chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient describes a seizure episode that occurred this morning.  Patient was feeling fine at her usual health, went and got the Johnson & Johnson vaccine.  Was monitored for minutes afterwards.  Patient stated soon as she got the vaccine, it just made her feel little bit funny but not really able to describe the symptoms further.  Went back to work and spoke with her coworker, and walls during the conversation, patient had approximately 2-minute seizure episode in which she became unresponsive, generalized shaking patient did not fall on the floor she was still in the chair.  She had a brief cessation of the seizure but then the had a 45-second seizure episode.  Patient was post ictal and afterwards became alert and oriented x4 however she had a persistent stuttering which is new.
Headache, meningitis-like symptoms, hospitalization, jaw and ear inflammation, diarrhea, tinnitus, weight loss, neuropathies, fever, diabetes insipidus, chemical sensitivities, anxiety, panic disorder.
Occurrence of tinnitus which Had long been in remission in one ear, and sudden unexplained hearing loss in same ear
I experienced at 1:00am and on 09-13-21 woke up with pain in my left arm, looked swollen, looked really red, area was really hard. At about 3:30am, I showed my mother and told her this does not look right. As I waited for a while to see if my swelling down, my arm started to blister. The site that they injected me, about 4 inches long, it is big. At 7am that morning, the blisters started to fill with fluid. I went to the ER at about 9:00am that morning, they looked at me and I told them this was from the vaccine. I had a lot of pain and trembling. At the ER they gave me steroids and Benadryl and asked me if I could swallow. They also said they could not drain my welch because it causes an infection. I still have my arm blistered up and I am in a lot of pain. I also do have a follow with my PCP to monitor my blister in my left arm. I also been out of work since the vaccine. I am so having trouble lifting my arm up and looks like a third degree burn. I have my left arm wrapped up.
Pneumonia; 3rd single dose of BNT162b2; 3rd single dose of BNT162b2; And then went to the A-Fibrillation; This is a spontaneous report from a contactable consumer (patient's wife).  An 84-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular injection in the left arm, on 19Aug2021, at around 10:30 - 11:00 AM (Batch/Lot Number: FC3182), at the age of 84 years old,  as 3rd single dose, for COVID-19 immunisation. Medical history included Crohn's disease, pneumonia approximately 10 years prior to the initial reporting (approximately in 2011), or maybe more. Concomitant medication included vedolizumab (ENTYVIO) every 6 weeks 2-6 weeks, for Crohn's disease. Prior vaccinations included flu vaccine yearly, but not received in 2021 at the time of the initial reporting. The patient received the 1st single dose of BNT162b2 (lot number: EL3246) on 03Jan2021, and the 2nd single dose (lot number: EL9262) on 26Jan2021, all as intramuscular injections in the arm, at the age of 84 years old. The patient had very, very minor reactions to the 1st and 2nd doses. The patient's wife stated that on 20Aug2021, within a day from having the 3rd single dose, her husband who was 100% well, developed pneumonia, for which he was hospitalized on 21Aug2021, and then went to the A-Fibrillation (as reported). She thought this was directly related to the booster shot. The reporter had no information regarding the treatment received due to pneumonia. The patient had not recovered from pneumonia at the time of the reporting, while the outcome of atrial fibrillation was not provided.   Follow-up attempts are completed. No further information is expected.
Within 3 hours of Flu vaccine, felt nauseous, had a headache, dizziness and chills, generally did not feel right. Slept for 3 hours after 6 hours had passed since Flu vaccine.
21 days after first injection the area swelled to the size of an egg, very itchy 3 days after 2nd injection ring finger on left hand turned black and blue and numb from second knuckle to tip of finger.  Massaged under warm water. Went away. Same thing happened the next day. Body aches, headaches from day one of second injection till today 11-12-2021.  Debilitating to the point I can not walk. Worse at night. Taking advil with zero relief.  Some days are better than others. Some days are very difficult. Left should feels like bursitis but not everyday. That was the arm I received my fist inject that swelled. Seeing arthritic signs on both hand first finger.  Toes on both feet feel the same as fist fingers.  This was not visible prior to injections.
Unauthorized Mix and Match for age group - 2 previous doses of Monovalent Moderna / this dose given was Bivalent Pfizer
After first shot began experiencing weakness in legs; fell several times; This is a spontaneous report received from a contactable consumer (the patient). This is the first of 2 reports. A 71-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. After first shot began experiencing weakness in legs and fell several times. The events onset date was 01Feb2021. "Steroids" was received for the event "weakness in legs". CT scans of entire spine and brain with unknown result. The events resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) :PFIZER INC-2021531421 same patient/reporter/drug, different AE in separated time
Morbilliform rash 9 days post MMR, T = 101 8 days after MMR. Poor sleep 2-9 days after MMR.
I want to preface this by saying that she had blood work on 6/9/21 and her bloodwork was normal. Onset of bruising, fatigue, and bleeding gums noticed on 3/16/22. Syncope led to a hospitalization with profoundly low platelets and hemoglobin (3/21/22). She required a transfusion and was referred to a hematologist for follow-up. She saw Dr. at Cancer center on 4/6/22. Dr. wanted to monitor her blood levels with weekly blood draws and put her on B-12. She was hospitalized once again on 4/24/22 as her levels continued to drop. Bone Marrow Biopsy was performed on 5/3/22. On 5/9/22, she was diagnosed with Acute Myeloid Leukemia. We were told she had weeks to live. We began hospice the following day. She passed away on 5/29/22.
When I received the J&J shot I had typical side effects (headache, pain at the injection site, and chills) for the first 5-6 days. The side effects subsided and I felt normal. About 3 weeks later I started to have pain at the injection site again which started very mild and then built up to nearly the same pain level I felt after the injection. The pain has since decreased and the pain is in a different part of the muscle. I feel a strong pinch in the muscle, almost like a pinched nerve, when my arm is at certain angles or doing a motion such as lifting, tugging, throwing, etc. The pain has been persistent for over a month. I am able to do most daily activities with manageable pain, but the pain is persistent and frustrating. There is no noticeable swelling or rash, nothing to visually indicate that there's pain in the muscle. I scheduled a telehealth visit with my PCP who said that delayed reactions had been documented in some cases with Pfizer but there wasn't data on J&J yet. She recommended that I monitor my arm, take Tylenol as needed, and keep her updated with any developments. I took Tylenol twice and it didn't do much. I don't know anyone else who has had this type of reaction and without data on J&J, I don't know how long to expect the pain to continue.
J96.00 ACUTE RESPIRATORY FAILURE 1/31/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
I'm sick with Fever; I'm sick with Fever; terrible headache; cold; dry cough; loss of taste and smell; loss of taste and smell; chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0173) via an unspecified route of administration, administered in Arm Right on 16May2021 at 10:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 09:15 AM (at the age of 33-years-old) as dose 1, single for covid-19 immunization. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient had no COVID prior to vaccination. On 30May2021, 2 weeks after the second dose the patient said, I was sick with fever, terrible headache, cold, dry cough, loss of taste and smell and chest pain. It was reported that, 2 weeks after the first dose on 04May2021 at 09:00 am I experienced severe abdominal pain and headache. I went to the emergency room 4 times; blood work and CT scan were good. Still don't know the nature of that pain. Today, 30May2021 2 weeks after the 2 dose I'm sick with Fever, terrible headache, cold, dry cough, loss of taste and smell, chest pain. Took a rapid COVID testing this morning, came back negative. The headache required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient under-went lab tests and procedures which included blood test that was good on 04May2021, computerized tomogram which was good on 04May2021. The patient took a rapid COVID testing, SARS-CoV-2, nasal swab, test came back negative on 30May2021. No treatment was given for adverse events. Device date was reported as 30May2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Cellulitis of left lower limb. Treatment - Children's BENADRYL 125 mg/5ml; 3 ml po q6-8 hrs prn; KEFLEX suspension 250mg/5ml po tid 7 days; TYLENOL 160ml/5ml, 5ml po q4-6 hrs prn.
Child received vaccines Friday had fever and fine rash all over body Friday night. Friday fever 104, Saturday 99. No fever Sunday or today, child still has a fine rash all over body - itches - cannot sleep for itching. No fever. No other problems 5/11 & 5/20 left messages phone calls not returned.
Feeling too weak; Had 2nd vaccine 7 weeks after getting the first; chills; FEVER; Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid), ASTHENIA (Feeling too weak), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first), CHILLS (chills) and PYREXIA (FEVER) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Covid), CHILLS (chills) and PYREXIA (FEVER). On an unknown date, the patient experienced ASTHENIA (Feeling too weak) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first). At the time of the report, COVID-19 (Covid) had not resolved and ASTHENIA (Feeling too weak), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first), CHILLS (chills) and PYREXIA (FEVER) had resolved.            No relevant concomitant medications were reported.    Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Report attached on 3-jun-2021, significant follow up, new events were added and patient declined further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Bad lung pain and burning while running (beyond anything I?ve experienced from asthma before) with wheezing lasting up to 3 days after..
rash got dark; red rash on her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on her legs and arms) and RASH (rash got dark) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (red rash on her legs and arms). On an unknown date, the patient experienced RASH (rash got dark). At the time of the report, RASH (red rash on her legs and arms) and RASH (rash got dark) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included hydrocortizone cream and Benadryl   Reporter did not allow further contact
Acute onset difficulty breathing with stridor/difficulty breathing. Tx as allergic rxn/anaphylaxis. Interventions from patient included albuterol breathing treatment.  EMS provided Solu-Medrol, DuoNeb breathing treatment.  Continued significant stridor on presentation to emergency department. Emergency department provided  IM epinephrine, IV Benadryl, IV famotidine, racemic epinephrine breathing treatment. Symptoms improved. Stridor resolved.
01/14/22 presents to ED for "headache and uncontrolled blood pressure". PMHx of "HTN, PAF on eliquis, HLD, TIAs"
Swelling/redness/pain at injection site; pt was seen at urgent care on 8/2/15 and diagnosed with cellulitis; pt was given Keflex and cortisone cream.
Per database, patient received three doses of Pfizer vaccines on 3/4/2021, 3/24/2021, and 11/20/2021; subsequently admitted to our hospital on 11/26/2021 and diagnosed with COVID-19 on 11/26/2021
Developed swelling, hardness, rash and itching at injection site on 4/2 2021
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain.  Patient now knows she was exposed before receiving vaccine.
Atrial fibrillation; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SELEXIPAG for Pulmonary hypertension.    The patient's past medical history included Arrhythmia (Abnormal heart beat Rhythmn) on 26-Apr-2021. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 1600 mcg twice a day. On 10-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-May-2021 to 15-May-2021 due to ATRIAL FIBRILLATION. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Blood disorder NOS, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.        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.   The patient was seen by his primary care physician on 10-May-2021, 12 hours after getting the Moderna vaccine.  The physician admitted the patient to the hospital due to atrial fibrillation.  The patient was discharged on 15-May-2021. The patient reported that he was in the hospital from 26-Apr-2021to 01-May-2021for abnormal heartbeat rhythm and the hospital ended up having to shock his heart to get it back to normal.  The patient had the second Covid vaccine done around 1 week before reporting date 02-Jun-2021 and said he seems to be doing well.  Treatment was not reported.  Based on the 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect  that can be stated as confounding factors that may play a possible contributory role.; Sender's Comments: Based on the 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect  that can be stated as confounding factors that may play a possible contributory role.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 20-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 19Feb2016 at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced leukopenia and became ill on an unspecified date with outcome of unknown. On 26Feb2016 leukopenia was found.
Patient called 12/16/21 stating her booster dose of Moderna caused her arm to swell, become red, and warm to the touch.  She stated her arm also started oozing at the site of administration. I told her some redness and tenderness was a normal reaction, but the oozing was concerning and she should be seen by her PCP. She stated she did not have a PCP so she will go to an urgent care for evaluation and treatment instead. Patient mentioned she did not have any issues with her previous two doses of Moderna. Patient stated she was just checking with me first and the phone call ended.
covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (covid-19) (seriousness criterion life threatening). At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.  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.  Company comment.  This life - threatening spontaneous case concerns a female patient of unknown age, with no medical history provided, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date from second dose was not reported; hence latency and temporal association cannot be properly assessed. The patient tested positive for COVID  19 approximately 9 months after the first dose of mRNA  1273 vaccine. The report mentioned the patient received medical treatment and intervention; however, no further information regarding the event was provided for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-623817 (Linked Report).; Sender's Comments: This life - threatening spontaneous case concerns a female patient of unknown age, with no medical history provided, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date from second dose was not reported; hence latency and temporal association cannot be properly assessed. The patient tested positive for COVID  19 approximately 9 months after the first dose of mRNA  1273 vaccine. The report mentioned the patient received medical treatment and intervention; however, no further information regarding the event was provided for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-623817:step dad case
Patient reported full body hives for 2 weeks after the incident. Patient reported she got a cream that settled the rash but was still there for a few more weeks.