chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is 94 yo male with PMH of afib not on anticoagulation, BPH, OA on chronic opioids, and depression. He presented to this institution on 4/19 with aphasia and confusion, concern for stroke. MRI showed no signs of stroke and at discharge 5 days later he was back to baseline. Pt underwent standard inpatient COVID-19 testing: rapid test was positive on 4/19, then PCR test was negative on 4/20. Patient is s/p Pfizer vaccine with his first dose on 1/20 and second dose on 2/10. He was asymptomatic, with no hypoxia and did not starts steroids nor remdesivir. Team decided that presentation is most consistent with false positive, but per ID and epidemiology, pt must remain in isolation for 10 days as a precaution.
Mother found infant dead in her crib at 6AM. 7/22 Coroner said infant died around 2AM. Infant was fed at 11:30 and mother heard nothing all night. Infant had no fever etc following imm. To ER by ENS, MD stated cause of death as unk on death certificate. Mother said they said if was probably SIDS. Death Certificate received and stated patient experienced unevaluated reaction.
Hypersensitivity reaction, erythematous itchy rash to left arm and right forearm and back.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles twice "in her 70's". On 01-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml (route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced the shingles three times. The outcome of the patient had shingles three times was reported as recovered/resolved on an unspecified date. The relationship between ZOSTAVAX and shingles was not reported. Patient sought unspecified medical attention. Additional information is not expected.
0.5ml dose given instead of 0.25ml dose, no adverse reaction at this time.
Vaccines administered on May 30, 2019.  Seen in ED and admitted to hospital on Jun 3, 2019 for headache, altered mental status, and seizures.  Meningitis as preliminary diagnosis, culture negative.
patient received first dose of shingrix on October 28th 2019. Never got his 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2019, from batch number 5482T, expiry date 11th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and never got his 2nd dose. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Patient presented to clinic for second Moderna vaccination in series.  Patient was scheduled for clinic and had been in waiting area for approximately 2 hours.  Vaccination clinic was over and patient was discovered in the waiting area. RN spoke with MA who roomed the patient and agreed to administer the vaccine.  RN confirmed patient name, DOB, consent and pre-vaccination questions with patient, confirmed that she was in clinic for second Moderna vaccination and reviewed patient's vaccination card. RN obtained vaccination from refrigerator.  RN administered Moderna 0.25ml booster dose in error as second vaccination in series instead of Moderna 0.5ml dose.  RN did not realize error until over an hour later while completing visit documentation.   RN notified Nurse Manager and Medical Director of practice. RN was instructed by Medical Director that patient needed additional Moderna 0.25ml booster dose.  RN contacted patient to inform her of error, need to receive additional dose and schedule her to come into the office.  Patient stated she did not understand, did not schedule appointment to receive second booster dose to complete full Moderna 0.5ml dosing.
Sore arm; Patient received the first Moderna Covid vaccine and a week later found out she was pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 12-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the first Moderna Covid vaccine and a week later found out she was pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications list was not provided.  Treatment information was not provided.   Patient decided at the time they were not going to get the second dose of the vaccine. Patient did not get the second dose of the Moderna vaccine. Patient reported  that since then she had her child and had spoken to some doctors about what she should do to become fully vaccinated. Patient would like to knowwhether she should start over or just get the booster shot.
The next day, I had a headache, 102 degree temp, vomiting, nausea, chills, body aches, dizziness , dehydration and diarrhea. I had no appetite from this time and for days after. I hydrated with water, and took Tylenol, but it had no real effect. Day 5 I drank Pedialyte mixed with water and was able to eat soup and keep it down. The fever above 100 degrees lasted through Day 4, then was low grade (99.9) through Day 8. Day 8 I still had a headache, low grade temp and shakiness/dizziness. Brain fog is all I can use to describe the inability to focus my thoughts during even the most mundane conversations. My left arm felt like it had been punched for 3 days after the vaccine was given.
Tingling at the back of the throat.  BP: 107/77 seen and cleared by EMS
The patient experienced the following reaction(s) during the immediate   of observation: 1240- pt received first dose of Prizer vaccine at 1220.  Pt was ready to leave and had a syncopal episode in her chair.  Pt was lowered to the ground and was not alert or oriented.  Mother was at the patient side.  Pt was able to open her eyes and state her name.  At this time the patient was placed into a wheelchair and during movement to post vac area, pt lost consciousness and had generalized muscle twitching resembling seizure like activity.  At no time did patient have airway compromise.  Pt was placed on the floor with feet up on the wheelchair.  Vitals are as follows BP: 92/52 P: 72 R:18 99% sp02.  Pt continued to answer questions appropriately with mother at her side. 1246: repeat vital signs BP: 118/64 P: 85 R:18 98% sp02 on RA Pt A&Ox4. Mother stated pt had same type episode 4 years ago while they were out of the country.  EMS  Was called to assess pt with possible transport to a higher level of care.  1259: BP: 110/72 P: 83 R:18 99% Sp02 Fire Department on scene speaking with mother and pt.  All pt care given released at this time to FD. Mother spoke with FD and decided against transport to the hospital.  Pt was observed 10 minutes longer and final set of vital signs done prior to pt leaving the facility. BP: 102/82 P: 75 R: 18 99% Sp02. Pt A&O x4, placed in a wheelchair and helped to vehicle.  All questions answered prior to leaving the facility.
Onset of IBS (Irritable Bowel Syndrome) with serious diarrhea after eating - especially vegetables. I have NEVER had a condition like this before in my life. Saw the Dr who did blood tests and took stoop samples. All negative. Problem has persisted from April to present. Began home treatment of pre and pro-biotics. Also ordered some IBS herbal treatment. The regiment of prebiotics seems to have helped the most in bringing my system back into alignment. I can now eat salad without racing to the bathroom, And the diarrhea has subsided. But I can tell from my gurgling stomach that I am not totally "cured".
On 2/14/22 the patient received the Pfizer covid 19 purple cap 0.3ml instead of the adolescent dose for their second vaccine.  I have spoken with the mother about the incident and she reported no side effects from the vaccine.
Immediately after the injection, I lost the sense of self. I didn't know where I am, I had no sensation or awareness of my body. I was very confused. Next thing I remember is the nurse asking me if I can breathe, and in that moment I was coming back to my senses, and I said "yes I can breathe". The nurse said I went into convulsions. It lasted about 10-15 seconds. I broke out into sweats afterwards, which lasted about 10 minutes.
arm  hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult 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 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 age at vaccination was not reported. The patient received her 1st dose of Shingrix vaccine 2-3 months ago in 2019. After receiving vaccine, the patient had her arm  hurt for 5-6 days. The reporter was requested to provide consent to follow up. For the tolerance with 2nd dose of Shingrix, refer linked case US2019226977.
Patient received COVID-19 vaccine approx 8.5 hours after the defined beyond use date. Discussed with Pfizer, and determined no need to redose patient based on data provided.
I received my first Pfizer booster for COVID-19 on 11/29/2021. In early August 2022, I ended up catching COVID-19. My symptoms were relatively mild. I had fatigue, sore throat, loss of appetite, and headache. The only treatment I received for the virus was monoclonal antibodies. The illness lasted for about a week, and I pretty much resumed my normal activities afterwards, though the sore throat and headache did linger for about a week longer. During my bout with COVID-19, I didn't have any issues with my breathing. However, since having had COVID-19, I have found myself having shortness of breath and a sore throat. These symptoms are not constant, but they do manifest on random occasions. I went to my PCP for some guidance on the matter, and she told me that she didn't really know why I was having these symptoms, but she did advise me to keep an albuterol inhaler on hand. I have had to use the inhaler on occasion, and it usually helps reopen my breathing passages.
Mother, presented with patient to be vaccinated at this health clinic. She documented the patient's birthday on her intake form. The same DOB was entered into the electronic database. However, the Immunization Registry lists patient's correct DOB as different date. She has other immunizations accredited to this entry and DOB. If system is correct, then this child is only 4 years old an was vaccinated.  The error was discovered while reconciling the records with system.
I have mild flu-like symptoms. I am achy, have chills, am sleepy, have a bit of a headache and my arm hurts. The first dose only caused a bit of arm pain.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Patient was 12 years-old at time of booster shot.  He should have received his second dose with the adult Pfizer formulation.  No adverse events occurred, but incorrect recommended vaccine was given.
4:00 pm mom gave TYLENOL 0.4 ml and stated infant felt warm. 8:00 pm gave more TYLENOL 101 deg. 2:00 a.m 104 Temp; Denies any redness, rash or swelling.
vomiting; high fever of 103.5; Low grade fever up to 100; All over red dots/hives; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 13-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 16May2021 at 13:00 pm (age at vaccination was 13 years) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies to eggs, tree nuts, peanuts and penicillin. Concomitant medications the patient received in two weeks included fluoxetine, sulfamethoxazole, beclometasone dipropionate (QVAR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jun2021, Tuesday at 20:30 pm, the patient had all over red dots/hives. The patient took 2 doses of Benadryl to calm down. On 03Jun2021, Thursday night at 2:00 am, the patient had vomiting and high fever of 103.5. The patient was given Tylenol too and it reduced the fever to 101. Low grade fever up to 100 was persistent until Saturday at 15:00 pm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0164, Expiration date: unknown) via an unspecified route of administration, administered at in left arm on 06Jun2021 at 13:15 pm (age at vaccination was 13 years) as dose 2, single for COVID-19 immunization. The outcome of the event low grade fever was resolved on 05Jun2021 at 15:00 pm. The outcome of the other events was resolving.  Follow-up attempts are completed. No further information is expected.
no adverse event; administration of vaccine following temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 11-APR-2022,the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter/once (lot number U024221, has been verified to be valid, expiration date: 04-AUG-2023), administered for prophylaxis (route of administration were not provided). Patient did not have any symptoms or adverse effects of receiving vaccine (also reported as no adverse event). The stored temperature was -13.0 degrees Celsius (C) and the time frame was reported as 1 hour. There was no previous temperature excursion. No further information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: Fj4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Statins allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Chills; fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills , fever on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
no adverse effect; longer than recommended interval; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date in July 2019, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration and anatomical location were unknown) with lot # 1621931 and expiration date 26-JAN-2019 for prophylaxis. On 23-DEC-2019 (also reported as longer than reported interval), patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration and anatomical location were unknown)  for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. There was no product quality complaint associated with the case.
15 mins. after pt rec'd vaccine: took elevator from 3rd to 1st floor experienced weak legs, faintness. Pt was taken to ER for F/U. Mother stated he was released from ER after EKG; Xray results normal along with vitals. Mother states he's resting but feeling "fine".
My hearing feels amplified and when others and I speak, I can hear this like sound as if when a speaker is on but the aux chord is not connected to anything, and one touches it, it'll make this buzz noise. I hear peoples voices in that buzz noise under their normal voice, almost like robotic. I don't know if this is related to the vaccine or not but I did notice it start the day after I got vaccinated.
Last night she really felt bad and the pain was so bad; Feeling unwell; Arthritis; Last night she really felt bad and the pain was so bad; tiredness; muscle pain; joint pain; chill; difficulty breathing; weakness; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TB" (unspecified if ongoing), notes: Lives in assisted living and has had TB twice a long time ago, before the shot. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chill"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Last night she really felt bad and the pain was so bad"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arms was sore; patient was tired the whole day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20-2A) for COVID-19 vaccination.     The patient did not have COVID-19 disease prior to or after the getting the vaccines. The patient was not immunocompromised.  Previously administered products included for Flu: Flu vaccine (the patient had received the annual flu vaccine). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high (had concomitant high blood pressure but controlled with a lot of medications).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day). At the time of the report, PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day) outcome was unknown.            Concomitant medications included unspecified blood pressure controlling medications.  On 01-Apr-2022, the patient received the second booster dose of the vaccine.  The patient experienced the symptoms of sore arms and tiredness in Apr-2022 after receiving the second booster dose.  No treatment information was reported.   This case was linked to MOD-2022-533357, MOD-2022-533519 (Patient Link).
AFTER RECEIVING THE SECOND MMRV ON 6/10/2020, THIS PATIENT WAS DIAGNOSED WITH SHINGLES ON 4/15/2021
Bones-joints and muscles, allergies, arthritis, balance problems, bladder problems, acid reflux, urticaria, gastric problem, loss of concentration, depression, delirium, alpha intrusion, digestive, sleep insomnia, nasal nose bleeds.
Breakthrough case admission after 2 vaccines 12/21/21 Moderna Lot# 005C21A;  Pfizer 6/23/22 Lot# FM7553