chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 24-APR-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported). On 08-MAY-2013, a second dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. On 19-NOV-2014, a third dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. On 21-JAN-2015, a fourth dose (extra dose administered) of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reproted) was administered. On 27-MAY-2015, a fifth dose (extra dose administered) of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-JUN-2008, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 658023/0824U with expiry date of 25-MAY-2009. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
SWEATS; SORENESS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On APR-2021, the subject experienced sweats. On APR-2021, the subject experienced soreness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweats, soreness and nausea was not reported. This report was non-serious.
Pt received first dose Moderna, immediately started complaining of throat tightening and lip swelling.  Epi pen 0.3mg, administered, and Diphenhydramine 50mg IM.  No stridor, wheezing, visible swelling or any other objective findings.  EMS called and responded within 5 minutes, patient was transported to the hospital.
This is a spontaneous report from a contactable male consumer via a Pfizer-sponsored program. A male patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unknown route of administration, on Feb 16, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. After the second shot of vaccine, patient was home and his leg below the knee had a little bit of a problem. His ankle had trouble like stiffness. The outcome of the event: unknown (at the time of this report). Information on the lot/batch number requested. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
Subsequently the pt developed "hepatitis-like" symptoms. The pt sought unspecified medical attention. Additional information has been requested.
Soreness in left arm that got progressively worse to the point where I could not use it.  Extremely painful.  Episode of dizziness which could have been due to incense during Christmas Eve church service.  After putting my head between my knees, it passed.  After almost 24 hours, the pain is getting better, but my arm is still very sore and painful.
Patient reports swelling and bruising that began the evening of the vaccination and continued to progress over 48 hours to soft-ball size and no fever.  Patient was seen at 48 hour mark at a Urgent Care.  They advised the patient to ice the area and take Motrin.  Patient is to return to Urgent Care if symptoms do not improve or worsen in the next 48 hours.  They state that they suspect the vaccine was administered too low.  Internal reviews and re-education measures are in place with the administrator at our facility.
The next morning he had a full seizure and was hospitalized at an unspecified hospital; This spontaneous report was received from an unspecified reporter via a company representative, and refers to a 16 year old male patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided).         On an unknown date (reported as "the next morning"), the patient had a full seizure and was hospitalized at an unspecified hospital.      At the time of reporting, the outcome of seizure was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the reported seizure was not provided.  Upon internal review, the event seizure was determined to be medically significant.
i suffered two DVT's in my left leg... These occurred 2.5 weeks after second Moderna vaccine.  I have a history of DVT and PE 20 years ago....I am on Coumadin... Coumadin was considered a fail and now I am on Xarelto.
Left upper extremity redness, itchiness, and swelling. Recommended to use ice pack to site, take Benadryl and ibuprofen.
Received the vaccine on the morning of 1/13/2021 and started feeling fatigued the night of 1/13/2021. My arm the injection was given in was swollen and raised and red and warm to the touch . The swelling lasted for about 5 days and started on the eve of the injection day. The next morning, 1/14/2021, I woke up with bone pain, body aches, fatigue, and a swollen lymph node on my left lower neck. I had chills, but never ran a fever. I also suffered from headache on 1/14/2021. On 1/15/2021, I woke up and all symptoms had resolved.
Lethargy, intense arm pain at injection site within 4 hours of injection 24 hours after injection: general malaise, moderate headache/migraine. 36 hours after injection malaise was gone, then resurfaced with mild headache at 48 hours.
RE-activated EBV; lasting lymphadenopathy "all over '' the body in different areas; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas) and EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphoma in 2019, EBV infection and Stem cell transplant in 2019. Previously administered products included for Vaccination: Pfizer vaccine; for an unreported indication: Lymphoma in 2014. Past adverse reactions to the above products included Lymphadenopathy with Pfizer vaccine.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV). At the time of the report, LYMPHADENOPATHY (lasting lymphadenopathy "all over '' the body in different areas) and EPSTEIN-BARR VIRUS INFECTION REACTIVATION (RE-activated EBV) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) relapse of EBV+ Classical Hodgkin. In 2021, Biopsy lymph gland: no cancer (normal) No cancer. In 2021, Positron emission tomogram: abnormal (abnormal) Lymphadenopathy.         Caller stated that ,EBV was positive before auto transplant but vanished after it. It seemed to have deactivated after the vaccine. Caller had a FNA biopsy that showed a relapse of EBV+ Classical Hodgkin; But another subsequent "excisional" biopsy of another lymph node showing no Cancer. No concomitant medication were given. No treatment information were given.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant Follow-up received on 08-Nov-2021: Contains historical vaccine details .Updated new event.
Pt seen at Health Center with c/o facial rash. Pt noted to have vesicular like lesions around both nostrils and above top lip with 1 sm lesion to L cheek. Mother says pt received varicella vaccine on 12/9/09. Rash started 12/20/09. Itchy and painful. ATARAX ordered for itching.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2015, at age 11 years, the patient received the first dose of the HPV vaccination series. The nurse states that is unknown if it was GARDASIL (dose, lot # and expiration date were not reported) or GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The nurse states that the patient received the second dose in the HPV vaccination series on 27-FEB-2017 and it was GARDASIL 9 lot# M036059, expiration date 03-JUN-2019 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Pneumoccal vaccine given 11/06/2002. Within 5 mins site at right deltoid- throbbed, continued to hur that day. Arm swelled by that evening, 9-10 hours later, decrease pain and swelling on Thursday. Area of arm near elbow, front and back- red, warm, entire arm painful. Went to MD 11/08/2002
daughter has had serious hives all over her body; This is a spontaneous report from a contactable consumer. A 35-years-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 35-year-old at the time of vaccination), on an unspecified date as single dose for covid-19 immunisation and no adverse reaction experienced. It was reported that patient was perfectly healthy and has had serious hives all over her body after the she got the second Pfizer vaccine for COVID and this has gone on for three months. Nothing she has tried has worked and it's really a terrible situation. I think this is a more common occurrence than we know and wonder if you recommend anything. On an unspecified date, the patient experienced daughter has had serious hives all over her body. Patient received treatment for event. The outcome of event was unknown.  Information about lot/batch number has been requested.
At about 24 hours, headache fever and chills and muscle aches.  At about 48 hours sudden severe confusion.  Unable to construct and speak a sentence.  Was unable to think to grocery shop and had to go home  Symptoms continued woth gradually lessening frequency over the course of the next 3 weeks to 3 months.
Left thigh redden, hot to touch at injection site with swelling, no fever, no rash, no difficulty breathing, reported 2/2/09 TX.  Benadryl ETix 120 mg 2.3 tsp every 4 hours, cold compress to site, rest.
Fever, itching very bad.  Stinging, rash , chills , headache. In bed for a week.  Had rash for several days.
pt recv vax 3JUN96 & 23JUN96 pt exp gen rash on back, head, neck, shoulders & chest consisting of fluid filled vesicles;no further details were provided;
medical assistant administered a Fluzone High-Dose to a patient who already had a Fluad injection on 25sep2019, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 89 years old female patient who received vaccines INFLUENZA VACCINE INACT SAG 3V [FLUAD] (not produced by Sanofi Pasteur lot number not reported via unknown route in the left arm) on 25-Sep-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AB, Exp. Date 01-May-2020 via intramuscular route in the left deltoid) on 22-Oct-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dementia.  It was a case of actual medication error due to extra dose administered.  It was reported that medical assistant administered a Fluzone High-Dose to a dementia patient and the patient had already had a Fluad injection on 25-Sep-2019.  At the time of reporting, no adverse reactions were 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 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.
While waiting in line she felt faint and collapsed - pt's brother grabbed her and lowered her to the floor. Placed pt with feet up gave water. Allowed to rest. Pt stated she felt fine (21 minutes later) - walked out with her brother. BP 118/69, HR 71, RR 16 Temp 97.8, O2 100% -- > 117/71; HR 66; RR 16
So far both menstrual periods since receiving the vaccine have been highly irregular. Periods began on 9/8/21 and 10/3/21. Both were a few days early when my cycle is usually 28 days like clockwork. More importantly, both period have been EXTREMELY heavy and have lasted twice as long as typical. The bleeding has been excessive and I've yet to receive my second dose because of how concerning this is.  have an appointment to discuss with my doctor coming up, but as far as I know I am 100% healthy otherwise.
Fainting, Stomach ache, and weakness. Ice packs back of neck and forehead.
Approximately 50 hours after receiving the second dose, I experienced angina in the area of the left cardiac artery . This angina lasted all day and into the night. It was gone by the following  morning.
she had sick stomach (nausea); she had sick stomach (nausea); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Illness at vaccination included: "nausea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "she had sick stomach (nausea)".  Additional information: Shortly after the dose, she had sick stomach (nausea). Someone told her that side effects don't happen right after the dose. It has happened to her after the first dose, yet it is worst this time around. She spoke to someone at the vaccination center who told her that it is a common side effect. She's wondering if it normal to have nausea and what is the time to onset of the side effect. In clinical studies, adverse reactions in participants 16 years of age and older included nausea (1.1%).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever ranging from 100.1F-102F Body chills Bodyaches  Headaches  Dizziness  Sorness and swelling at the injection site   Took Tylenol to treat fever and bodyaches
1. RECIEVED BOTH DOSES OF COVID VACCINE ON 01/08/21 & 01/28/21 2. HAD NEGATIVE RAPID COVID ON 02/04/21 AND NEGATIVE COVID PCR ON 02/05/21. 2. HAD HIGH RISK EXPOSURE TO COVID + PERSON ON 01/31/21 & 02/08/21AERZ 3. ICC VISIT FOR FOLLOWING SYMPTOMS: CHILLS, HEADACHE, SORE THROAT, COUGH, SHORTNESS OF BREATH, AND DIARRHEA X1 DAY.  4. TESTED NEGATIVE RAPID COVID ON 02/08/21.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. No Clinical concerns were reported.
3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 2022 with batch number 3AA9T and expiry date 20th April 2023) and Shingrix (2nd dose received on 1st May 2022 with batch number DC434 and expiry date 3rd June 2023).   On 14th October 2022, the patient received the 3rd dose of Shingrix. On 14th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Pharmacist reported that the patient inadvertently received a third dose of Shingrix today(day of reporting). The reporter consented to follow-up. Additional Supportive Information: The patient inadvertently received a third dose of Shingrix, which led to Extra dose administered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "scleroderma" (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing); "Immune compromised" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: most pain meds" (unspecified if ongoing); "Immune suppression" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; MESTINON; AZATHIOPRINE taken for immunosuppression, stop date: 04Jun2022; DYAZIDE, stop date: 04Jun2022; DILTIAZEM, stop date: 04Jun2022; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: (unspecified date) Low, notes: low O2; SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (10Jun2022) Negative, notes: By day 7 I was testing negative until day 9; (13Jun2022) Positive, notes: tested weak positive Day 10; (14Jun2022) Positive, notes: tested weak positive Day 10 and 11 (today) strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Felt better 6 hours after the first dose of Paxlovid. By day 7 she was testing negative until day 9 when she started with all the symptoms again and tested weak positive Day 10 and 11 (today) strong positive and feeling as bad as day 1. Paxlovid rebound for sure. Difficulty breathing and low O2. Trying to manage at home with inhalers and steroids but instructed to go to the hospital if it gets worse. Other medication received in 2weeks product received was Steroid, Immune suppression, Water pill and in 2weeks stopped on 04Jun2022. Paxlovid treatment started on 04Jun2022 and stopped on 08Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea. Thought to ?sit down before you fall down? then ?came to? next to toilet. Head resting on toilet seat. Had some bruising on cheek but don?t remember going to floor. Rest of day was okay with just the most common side effects. Never fainted before but not uncommon for me to be lightheaded with nausea. Most embarrassing...passed some stool.
Patient reports she started to experience feeling a sense of doom, stool incontinence, left-sided numbness, altered mental status in the early hours of 3/28/21. Of note, patient received her second dose of the Moderna vaccine on 3/25/2021 and felt poorly the day after with body aches and fatigue. The patient was admitted to ED with suspected stroke, but no ischemia or hemorrhage was shown on MRI. In addition, her blood pressure at the ER was 196/104 and her troponin was elevated and reached a peak of around 5. Cardiac Catheterization showed no acute disease but chronic and unsubstantial changes that did not require intervention.  An EEG from 3/29 was concerning for subacute seizure like activity and She was started on IV Keppra. MRI at the same time, also revealed a right-sided cavernoma. During her hospital stay, she had ongoing confusion and disorientation with hallucinations, concerning for an encephalitis. She also received 3 days of ceftriaoxone for a potential unseen infection, but cultures were negative and PCR for viral pathogens was also normal. She was seen to have leukocytosis but the cause was not determined. Eventually, she regained her baseline mentation with no residual deficits and was discharged on Keppra to follow up with neurology.
The first few days (06/06) she was extremely cranky and really lethargic, after that she broke out with a rash all over her trunk and it spread a bit.  I contacted the office and they informed me that she was just having a side effect and to continue watching her.  The rash lasted for four days before it began to get better.
Red sore eyes with mucous discharge.  Swelling of throat with difficulty swallowing.  Fainting, shock, profuse sweating, extremely low blood pressure, spike in blood sugar.
patient states after he left the store (exact amount of time late unknown) his blood pressure went to "over 200"
patient right arm with burning  and was swollen, warm and redness on the day after receiving injection.   seen by PMD on 4/5 and was prescribed Bactrim. per MD note:R arm + redness , warmth with spreading of erythema down and up arm, blotchy red area over chest wall
FLU LIKE SYNDROME, EXTREME PAIN AT INJECTION SITE, UNABLE TO MOVE ARM WITHOUT SEVERE PAIN.
Diffuse myalgias & arthralgias beginning within few days after influenza vax; has features of an atypical rheumatoid arthritis;