chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second shot, I expected mild side effects and experienced some: mild headache, sore left arm around injection site, fatigue, brain fog. I was walking to my garage with a small package of papers when suddenly my lower back spasmed sharply. The pain was intense. I thought it would subside so I managed, with difficulty, to make it into my car. When I was seated in the car, the spasms subsided. I considered not driving to my two errands but decided that I felt well enough seated in the car to drive and deliver the papers to my tax preparer  and the carful of donations to Goodwill. At the tax office, I called an assistant to come to the parking lot to pick up the papers, which she did. At Goodwill, one of the attendants emptied my car. When I got home at about 10:50, I had to call my husband to help me into the house. I spent the next several hours in agony (11 on a scale of 1-10) with spasms, punctuated by absolutly not moving. The spasms were so bad I could not breathe. My doc prescribed a muscle relaxer, then the next day prednisone, which has helped. Today I will have an mri to determine if the spasms herniated a disc.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included: insulin dependent. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 in right arm in the morning for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced confirmed immunological vaccine failure. The patient underwent a Immunoglobulin G/Immunoglobulin M (IgG/IgM) COVID-19 combination antibody test, which resulted into negative antibodies (Ab).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210847388-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Vaccine Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
100.9 fever, trembling and shaking, joint pain, tired, couple spots of hives
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL9262), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Vaccine brand other=Moderna; vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 16Aug2023 to 20Aug2023. Patient had no known allergies; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported events 'Drug Ineffective' and Covid-19. Interchange of vaccine products might have played a causal role in the reported events.,Linked Report(s) : US-PFIZER INC-202300285826 same patient, different drug/event;
Pt received 5th dose DTaP (TRIPEDIA from Sanofi) on (R) thigh on 10/29/08. Woke up on 10/31 (<48 hrs) with red, itchy, hot enlarging rash at the vaccine site, had 5x inches indurated, hyperemia all around the vaccination site. RTC BENADRYL, KEFLEX given cold/warm compress.
20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.
This 54 year old patient presents for Arm pain and IZ. Onset: 4 days ago. Duration: 4 days. Severity level is 9. Location: bilateral shoulder. The pain is burning and deep. Context: there is no injury. The pain is aggravated by touch. The pain is relieved by massage. Associated symptoms include bruising, swelling, weakness and itching and red. Pertinent negatives include tingling in the arms. Addition information: Pt state received TdaP and flu on Monday and since then arms have developed knot and is irritating. Pt just received flu and TDaP in each arm. Both had reaction. Pt has had these vaccines in the past without allergic reaction. Now mild erythema and pruritus. Pt has not try taking BENADRYL or putting cream over site of injection. Denies fever or shortness of breath. IZ.
pt recvd vax p/2 pregancies & failed to seroconvert; No further details were provided;
dose of menactra given after the expiration date with no reported adverse event; Initial information was received on 26-APR-2022 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involves a 17 years old female patient who experienced dose of menactra given after the expiration date with no reported adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Apr-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot-U6921AB, expiry-17-Apr-2022) via intramuscular route in the left deltoid for immunization.  On 26-APR-2022 the patient developed a non-serious dose of menactra given after the expiration date with no reported adverse event (expired product administered) (latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event dose of menactra given after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Started crying a lot, she was irritable, then high fever appeared up to 104.5 but never low than 102. She stop eating, crawl and when you call her she barely open her eyes. The eyes looked teary, the nose and cheeks red, chills, tremors, she was so weak.
Information has been received from a LPN concerning a 36 month old white male with an unknown medical history (previously reported as no medical history and no known drug allergies) and an unknown history of chickenpox who on 02/01/01 was vaccinated SC in the right lower thigh witha  first dose of varicella virus vaccine live (Lot # 9043905, invalid for this product). There was no concomitant medication. It was unknown if the pt was ill at the time of vaccination, had any adverse events following prior vaccinations, pt was ill at the time of vaccination, had any adverse events following prior vaccinations, or had a recent exposure to chickenpox or herpes zoster. It was unknown if the pt developed a rash at the injection site or elsewhere within 42 days after vaccination because the pt was not given the vaccination at the reporters' office. On 02/03/03 the pt was seen in the office for shingles. The date he started with symptoms was not available. The affected area was described as a fine, red rash with raised bumps under the right arm, right back and side and up to the right shoulder. Clear vesicles on an erythematous base were noted on the right upper back, right chest and right upper arm per dermatology. The pt had a temperature of 98.2 at the time of the office visit. The maximum temperature was unknown. It was noted that a direct fluorescent antibody and PCR was not done at the reporter's office. The pt's pain was rated an 9 on a scale of 1 to 10. That same day the pt was seen by a dermatolgoist who confirmed shingles and treated him with acyclovir and aceptaminophen prn. It was also reported that the pt had "probable" shingles. On 02/07/03 the pt was seen in the office for a non-related left ear infection with no mention on his chart of the shingles. On 03/24/03 it was reported that there had been no further contact from the pt's parent and it was unknown if he had been seen again by the dermatologist. On 05/06/03 information was received from a LPN that the pt had recovered on an unknown date. No further information is expected.
Gave 1 shot 1 day past BuD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past BuD) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past BuD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 1 shot 1 day past BuD) had resolved. 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.   No concomitant product use was provided by the reporter.   No treatment medications were reported.
I had extreme bilateral throbbing leg pain; I had extreme bilateral throbbing leg pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old non-pregnant female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN5318), via intramuscular route administered in left arm on 13Feb2021 at 09:15 AM (22-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included Numbness, tingling, burning, hypersensitive, tourniquet feeling in thigh, cold leg and foot, extreme dull ache pain, pressure in leg, extreme leg weakness and Progressive neurological symptoms over the course of the past 8 months from 17Jan2021 and ongoing. The patient's concomitant medications were not reported. The patient previously took Percocet (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) and experienced allergies. The patient had not received any vaccine within four weeks. The patient was tested since vaccination. On 13-FEB-2021 12:15, 3 hours after Dose 1 of Pfizer vaccine, the patient experienced extreme bilateral throbbing leg pain. The patient was hospitalised for 3 days. Therapeutic measures were taken for the event using medications. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab testnegative on 01Sep2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: The event of Pain in extremity and Pain are assessed as possibly related to the suspect drug BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.
he tested positive after the 1st dose.; he tested positive after the 1st dose.; This is a spontaneous report from a Pfizer-sponsored program.  A contactable Consumer reported for his father.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Solution for injection, (Lot number and Expiration dates were unknown), via an unspecified route of administration on an unknown date, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that, his father (patient) has an appointment tomorrow for the 2nd shot of the vaccine. The patient had a COVID test yesterday and tested positive after the 1st dose. The reporter is asking to reschedule the 2nd dose of the vaccine. The patient underwent SARS-COV-2 test and resulted positive on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient states that her mouth became "raw" about 48 hours after vaccination.  States that some spots on the inside of her cheeks were so raw that the skin would peel right off.  States she had a lot of swelling inside of her cheeks and described them as "chipmunk" cheeks.
Student complaint of feeling faint and nauseas. Was pale and vomited x 1. Vital signs taken B/P - 112/70, HR - 72, PO 98 %.  Student stated he suffers from anxiety and felt anxious right before receiving the vaccine. Student asked to place head down between his legs and about 3 minutes later his color came back and stated he was feeling better. He was given water and a fruit snack bar.
Headache - treated with ADVIL, abated by Monday, 8/28/17 by noon, dizziness - treated with rest, abated by Sunday, 8/27/17 by midday feeling of discomfort in neck/chest - confirmed breathing was fine with dr visit at 3pm on 8/25/17 treated with rest, abated by Saturday, 8/26/17 by 5pm.
Narrative:  HPI: Patient is a 63 who presents for evaluation of itching eyes, feelin of nasal swelling immediately after receiving COVID-19 vaccination. Patient reports approximately 15 minutes after receiving vaccination, she started feeling as if her nostrils were swelling, her eyes were itching and her tongue "started to feel funny." Patient reports prior history of anaphylactic reactions to multiple allergens. She was given diphenhydramine 25mg IM once and transported to ER. At ER she was given diphenhydramine 50mg oral, famotidide 40mg oral, and acetaminophen 925mg oral. At ER patient reported 20 minutes after COVID vaccine her lips and tongue began to feel tingly and larger inside her mouth. She reported she has had reactions before to some immunotherapy drugs some years ago. She denied any symptoms of difficulty swallowing, wheezing, difficulty breathing, chest tightness, abdominal pain, nausea, vomiting, diarrhea, sweating, runny nose, eye itching, or any other symptoms at this time. Physical exam was unremarkable, no obvious swelling noted, no rash or hives noted, no secondary signs of allergic reaction, vitals remained stable, no hypotension or tachycardia. She was discharged home with instructions to continue taking diphenhydramine every 8 hours for 24 hours and to follow-up with primary care in 1-2 days.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose unknown, lot # L048849, expiration date: 04-FEB-2018, lot # M008551, expiration date: 02-JUN-2018, lot # M000442, expiration date: 31-MAR-2018). No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. On 28-AUG-2018, the patient was vaccinated with M-M-R II subcutaneously, lot# N023145, expiration date 24-AUG-2019 (dose of the vaccine was unspecified). It was reported that a dose of M-M-R II was reconstituted with 0.5 ml of Sterile Saline for injection, manufactured by Excelsior Medical, 0.9%, 5 ml, lot# 3129219, expiration date 01-DEC-2018 instead of sterile diluent. No adverse effect has been reported.
COVID+ on 9/28/21 s/p 2 doses of Pfizer (last on 3/19/21) & admitted to hospital
testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 28Nov2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Started packs love it within hours of testing positive; (08Jun2022) Negative, notes: I completed the 5 day course and tested negative; (11Jun2022) Positive, notes: 3 days later I once again had a scratchy throat and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient started packs love it within hours of testing positive. Patient had no more than a scratchy throat. she completed the 5 day course and tested negative. 3 days later she once again had a scratchy throat and tested positive. Patient  had achy body and head congestion with yellow mucus, runny nose and a mild sore throat the first day. Patient still sick 3 days later.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed tingling and numbness in the L forearm, volar side ring and small finger.  This is the same arm in which she got the vaccine.
My immune system was compromised; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation Solution for injection) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced "my immune system was compromised on an unspecified date. "Patient added, "I had an adverse reaction to the first one on April and the violent one where I thought I am going to die was on the second one" so, the patient's doctor told the patient to report it and that patient have a severe reaction to both doses and advised the patient to not have the booster shot since it will exhaust him/her. The reporter also stated, "I went to my doctor, my doctor told me to call to let the CDC know what exactly side effects I have". The seriousness of the event was non-serious. The outcome of event was unknown.  Follow-up(27May2021): New information was received from a contactable consumer includes: Reporter stated that the seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect was reported as no.   Information on the lot/batch number has been requested.
booster; off label use; Been with her granddaughter and just found out granddaughter tested positive for COVID; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included COVID-19 Vaccine (Manufacturer unknown, lot number was not reported) as dose 1 and dose 2 for covid-19 immunisation. The patient experienced reported booster and off label use on an unspecified date. On an unspecified date, she had been with her granddaughter and later found out granddaughter tested positive for COVID. She wanted to know if she needed to be concerned. The outcome of exposure to Covid-19 was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (29Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt. rec'd Hep A vaccine at O.V. on 03-14-16; new onset of fever 24 hours later (101 degrees max). Also presented with mild (Lt) eye erythema and scleral edema. Fussy; increased sleeping. Dx with fever, (Lt) conjunctivitis and URI (viral -vs- allergic) - ? adenovirus. TX with allergy OTC.
PATIENT ALMOST PASSED OUT ALMOST 5 MINUTES AFTER RECEIVING THE VACCINE. PATIENT  WAS RECOMENDED TO SIT AND SHE WAS OBSERVED  BY THE PHARMACIST AND PATIENTS MOTHER SHE REPORTED HAVING SOME VISUAL DISTEBASES AND RINGING IN THE EARS.
Maculopapular rash is arms, legs and trunk associated to unquantified fever that stated 5 days after immunization.  Treatment ZYRTEC 1mg/ml 2.5 ml by mouth daily.
Myalgia, Arthralgia, Fever & Diarrhea Narrative: GOING HOME EARLY FROM WORK
It turned red at the time of the vaccine up to the shoulder, red.  She went to the doctor who did not feel that it was the shot, but injection given wrong but was concerned that it might be infected.  Was nauseated, felt sick, chills.  Her energy level is still not there, and the entire arm hurts.
Information has been received from a physician concerning a patient (age and gender unknown) who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the patient experienced patient had unspecified reaction to measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Unknown if patient sought medical attention. No product quality complaint. Additional information has been requested.
Staring, dazed appearance for 4 hrs from 7-11 PM. Slept 11 PM - 3 AM, whining/crying just wanted to be held from 3-7 AM. (Completely NL from 8 AM 4/14/09, running, happy, eating well).
Persistent Muscle Ache/Pain reported by the patient. No treatment sought from anywhere, however pain has been uncomfortable for over one month. Patient reports discomfort when trying to raise arm.