chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My father went from being totally independent (lived alone, etc) to being an invalid in one fell swoop. He had a mild Covid case in March 2020. Recovered. Got first Pfizer vaccine in April 2021 (or so). Terrible side effects. Lost all strength, intense pain. Decided at that point not to get the 2nd one. I mean why?  Anyway, he changed his mind and got the 2nd one in June.  Had tremors all night, 103.9 fever and ultimately collapsed. Ended up in the ER one day after vaccine. Still in rehab unable to walk on his own, so weak, heart and lung issues, etc. Though nothing was broken, he cannot walk, get up, dressed, go to toilet on his own. Go figure.
w/in 5 mins of shots pt spit up in moms arms, then turned pale & limp & nonresponsive;
The patient received SHINGRIX on 2/23/19, came back 2/27/19 with rash. Instructed to see medical doctor. The patient went to emergency department. Emergency room Dr. diagnosed rash as chicken pox 2/28/19.
Rash; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in deltoid left, administration date 22Nov2021 (Lot number: FH8030) at the age of 47 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1; Lot number: FF8841; at 17:00 intramuscularly in the left shoulder), administration date: 14Oct2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Splotchy, red, and itchy raised rash under both arms and along side of torso", "Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin", "Splotchy, red, and itchy raised rash", "extremely itchy and dry elbows", "extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist", "rash under arm", "rash thighs & calves". The following information was reported: RASH (medically significant), outcome "recovering", described as "Rash". The clinical course was reported as follows: Upon receiving the first dose of the Pfizer COVID-19 vaccination shot, the patient began feeling extremely dry areas on the elbow. The dryness began a few days after my first dose. The dry progressed to a rash. The rash was red with small red bumps. This rash progressed into Nov2021 to areas on flanks on the side of torso as well into my waistline. A few days later, the patient began noticing areas on the back of the ankles and further areas around waistline. The patient began using hydrocortisone uptime on the areas around 03Nov2021/04Nov2021. A few days later, the patient noticed a rash on the right side of the thighs which progressed to the left side down. The symptoms began to subside in late Nov2021/early Dec2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Aug2021) positive, notes: 65.6 U/mL.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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
was sick as hell / got so sick on the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced sickness. Shingles vaccine was interrupted. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as hell. The patient was told to come back in 28 days for the shingles shot. The patient stated that there was no way he or she would be getting the 2nd shot.
8/27/14 PM - warm, red, swollen at site of injection. 8/28/14 AM - above - worsening. 8/28/14 PM - urgent care visit. Dx - cellulitis. Tx - antibiotic/diphenhydramine.
Breakthrough COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID-19). At the time of the report, COVID-19 (Breakthrough COVID-19) outcome was unknown.            Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred at an unknown date after the second dose of Spikevax. No further information was provided. The rechallenge is not applicable, since the only reported event was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not capture since there is lack of information regarding the schedule of vaccination and temporal association with COVID-19.   This case was linked to MOD-2021-362733 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred at an unknown date after the second dose of Spikevax. No further information was provided. The rechallenge is not applicable, since the only reported event was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not capture since there is lack of information regarding the schedule of vaccination and temporal association with COVID-19.
SICKNESS; BLOOD PRESSURE HIGH; This spontaneous report received from a patient 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 08-MAR-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 an unspecified date, the subject experienced sickness, and blood pressure high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickness and blood pressure high was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436063.
Patient present with his aunt requesting for COVID Vaccine booster without vaccine card. Both patient and aunt insist that they are needing their COVID booster vaccine. Nurse verified Electronic medical record and State registry for vaccine. Both showed only 2 previous administrations on 3/9/2021 and 3/31/2021. Nurse inquired multiple times for vaccine card and immunization history. Patient responded that he do not have a card and only received 2 COVID vaccines in the past. Nurse proceeded to obtain consent and administer booster dose of Moderna Vaccine.  Patient was allowed to wait for 15 minutes after the vaccine. After the visit, patient returned to the nurse's station with his previous vaccine card, which shows 3 COVID Vaccine administration with last dose administered in November 2021. Patient and provider were notified. Patient is stable and no further orders given.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient still feeling the nerve damage from the shingles and patient scheduled to have the second dose on Thursday   Reporter did not allow further contact
Severe abdominal cramping, rapid heartbeat, shallow breathing,cramping, clammmy and sweaty, nausea, faint  Called 911 and went via ambulance. Suspected angina, but heart was ok. Released at 4:00 AM.
Vaccine given 2.28.12. Pt states on 2-28-12 he had body aches, back pain , & HA. 3-2-12 Pt calls clinic with above info but states symptoms are getting better each day.
A mother states after an hour she left the clinic, the child started to vomit and it was persistent. She went home and called the clinic. The child returned to the clinic, was evaluated and referred to the ER for further observation. Discharged from the ER on the same day.
When to ER Hospital at university, Also when to sports center, saw doctor. Then saw another doctor at the hospital. Diagnotes with severe never damgge.
Two hours after receiving vaccines, pt became very fussy and would not nurse. Left thigh became red and swollen slightly. Came to physician's office at 2:30 PM. No fever noted.
At 09:30 am patient was ordered to be administered Pfizer SARSCOV2 Tri-Sucrose, 30mcg/0.3mL and patient was administered Pfizer SARSCOV2 bivalent booster 30mcg.0.3mL instead. Patient was monitor for 15 minutes with no adverse reactions.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient almost passed out after getting Covid vaccine and Boostrix, emergency number was called. EMS reviewed and patient was ok to go after about 40mins
Vaccine Tdap administered 5-7-12. Within 24 hrs, arm red, itchy, swollen. Some difficulty with range of motion. No previous adverse reaction to Td. Patient seen in clinic 5-11-12. Left arm had extensive swelling & redness - 3/4 lateral arm just above elbow to proximal arm. Some heat, some bruising.
patient had received an underdose of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number JN7YG, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's comment: Pharmacist reported that a patient had received an underdose of Fluarix QIV. The vaccine administration facility was the same as primary reporter. HCP (Health Care Professional) gave consented to Follow-up via phone number. Additional Supportive Information: The patient had received an underdose of Fluarix Quadrivalent 2022-2023 season, which led to underdose.
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
Per Dr. office note - pt developed red patches all over body, not raised, no swelling, no change in mouth or eye mucosa. Rash went away within 10 minutes.
Over the course of 24 hours developed fever, muscle pain and weakness that resulted in her being bedridden. Lasted 24 hours.
This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 58-year-old female subject who was vaccinated with Fluarix for prophylaxis. No relevant medical history. The subject had previously received influenza vaccines and had not experienced any reactions. On 14 November 2007 at 17:00 the subject received unspecified dose of Fluarix (.5 ml, unknown arm). No other vaccines were received on 14 November 2007 with Fluarix. On 14 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm soreness at injection site and tenderness at arm injection site. Approximately one week after the subject was vaccinated with Fluarix, she experienced weak arm muscles, especially at night, and she could not use her arm very well. The pharmacist noted that this has "eased some" but at certain times her arm feels weak. Medical attention was required at the physician's office. The pharmacist considered the events were disabling. At the time of reporting the events were ongoing and improved. The pharmacist considered the events were probably related to vaccination with Fluarix.
I started feeling I had a sore throat and more congestion and coughing then I'm used to. When I laid down i continued coughing. I had extreme fatigue, headache, chills, chest congestion, lost my taste. My doctor subscribed me Paxlovid. I used cough syrup and Tylenol.
BRUTAL NIGHT OF SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced brutal night of side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from brutal night of side effects. This report was non-serious.
Mom stated pt was eating lunch on 10JUN92 slumped over @ the table & loss consciousness for a few minutes; t98.3, h/a since; seen by MD mom instructed to watch pt;
Information has been received from a Nurse concerning an 18 year old female patient with gaucher's disease type I and von willebrand's syndrome with heavy period controlled with birth control, who on 15-AUG-2007 was vaccinated IM with the first dose of Gardasil (lot # 658488/0930U). Concomitant therapy included weekly infusions of electrolytes (unspecified) and birth control (unspecified). Subsequently the patient experienced neurological problems and gaucher's disease progressed to type III (possibly terminal stage). Unknown medical attention was sought. The patient had not been recovered. No product quality complaint was involved. Additional information has been requested.
This case was reported by a pharmacist (also the subject) and described the occurrence of feeling woozy in a 60-year-old male subject who was vaccinated with FLULAVAL. On 9 October 2008 at 12:50 the subject received a dose of FLULAVAL (1 ml, unknown, left arm). On 9 October 2008, 1 hour after vaccination with FLULAVAL the subject experienced feeling woozy, headache and overdose. The pharmacist reported that he received FLULAVAL at work and was given 1 ml instead of 0.5 ml. At the time of reporting the events were unresolved. Follow-up received on 31 October 2008 indicated that the events were just temporary and passed soon. The events were resolved at the time of follow-up. No additional information was reported.
muscle pain on my right side, like an extreme muscle pain; fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever). At the time of the report, MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) outcome was unknown. Not Provided      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.   Treatment- Muscle relaxant
During the evening of the 09/18/22 I had chills and body ache. I woke up on 09/19/22 and had a sore throat, felt fatigued the chills were still there and the body aches were even worse, I had a low-grade fever. I home COVID-19 test that came back positive very fast. I called my PCP as soon as it was positive to let him know I tested positive. He advised me as to which medications to stop taking, the one I needed to cut in half and I started PAXLOVID immediately. I started feeling better in a couple of days from body aches and fatigue, by 09/23/22 I felt better. I did get rebound COVID-19 but finally was able to feel like myself 12/06/22. I do still have a bit of a lingering cough.
About 2 hours after receiving both vaccines, she started having pain going up the arm, shoulders, neck and then she got a migraine.  She then could not stay away and slept for 3 days.  On day 3 she started having muscle aches all over body.  There was no fever reported.
Two days after getting the shot patient experiences rash on chest. He is not certain if it started earlier but did not notice rash until today.
- a constant Headechs  -  Random body twitching sometimes strong some time minor  - mental limitation (new) - a death experience  - odd hallucination with a physical hallucination including dreams. - body over heats more than often - new disease (hemroid) - odd hiccups after eating or drinking( was more saver in the beginning)
Right thigh appeared red, swollen, hot to touch and painful on 2/16/12. Mother took pt to ER 2/16/12 and pt was diagnosed with (R) thigh cellulitis.
23MAR rash-few rash on chest, underarm;24MAR chills no temp;aches all over;24MAR sl swelling under ears;
The patient reported tingling and numbness of the right arm starting about 5 minutes after the time of vaccination
Fever high of 100.6 Headache Chills Fatigue  Body aches Upset stomach  I had all of them from 10:00 am to 5:00 pm when fever suddenly subsided and so did all other symptoms.  I finally too 2 extra strength Tylenol at 3:00
Paralyzed from the waist down. Treated with steroids (4/22/13). Diagnosed with Transverse Myelitis. Three plasmapheresis events, week of 4/22/13.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000587: US-009507513-1809USA000592: US-009507513-1809USA000593.
Lethargic, sleeping a lot, could barely hold up head, spacy. 3 QDS.
site redness, swelling, painful to touch, chills, fever, and not feeling well in general.
Arrived @ ER in cardiac arrest @ 6pm apparently choked while being fed.  Autopsy Dx = SIDS. 3/17/08-Autopsy report received-COD-Sudden Infant Death Syndrome. Apparently had been healthy. Parent had been lying on bed with child feeding it with a bottle when both he and the child apparently went to sleep. The 4 year old sibling noticed child was face down in crook of parent's arm and turned the child and woke father. Autopsy revealed a normally developed and well cared for appearing child, no evidence of injury, no congential or acquired condition that might explain her death was found. The circumstances raise the possibilty of accidental asphyxia but it does not appear from account available that in the position described the child's breathing would necessarily be compromised.
Patient experienced elevated heart rate(peak 93).  Slight facial tingling and dizziness.  Symptoms presented rapidly after vaccine administration.  Pt was kept in the immediate pharmacy area for supervision, heart rate monitored(had a device that did on her person). Also temperature checked and found to be 99.3 F.  After 30 minutes of observation symptoms subsided.  Patient advised to communicate any change of symptoms
9/3 Saturday 8 pm - taken to ER for seizure - 1 seizure approx. 10 minutes. Swelling, eyes rolling back. Temp 101.8 as reported by mom. F/u with pneumonia 8/7/11.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient received vaccine on 11/11/2021. During observation period, father reported that patient began to shake and his eyes rolled back (vasovagal). There was no loss of consciousness and no seizure activity. Recipient was complaining of stomach ache. Patient was given water and recovered. Recipient was discharged to home.
Breakthrough COVID infection in fully vaccinated patient. Positive date 10/11/2021.
Had shots 10/1, went to ER 10/2 because of rash and mom stated "throat swelling" - we saw 10/3 - doctor dx urticaria.  24 hours after shots and immediately following dinner.