chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022; Vaccines were administered beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient took  booster of Moderna and took total 3 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion  It was reported that as per Moderna lot analysis regarding doses administered on March 11, 2022 and March 16, 2022 from lot number 033H21A, and doses administered on April 20, 2022 from lot number 083J21A, Moderna cannot guarantee patients received full protection against the Covid-19 virus.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contains No new information
13 y/o patient was scheduled for a Pfizer COVID booster. Once the pt arrived, her mother asked if she could receive a Moderna booster instead (which is currently only approved for 18+). Patient was administered a Moderna booster.
4 year old child received one dose of Rotavirus vaccine in error. No immediate adverse event.
Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Vaccine given in the afternoon. That evening erythematous dry rash appeared bilateral legs, arms, trunk. Eczema appearing but much worse than previous flare ups. Resolved within a couple days
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 48-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number H79Z3, expiry date 12th June 2019) for prophylaxis. Concurrent medical conditions included glenoid labral tear. On 5th November 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). On 6th November 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The physician reported the case for himself. The patient received FLULAVAL QUADRIVALENT 2018-2019 season on the left deltoid. The patient experienced difficulty in raising arm. The batch number reported for FLULAVAL QUADRIVALENT 2018-2019 season (H7923), did not exist and was updated to H79Z3, as per sales database. The reporter gave consent to follow up.
Information has been received from a physician concerning a male patient who on 6/29/1998 was vaccinated once with a 0.5ml subcutaneous dose of varicella virus vaccine live. On 6/18/2005 the patient presented with a varicella breakthrough with less than 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The patients brother experienced a varicella breakthrough with less 50 lesions following vaccination with varicella virus vaccine live (WAES0506USA03873). Additional information has been requested.
>100 fever, chills, muscle aches, hot and then cold, exhaustion, lack of appetite, missing work, having to sleep, going on 3rd day
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Chest pains at/around the heart; back pains - left side of back, on and around shoulder blade.  Chest/back pains come and go and are particularly sharp when driving.  Walking around helps, but back and chest still feel tender to the touch.  Hurts to bend over. Hurts to bend/turn while seated. Diet doesn't seem to play a major factor. This was all after the Moderna Booster shot on 1/3/2020, NOT the J&J shot from April 2021.
This case was reported by a pharmacist and described the occurrence of injection site leaking in a male subject of unspecified age who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 21 October 2008, the subject received a dose of FLUARIX (intramuscular, unknown arm) and experienced injection site leaking.  Pharmacist stated that a nurse gave a male subject FLUARIX and after the intramuscular injection, "some of the mediation bubbled out of his arm".  The pharmacist stated the medication came because the subject did not have "very much muscle mass".  No other information was provided.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 10 November 2008 via pharmacist who reported that she had no additional information to provide.  She contacted us to state she will not be providing any additional information.
Normal arm discomfort for the first couple days after vaccination, which then completely went away. Had slight headache the day after the vaccine. Then, 6 days later, it began to hurt again at the injection site, along with redness, swelling, and itching. Additionally, I experienced a swollen lymph node in the underarm of the same arm. These symptoms lasted about 1.5 days, then completely dissipated.
Hives and rash at injection site (right deltoid) dizziness  and palpitations noted by patient 2-3 minutes after injection. Tx: 50 mg IM administered of Benadryl.
pt recv fever 104.8 & sz w/in 12 hrs of vax; dx w/accompanying ear infect; placed on ATB; meds changed 14AUG95; has RTC 28AUG95;
Worsening of tinnitus (went from mild to severe).   Aware of increase in severity at the beginning of April.  Sound is constant and loud enough to be distracting.  At times I believe it interferes with understanding other sounds around me.  At times it increases in intensity and then tapers back to the steady constant.  I do fall asleep at night but I am aware of the sound right as I fall asleep and first thing when I wake up.  At times the wake up sound is slightly less intense.  First vaccine:  had no reaction, no fever or nor mild symptoms of any kind.  Second dose:  started with severe headache about 16 hours after receiving vaccine; severe nausea and vomiting.  All symptoms subsided within 36 hours.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2010, the patient was inoculated with ZOSTAVAX at the internal medicine office, by a physician's assistant, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, he was treated by a physician at the internal medicine office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with complications. The patient has been prescribed VALTREX, LIDODERM, and acetaminophen, PERCOCET for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
just feel tired; Achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: just feel tired) and pain (Verbatim: Achy).  The outcome of the tiredness and pain were not reported.   It was unknown if the reporter considered the tiredness and pain to be related to Shingles vaccine.     It was unknown if the company considered the tiredness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.
patient stating that he had pain originating  in the center of left  deltoid and radiating downward to the middle of humerous.  states that pain is increased when raising arm to 90 degrees from midline and when trying to lift heavy objects.  Pt was seen by PCP and prescribed diclofenac. Patient states pain is lessoned but not alleviated when medicated.
Muscle/body aches Shivering  Took Extra Strength Tylenol and they went away. Shivering came back later in the day but was stopped by another dose of Tylenol.
Pt. preSARS-CoV-2 (COVID-19) by NAA, Micro sented to EC w/ shortness of breath, chest tightness, and hypoxemia; diagnosed with PE; discharged home on 04/15/21.
This spontaneous report was received from a female patient of unknown age who was referring to herself. There was no information regarding the patient's medical history, concomitant medications drug reactions or allergies provided. In early September 2005, the patient was vaccinated with ZOSTAVAX, intravenously for prophylaxis (dose, lot number and expiration date were not provided). The patient stated, that the vaccine was transported from a drug store to her doctor's office and may had thawed. The patient contacted her health care professional, however the clinician was uncertain how to proceed. The outcome of the event was unknown.
no adverse event; patient was administered a dose of GARDASIL 9 after the labeled expiration date; This spontaneous report was received from a license vocational nurse and refers to a patient of unknown age and gender.The patient's medical history and concurrent conditions were not reported. On 09-MAY-2022, the patient was administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) after the labeled expiration date (lot # S028738, expiration date reported as 22-MAR-2022, but confirmed to be 03-APR-2022 upon internal validation) (dose and route not reported). The vaccine experienced no temperature excursions.
Headache, Myalgia & NauseaVomiting Narrative: Patient received 2nd dose of vaccine 2/10/21 at 845am and began experiencing symptoms by that evening. Reported symptoms include headaches, body aches, and nausea. No medication were used per patient report.
Upset stomach, headache, eyeache, chills, sore throat, nightmares, insomnia - now 10/28/2009 still not feeling well
Patient experienced fogginess, slightly elevated BP (142/82) for several hours. Discharged at 12:07 once symptoms were resolved, went home for the day to rest.
Weak as a cat; feeling very horrible and as bad as when he had the virus in April; Pounding headaches; Chills; Fever; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak as a cat), FEELING ABNORMAL (feeling very horrible and as bad as when he had the virus in April), HEADACHE (Pounding headaches), CHILLS (Chills) and PYREXIA (Fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection (he felt when he had the virus in April of last year) in April 2020.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Feb-2021, the patient experienced ASTHENIA (Weak as a cat), FEELING ABNORMAL (feeling very horrible and as bad as when he had the virus in April), HEADACHE (Pounding headaches), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, ASTHENIA (Weak as a cat), FEELING ABNORMAL (feeling very horrible and as bad as when he had the virus in April), HEADACHE (Pounding headaches), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle aches) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: inconclusive (Inconclusive) Fever.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Suspect drug details, event outcomes were updated.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Nov2021 (Lot number: FK5615) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 06Nov2021, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022 17:30, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: The reporter's son tested positive for COVID on Thursday, 20Jan2022. The only symptom resent was cough. No known allergies. No other medical history. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks.
Vertigo / dizziness about 22 hours after first dose. Extreme nausea and vomiting for following 24 hours. Chills, sweating, fatigue, and extreme dizziness.  Went to urgent care where they prescribed Meclizine and Zofran. Vertigo is still occurring nearly a week later.
reported on 13AUG93 swollen rt arm & area of inject hot & heart palpitation;
MEDICATION ERROR; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine was not applicable. The outcome of medication error was not reported. This report was non-serious.
Flu vaccine was given at the clinic. Pt states approx 5 hours after getting the flu shot her eyes got very red, itchy and swollen. Pt notified the clinic where injection was given and the doctor's office.
Upon administration, felt an immediate thickening on left side of throat and numbness on left side of face under eye and on cheek bone.  Associate stayed for observation period of 15 minutes and was released to return to work.
1/4/22 This 76 year old gentleman who presented to the emergency room from oncology; he is undergoing treatment for multiple myeloma and was there to get IV fluids. While there he was hypotensive and noted to have AFib with RVR. He was also neutropenic; he denies fever or chills; was subsequently found to be positive for Covid-19. He has history of COVID-19 infections in 6/2020 and 12/2020.
No Adverse Event; Dose administered after 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2022, 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 23-Dec-2022,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture).    No relevant concomitant medications were reported.  No treatment information was provided.
Patient originally diagnosed with COVID on 10/4/21. Patient presented to ER on 10/7, 10/9 and was admitted 10/11/21 for progressively worsening symptoms. Patient has symptoms of confusion, shortness of breath, diarrhea, and patchy infiltrates on left lung.  Patient was admitted overnight for observation and supportive therapy and discharged the next day. Patient was treated with Dexamethasone.