chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arrhythmia episode; This is a spontaneous report from a contactable consumer (patient). A 68-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, on 03Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included occasional palpitation episodes which has been self-terminating. The patient's concomitant medications were not reported. The patient had the first COVID-19 shot and had some questions about possible side effect from that. The patient was a healthy person but in the last several years I have had occasional palpitation episodes which has been self-terminating. Anyway, the day after the patient's first COVID-19 shot (04Mar2021), the patient had arrhythmia episode and that was unusual for the patient and it lasted till 3:00 PM. The patient didn't have in several months and since then, the patient had four more episodes. Now, the only thing the patient wanted to mention is that it (arrhythmia) started on 04Mar2021 and on 05Mar2021, the patient started to take unspecified (as voice not clear), so that is going on. The patient had the second shot scheduled this afternoon, so the patient's question is if it is safe to get that or should the patient be suspicious about these episodes. The outcome of the event was unknown.
Injection site haemorrhage; injection site mass; incorrect route of drug administration. Information has been received from a registered nurse (RN) concerning an adult male who on approximately 12-AUG-2005 was vaccinated SC with a dose of hepatitis A virus vaccine inactivated. There was no concomitant therapy. The RN reported that on approximately 26-AUG-2005, the patient's vaccination site became bruised with a lump. Unspecified medical attention was sought but treatment was not required. At the time of this report, the patient had not recovered.  Additional information has been requested.
Subacute thyroiditis starting on Aug 19. Swelling on right side, severe pain, very low TSH
Discharge Provider: MD Primary Care Physician at Discharge: None Physician, DO None Admission Date: 3/10/2023 PRESENTING PROBLEM: Septic shock (HCC) [A41.9, R65.21] Shock (HCC) [R57.9]   HOSPITAL COURSE: Patient is a 67-year-old female with past medical history of CAD (CABG 2016 with stemi 9/2022), dHF, HTN, HLD, CVA R MCA, hx RLE dvt (eliquis), and recent COVID infection a couple weeks ago who presents with difficulty breathing.  Transferred from outside hospital with concerns for septic shock on vasopressors, intubated for airway protection.   Patient initially presented from a skilled nursing facility.  Per their report, the patient vomited in the morning and did have an aspiration event. In the emergency department, patient was in respiratory distress and not protecting her airway so she was intubated.  Black emesis was noted in the posterior pharynx that was heme positive.  There is some abdominal distention and an OG tube was placed.  Vasopressors started for persistent hypotension.  Lactic acid 9.5, WBC 23, BNP 15000, initial pH 7.26. Patient was COVID positive but this was suspected to be secondary to previous infection.  Patient was started on vancomycin, cefepime, Flagyl. CT thorax, abdomen, pelvis without contrast showed diffuse alveolar infiltrates and increased consolidation left lower lobe, concern for possible colitis.  Stress dose steroids were added and patient was bolused with Protonix and started on a Protonix drip.  Patient was then transferred to intensive care unit for further management.   GI was consulted for GI bleed and repeat CT abdomen pelvis showed increased gallbladder distension, increased small amount of pelvic free fluid, and similar bowel distension.  While lactic acid was initially downtrending, it subsequently increased from 4.7 to 5.3.  The patient also was hyperkalemic, acidotic, and had worsening creatinine.  Insulin, calcium, lokelma, and started on a bicarb drip.   On 3/12 night, stroke code called and CT notable for large right ACA and MCA infarct. Cytotoxic cerebral edema with midline shift noted. Goals of care discussion were held with family, who decided against intervention and chose to pursue comfort care.    Patient died in hospital on 3/13 at 9:02 PM with husband and son present at bedside.    Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
pt states that devel a h/a on the evening of vax & that it was constantly present x 21-23 days; It was not a migraine; there were no other sx & it did not prevent from working;
I just got shingles out of nowhere and wanted to make this known as I have heard this can be related to COVID or the vaccine. I got the Pfzir.
Chills, fever, headache, fatigue, soreness and redness at site of injection.  Treated with Tylenol and/or Motrin.  Symptoms  lasted approximately 12-14 hrs.  One week later, 02/14/2021,  chills, fever, fatigue, soreness and incresed redness  at injection site  occurred again and  lasted approximately 12 hrs.  On 02/15/2021, went to Urgent Care and had a Covid Test which was neg. and was told it was a reaction to the vaccine.   The next day went to my PCP due to increased redness at site, felt it was still a reactin but was given Keflex for 7 days to make sure an infection did not develope.
Immune Thrombocytopenic Purpura; Iatrogenic thrombocytosis; This is a literature report for the following literature source:  A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cataract" (unspecified if ongoing); "squamous cell carcinoma" (unspecified if ongoing); "basal cell carcinoma" (unspecified if ongoing); "Bruising" (unspecified if ongoing); "gum bleeding" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), 14 days after the suspect product administration, outcome "unknown", described as "Immune Thrombocytopenic Purpura"; THROMBOCYTOSIS (non-serious), outcome "unknown", described as "Iatrogenic thrombocytosis". The event "iatrogenic thrombocytosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: High; Blood lactate dehydrogenase: High; Neutrophil count: 5 x 10^3/uL; Platelet count: 5 x 10^3/uL. Therapeutic measures were taken as a result of immune thrombocytopenia with platelet, IVIG, dexamethasone, TPO-RA, vincristine, and prednisone. Additional information: The patient was discharged for the event Immune Thrombocytopenic Purpura with return to ER for iatrogenic thrombocytosis. No comment if the second dose was given.; Sender's Comments: Based on the temporal relationship, the association between the events immune thrombocytopenia and thrombocytosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Headache, nausea, fever, chills, aches all over, extremely tired.   Slept for about10 hours and took 2 Tylenol.   Fever disappeared and nausea got better  after about 12 hours    Still have some fatigue that is not normal for me.
Expired Havrix administered; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 10-year-old male patient who received HAV (Havrix) (batch number L435X, expiry date 16th February 2023) for prophylaxis.   On 20th February 2023, the patient received Havrix (intramuscular) .5 ml. On 20th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 21-FEB-2023 Reporter's comment: This report was submitted by public reporting. The reporter was the patient.   The vaccine was administered after expiration date. No adverse reactions noted or reported at this time. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
1.7C for 30 minutes due to the thermometer being set too cold with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from health professional.  This case is linked to case 2022SA192000(CLUSTER).  This case involves a 10 years old male patient who experienced 1.7c for 30 minutes due to the thermometer being set too cold with no reported adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac], diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel](Vero) and ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (Hepatitis B Vaccine) for Prophylactic vaccination.  On 02-May-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) with lot number T1E871M, expiration date- 10-Oct-2022 via intramuscular route in the left deltoid with unknown strength for immunization.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot number, expiration date, dose, strength not reported via unknown route in unknown administration site for Prophylactic vaccination.  On 02-MAY-2022 the patient developed a non-serious event "1.7c for 30 minutes due to the thermometer being set too cold with no reported adverse event (product storage error) " (same day latency).  It was reported " Caller reported a temperature excursion involving punctured, and administered to 3 patients after the excursion, IPOL, and unopened PENTACEL and TENIVAC and is requesting stability information. The condition was 1.7C for 30 minutes due to the thermometer being set too cold (not human error). The IPOL was not supported by the extended stability data, however the unopened PENTACEL and TENIVAC were supported by the extended stability data. "   Action taken was 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.; Sender's Comments:  01115339: 01115364: 01115305:
At about 6am after receiving the shot I felt very tender at the injection site almost as if it was bruised. Then over the course of the day I started to feel very itchy all over my body but mainly on my right side.  10pm I got up for work, and could barely move, I'm feeling intense back pain on my lower back on the right side. I can walk but its all very limited motion, I can really only manage by putting all my weight on my left side.
Localized reaction at injection site - erythema and fever (101 degrees F-rectal)
RIGHT ARM VERY SORE; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on Right arm from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE (first dose) for covid-19 immunisation.  Medical history included PCOS, hypothyroidism, hyperparathyroidism, hypertension. The patient has allergies with amoxicillin and oxybenzone. The patient experienced right arm very sore on 05Jan2021 with outcome of recovered.  The patient is not pregnant at the time of vaccination. No treatment was received for the event.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
From an initial report received on 11-Jan-2001, it was reported a 45-year-old male patient was given a yellow fever vaccination sometime in Aug. 1996.  Reportedly the patient developed "flu-like" symptoms immediately, in 1997 patient reportedly developed extreme thirst , all hair on legs fell out, legs, and feet became numb. Tests indicated diabetes. Now taking insulin to control blood sugars. (Reported by patient-has list of vaccines and lot numbers  administered but must  locate the list)
8:45-Vaccinated 9:20- C/O lightheadedness, tingling-throat/dry throat, facial swelling Vital signs within normal, O2 sat 98-99 Symptoms improved after given water and observed in recumbent position. 9:50 discharged home.
swollen lymph nodes under her right arm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: (normal) Clear. On an unknown date, Ultrasound scan: (normal) Clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications for Blood Pressure and Hormonal replacement.  Action taken with mRNA-1273 in response to the events was not applicable.
Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A female patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 12May2021, outcome "unknown", described as "Headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of administration of expired product was received from a physician concerning a 11-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Dec-2010. The patient received the expired FLUMIST on 04-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Heart palpitations-felt like heart hiccup, happened 4x?s in 1 hour. No treatment sought, patient otherwise felt normal.
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours.  After 4 hours weak for several hours.
IVF/Surrogacy Pregnancy has had no complications at all, due date is June 6, 2021. Night of vaccine woke up with chills and nausea, woke up another time with body aches and extremely hot as if I had a fever plus headache. I have had a headache ever since (3 days later) with nausea, sensitivity to light and noise. Tylenol and fioricet is not helping at all.
fainted right in front of me; lost her balance; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age, described as young. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, intramuscularly (exact dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date, after the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient lost her balance and fainted right in front of the reporter.   At the reporting time, the outcome of the events was not reported, and the causality assessment was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
This spontaneous report as received from a physician via a representative refers to a 61 year old female patient with hypertension and hypercholesterolemia. On 23-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, vial, (lot #, expiration date and dose unspecified). Concomitant medication included unspecified medication for hypertension. On 04-FEB-2014, the patient was diagnosed with shingles with a distribution of the right breast radiating to her back. The patient sought medical attention via office visit. The patient was prescribed VALTREX and an unspecified pain medication. No lab diagnostics studies performed. The events outcome was reported as recovering. Additional information has been requested.
testes positive for covid after; testes positive for covid after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine" (not ongoing), notes: 1st, 2nd (moderna vaccines) and boosted from Pfizer . The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "testes positive for covid after". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Call was answered by consumer (patient wife). Consumer does not wish to be contacted any further. Reporter also stated "Both she and her husband have been vaccinated with 1st, 2nd (moderna vaccines) and boosted from Pfizer and both tested positive for covid after. They are fine now. They also took Paxlovid and it helped to recover faster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202200650609 same reporter/drug/event, different patient
Per police report, pt was found deceased in parents bed, in prone position. Vaccines were given 4 days prior to death. No complications occurred in Dr office on that day.
Left upper arm hematoma-site of 1 injection below hematoma 12cm x 12cm circular raised swelling warm-had been increasing.
I have not had a menstrual cycle since February 18th. I have also experienced heightened pms symptoms and muscle aches and pains.
UNSPECIFIED ADVERSE EVENT; 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 not reported, batch number: Unknown) 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, involving the same patient is linked to 20211129919.
Information has been received from a 67 year old male physician with atrial fibrillation an no know drug reactions/allergies, who on 29-APR-2011 was vaccinated into the deltoid with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included TOPROL XL (tablets) and unspecified blood pressure medication. Physician reported that on 30-APR-2011, he experienced soreness at the injection site, fever, shaking chills, muscle aches and fatigue. It was unspecified if the patient sought medical attention. No lab diagnostic studies were performed. Physician reported that he treated himself with hydration and unspecified doses of NAPROSYN. Physician reported that he was more active on Sunday, 30-APR-2011, but that he had to rest following each activity. Physician reported that on 02-MAY-2011 he was not recovered yet, but he felt well enough to return to work. The physician also mentioned that he always experienced similar reactions to the annual influenza vaccine (manufacturer unspecified). Additional information has been requested.
Mom reported rash that developed 1 day following injection. She did not bring her back for evaluation so no exam was done. No fever or GI symptoms. (+) pruritus.