chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed in his home and died on the way to hospital; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 23 years old and unknown gender patient who collapsed in his home and died on the way to hospital while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event collapsed in his home and died on the way to hospital (Loss of consciousness) (unknown latency) following the administration of Influenza Vaccine.  It was reported that e Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 23 year old collapsed in his home and died on the way to hospital.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event collapsed in his home and died on the way to hospital. No autopsy was done. The cause of death was reported as Loss of consciousness.  Seriousness criteria : This event was assessed as medically significant and was leading to Loss of consciousness Final diagnosis was (fatal) collapsed in his home and died on the way to hospital.; Sender's Comments: Sanofi company comment dated 03-Feb-2022:This case involves a 23 years old and unknown gender patient who collapsed in his home and died on the way to hospital while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications and autopsy findings . The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: collapsed in his home and died on the way to hospital
patient received 2 vaccines today. Fluzone HD and Moderna booster dose. 83 year old patient was with his adult daughter (she takes care of him) and she brought him in to get vaccinated. He was screened by pharmacist and vaccines administered by pharmacy tech. He was informed during screening about the requirement to wait for 15 minutes in wait area. After vaccines had been administered the daughter said that her Dad needed to go to bathroom and she was going to take him. A few minutes later an associate said someone needed assistance up front at the bathrooms. When I (pharmacist) got up front, I saw that it was the patient (83 yo) that we had vaccinated a few minutes earlier. He and his daughter were in front of bathrooms up front. She said he tried to stand up to go to bathroom and his face went blank and his eyes rolled back in his head. She got him back in the wheel chair that he uses. The patient was somewhat responsive, breathing, sweating and cool to touch. He did have a pulse. We applied cool compresses, but he seemed to not be getting betting after a couple of minutes, so I had the front end assistant call emergency services. I tried to get a blood pressure reading but patient had on sweatshirt and heavy jacket. We removed the jacket and were about to get a blood pressure reading when EMS arrived. They got patient history from daughter and I informed them of the 2 vaccines administered to him. They transported patient to hospital. This happened about 3:25 pm today. I called the daughter a few minutes ago to check on the patient. The doctors told her that he did NOT suffer a stroke or heart attack. They were running bloodwork and she stated they would probably release him this evening.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2021, the patient received the 2nd dose of Shingrix (intramuscular). In December 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine and had sore arm. The patient did mention she did not had side effects with Shingrix except a sore arm. The reporter consented to follow up.
This is a spontaneous report from a contactable consumer via a sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown. The information on the lot number has been requested.
This spontaneous report was received from a register nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The nurse reported that improperly stored doses of RECOMBIVAX HB lot # M031574 with expiration date of 11-NOV-2018; lot # L048848 with expiration date 09-AUG-2018; lot # M036156 with expiration date 23-FEB-2019; and lot #M037248 with expiration date 21-FEB-2019 (dose, frequency and route were not reported) for prophylaxis, were administered to patients from 01-MAY-2017 to 30-MAY-2017. The vaccines were exposed to temperature excursion of 9° Celsius (°C) to 25°C for a time frame of 1 hour 9 minutes because of data logger. The vaccines had a previous temperature excursion of 9°C to 25°C, for a time frame of 7 hours 50 minutes. Nurse stated that no adverse effects had been reported by any patient and that she was unable to provide any additional patient information for patient who had received supported vaccines. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-706USA006155: US-009507513-1706USA006156:
Pt received 1st dose @1100. waited in clinic for 15 minutes. Pt left. 30 minutes later Pt started to feel per Pt "like my throat was closing". when PT returned to clinic seen by Provider and administered .25 mg of diphenhydramine @ 1155 IM. Vitals signs taken and where as follows. B/P 124/87, HR 82, O2, 100 n RA.
Bell's Palsy; arm became hot; area became red (Approx 6 inch diameter); This is a spontaneous report from a contactable pharmacist via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter mentioned within minutes (after vaccination) patients arm became hot, and area became red (Approx 6 inch diameter). Within 24 hours patient had bell's Palsy. Reporter was inquiring if the patient should receive the second dose. What are the current recommendations under this situation?. Therapeutic measures were taken for bell's palsy under MD treatment and care. Outcome of event bell's palsy was recovered on an unspecified date in 2021 and other events it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the event bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented to the ED and was subsequently hospitalized for severe sepsis within 6 weeks of receiving COVID vaccination.
Right after shot I started to feel tingling in hands and feet. Pain increase throughout the night. Became unable to sit or lie down without pain. calves, ankles, and feet became too tender to touch. Pain has lasted 3 days, just starting to feel better.
On 11/3/2016, we noticed some rashing around the diaper region and assumed it was something of a diaper rash. This morning on 11/4 the rashing was all over the body, head to toe. Contact doctor and we are getting BENADRYL per doctors request to see if this will assist in the break out.
02/01/22 presents to ED for "Abdominal Pain". PMHx of "obesity, hypertension, diabetes, ESRD with renal transplant"
his arm was real sore; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative, reported for himself that a male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported having first shot and said his arm was real sore. Event took place after use of product. Outcome of the event was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Slightly elevated temperature - 99.2F; Pain at the injection site; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 10:00 (Lot number: EL3247) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing); "Arthritis" (ongoing), notes: Pertinent details: minor arthritis in hands and feet, age related.; "High Cholesterol", start date: Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased, start date: Oct2020 (ongoing). Vaccination history included: Bnt162b2 (First dose, Time; 10:00  Am, Date: 11Feb2021, Anatomical site of the injection: left arm, Parent route of administration: intramuscular, Lot/ batch number: EL3247), administration date: 11Feb2021, for COVID-19 Immunisation, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Slightly elevated temperature - 99.2F"; VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Pain at the injection site"; HEADACHE (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, vaccination site pain, headache.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient have not been tested for COVID-19. The patient received third dose of bnt162b2 (BNT162B2, Batch number: EW0217) via an Intramuscular route of administration on left arm on 14Oct2021 for COVID-19 immunization. She became aware (i.e., made connection between her symptoms and the vaccine received) in the evening of 4Mar2021. She filed her report on March 5, in the morning. At that time she realized that her symptoms started earlier the day before (she was not aware of it then, made no connection). She had a progressively worse reaction to the vaccinations practically none with the first dose slight fever/ injection site pain with the second. After third dose she had 38.2 c fever for two days in the morning of the second day she was not able to stand due to feeling dizzy (symptoms resolved by the evening). She had slight diarrhea for a day. The injection site was painful for year couple of days then become red and itchy. All symptoms got resolved. She was healthy and active 71 year old. No follow-up attempts are possible. No further information is expected.
pt recvd vax & died due to sudden infant death synd; pharmacist reported 2 pts; They were assigned WAES #93040017 & WAES 93040018; addtl info has been requested;
Started having chest pain since the vaccination. Started mild and increasingly worse over period. Admitted in hospital on 6/9/2021 with severe chest pain. Diagnosed with heart attach upon admission to hospital
Patient  received Pfizer Covid vaccine (1st dose) on 2/28/2021 during post-administration observation she complaint about numbness on her upper lip only (no shortness of breath or itchiness).  Patient was give 20 ml (50mg) of Benadryl.   She was asked to stay 15 minutes past her post observation time for further observation a pharmacist stayed close to her car.   Upon the additional 15 minute mark she stated she felt better and the numbness was going away.  Patient was instructed to call EMS or go to a near hospital if she experienced Shortness of breath and/or itchiness.   Patient was informed that we will call her for follow up later today and the following as well.  Called patient one hour post administration she stated the numbness went away no other adverse reactions experienced.
mother called in stating that patient had red rash on both legs that was irritating the patient and patient was scratching at rash. Mother states that rash was worsening on legs. Denies breathing difficulties or any reaction at injection site. Mother instructed to contact pediatrician. Mother verbalized understanding of all information provided.
NO PERIOD SINCE COVID-19 VACCINATION; This spontaneous report received from a consumer and concerned an adult female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced no period since covid-19 vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no period since covid-19 vaccination. This report was non-serious.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified group of patients of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration, indication and lot # were not provided) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pulse very high; A regulatory authority report was received from a consumer concerning a, female patient whose ethnicity was unknown, who received Moderna's COVID-19 Vaccine (mRNA-1273)on 22JAN2021 and experienced events on 22JAN2021 , In the first four hours, her pulse was very high. It went down after four hours.  The patient's medical history was not provided. .  On 22JAN2021, the patient received their first of two planned doses of mRNA-1273 (lot number /Batch no: unknown) unknown route of administration for prophylaxis of COVID-19 infection.  Laboratory details was not provided.   Concomitant medications was not provided  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the reported events high pulse rate was recovering /resolving, In the first four hours, her pulse was very high. It went down after four hours.  Causality was not provided .
Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs.  IV was started and patient was given Solumedrol and Benedryl before being taken to ER by EMS.
Information has been received from a health care professional at a physician's office concerning a 13 month old Hispanic male with congenital glaucoma who on 10/29/2001 at 3:30pm was vaccinated in the left thigh with a first dose of MMR II. Concomitant vaccinations included a first dose in the right thigh of varicella virus vaccine live, a third dose in the right thigh of IPOL, and a third dose in the left thigh of Prevnar. Illnesses at the time of vaccination included an upper respiratory infection and a right otitis media. On 10/30/2001 at 9am, the child presented with a 9cm red raised area to the left leg. It was also reported that the area had slight induration, and was warm to touch. It was also reported that the child experienced tenderness at the site. The child was treated with Benadryl, Keflex, and Motrin and on 11/02/2001 was noted to have recovered from all of the events. No further info is expected. The records of testing prior to release of these lots have been checked by GMP Compliance and found to be satisfactory. The lots comply with the standards of the Center for Biologics Evaluation and Research and were released. The physician also reported that a 4 year old female developed injection site erythema, induration, warmth, swelling, and tenderness and cellulitis (WAES01110332) and that a 12 month old female developed a skin lesion, and injection site sweling and tenderness (WAES01112258).
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions , concomitant therapies and previous drugs reactions or allergies were not reported.  On 23-JAN-2023, the patient was vaccinated with an improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #W008711, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  pneumococcal vaccine conj 7v (crm197) (PREVENAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided) following a temperature excursion of -10.5 degrees Celsius for 1hour 34 minutes (product storage error). It was stated that a data logger was involved and no previous temperature excursion occurred. No adverse reaction reported.  This is one from several cases from the same reporter.
Overall fatigue, chills, muscle aches, headache, reaction (redness) at the BCG vaccine scar location (BCG vaccine received at birth)
Received 2nd dose of Moderna on 1/26/21.  Went to the hospital and admitted 2/21/21-2/22/21 for UTI, weakness, and neck pain.
Had Varicella 2/19/02. Woke up crying early am of 2/28/2002 with fever and a few spots. by morning of 2/28/2002 child is "covered" in chicken pox including face, neck, trunk, arms and legs. When asked of possible exposure to another child with chicken pox, mother stated "he never goes anywhere" and denied any known exposure. Parent had contacted doctor, prior to phone call to Shawnee County
Halucinations- hearing  things such as race cars, weedeaters, chainsaws, a choir. ALL hours of the night and day. Yet couldn't hear an actual conversation with people right in front of me. Can't sleep no matter how tired. A few nights didn't even close eyes.  Saw some very weird things on the ceiling at night while in bed (room was pitch black).   Visual- saw things moving that really wasn't moving.   Memory- trouble remembering simple things especially timing of things.   Nauseated and throwing up. Head hurt.  Trouble walking- couldn't stand up fully and very feeble acting   A few things still going on as of today 4-19-2021
approx 5min p/vax pt fell-passed out-eyes rolled back, shaking hands, arms;approx 5-10sec, come to , pale, P70, regular, strong;BP 118/60;also bloody nose;elevated temp;
This spontaneous report as received from a medical assistant via a company representative refers to a male patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (exact dose, lot# and expiry date were not reported) for the prevention of herpes zoster. There were no concomitant therapies reported. On an unknown date, reported as the next day, the patient experienced shingles, and visited a doctor's office due to the event. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided.  Additional information has been requested.
Ataxia starting about 7 hours after immunizations given. Pt afebrile, otherwise normal exam. No bruising, edema, erythema at injection site.
On April 19th, the patient began having fatigue, joint aches, chills and felt feverish (but has not had a fever). He also had a metallic taste in his mouth, nausea and was burping after eating. The patient visited Urgent care on 04/24/2018. They treated him with Advil which gave some relief but did not help with his fatigue. He followed up with his primary care provider on 4/26/2018. At that appointment, he complained of being fatigued, having bad headaches every day, having chills, feeling hot, and missing multiple days of work. Multiple laboratory test were preformed and the test results showed a possible reactivation of EBV. The patient was referred to infectious disease and rheumatology. The patient saw a provider outside of our system and was prescribed Valacyclovir 1 gm for 7 days.  He reported improvement after receiving the antiviral.
Pain, swelling and redness over entire upper arm, extending to lower arm. Treated with ice packs, prednisone and Benadryl.