chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered in right arm on 10Jun2021 15:09 (Batch/Lot number: EW0187) (age at time of vaccination) as single dose for COVID-19 immunization. The patient took the Pfizer COVID-19 Shot as she did not want to get COVID-19 and too many people were dying. Vaccination Facility Type: Other, please specify: Clarified as the racetrack. The patient's medical history included ongoing asthma (20 something years ago), ongoing sleep apnea (20 something years ago), ongoing diabetes (20 something years ago), ongoing chronic obstructive pulmonary disease (COPD) (20 something years ago), ongoing blood pressure high (20 something years ago) and ongoing heart condition (20 something years ago). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at the age of 49-year-old) administered in right arm on 27 May 2021 (Lot number: EN6199, NDC number: Not provided, Expiry date: Unknown) as single dose (exact dose unknown) for COVID-19 immunization. On an unspecified date in June 2021, the patient experienced body aches, throwing up, tired, fever and chills. Yesterday, 10Jun2021 she got her last COVID-19 shot. She mentioned she was fine yesterday after getting the shot, but at some point while sleeping sometime between 10Jun2021 and 11Jun2021 she had body aches, throwing up, was tired, had a fever with a temperature of 100.7, and chills. She mentioned that events could have happened after midnight. All she knows was when she woke up in the morning, she had the events. It hurt her to sit. She was rocking back and forth not wanting to throw up again. She confirmed they all started around same time. She questioned if it was part of the side effects from the vaccine. She commented she would rather have this than go have COVID-19. Outcome of events: She confirmed as unknown. She cannot tell at this time. She mentioned if it gets worse she will call back and go to the Emergency Room. She hoped it gets better, but she could not tell if it was better, worse, or same at this point. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.
pt brought to hosp from his home after a fall and worsening mental state ; history of positive COVID test 9 days prior; dx with COVID pneumonia; poor prognosis; AKI; DNR;  comfort care; started on comfort medication and kept comfortable until he passed away in the hosp
This spontaneous report as received from a licensed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, RECOMBIVAX HB was exposed to -2, f for one month; this includes more than two cycles into and back out of the temperature range of below 0, f. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccine (Lot#, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of several reports that received from the same source. Additional information has been requested.
Localized right arm tenderness, very minor headache, very minor body aches, right clavicular lymph node swelling/tenderness.
ON 6/20/21 I DEVELOPED HIVES ALL OVER MY BODY. BENADRYL HELPED, BUT THEY CAME BACK AFTER THE MEDS WORE OFF. HIVES WERE CONSTANT, SOME DAYS WERE WORSE THAN OTHER WHERE I WAS COVERED HEAD TO TOE WHILE OTHER DAYS I HAD JUST A FEW PATCHES. INTERNIST DID COMPLETE ALLERGY BLOODWORK WHICH WAS ALL NEGATIVE. TRIED OTC MEDS ALLEGRA, XYZAL, BENADRYL,...WOULD HELP UNTIL IT WORE OFF AND HIVES WOULD REAPPEAR. VISITED AN ALLERGIST WHO STARTED ME ON XOLAIR INJECTIONS MONTHLY BEGINNING AUGUST 2021.
missed second dose of GARDASIL 9.; No additional AEs were reported; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.  On 11-JUL-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # U008316, expiration date 15-AUG-2023; strength, dose and route were unknown) for prophylaxis. On an unknown date, the patient missed the second dose of vaccine. No additional adverse event was reported.
This is a spontaneous report from a noncontactable consumer or other non-HCP. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Mar 4, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a very bad reaction, which affected her heart (cardiac disorder) and felt cold (non-serious) Mar 2021; with outcome of unknown. The action taken in response to the event(s) for BNT162B2: not applicable.
Atrial fibrillation and fast hearbeat detected on EKG on January 7.  Cardiology nurse said it could be related to vaccine.
My face turned red (flushed) and I got the chills.  We were driving on the highway and the traffic started slowing down. I then had a red blotch on the right side of my neck, and my face got tingly, and then my tongue got tingly.  I took my temperature and it was normal.   We were then stuck in standstill traffic on the highway waiting for an accident to clear.  I took a Benedryl capsule and tried to breathe to relax.  Those symptoms cleared up in an hour.  Over the next week I experienced periodic tingly in my arms and was very nauseous.
an eleven year old received a dose of Infanrix.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The medical assistant reported that an eleven year old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The health care professional declined to provide demographic details, lot number, or expiration date. The reporter did not consent to follow-up.
within 10 days of the second shot I started getting symptoms of a menstrual period for 2-3, which I haven't had in the 10 years that I've been on the Mirena IUD (except for the few months between removing my first IUD and getting pregnant with my first child). About a month after that first bout of light spotting, I've had another "period", which included heavier menstrual bleeding, cramping and back pain, all of which resolved after 3 days. I can't say with certainty that I've "recovered" from the adverse event until the cycling bleeding/cramping stops.
Had vaccine on a Friday 2/26/2021 began feeling weird, during the night fever began could not move out of bed took temp 104, took Tylenol, began vomiting, chills teeth chattering, dizzy, the fever broke on Sunday then chills teeth chattering unable to eat drank only Gatorade and some soda felt nauseous. Began feeling a little better on Monday 3/1/2021, today is Wednesday 3/3/21 feeling better able to eat and sit up and walk from bedroom to living room. Still feeling weak not myself staying close to home
got vaccinated and got them shingles again / Suspected vaccination failure; got them shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccinated and got them shingles again / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them shingles again).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient's neighbor via interactive digital media. The patient was a physician. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
I experienced shortness of breathe, chest tightness, and chest pain that began a month after receiving dose 2. These symptoms of chest pain and chest tightness were intermittent, but the shortness of breath increased over time. I was an avid hiker in decent shape prior to receiving dose 2. My doctor had been monitoring my symptoms after my labs came back normal. On 05/04/2022 I went to the ER thinking that I was having a heart attack. They did and EKG, labs, chemical stress test, chest x-ray and after testing they suspected it was a micro vessel even and I was given Nitro. I took Nitroglycerin 05/12/2022 for the pain again. I was placed on half time for work as well, and I've been very fatigued. I have a follow up appointment with my Primary Care Physician on 07/21/2022 for these tests and symptoms. The shortness of breath has still not resolved, fatigue, and chest tightness and pain are still intermittent.
Severely sore arm starting within 4 hours. Still significant 36 hours later but only mild after 48 hours. The day after shot but resolved within 36 hours. Fever overnight after shot beginning 14 hours after and resolving 18 hours after shot.
Possible rebound Covid; Possible rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "asthma" (unspecified if ongoing); "triple negative breast cancer", start date: Dec2019 (unspecified if ongoing), notes: triple negative breast cancer (treatment completed Dec2019.; "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: almonds" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Betadine, reaction(s): "Known allergies: betadine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Possible rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: rebound.  No follow-up attempts are possible. No further information is expected.
Patient received PREVNAR 13 inj on 1/13/16, site became very painful 2 days later and continues to be painful almost 2 months later. Patient referred to primary care physician.
Blood pressure went sky-high/Still had occasional high blood pressure; Blood pressure went low; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure), HYPOTENSION (Blood pressure went low) and COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 061E21A, 038A21A and 007M20A) for COVID-19 vaccination.     The patient had no allergies.  Concurrent medical conditions included Low blood pressure.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure) and HYPOTENSION (Blood pressure went low). In 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIFEDIPINE at a dose of 10 milligram. At the time of the report, HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure) had not resolved and HYPOTENSION (Blood pressure went low) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 and 140. On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  This event caused patient to visit the emergency room , they monitored her and said her blood pressure was 170 . They monitored her until it was on 140 and then she got released.  Company Comment: This is a spontaneous case, concerning a 49-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected of COVID-19, in an unknown date, in the context of the administration of the second booster dose of the mRNA-1273 vaccine (of a correct primary dose administered). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-646305 (Patient Link). Sender's Comments: This is a spontaneous case, concerning a 49-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected of COVID-19, in an unknown date, in the context of the administration of the second booster dose of the mRNA-1273 vaccine (of a correct primary dose administered). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Received 3rd Shingrix shot on 11-16-2022, had first two shots on 4/25/2022 then 7/2/2022, when asked what shot in the series she was here for, she stated second dose. It was later discovered already received two doses .
After receiving the second dose of the vaccine, I began experiencing mild/moderate wheezing. I was seen by my primary care doctor and diagnosed with asthma. I have not had wheezing at any point prior in my life.
Shortness of breath, fever, chills, body aches, chest pain, Low oxygen level,.
Is mild to moderate swelling all over the body normal; three vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Is mild to moderate swelling all over the body normal) and EXTRA DOSE ADMINISTERED (three vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Is mild to moderate swelling all over the body normal) and EXTRA DOSE ADMINISTERED (three vaccine). At the time of the report, SWELLING (Is mild to moderate swelling all over the body normal) outcome was unknown and EXTRA DOSE ADMINISTERED (three vaccine) had resolved.            No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
07/28/04: Grandmother called, child spent the night with a friend while at friends house, broke out in a rash on back.  Itching and states "trouble breathing last night". Child is still at friends house called her grandmother who called nurse.  Counselor and phone # for CDC. Take Benadryl as needed. Deny distress at this time. Client took Benadryl (next day), rash stayed 2 days, no other symptoms.
extreme fatigue; nausea; daily headaches; muscular pain for 3 months; Later hypertension/ extreme hypertension; SVT; This is a spontaneous report from a contactable physician (patient) reporting for himself. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, at 50 years old, on 16Dec2020 10:00 (batch/lot number: EK5730) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included allergy (Sulfa, H1N1 vaccine) from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 (at 12:00am), the patient experienced extreme fatigue, nausea, daily headaches, muscular pain for 3 months, later hypertension, and svt (supraventricular tachycardia). The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Patient also had treatment for extreme hypertension. The outcome of the events was not recovered. The events were reported as serious, life threatening illnesses (immediate risk of death from the events). Since the vaccination, the patient has been tested for COVID-19 on an unknown date using Nasal Swab test and patient tested negative.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Fatigue, Nausea, Headache, Myalgia, Hypertension, Supraventricular Tachycardia. 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.
aching legs lower torso; cold like sx; sore throat; feverish; t100 on 12OCt93;
MOTHER RETURNED WITH STUDENT AT 1:00 PM STATING THAT HE HAD A HEADACHE. DENIED MUSCLE ACHES, DENIED UPSET STOMACH. TEMP 97.8.  MOTHER STATED THAT HE DID NOT EAT OR DRINK WATER THE ENTIRE DAY BEFORE THE HEADACHE STARTED. PATIENT STATED THAT AFTER EATING LUNCH HEADACHE WENT FROM AN 8 TO A 5 ON THE PAIN SCALE. STUDENT RETURNED TO THE CLINIC ON 11-2-17 AND STATED THAT HEADACHE WENT AWAY ON 10-30-17 AND THERE HAVE BEEN NO FURTHER ISSUES.
heart attack; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in approximately January 2018, the pt was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for the prevention of shingles. On 30-MAR-2018 (also reported as shortly after receiving the vaccine), the pt suffered a fatal heart attack as a direct and proximate result of the zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt suffered painful injuries, damages, and wrongful death. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury and wrongful death. It was reported that the pt incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX). The causal relationship between the event was reported as related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: heart attack
I had tender areas on the inside of my left leg starting about mid or late March in the upper thigh region and some aching in the inner aspect of the calf portion of the leg. This became worse over the Easter weekend and I went to  clinic on April 6, 2021. I had a superficial blood clot just above the knee on the inner aspect of my left leg. After that appointment the redness and soreness and very hard feeling of the veins extended up my leg 8 to 10 inches. I did not have a blood clots in the deep veins. I have had some varicose vein?s  and surgery for such about five years ago. The clinic did not say the clot was due to the vaccine but I had no injuries, no recent surgeries and nothing unusual that would have caused the clot other than the vaccine