chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; MASSIVE HEART ATTACK; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, form of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, form of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced massive heart attack  (Dose number in series 2). On an unspecified date after 28 days of Janssen booster, the patient died (Dose number in series 2). The date of death and cause of death was unknown. It was unknown whether an autopsy was performed. It was reported as " My husband died 28 days after his J&J booster. massive heart attack gone in minutes. I will never get another one". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221242060 -died. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.   20221242060 - massive heart attack.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Slight arm soreness and headache; Slight arm soreness and headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 1st of 2nd report.  A 73-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05Mar2021 02:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunization.  The patient's medical history and concomitant medica-tions were not reported. He took her dose 1 Caller, and her husband had the first dose via an un-specified route of administration, administered in Arm Right (Batch/Lot Number: EN6200) as sin-gle dose for covid-19 immunization.  Caller and her husband had the first dose vaccine on 12Feb and are scheduled to have the second dose on 12Feb2021 2:15 She called the vaccination site and they told her that they could only be given the vaccine at the end of Mar. She is concerned since it will be 6 weeks after the first dose rather than 3 weeks. Is it ok. Had the first dose on 12Feb2021 and scheduled to get the second dose on 15Mar2021 but the caller stated that she tried to call the facility to confirm it, but the available date for her to take the second dose will be by the end of Mar as per the Facility. Caller and her husband had the first dose of the vaccine. she stated that her husband and herself both got the shot on the same day and experienced slight arm soreness and headache on Mar2021. The outcome of the events was recovered on Mar2021  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021201092 Same Vaccine/event, different  patient
Abdominal pain, diarrhea, night sweats.  All disappeared on following day
Mainly stomach problems. Things that messed with my abdomen area; Nausea; Chills; Patient received First dose of modenra Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine). At the time of the report, GASTROINTESTINAL DISORDER (Mainly stomach problems. Things that messed with my abdomen area), NAUSEA (Nausea), CHILLS (Chills) and WRONG PRODUCT ADMINISTERED (Patient received First dose of modenra Bivalent vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 11May2021 at 17:15 (at the age of 66 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. The patient has no other medical history. The patient was not pregnant at the time of vaccination, has no allergies and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient has no list of any other medications the patient received within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 at 19:00, the patient experienced a rash at the injection site on left arm, neck, face, chest and stomach. Rash was itchy and was red. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.  Information on the lot/batch number has been requested.
Immediately killed her arm/arm got so bad/she could not use it or anything; Maybe needle went in wrong spot/needle went pretty high; Felt like HCP stabbed a rock in her arm; Arm in pain, could not use her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm in pain, could not use her arm). On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm). At the time of the report, LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Patient went to see an orthopedic doctor, and doctor said her arm looks okay but may the needle went in the wrong spot, it went pretty high.   This case was linked to MOD-2021-353568 (Patient Link).
DTaP was given instead of TDaP. TDaP should have been given due to patient's age. Health Department was contacted and instructed me to fill out VAERS form. Attempting to contact patient to inform. Patient has not yet called back.
My arm where vaccine was administered is itchy,  red and swollen.  Started last night.  When I first got the vaccine my right hand was tingly and later that afternoon it radiated down to my right foot. That feeling was gone the next day. I had headaches for a few days afterwards.
Prevnar caused inflammation, warmth and redness to upper thigh from knee up-advised cool compress and Benadryl as needed.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Curry" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Pituitary adenoma" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Major depressive disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid treatment from 01Feb2023 to 06Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patient received his second Moderna dose on day 18; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
pt recv  vax 9/30/97 & became preg LMP 10/15/97;expected date of delivery 7/22/98;pt had two sonograms during preg which showed placenta previa & oligohydramnios;
Hospitalization for syncope and COVID-19 on dates 5/6/2022- 5/8/2022. Treated with cholecalciferol, ascorbic acid, zinc.
The patient experienced injection site redness after receiving the ZOSTA VAX vaccine 5 years ago; for shingles; This spontaneous report was received from a female patient of unknown age referring to herself. Information about medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was not provided.  On an unknown date in 2014 (reported as five years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (one single shot, route of administration, lot# and expiration date were not reported) for shingles (product use in unapproved indication), and in approximately 2014 after receiving zoster vaccine live (ZOSTAVAX), the patient experienced injection site redness. The redness went away within a couple of days. The causality between the event and zoster vaccine live (ZOSTAVAX) was not provided.
they gave an expired IPOL and it was expired for 14 days. lot number and expiration date she states that she doesn't have it and that it disappeared off her screen with no ae; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from an other health care professional and consumer non health care professional via Medical Information (MI) number: 00809601.  This case involves an unknown age and unknown gender patient who was administered an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (Expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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 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 described feeling weak/fatigue, having fever and joint pain starting approximately 1 day after receiving vaccination. Symptoms lasted approx 3 days. Patient did not self medicate or seek treatment.
She had a fever of 103.5 or higher for 3 days. Then she slept for a day, if she wasn't sleeping she was staring off into space. She then came down with red raised bumps all over her body. She had those for about 5 days.
Elevated white cell count of 11800; This spontaneous case was reported by a physician and describes the occurrence of LEUKOCYTOSIS (Elevated white cell count of 11800) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced LEUKOCYTOSIS (Elevated white cell count of 11800). At the time of the report, LEUKOCYTOSIS (Elevated white cell count of 11800) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, White blood cell count: 11800 (High) 11800 count.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height 7.1 foot. No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2022-488826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2022: Follow-up received, contains updated patient demographics and patient route of administration of suspect vaccine.
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium
About 3 weeks after receiving the 2nd dose, I started to experience severe palpitations of my heart that occurred everyday, all day long. Had to see a cardiologist and diagnosed with supraventricular and atrial tachycardia/arrhythmias. Put on metoprolol succinate 25mg 1 QD to try and control rhythm. Worked for about 2 months, then during evening after work, rhythm not controlled so had to add a 25mg tab in evening (now on metoprolol 25mg twice a day). Seeing cardiologist again end of June.
Rash X3 days, Swelling at site, BENADRYL 25mg TID PRN prescribed to patient.
Patient received vaccine on 4/1 at 1130. Patient developed a metallic taste in his mouth on 4/2 while eating dinner. Patient vomited twice 4/3 in the morning. Metallic taste has not resolved.
Patient had a rash starting right below her deltoid muscle extending to the folds of her arm going anterior in the arm. However the site of the immunization remained clear. Both the shots were given on the same arm and the area of administration did not have any redness of swelling.
Bad headache, sore back, sore neck, sore shoulder, sore arm, dizzy, stiff muscle in arm,
Info has been received on 6/6/02 from a nurse practitioner concerning a 23 y.o. female who was vax'd w/a 1st and 2nd dose of Hep B vax recombinant. Subsequently, a few hrs after each vax, the PT had panic attacks. It was reported that "this lasted for a short period of a few hrs." The PT was treated w/clonazepam (Klonopin) and paroxetine HCl (Paxil), "after the panic attacks started." The PT sought unspecified medical attention. Add'l info has been requested.
Case number PHEH2014US003878 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration).Case number PHEH2014US003967, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up received from a pharmacist on 01 APR 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) which she tolerated well. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A, and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the right deltoid on 07 JAN 2014 at 16:45 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up received from pharmacist on 01 APR 2014: Updated vaccination history, time and site of vaccination.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Within several minutes of injection my vision became very blurry and I was lightheaded. A nurse took my vitals and they were normal, although the BP was on the low side (I believe 95/54). They had me lie back in a recliner and kept checking me. After about 45 minutes my vision cleared and I sat up. About 10 minutes later I walked within the hospital to be sure I was safe to drive, and I was. The doctor on duty did also check me before I left.
No symptoms other than slight pain for 7 days.  Evening of 1/15/2021 my upper arm was itchy - I scratched it once (I was wearing a heavy coat at the time) without thinking.  It immediately began aching.  When I got home I found a bright red group of bumps on my upper left arm.  It remains itchy and achy at this time which is 3 days later.  I also report that when the vaccine was administered, I felt a hot sensation in my arm. I tried phoning the CDC and the Moderna reporting sites to no avail,
Pt. admitted to hospital 10/27/11. About 4 wks prior had begun feeling weak, stumbling, fatigued. Has lost 15-20 pounds over past mo. Past 3-4 days family reported no verbal responses. Sleeping 16 or more hrs/day. Treated with Acyclovir IV.
Headache, Fever, Nausea Vomiting,  CHILLS,
within one minute of receiving the influenza vaccine, patient had choking/gagging on secretions, emesis, alteration of consciousness with eyes rolling back in head.  she had an urticarial rash on both thighs and was having difficulty breathing with perioral cyanosis and pallor.   she did not have wheezing or stridor.   she was treated with epinephrine injection, oxygen and then oral diphenhydramine.  she recovered quickly and was observed for 2 hours without further adverse reaction.
On 3-3-11 received immunizations --> Hep A, MMR, PENTACEL, VARIVAX. On 3-5-11 pts mom called to report mild local reaction at injection site --> red, hard, warm to touch.
Three days after receiving flu shot? sores stated to develop in one area and resolve then appear in another area. First on tongue - resolved and then inner lip - resolved, inside of left nostril, outside up; all have resolved with med. x 2 1/2 wks.