chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
warm; big red mark at the injection site; very itchy; swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm), INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen). On 12-Feb-2021, INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen) had resolved. On 14-Feb-2021, INJECTION SITE ERYTHEMA (big red mark at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       No concomitant medication history reported. Treatment information is not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021:
I developed 8-9 days after my first dose, a rash (red border), in irregular shape and little itchy at the injection site. I contacted my employee health about my reaction.  I am feeling okay now but this was concerning to me.
I was supposed to get my period a day or two after I was vaccinated, but it was delayed by 10 days . My period has never been this late before, but luckily I got it today. Otherwise, my reactions were fine/mild, feeling tired and with a headache the evening of the shot and the next day.
Pt administer with Bivalent booster vial that had been thawed 4-6 weeks beyond unfrozen date.  No adverse signs and symptoms reported.
Swelling in arm where vaccines were given, not limited to injection site. Saw PCP 10/2/18 and received Rx's for Prednisone 40mg QD x 5 days and also antibiotic for UTI.
pt recv vax;mom reports axillary T of 105 the day p/ vax;mom contacted er & was told that fever caused by rxn to vax & to cont acetaminophen & baths;mom also contacted PMD & prescribed Ibuprofen;fever resolved 3-4 days later;
7/20/2022-Presnts to ED, Admit chronic hypoxic resp failure s/t to severe COPD with recent exacerbation and unresolved pna. Covid + test. Ordered Levaquin, decadron and  bebtelovimab. On 3L NC, on baseline oxygen . WBC-27.3 Recent IP stay 7/10-7/14/2022 for PNA had been on ceftriaxone and azithromycin.  Chest CT potential R lower lobe infiltrate.  7/22/2022. Improved, continue prednisone taper ad Levaquin. WBC-22.6. D/C home with home health services.
pt to hospital with generalized weakness and fatigue; acute encephalopathy; pt had a positive COVID test; admitted for management of sepsis due to COVID vs UTI; tachcardia/hypotension; AKI due to dehydration; acute on chronic IDA requiring transfusion; electrolyte abnormalities; started on broad spectrum ABX, steroids, remdesivir; pt's condition worsened; DNR/DNI; transitioned to hospice where she passed away
Narrative:  COVID infections following completion of COVID vaccine series 01/07/21 COVID vaccine dose #1 02/01/21 COVID vaccine dose #2 06/11/21 Suspected recurrence of adenocarcinoma RUL; pt prefers to wait 3 months and re-evaluate 07/24/21 Pt presents to ED reporting cough, general weakness x7 days, dry cough, shortness of breath, occasional headache; COVID POSITIVE, chronic elevated troponin with no chest pain, CXR and CT head wnl; admitted inpatient 07/25/21 Pt reports congestion, dry cough, and intermittent left sided chest pain; CT brain wnl 07/26/21 Pt reports cough improved and overall feeling better; ECHO revealed normal left ventricle size with severe concentric hypertrophy, LVEF 35-40% 07/27/21 Pt discharged with rx for DM/guiafenesin, lisinopril, polyethylene glycol, albuterol/ipratropium 07/30/21 Pt reported to not be eating or drinking and has diarrhea; reports extremely fatigued; advised to stop miralax 08/01/21 Pt remains weak but stable, reports BP is low; diarrhea has lessened but has bowel/bladder incontinence 08/02/21 Pt is improving, reports fatigue 08/04/21 Daughter calls into CCC reporting low BP 83/49; presents to ED reporting weakness and fatigue with shortness of breath and decrease PO intake; CT head wnl, CXR indicative of pneumonia; treated with IV fluids and discharged with rx for azithromycin, thiamine; advised to decrease dose of lisinopril to 10mg 08/05/21 Daughter reports difficulty in splitting tablet and has held BP medication due to low BP readings in the 70-80s/40-50s
I was given the Pfizer vaccine at 1630 on 7/5/2022.  Symptoms began around 1200 on 7/6/22.  Started with right side chest pain that radiated down my arm, headache, fatigue, muscle pain, and a fever of 99.2.  Later in the day the symptoms became increasingly worse,  fever increased to 101.4, headache was not well controlled with migraine medications,  SPO dropped when laying down with an increased feeling of pressure in my chest.  Additionally, I was getting random sharpe nerve pains on my left side and my blood pressure and heart rate were elevated.  Eventually I decided I should go to the ER at 2000, since the urgent care was closed.  I was given 4, 81mg Aspirin and Tylenol.   All tests were with in normal limits and I was discharged.  The next day my symptoms were mildly improved however I still had a fever, headache, fatigue, body aches,  decreased chest pain, and nausea.  As of today 7/8/21, I only have a head ache, however I have taken 2 doses of Aleve and that has not helped but I am able to work.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with nonsteroidal anti-inflammatory drug (also reported as NSAID) allergy, penicillin allergy and Sulfa allergy. On 22-NOV-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J007207, expiration date 20-SEP-2014), subcutaneous for prevention of shingles. Concomitant therapies included estrogens (unspecified), omeprazole (manufacturer unknown) and Zocor. On 22-NOV-2013, the patient experienced a 50 cent  sized, dark red circle surrounded by a three inch, light red, outer circle at the injection site, which felt hot, after patient received ZOSTAVAX. The circle had not increased in size in the past 24 hours. The patient saw the pharmacist. Ice packs to injection site was given for treatment. The events outcome was unknown. Additional information has been requested.
Mild nausea, chills, back ache, fatigue, headache. Nausea went away within an hour. Chills went away after approximately 2.5 hours. Body aches went away after approximately 4 hours. Fatigue lingered overnight and into next morning, to mid-day. Headache went away with Tylenol, then reappeared next morning and subsided after an hour or two.
I had sore throat, fever, headache, mild cough and rash. These lasted for about 2 weeks. On Dec 30th, I tested positive for Covid-19.
I experienced parasthesia from my bellybutton all the way down to my toes that increased in severity over the course of about 4 days. At the same time I had pain and discomfort in my abdominal area and went to my primary physician. The pain from the abdomen and severe discomfort from the parasthesia, made the primary consider it was appendicitis. He sent me to the ER. At the ER, I had an abdominal MRI. Appendicitis was ruled out and a neuro consult was given. Neurologists thought it was a nerve problem related to a prior back surgery from 2019. I had to wait a few days to see my back surgeon. Back surgeon took xrays, found small inflammation that did not cause the pain I was having but gave a Z-pack and recommended.  Aleve for pain and swelling. He also recommended follow-up with neurologist. I followed up with my regular neurologist and he was extremely concerned about transverse myelitis and sent me back to the ER for further immediate testing and possible IV steriod treatment. Additional MRI and CT scan with contrast was taken. TM was ruled out. Parasthesia slowly began to lessen and eventually go away after a number of weeks. I saw my neurologist a few times to follow-up. The second dose of the COVID vaccine was taken on 3/29/21. Parasthesia began approximately 4 days later with no other possible incident or potential cause. Symptoms of pain and discomfort lasted for approx. 3.5 to 4 weeks. IV morphine (and possibly other pain relief) was given during first visit to ER which greatly helped with initial severe pain in legs. Z-pack and Aleve was taken as well.
a tender arm; This is a spontaneous report from a contactable consumer. This 08-decade-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via unspecified route of administration, on 09Feb2021, as dose 1, single for covid-19 Immunization. Medical history included covid-19 on an unknown date in Oct2020 and pneumonia. Concomitant medications were not reported. The patient stated that he heard that shouldn't take OTC medication for the side effects like headache after the vaccine. On an unknown date in Feb2021, the patient experienced tender arm which was normal. The patient was enquired about after the 2nd dose they may have side effect worse than the first. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Bell's palsy (a neurological condition where drooping of the eye lid and the face happens); This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LOVASTATIN, QUETIAPINE FUMARATE (SEROQUEL) and TRAZODONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No adverse event as Medical History was reported.  Patient did not receive the second dose of the vaccine due to this condition.  Treatment information not provided.  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.; 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.
Local swelling and erythema hot to touch appears like cellulitis around 5 cm area right thigh has small area on left around 1-1.5 cm but only slight/ erythema on this leg. + Tender to palpation. Treated with Augmentin and Ibuprofen. Has follow up scheduled.
diagnosed with transverse myelitis; paralyzed from her waist down; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age (family friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that he has a really close family friend that is a female and she was diagnosed with transverse myelitis in T2 and was paralyzed from her waist down and she received the Pfizer Vaccine as well and it came on out of the blue that morning and she felt tingling in her legs like he did and within an hour she could not move her legs and they did diagnose her as well with transverse myelitis (hospitalization). Outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 same reporter/drug, similar event, different patients
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 37 year old male. 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 not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from expired vaccine administered. This report was non-serious.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 30-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
patient not 18 years old. received Moderna vaccine not yet approved for this age group. sx at this time include fever and arm pain, sx began 1/25/2022 evening
Urticaria, diffuse. No history egg allergy. No other exposures - possible reaction to flu vaccine. Had similar episode after flu vaccine last year. Rxd: BENADRYL, PEPCID. Referral to allergist.
bad rash on her arm; blood pressure high (180 over 150); legs didn't work; so tired she couldn´t wake up until the next day; spike headache; head felt like a balloon/felt crappy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head felt like a balloon/felt crappy), RASH (bad rash on her arm), HYPERTENSION (blood pressure high (180 over 150)), LIMB DISCOMFORT (legs didn't work) and FATIGUE (so tired she couldn´t wake up until the next day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (head felt like a balloon/felt crappy), HYPERTENSION (blood pressure high (180 over 150)), LIMB DISCOMFORT (legs didn't work), FATIGUE (so tired she couldn´t wake up until the next day) and HEADACHE (spike headache). On 01-Apr-2021, the patient experienced RASH (bad rash on her arm). On 31-Mar-2021, HYPERTENSION (blood pressure high (180 over 150)) had resolved. At the time of the report, FEELING ABNORMAL (head felt like a balloon/felt crappy), RASH (bad rash on her arm), LIMB DISCOMFORT (legs didn't work), FATIGUE (so tired she couldn´t wake up until the next day) and HEADACHE (spike headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 180 over 150 (High) 180 over 150 and 127/84 (normal) 127/84.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Tested positive COVID 19 after 1st dose; Did not receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose) and COVID-19 (Tested positive COVID 19 after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose). On 04-Mar-2021, the patient experienced COVID-19 (Tested positive COVID 19 after 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose) had resolved and COVID-19 (Tested positive COVID 19 after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID -19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Products include Vaginal Steroid. Treatment received includes antibiotic medication and vitamins.
Patient started developing signs and symptoms of shingles on 06/5/18 which included extreme pain and rash. MD prescribed NORCO, VALTREX and Prednisone for treatment.
Started 36 hours after shot, itchiness everywhere and hives accompanied. Redness on face, arms, shoulder, legs, chest, and back.
Notified by friend of mother-infant was seen in ER on 11/24/05 due to jerking motion after shots given. No fever or lethargy noted. Seen by MD. Baby had 2 episodes of mycolonic jerking? CBC & BMP done mother was instructed to follow up with private doctor. No other problem reported since 11/24/05. Will call mom to follow with her doctor.
Patient had swelling of throat, nasal passages, hard to swallow & breath. Had to call doctor.
Narrative:  COVID infection following completion of COVID vaccine series: 03/03/2021 COVID vaccine dose #1 03/24/2021 COVID vaccine dose #2 06/28/2021 Pt reported onset of chills 07/07/2021 Pt reported "not feeling well" for approx. 1-2 weeks. Recently experienced productive cough, clamminess, and sore throat. Advised to get COVID test. 07/07/2021 COVID positive (nasal swab as recommended) 07/08/2021 Pt reported loss of appetite and feeling "a little feverish." Had been treating cough with Mucinex. Pt educated on s/s that would necessitate hospitalization. Advised that self-isolation period is completed since sx started on 06/28/2021. 07/10/2021 Pt reported feeling better.  07/11/2021 Pt reported experiencing fatigue and decreased appetite/diminished  taste and smell. 07/12/2021 Pt reported experiencing fatigue and decreased appetite/diminished taste and smell. C/o "upper to midback rash" present for the past 7-10 days. Prescribed topical steroid with planned  f/u in 1 week. 07/12/2021 Clinical resolution of COVID infection.
Acute sudden onset afebrile seizure. Generalized x3 in 1.5 hours. MRI, EKG, CT Scan, Spinal tap all negative. Currently on Phenobarb
Pt administered 10ug bivalent dose instead of recommended 25 ug, parent advised to repeat dose
Red rash, swelling, and itching at the injection site 9 days after injection.
adult dose of hepatitis  b vaccine energix B given to pediatric patient no known adverse reaction at this time.
left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; arm where she got the shot was sore after first dose/after her second dose; her left arm is sore; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 24Aug2021 at 15:45 hours as dose 1, single (at the age of 37-years-old) and received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: 30135BA, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 15Sep2021 at 09:15 hours as dose 2, single (at the age of 37-years-old) both for COVID-19 immunisation (at  Clinic). Patient had no medical history (including any illness at time of vaccination) and had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Patient had no additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other products/concomitant medications. Patient stated that she was healthy with no health issues and takes no medication. On 24Aug2021, patient stated that the arm where she got the shot was sore. On 25Aug2021, after the first dose, the second day, patient experienced that her left leg from the thigh down to her foot was numb and tingling, on and off. Patient stated that first time arm was sore for two days. On 15Sep2021, patient got her second dose and her left arm was sore; and her left leg from thigh down to foot was numb or tingling and it was doing the same thing, it was back the same way, it feels funny. Patient stated that she did not feel that feeling until when she goes to bed at night, she laid down it starts to feel numb and tingling, last night (15Sep2021) up to today (16Sep2021) and now she was at work in the day, and it had the same feeling and stated that arm was still sore from the second dose. Patient stated that her left leg from the thigh down to her foot was numb and tingling, never totally stopped since then it was persisting, and patient still experience this until now. No relevant tests were performed. Patient just called the doctor this morning (16Sep2021) and they gave her the number to call Pfizer, but if her symptoms do not go away, she was going to call back to be seen. Patient had no emergency room and physician office visit for the events. On an unspecified date 2021, patient had tuberculosis (TB) test done for work and results were unknown. The outcome of all the events was not recovered.