chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 3 months old non pregnant female patient. The patient had non medical, drug and allergy history. On 15-JAN-1996 the patient was vaccinated with the first dose of RECOMBIVAX HB Injection (strength, dose, frequency, route, lot number and expiration date were not provided) to prevent hepatitis B, on 18-MAR-1996 the patient received the second dose of the vaccine and on 21-MAY-1996 The patient was vaccinated with the third dose. The patient had non concomitant medications.   On an unspecified date, in May of 2017 (reported as "last week") the patient was performed a Hepatitis B antibodies titer and the result was negative. The patient did not receive any treatment. The outcome of the patient was unknown and the causality assessment between RECOMBIVAX HB and negative Hepatitis B antibodies titer was not reported. Additional information has been requested.
After having my second dosage on Thursday (06/03/2021) at 4:30pm I was feeling ok until Friday (06/04/2021) morning I was really achy and could not get out of bed because my whole body was hurting. I was experiencing pain in my joints and could not bend my fingers from either hand. I was having slight fevers on and off.  The pain in my joints and aches in my body continued through Sunday evening 06/06/2021. On Monday 06/07/2021 I was still achy but was able to be more mobile and was almost back to my normal state of being. On Tuesday 06/08/2021 At 9:30pm I went to take a shower and started feeling like I was beginning to feel unwell. I started to feel light headed and  like I was going to faint so I sat down. I went to lay down for about 15min and started to feel better by 10:30pm.
I did not feel any pain, or see any redness the day that the shot was administered. While at work the following day, I noticed that my upper arm felt sore. I also noticed that there was a raised red bump where the shot was administered. The bump felt hard to the touch.
STARTED WITH PAIN IN THE WRISTS AND WITHIN A DAY BOTH HANDS SWELLED UP AND HAVE BEEN SWOLLEN EVER SINCE
marked induration/erythema/warmth over lt upper arm (site of inj) lasting >1wk w/associated myalgia/h/a, transient rash to wrist & paresthesia lt arm;
Caused my neck to hurt; inappropriate route of vaccination; Pain; Tingle of electicity at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE DYSAESTHESIA (Tingle of electicity at the site), NECK PAIN (Caused my neck to hurt) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (inappropriate route of vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LEVOTHYROXINE SODIUM (LEVOXYL) and VITAMIN D3 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Pain), VACCINATION SITE DYSAESTHESIA (Tingle of electicity at the site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (inappropriate route of vaccination). On 04-Feb-2021, the patient experienced NECK PAIN (Caused my neck to hurt). On 03-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (inappropriate route of vaccination) outcome was unknown. At the time of the report, PAIN (Pain), VACCINATION SITE DYSAESTHESIA (Tingle of electicity at the site) and NECK PAIN (Caused my neck to hurt) outcome was unknown.            Treatment information provided was Patient took Tylenol, Advil, and Valium.   This case was linked to MOD-2021-027391 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: NNI follow up recieved
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment  medications were reported
Syncopal episode, convulsions (rule out seizure disorder). Patient was sent to ER via ambulance.
N/V and HA within 24 hours after getting 2nd Anthrax.
Mixed Connective tissue disease; significant fatigue; no appetite; foggy head; isolated palpitations; lost 15 pounds; This is a spontaneous report from a contactable physician. A 74-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date that had COVID last November, Mild fatigue only. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) as dose 1, single on Mar2021 (at the age of 74-year-old) for covid-19 immunisation without problems. The patient experienced mixed connective tissue disease, significant fatigue, no appetite, foggy head, isolated palpitations, lost 15 pounds. The patient underwent lab tests and procedures which included cardiac workup: unknown result, Lab work: unknown, weight: lost 15 pounds. The outcome of the event for significant fatigue, no appetite was recovering and outcome for foggy head was not recovered, rest all event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events  Mixed connective tissue diseaseand suspect drug BNT162B2 cannot be excluded 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.
Loss of taste; This is a spontaneous report from a contactable consumer (patient) through a -sponsored program, SUPPORT. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 28Feb2021, the patient had loss of taste. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
an expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 1 years old female patient who received an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine (Fluzone) for Prophylactic vaccination.  On an unknown date, the patient received 0.25 ml (dose 4) of suspect HIB (PRP/T) vaccine (strength - standard, frequency - once, lot UJ648ABA, expiry date - 16-Mar-2023) via intramuscular route in site for prophylactic vaccination which was expired with no reported adverse event (expired product administered) (latency: same day) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
The patient experienced redness, swelling, and erythema about one inch below injection site. Patient is self treating with TYLENOL and ice pack. Symptoms started the morning after she received her shot and were still present at day 3.
gave expired Daptacel to a child, no ae; Initial information was received on 03-Feb-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 16 month old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 03-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE once (lot C5367AA, Expiry date 30-Jan-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  The staff member just gave an expired Daptacel to the patient. The medication expired on 30-Jan-2020.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient said the shot hurt during administration of the pediatric COVID-19 vaccine. She put her head down by her legs while seated in the chair. She then rolled over onto the floor. Patient came to within seconds. She laid down for a couple of minutes, then sat back up and drank some water.  Then waited 30 minutes for observation. Likely injection anxiety.
Fatigue; Second dose 14-APR-2021/ Booster 1 19-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 19-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021) outcome was unknown.            No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Swollen Lymph nodes under my right arm pit, and right side of face the day after my first vaccine dose. Currently, it is day 2 since my vaccine and under my arm pit my lymph node is the size of a golf ball, and hurts. concerning was the continuous ringing in my right ear for hours. My ear felt full and kept ringing for hours after I received my first vaccine dose. I got the first Moderna vaccine around 7am, and abiut 830 pm the same day of my initial vaccine dose, my ear began to feel full and had a piercing ringing sound almost all night, which prevented me from a good nights sleep. Finally, it went away by 6am the next day.
Severe headache; Throwing up; Nausea; Body aches; Fatigue; A spontaneous report was received from consumer who is a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, throwing up, nausea, body aches and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported.  On 30 DEC 2020, the patient received their first dose of mRNA-1273 (Batch number: unknown) intramuscularly in her right arm for prophylaxis of COVID-19 infection.  On 30 DEC 2020, the patient experienced severe headache, throwing up, nausea, body aches and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, severe headache, throwing up, nausea, body aches and fatigue, were considered resolved; Reporter's Comments: This case concerns a 49-year-old female who experienced nonserious expected events of headache, pain, fatigue, nausea, vomiting. Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A nurse reported the occurrence of injection site pain in a 50 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received her third injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to complain of "severe" injection site pain. The event resolved after an unspecified period of time. The reporting nurse considered the event to be possibly related to Engerix B administration.
Information has been received from a registered nurse concerning a 16 year old female who on 09-AUG-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy also given on 09-AUG-2007 included MENACTRA. On 10-AUG-2007, "24 hours after receiving GARDASIL", the patient experienced swelling in her tongue and throat. The patient was admitted to the emergency room. On an unspecified date, the patient recovered. Additional information has been requested.
STILL WARM/HOT; CENTRAL AREA IS ABOUT 1.5CM HARD; INJECTION SITE SWELLING; TENDER TO TOUCH; INJECTION SITE REDNESS; INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included controlled mild hypertension, controlled mild cholesterol, and mild reactive airway disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced injection site reaction. On 27-JUL-2021, the subject experienced injection site swelling. On 27-JUL-2021, the subject experienced tender to touch. On 27-JUL-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced still warm/hot, and central area is about 1.5cm hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site reaction, injection site redness, still warm/hot, injection site swelling, tender to touch, and central area is about 1.5cm hard. This report was non-serious.
Approximately 6 to 7 hours after vaccine administration, patient developed acute onset of fever, emesis x 1, and rapid breathing.  All symptoms resolved spontaneously.  Patient had normal exam when seen about 8 hours after vaccine administration.
Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)
Shoulder pain has continued since the event. Severe tinnitus has continued since the event. For about 2 months following injection, I experienced dizziness, shortness of breath and heart palpatations.
On an unspecified date, the pt received her 1st injection of Lymerix and about 1 week, post vax, she experienced extreme pain in her joints. She has also "since tested DR4 possitive". The most recent information received on 2/17/2000, does ot provide outcome.
No bowel movements, foul smelling flatulence, panicky latch on at the breast, rapid head and eye movements left to right, grasping fists quickly.
Acute onset, subjective throat tightness and numbness. Recurred with second dose. No treatment, vital signs stable.
Left shoulder joint pain very extreme went to ER three (3) times and saw personal doctor within three weeks, pain meds, 2 injections, still no relief of numb finger and bicep arm weak.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Had injection administered, pt walked from exam table to chair, gave sibling her injection went to sit and start paperwork. Pt head went down, slumped in chair, eyes rolled back and arms started shaking with seizure like activity. Help was summoned, pt was addressed by pediatrician. Seizure lasted about 30-35 seconds. Patient recovered with no lingering symptoms, physician discharged home with directions to call if symptoms returned.
Patient developed rash on shoulder after receiving PREVNAR 13. Rash was still present 2 weeks later. Patient saw PCP and received a steroid shot.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients. On an unknown date, the patients were vaccinated with VARIVAX (Merck) that were improperly stored (lot  # J009004; Expiration date 19-JUL-2015) (lot # K005176; Expiration date 10-APR-2016) (lot # J009987; Expiration date 12-AUG-2015) (lot # K011799; Expiration date 21-AUG-2016) (lot # K011082; Expiration date 08-AUG-2016) (lot # K016130; Expiration date 23-SEP-2016) (lot # K021936; Expiration date 10-NOV-2016) dose and route of vaccination were unknown. No adverse events reported. This is one of two reports from the same reporter (1507USA001059). Additional information has been requested.
MILD REACTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported, and dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Off label use. 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 patient experienced mild reaction, and off label dosing frequency. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild reaction and off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220945170.
Temperature 102 degree all night.  1/18/07 Received medical records from hospital which reveal patient seen 10/30/06 in ER for fever 102.2, cough & vomiting following vax day before.  LP done in ER & patient to be admitted for acute pyrexia & r/o sepsis.  Received multiple IV antibiotics in ER.  Parent refused admit & patient was d/c to home AMA.
All died within the 5 weeks after there first shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for six patients.  This  is the sixth of six reports.  An elderly patient of unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021, as single dose for covid-19 immunization. The patient' s medical history and concomitant medications were not reported. Patient was residential home with 5 other elderly residents patient. Reporter stated that they all got vaccinated with the first Pfizer shot (Confirmed as Covid 19 vaccine) and they all died within the 5 weeks after their first shot. By 18Mar2021 these residents in the house would have died. The reporter stated that they should not have died they just died. The reporter doesn' t know if it was a side effect, he knows if it was a reaction but all of the six residents that got vaccinated died within their first vaccination shot. Within the 5 weeks after the first vaccination. Reporter stated they died in their sleep supposedly. They died in their sleep.  Outcome of the event was fatal. It was unknown if an autopsy was done.  The information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter/SD/AE, different  patients; Reported Cause(s) of Death: died within the 5 weeks after there first shot