chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a patient receive COVID vaccine and 3 days later developed bilateral pulmonary embolisms; This is a spontaneous report from a contactable physician.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The physician had a patient receive COVID vaccine and 3 days later developed bilateral pulmonary embolisms on an unspecified date with outcome of unknown. Have there been any similar reports of such events within short time frame of receiving the vaccine?  Information about lot/batch number has been requested.; Sender's Comments: The information provided is limited and doesnot allow a full medically meaningful assessment.  This case will be reassessed should additional information, especially patient age, relevant medical history, concomitant drugs and clinical course, become 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.
BODILY DISCOMFORT; LITTLE TIRED; HEADACHE; This spontaneous report received from a consumer concerned a female 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bodily discomfort, little tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, little tired and bodily discomfort was not reported. This report was non-serious.
Hair loss in one spot.  Completely bare as if it had been freshly shaved, only with no stubble or growth at all.  The spot got larger after a couple of weeks and we sought medical treatment.  She developed several other similar spots over the course of a year.
Achiness all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine about 2 to 3 months before the date of reporting and experienced an achiness all over. For tolerability of 2nd dose of Shingrix, refer case US2019140566. The reporter did not give permission to follow up.
CRASHED IN FELL ASLEEP; NIGHT CHILLS; FATIGUE; HIGH TEMPERATURE; TEMPORAL HEADACHE; PAIN; This spontaneous report received from a patient concerned a 4 decade old of unspecified sex. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced night chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced high temperature. On APR-2021, the subject experienced temporal headache. On 13-APR-2021, the subject experienced crashed in fell asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, fatigue, high temperature, temporal headache, and night chills, and the outcome of crashed in fell asleep was not reported. This report was non-serious.
moving around is making her dizzy; Headache; Hot and cold flashes; Body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 08:30 (Lot number: EW0191) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Headache"; HOT FLUSH (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Hot and cold flashes"; PAIN (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Body aches"; DIZZINESS (non-serious), outcome "unknown", described as "moving around is making her dizzy".  Additional information: She took the Covid-19 Vaccine at about 0830 this morning. She took the vaccine and one of the nurses told her to wait to see if she had side effects for 15 minutes after receiving the dose and she was fine. Around 10:30 she started to get a headache, hot and cold flashes, and her body aches real bad. The headache was not going away. She was at work and has notified her supervisor. she visited different doctors when she goes to the doctor s office. Her symptoms started about 30 minutes after she took the vaccine. She works in housekeeping and moving around is making her dizzy so she has to sit down. she stated that she has to go because she has a discharge room that she has to take care of as she is at work.   Follow-up attempts are completed. No further information is expected
Eleven mins after shot, pt notified me that she was feeling dizzy and c/o burning to bilateral eyes. Escorted pt to lie down on gurney. Three minutes later, observed bilateral eye swelling. Pt was hypertensive 221/105. Pt also had headache. Pt then c/o Left throat soreness then abdominal pain. Pt had chills, temp was normal. EMS called, pt transferred to nearest emergency department.
Developed fever overnight - unknown how high, body aches and stiffness, headache and entire body was numb/tingling. Took ADVIL after breakfast and symptoms got better by mid-afternoon. Unsure if 2nd dose should be taken.
9AM started w/aching all over, chilling, feeling tired, t101 all day 6APR92; took APAP; 7APR92 t99.7 felt tired & weak, no appetite; cont w/APAP 10APR92 devel rash on neck & rt hands & wrist;
5MAY92 pt devel t103 R, fussy,  lt site reddened & swollen p/nap; no APAP given; temp cont pt taken to hosp; MD stated tonsils enlarged & inflamed; fever related to cold & tonsils; pt given ATB; pt sleep more, sl t104 R, fussiness;
My Boyfriend received the first shot of moderna on the last Friday of October.   He was then administered another dose 7 days later the following Friday and communicated that he has been feeling extremely ill.   His medical records were misplaced when he was transferred to a state Prison and he was place in solitary confinement because they do not have records indicating he has received both doses of the vaccine.   He now has a 3rd dose scheduled in December because of this clerical error so I?m fearful that he may be receiving too many doses.   We have called the prison multipack times to investigate and tired calling the ombudsman - but no response yet. They have just noted that their records indicate he has only received one dose.   He has been very i
I had a sore arm the day I got the shot. The next day (about 24 hours later), I started feeling like I was coming down with something. About an hour later, I started getting bone pain. It quickly got worse. Every bone in my body hurt, and it came in waves. I could feel every rib at times, other times my arm bones, leg bones, etc. It was excruciating pain. It lasted for about 24 hours. The next day it was more numb than painful, and by Sunday finally subsided completely. Saturday evening I started getting a large red welt on my arm that was burning and itchy. Today it is finally gone.
fever of 101.2 for about 8 hours/feeling like she was coming down with the flu; fever of 101.2 for about 8 hours/feeling like she was coming down with the flu; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received second dose of BNT162B2, via an unspecified route of administration at arm left on 19May2021 (Batch/Lot Number: EW0179) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and known allergies: penicillin. The patient received first dose of BNT162B2 at arm left on 27Apr2021 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient was not diagnosed with COVID-19 prior to vaccination, did not tested for COVID-19 since the vaccination. The patient had a fever of 101.2 for about 8 hours from 20May2021 09:00. It occurred the next morning after receiving the vaccine. The patient was feeling like she was coming down with the flu or something else. The event was recovered on 20May2021 17:00.
Wrist pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Wrist pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Wrist pain). At the time of the report, ARTHRALGIA (Wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Right arm became swollen and red, as well as a fever onset on 12/14. Arm was tender to touch. As of 12/17 when patient presented, no necrosis of tissue but still redness. Patient had no fever on 12/17. Patient stated this had happened on previous vaccination years ago.
10/23/08- runny nose.  10/25/08- sore throat.  10/26 to 30- fever, felt sick, sneezing.  11/1/08- diarrhea.  11/5/08 vomiting, seen at emergency room.   11/15/8- diarrhea. 11/17-20 still sick.  11/24- finally better.
PFIZER BOOSTER GIVEN AS 3RD SHOT. PATIENT HAD MODERNA FOR PREVIOUS 2 VACCINE.
This spontaneous report was received from a physician via field employee regarding unspecified number of patients of unknown age and gender. The pertinent medical history of the patients and their concurrent conditions, concomitant medications were not reported. The reporter stated that there was general increase in syncope reported with GARDASIL 9 (vaccination, dates, lot, dosing details, route unknown) compared with GARDASIL (vaccination dates, lot, dosing details, route unknown). The outcome of general increase in syncope was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not filed. Additional information has been requested.
Localized - Red, swelling, warmth to touch, 3" diameter R thigh, 1" L thigh - Treatment 12.5 mg Benedryl
Information has been received from a physician concerning a female who tested positive for infectious mononucleosis who was intramuscularly vaccinated with the first dose of Gardasil.  Subsequently the patient experienced hives.  The patient sought unspecified medical treatment.  Additional information has been requested.
Equipment failure on vaccination in L deltoid. Needle was inserted to deltoid, when plunger was depressed close to 100% of vaccine estimated to leak out at hub of low-dead volume single piece syringe and needle. Repeated IM dose. with new dose of same vaccine. Parent requested dose be repeated in same arm , staff repeated dose without issue in L deltoid IM.
OFFENDER RECEIVED 1ST PFIZER COVID VACCINE ON 3-25-21 (LOT #ER8732).  HE  RECEIVED THE MODERNA VACCINE ON 4-8-21 BY MISTAKE.  OFFENDER ANSWERED NO WHEN ASKED IF HE REC'D A PREVIOUS COVID VACCINE ON THE VACCINE CONSENT FORM.  HE WAS EVALUATED APPROX 4 HOURS AFTER RECEIVING THE VACCINE WITHOUT ANY COMPLAINTS OR ABNORMAL ASSESSMENT BY NURSING.  HE WILL BE SEEN AGAIN TOMORROW (4-9-21) BY NURSING.
Patient was 12 days away from turning 5 years old when administered first covid-19 vaccine. No adverse events were experienced.
Cough and nasal congestion developed on 7/25/2021.  Tested positive for COVID on 7/26/2021
Hives, systemic Right thigh @ site of varicella vaccine swollen, warm and raised.
Vaccine given at approx 10:30 am, about 6:30 Patient had difficulty breathing, tightness in chest, soreness in arm, weak, rapid heart rate. Mom called 911 patient transported to ER. Given Claritin symptoms lasted 6:30 to 10:30 Pt discharged.
Mother reports child developed a high fever and stiff neck after receiving immunizations-onset of symptoms unclear to this provider. Mother states she took patient back to Clinic on 5/18/2017, Clinic sent patient to ED. Clinic referred patient to a pediatric neurologist. Patient seen by neurologist 6/23/2017 who noted child had high fever and stiff neck after getting DTP vaccine (incorrect vaccine noted). Neurologist not indicated patient has had jerking of bobbing of his head since then. Assessment: mostly aseptic meningitis and Tics secondary to Pertussis vaccination.
swollen eye; sore arm; not a common rash, it was the same type of rash observe in Covid-19 patients; This spontaneous case was reported by a health care professional and describes the occurrence of EYE SWELLING (swollen eye), VACCINATION SITE PAIN (sore arm) and RASH (not a common rash, it was the same type of rash observe in Covid-19 patients) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Jan-2021, the patient experienced EYE SWELLING (swollen eye), VACCINATION SITE PAIN (sore arm) and RASH (not a common rash, it was the same type of rash observe in Covid-19 patients). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swollen eye), VACCINATION SITE PAIN (sore arm) and RASH (not a common rash, it was the same type of rash observe in Covid-19 patients) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient treatment includes steroids and Benadryl. Concomitant medication was not provided.   Reporter did not allow further contact
mom described left arm as bigger than a half dollar, red but not beet red. No pain or tenderness. Child stated only itched a little mom not giving Tylenol but instructed to use Benadrylfor  itching and a warm cloth.
PT RECIEVED ANTHRAX VACCINATION AS A TUBERCULOSIS TEST ON HIS LEFT FOREARM.  HE HAD THE NORMAL SIDE EFFECTS OF THE ANTHRAX VACCINE; REDNESS, AND BURNING.  AT 3:00 PM ON 30 MARCH 2009.
Potential administration in thigh; would like to administer in the thigh; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingrix (unknown thigh). On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Potential administration in thigh) and vaccine administered at inappropriate site (Verbatim: would like to administer in the thigh). The outcome of the circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.   Additional Information: GSK receipt date: 01-AUG-2023 The pharmacist informed that a patient was not able to receive Shingrix due to a cancer (not specified) and that would like to administer in the thigh which led to circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates starting on or after 08-JUL-2016, the patients were vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration and anatomical location were unknown) with lot number M006724 and expiration date 08-FEB-2018 for prophylaxis, which was stored at more than 14 Fahrenheit degrees (°F) to less than 46 °F for 45 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes; 5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes; 15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away). On 02-Jan-2021, HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment for the events was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue, fever, malaise  Red hot raised firm painful lump in each arm. On left at influenza site size is approximately 2.5 inch x 2.5 inch x 0.5 inch. On right arm 1.5 inch x 1.5 inch x 0.25 inch with a bruise at infection site of 0.5 inch x 0.5 inch. Both sites are tender to light touch and the pain interrupts sleep.  Actual brands of influenza and pneumonia vaccines are guesses. I do not have that information.
rt arm red swollen & warm to touch over deltoid area;mom reports swelling inc since yesterday;denies any diff breathing or scratching of area;MD assessed, no tx;
INADVERTENTLY VACCINATED BEFORE AGE 12 YRS OLD.INFO COULD NOT BE CLARIFIED.
Initial unsolicited report received from a physician on 06 August 2015. A three years old male patient (exact age at onset was three years and nine months), whose medical history and concomitant medications were not reported, had received a dose of IPOL (batch number-K1649, site of administration was not reported) via intramuscular route, a dose of DAPTACEL (batch number-C4694AA and site of administration was not reported) via intramuscular route, a dose of MMR (manufacturer- Merck, batch number, route and site of administration were not reported) and a dose of VARIVAX (manufacturer- Merck, batch number, route and site of administration were not reported) on 09 March 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 09 March 2015, 15-30 minutes post vaccination, the patient experienced red rash, hives, coughing, wheezing, fatigue, unusual behavior, hypotension and dusky lips. Patient was diagnosed with anaphylactic reaction and etiology was yet to be determined. Patient required ER/doctor visit. It was reported that patient was treated (treatment was unspecified) and evaluated in the hospital. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient recovered from all the events. Documents held by sender: none. Sender's Comments: This case meets level 2 of the Brighton Collaboration case definition for anaphylaxis. Anaphylactic reaction is listed with both IPV (VERO) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Also the time to onset and symptoms are compatible with the diagnosis. Information on adverse reactions to previous vaccinations and identification of the culprit antigen would be helpful to further assess this case. Further as four vaccines were administered concomitantly, it is difficult to assess the role of each vaccine in particular. Based on the information available, no conclusion can be drawn.
Pt recvd vax on 30APR92 & exp h/a, dizziness, severe fatigue & felt like was drinking;
Client complained of difficulty breathing, fast heart rate and then passed out.  Father called 911 and client was taken by ambulance to Hospital.  Client had elevated blood pressure and was given Ativan.  All x-rays and blood work were negative per mother.  Client was released to home at 11:30 PM.