chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever  100F, chills, body pain from 11pm  till 6 pm the next day.  Vaccin was administered the same day at 10:30am
rash on the top of his foot and ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the top of his foot and ankle) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02821A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash on the top of his foot and ankle). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (rash on the top of his foot and ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
3 days after receiving the 2nd dose of the Pfizer vaccine, I experienced ever floaters large enough to cause concern and I went to the ER. Once there they discovered that my blood pressure was extremely elevated and I was in Atrial Fibrillation. They put me on blood thinners and admitted me overnight.  The kept me on blood thinners and put me in a heart monitor. The follow up to the eye doctor discovered  a detached retina that required emergency surgery to repair.
Fever. Chills. Nausea. Fatigue. Tachycardia. Body aches.  4 days.
The vaccine has been making break out in hives since Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: ER8735), in left arm and on 26Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 06Jun2021, outcome "not recovered", described as "The vaccine has been making break out in hives since Jun2021". The event "the vaccine has been making break out in hives since jun2021" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria.  Additional information: No. issues with Pfizer product and reported issue does not occur after use of Pfizer product. Dec2021, hives stopped for a month and then started up during the day and at random times. May have been infected by COVID. No serotyping done. No prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EN6203), in left arm, on 31Mar2021 at 13:00 as dose 2, single (Lot number: ER8730), in left arm, on 08Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (05Feb2023) Negative; (07Feb2023) Negative; (11Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: 1923798A) from 01Feb2023 to 05Feb2023. Clinical course: The patient first tested positive on 30Jan2023 with no symptoms. Then tested negative on 05Feb2023 and 07Feb2023. But again, tested positive on 11Feb2023 with cold symptoms, slight fever.
REALLY SICK FOR 2 DAYS; SEVERE BACK PAIN; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 for prophylactic vaccination. 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 really sick for 2 days, severe back pain, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really sick for 2 days, and the outcome of severe back pain, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211254498.
Random, sporadic pain sensation on sagittal and right parietal area.  Everyday, from 15 to more times a day.  The light pain sensation also brings dizziness. Some ocassions lack of balance.   NOTE:  Is not strong pain.  Able to continue activities, but uncomfortable. I waited for few days for this effect to pass. But, it continues after second dose. Has not stopped
Patient reported large area of swelling and redness and a small bruise site around injection area upon arriving at home at approximately 6:40 pm just after receiving injection. Reported this to her allergy doctor at a visit thereafter, reported to the pharmacy on 8/14/17. Was told by allergy doctor that this reaction seemed more pronounced than usual and to contact pharmacy where injection was given.
Immediately after the vaccine (within the first couple of minutes), I had loss of muscle (loss of strength) in my right arm and severe tenderness. That lasted to July, where it was really severe. It's not quite as severe now but still experiencing tenderness and there is still a little bit of loss of strength yet. It's not back to where it was. I have tried stretching, initially I tried ice, heat and ibuprofen. Those didn't help the symptoms.
pt recv vax 17SEP97 & the next day pt exp an inj site rxn consisting of a 3-4 inch red welt, irritation & itching;
rash; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and CHILLS (chills) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced RASH (rash) and CHILLS (chills). At the time of the report, RASH (rash) and CHILLS (chills) outcome was unknown.            No Concomitant and Treatment Medications Information provided   This case was linked to US-MODERNATX, INC.-MOD-2021-094798, US-MODERNATX, INC.-MOD-2021-095735 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-094798:Reportes case US-MODERNATX, INC.-MOD-2021-095735:
having fluid on her lungs; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient states after she received 2 COVID vaccines she started having fluid on her lungs from an unspecified date and has to have it drained regularly. Also started on Entresto and Farxiga (no diabetes), and diuretic. Pulmonologist advised to have kidneys checked monthly but patient does not think she has kidney problems. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history who on 29-JUN-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 08-JUL-2007 the patient was diagnosed with an outbreak of HPV.  The patient sought medical attention when she returned to the nurse's office for the second vaccination with Gardasil.  As of 28-AUG-2007 the patient had not recovered.  Additional information has been requested.
Achy; My joints were bothering me; Pain at the spot where I got vaccinated; Little bit of red at the spot/red spot has gotten bigger; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery in my right arm.). Concomitant products included IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Surgery, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she used a cold cloth on the site.
Around 6 pm on 7/31/18; pt noticed her right arm swelling, red, hot tender to touch. She ignored it at first and decided it would go away by next day. On 8/1/18, (morning), Sx still persisted and did not resolve. Still her arm was hot to touch, swollen, red and fluid accumulation on 8/1/18, she went to urgent care and was Dx w/cellulitis and was prescribed an antibiotic (KEFLEX) filled at pharmacy.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA011831.
5/15/2023 - 5/18/2023 (3 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: UTI (urinary tract infection)  Weakness  Acute cystitis without hematuria  Pneumonia of right upper lobe due to infectious organism  COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with PMH of GERD, GAD, HLA b27 spondyloarthropathy and ho presents today with cc of sob. She reports she has been having sob accompanied w chills since Saturday. Has also been feleing weak and fatigued.   In ED pts VS stable. Pertinent labs include: elevated wbc count, positive UA. Chest xray showing RUL pna. CT head, C-spine were unremarkable for any sign of acute traumatic process.  COVID was positive. CTA was obtained which does show a 7 mm pulmonary nodule which is recommended to have follow-up in 6 months.    The patient was on room air throughout her stay.  No steroids or remdesivir were initiated.  Patient was treated for urinary tract infection as well as pneumonia.  On discharge she was switched to levofloxacin to complete a 5 day course for the pneumonia.  During her hospital stay the patient did report having diarrhea after antibiotic administration, however that resolved prior to discharge.  The patient was feeling much better than when she 1st came in and she was instructed follow up with her primary care doctor for further monitoring.  The patient was discharged in stable condition.
This case was reported by a pharmacist and described the occurrence of injection site cellulitis in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix), plus a separate injection of 23-valent pneumococcal polysaccharide vaccine (Pneumovax) for prophylaxis. Medical history included cellulitis following prior receipt of concomitant administration of influenza virus vaccine and Pneumovax and sickle cell anemia. The subject received multiple unspecified concurrent medications. On 30 October 2006 at 9:00 a.m., the subject received a dose of Fluarix in the right thigh. On 30 October 2006 the subject also received a dose of Pneumovax at an unspecified site of injection. At the time of the concomitant administration of Fluarix and Pneumovax, 30 October 2006, the subject was hospitalized for sickle cell anemia. On 31 October 2006, 1 day after vaccination with Fluarix and Pneumovax, the subject experienced injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The subject's hospitalization was extended as a result of the injection site cellulitis and the pharmacist considered the event was disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with intravenous and oral clindamycin. At the time of initial reporting, 07 November 2006, the injection site cellulitis was ongoing. The pharmacist reported that she "does not know if the injection site cellulitis is due to the Fluarix or the Pneumovax".
he said that there was no vaccine in syringe; 1ml dose for first injection; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection). On 14-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Event added
Patient received Moderna at the age of 16 and it is only approved for 18 and above. No adverse reaction noted
Patient is resident of a facility, tested positive for Covid 19 on 08/21/2021, and started on isolation at facility. On 08/296/2021, nurse entered room and patient was found laying on his back and non responsive, with no pulse or respiration.  CPR was initiated, and CODE blue called overhead.  Patient expired.
FAINTING SPELLS/ SYNCOPE; DIZZINESS/ LIGHTHEADEDNESS; NAUSEA; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. The patients' heights and weights were not reported. The patients had no known drug allergies. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that, on 10-APR-2021, the patients experienced side effects which included fainting spells/syncope, dizziness/lightheadedness and nausea within 15 minutes or so after vaccination at a mass vaccination clinic.   The events were reported as serious by the reporter.   The patients visited a healthcare professional office for fainting spells/syncope, dizziness/lightheadedness and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting spells/syncope, dizziness/lightheadedness and nausea were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report from a health care professional concerns multiple adult patients of unspecified age and gender from a mass vaccination site who experienced fainting spells/syncope, dizziness/lightheadedness and nausea within 15 minutes or so after the Janssen COVID-19 Vaccine Ad26.COV2 had been administered. Given the close temporal relationship and the nature of the events, the events are considered possibly related to the vaccination.
A week after my second dose, my tempter was between 99.1 to 99.4 for seven days straight.  My normal tempter is 97.9.  I took Tylenol that did not help.  On May 21st, I had a miscarriage,  Went to the ER  (Keizer Bellevue).  They did the blood test, physical test, and 2 ultra sounds (external and internal).  I come from a long line with a history of mom's with zero history of miscarriages.
Patient presented to the ED with sharp, non-radiating chest pain & 1 episode of NBNB vomiting. EKG showed nonspecific T wave changes without ST elevations. Initial troponins negative, however repeat elevated at 0.31. Patient was taken to the cath lab. Findings revealed a left ventricle that was globally dilated and severely hypokinetic with an EF of 10-15%..Diagnosis: nonischemic cardiomyopathy. Patient will be referred to another facility where he will likely need myocardial biopsy.
vasovagal syncope occurred about 5 minutes after giving the vaccine. patient was out of it for about 5 to 10 seconds then came to. gave her cookies and water. she layed down for about 15 minutes and then felt much better and then left with her boyfriend when she felt good.
expired DAPTACEL vaccine that was given , Vaccine was Administered on 5/1/2022 but it expired 4/24/2022 with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 5 years old female patient who got expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].vaccine that was given on 01-May-2022 but it expired 24-Apr-2022 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 HEPATITIS A VACCINE INACT (HEP A IN VAC) for Immunisation.  On 01-May-2022, the patient received 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) (lot C5732AA, Exp date: 24-Apr-2022) via intramuscular route in the right deltoid for immunization.  On 01-MAY-2022 the patient developed a non-serious event of expired daptacel vaccine that was given , vaccine was administered on 5/1/2022 but it expired 4/24/2022 with no reported adverse event (expired product administered) (latency: same day ) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  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 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.
He had Covid one time and then he got the first vaccine and then he got Covid again.; He had Covid one time and then he got the first vaccine and then he got Covid again.; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: He had Covid one time and then he got the first vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He had Covid one time and then he got the first vaccine and then he got Covid again.".Clinical course: Is report related to a study or programme was yes. She has a Nurse calling for the Doctor in her office and the patient has been administered the first dose and he has got Covid twice and she is asking should they start the series over or start the second vaccine. Agent said the age group was 5-11 years. The product was the Pfizer Covid-19 vaccine. The caller clarified the details provided by the transfer agent. She clarified the only correction was he had Covid one time and then he got the first vaccine and then he got Covid again and he qualifies for the second dose and the Doctor wanted to clarify she did not need to start the series over or ok to give second dose. Caller asked for USMI number and said she would call back later. Caller declined to complete report. Is there a product complaint to report was yes. Caller said patient had Covid one time and then he got the first vaccine and then he got Covid again. Caller declined to complete a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Wednesday night fever 101-102 degrees, emesis et dyspnea pain at injection site, no redness.