiencing a "productive cough, low-grade fever, fatigue, and flu-like symptoms", which continue to persist approximately 7 weeks later.  He was hospitalized for the continuing symptoms on 02/02/2003, and remains hospitalized.
This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. An adolescent female patient received TRUMENBA for immunization, via an unspecified route at single dose on unknown date. The patient had received also other unknown vaccinations. Medical history and concomitant medications were not reported. On unknown date in 2016 the patient experienced faint with outcome of recovered on unknown date in 2016.
Nausea, dizziness, fainting. Pt was caught before hitting the floor, taken to a room for observation, and given water, Gatorade, and ice. He sat for 30 minutes under observation.
erythema @ site of inj, warmth, erythema & edema of distal forearm (ipsilateral);
This spontaneous report was received from a registered nurse via medical assistant and refers to a 2-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458:  US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "collapsed due to a cardiac arrest", "cardiac arrest was caused by an arrhythmia" and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.  The patient's pre-existing long history of congenital heart issues might have provided alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan
vaccination failure-7JUL97 pt has moderate case of varicella p/exposure to it 2wk ago;pt recv vax against varicella on 1SEP95;
CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea. This report was non-serious.
Severe pain upon administration. Then redness and hard lump in the administration area (2 in across by 1 inch height) and swelling from shoulder to elbow the next day. Treatment consisted of ice and Aleve. Redness, pain and swelling went away after a week but was itchy and still hard. After three weeks, there is still occasional itching and a hard lump by administration sight the size of a pea.
Patient was given a Covid booster with the Pfizer monovalent vaccine instead of the Pfizer bivalent.