chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SARS-Cov2-RT PCR tested positive; SARS-Cov2-RT PCR tested positive; This is a spontaneous report from a contactable nurse. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included dementia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, SARS-Cov2-RT PCR on 01Feb2021, result was positive. The reporter considered all events was non-seriousness. There was no treatment received for the adverse events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV2-RT PCR test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event "Systemic pruritis (itching) all over body". The outcome of the event "Systemic pruritis (itching) all over body" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition
This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter o 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself).  A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks.  Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received.  The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional information is available.  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.
Nausea, tingling feeling in upper arm, muscle in arm hardened and inflamed.
VARIVAX & influenza given in left arm 12/1/08, returned to office 12/4/08, developed rash 12/3/08 which is expanding, area itchy, located medial left upper arm, central papular 2 X 25 cm central exudated area. 7 X 10 cm surrounding erythemea & heat, Temp 98.1 degrees F.
12 hrs after shot fever 103.5, aches, headache, dizzy.. lasted 42 hours
loss of smell; rash/hives back and neck; rash/hives back and neck; difficulty breating; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN and BUDESONIDE (NASOCORT) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell). At the time of the report, RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) She has had three Covid19-test and they are all negative..         Treatment information was not provided.
pt called to report shortness of breath with limited activity (on o2, her sats drop to 85) since her shot last thursday; also reports worsens when lying down, did report to her doctor and has appt tomorrow
Possible dose of Boostrix administered to 7 year old; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Possible dose of Boostrix administered to 7 year old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023. Possible adverse event submitted via sales representative on behalf of RN.  The vaccine administration facility was the same as primary reporter. Possible dose of Boostrix administered to 7 year old which lead to Inappropriate age at vaccine administration.  No additional adverse event information provided. Sales rep information emailed to safety team
24 hours after receiving the vaccine I had a fever of 103, couldn?t get out of bed, nausea, extreme fatigue, massive headache (felt like a migraine). Lasted for 48 hours.
Low grade fever, achy joints and headache were experienced for both injections in the series.  Unable to function for about 28 hours after both injections.
VERY SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
employee received second dose of covid vaccine 1 week early.   1st dose given on 12/28/2020,  2nd dose scheduled on 1/18/2021,  dose received on 1/11/2021.
Patient reported a sore arm for a few days post injection that went away and then reappeared as a hot/tender arm with a bump at the injection site "about 4 days ago."
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  Patient received the last shot the bivalent and wanted to know how long the sore arm was going to last.             No treatment information was provided by the reporter.   Reporter did not allow further contact
Dose administered to patient after morethan 24 hours of vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2022 at 1:45 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 19-MAY-2022, the vial was initially stored in refrigerator and on 31-MAY-2022 at 8.55 AM the vial was initially punctured.  On 01-JUN-2022 at 1:45 PM, vaccine was administered to patient and vial was stored in fridge post puncture and vial didn't undergo any temperature excursions.  Patient received second booster dose of Moderna COVID-19 Vaccine and patient has not reported any adverse reactions to expired dose.  Treatment information was not provided.
Injection site red, swollen and warm to touch. Rash (small bumps) on whole body. Injection site sore and sometimes itchy.
pt recv vax 11MAR96 & 20MAR96 pt exp mild case of chicken pox w/approx 15-20 lesions;
Pt reported blurry vision and lightheaded.  @1115 BP 110/54, HR 63, OxSat 92%.  At 1125 BP 108/70, OxSat 98, HR 64.  At11:39 BP 106/62, HR 74.
Slighly warm at injection site; Area around injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Slighly warm at injection site) and VACCINATION SITE ERYTHEMA (Area around injection site redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN), METOPROLOL SUCCINATE (TOPROL XL), LOSARTAN POTASSIUM (LOSARTIN), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), ASA, VITAMIN D [VITAMIN D NOS], FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR), TOCOPHERYL ACETATE, UBIDECARENONE (COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]) and ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Slighly warm at injection site) and VACCINATION SITE ERYTHEMA (Area around injection site redness). At the time of the report, VACCINATION SITE WARMTH (Slighly warm at injection site) and VACCINATION SITE ERYTHEMA (Area around injection site redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medication. It was reported that the redness was 2 by 2 in area and on 12-Feb-2021 the area was red again but not bright.
12/20 1 1/2 area of redness with elevated temp and soreness at injection site. 12/25 redness and elevated temp resolved, quarter" sized knot at site 1/7 soreness right elbow, lump "nickel sized" elevated d pain- saw MD- nodule aspirated- clear serousang. Fluid. Prophylactic antibiotic Bactrim DS 1/1 bid po #14 prescribed 1/8 lump "dime sized" decreased d pain. See attached progress note from doctor.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in September 2018, reported as "last week",  the patient was vaccinated with GARDASIL 9 lot # R003557, expiration date 20-NOV-2020 (dose and route were not provided) for prophylaxis (drug administered to patient of inappropriate age).  No adverse effects were reported.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed rash characterized by papular vesicles. There were less than 50 lesions widely spread on his stomach and eyes. The pt was exposed to chickenpox two weeks prior to onset. The pt was diagnosed with atypical varicella.
Pain in arm, redness and warmth. Pain after injection, symptoms increased over next two days.
patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient 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: FOOD ALLERGY (non-serious), outcome "unknown", described as "patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine".  Additional information: The pharmacist asked if there was an easier way to find this information in regards to ingredient content (i.e. presence or absence of animal products) as her patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine, and thus the patient was no longer able to consume animal products. It was double-checked with the pharmacist in regards to if it was the Pfizer COVID-19 vaccine for AE Reporting, the pharmacist noted that the patient said it was the Pfizer vaccine, but the pharmacist was not sure and she said she would need to check the patient's file again (and was not able to confirm at this point, as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states her arm hurt immediately with burning at time of injection then immediate soreness afterwards. 3 days after immunization her arm was still sore and developed bruising, swelling, and heat at site of injection and traveled down her arm (about 2 1/2 inches from injection site). She states these symptoms existed for 2 weeks before resolving. She still has a scar on her arm from where injection was given.
The day of vaccination pt experienced throbbing sensation with pain that radiates into shoulder that is still present.  Pt was advised to see his PMD to be evaluated.
patient fainted, recovered and left with her mom and friend after the vaccine. this also happened after the first vaccine also. (possible fear of needles and anxiety from the vaccine).
chills; fever; This is spontaneous report from a contactable consumer (patient) from Medical information Team. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient received the second dose of the Pfizer covid shot, yesterday, she was experiencing chills, and fever and wants to know how long will symptoms last. There was given the response which included side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body was building protection and should go away within a few days These side effects usually start within a day or two of getting the vaccine. Side effects might affect your ability to do daily activities, but they should go away in a few days. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information was expected. Information about lot/batch number cannot be obtained.
patient passed out and became very sweaty and pale. When he came to he threw up. He was non responsive at first when he opened his eyes and very shaky. By the time he left the pharmacy he was ok. He walked away by himself and was responsive and talking when he left.
Patient reported severe arm pain located at the injection site. Patient states that the pain has been continuous since her inoculation date on 9/25/2021. Patient underwent ultrasound procedure from her medical doctor because of the post-inoculation pain she experienced and continues to experience. Patient states she has been undergoing physical therapy on her arm  three times a week for the pain.
27 years ago I had Epstein Barr ( Mono). One week after my second dose I have a resumption of symptoms including night sweats, fatigue and sore joints. These symptoms are still present
I had a fever of 104 for 2 and a half days. I had constant chills with violet shivers. My symptoms were worse than when I had Covid 19.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: got light headed and felt a tingling in her head then vision went black -Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: 4 days after 2nd dose patient felt lightheaded, tingling in her head, then everything went black for a moment. she still feels light- headed
Persistent shingles. Starting 8/1/2021 3 rounds of anti virals abs or still won?t go away
Approximately 45 mins post vax, pt developed pain at the injection site. The reporter described this as "excruciating right interior shoulder pain that is going down through her arm" and is exacerbated with "movement." She was seen by the MD who noted that the injection site "looks good." The pt recovered.
minor body aches for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor body aches for a few hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Prostate cancer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN (minor body aches for a few hours). At the time of the report, PAIN (minor body aches for a few hours) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-302008 (Patient Link).   Reporter did not allow further contact