chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incessant severe inflammatory phenotype pericarditis requiring hosp admit x3 multiple docs, drainage, steroids, colchicine + still not resolved. Needed pericardiocentesis due to almost tamponade
8 days after shot Body aches, headaches, chills, swollen red stem at injection site, 11 days after shot a rash.
Approximately 17 minutes after vaccination to right deltoid,  (patient)  approached medical assistant in observation area reporting difficulty breathing and feeling of throat swelling; verbal and visual evaluation performed promptly by COVID-19 RN in observation area, as exam room was occupied by another patient; patient then escorted to office room adjacent to exam room and placed into sitting position in office chair by COVID-19 RN ; (nurse practitioner) notified as  was escorted to office and verbal and clinical evaluation performed by RN after patient  placed into seated position;  erythematous patch noticed circumscribing injection site during visual inspection; Epinephrine administered via auto-injector to left vastus lateralis at 20min minutes post immunization as patient reported worsening tightness in the throat and chest and increasing difficulty breathing ; EMS personnel, already onsite for other patient, responded and assumed care shortly after administration of epinephrine;  patient alert and accompanied by one of her co-workers  for transport to Hospital via EMS
Patient noticed large red mark and felt hot spot and golf ball sized welt at injection site. Had low grade fever.
neuritis symptoms of upper and lower extremities starting distally in the feet and hands moving to above the elbows and knees and lower face over several weeks. Weakness of hands. Intermittent weakness of legs. Current treatment: Lyrica to relieve dysesthesia. Symptoms ongoing.
Pfizer-BioNTech COVID-19 Vaccine EUA: within five minutes of vaccination patient with seizure disorder experienced a seizure that resolved spontaneously. Emergency response activated immediately, patient evaluated and found to have vital signs all within normal ranges, remained awake and alert (never lost consciousness), able to drink water, observed, and discharged home stable with caregiver.
pt devel small rash on lt side of body same day recvd vax; 30JUn rash spread to entire trunk, arms & legs; 1JUL fever 103 all day; 4JUL rash itchy; 6JUL pt recvd Atarax & w/in 45min pt silly hyper; 7JUL pt screaming; twitching, jerking;
lost weight; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 16 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number-EW0183), administration date: 16May2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; lot number-EW0186), administration date: 07Jun2021, when the patient was 16-year-old, for Covid-19 immunization, reaction(s): "vaccination failure", "COVID-19". The following information was reported: WEIGHT DECREASED (non-serious) with onset May2022, outcome "unknown", described as "lost weight". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was also reported that the patient received his first booster of the gray cap formulation of the Pfizer BioNTech Covid 19 vaccine on 29Jan2022, but was accidently given another booster on the reporting day of the gray cap. Nurse clarified that caller had Covid in Dec2021 around Christmas and then lost weight (post Covid weight loss in May 2022) for three months afterward, but is otherwise healthy, and not immunocompromised.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. On 17-AUG-2017, 1 day after onset of therapy the patient experienced accidental exposure to product, occupational exposure to product and syringe issue. On an unknown date the patient experienced no adverse event. The outcome of occupational exposure to product, no adverse event, syringe issue and accidental exposure to product is unknown. The reporter considered accidental exposure to product, occupational exposure to product, no adverse event and syringe issue to be not related to M-M-R II. Sender's Comments: US-009507513-1708USA008230.
First dose given 2 years ago. Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date  2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported Shingrix second dose than 6 months. Till the time of reporting, the patient did not receive the second dose, which led to, incomplete course of vaccination.  The healthcare professional could not provide date of first dose, lot number, or expiration date.  The reporter consented to follow up.
Started a mild headache a few hours after the shot, then progressed to a moderate headache that evening with body aches.  Friday morning, woke up with chest tightness.  By Friday afternoon, headache was blinding, and can't breathe well.  Go to ER around 430pm.  Had fever of 100, tachicardia.  Given IM Tordol to help with the fever, body pains, and migraine.  Sent home withSteroid inhalants through nebulizer prescribed and picked up at 6pm and started at 7pm that evening.  Sunday morning at 4am, back at ER for severe can't breathe, migraine back.  Tachicardic again.  IV Benedryl, Reglan, and Tordol given.  Sent home.  Body aches remained, headache stayed moderate from Sunday to Thursday at 2am, when headache became blinding again, chest was tight again.  Back to ER.  Given muscle relaxer and sent home.
50 cent size redness and larger area of swelling, headache, local area itchy.
covid arm.    pt states occured two days post injection.  no issues with previous phizer covid vaccines.  pt states itchy first few days no only red rash. no other symptoms.  pt requested we sumbit  VAERS report
102 fever, extreme chill, sore and stiff neck, body aches, joint pain, very bad headache, restless legs, hot flashes later, nausea, weak, fatigue, and the next morning I still had a fever, fatigue, weakness, and joint pains.
Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hydroxyzine about 6 hours apart. Symptoms  resolved and did not return.
This spontaneous report as received from a physician refers to a 70 years old female patient with no pertinent medical history. The patient was vaccinated with ZOSTAVAX in the left arm on approximately 08-OCT-2012 "about a week and a half ago". Lot# was unspecified. Other suspect therapy included influenza virus vaccine (manufacturer unknown) in right arm on 08-OCT-2012, the same day that she received ZOSTAVAX. On approximately 11-OCT-2012, "about 3 days after receiving ZOSTAVAX", the patient developed a vesicular, urticarial rash on her right shoulder and right side of her neck. Unspecified topical cream was given as treatment. The outcome of patient was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information has been requested.
Positive covid test; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid test), PYREXIA (Fever) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). On 26-Jan-2021, the patient experienced COVID-19 (Positive covid test). At the time of the report, COVID-19 (Positive covid test), PYREXIA (Fever) and MYALGIA (Body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         No relevant concomitant medications were reported. Treatment information was took medicine and the symptoms were gone in three days.   Reporter did not allow further contact
pt recvd vax; immediate redness & swelling to site w/ itching; swelling after 24 hrs included entire top of arm; fatigue, low grade t; lasted approx 2 days; swelling & redness to arm lasted 1 wk;
Tongue swelling after 2weeks of first dose,  and continued.  2nd dose diarrhea and bad continue through now. Comes and goes, terrible headaches, neck and back pain and all over body pain. Left sided tingling and numbness, swollen lymph nodes.
Information has been received from an unspecified reporter referring to a 14 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
At 4:00AM on May31, 2022 I felt like I got hit by a freight train. I had nausea, chills, diarrhea, muscle fatigue, fever, headache, sore throat, hacking cough. I took two home COVID-19 test that came back negative. The next day on June 01. 2022 I took a third home COVID-19 Test that came back positive. I called my doctor and the local department of health. I was prescribed azithromycin for me to take once daily for ten days. I am still not anywhere near to where I was before I got COVID-19.
This patient was admitted to Hospital on 1/22/2022 for COVID related symptoms. This is considered a breakthrough case.
received booster instead of 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose). On 11-Nov-2021, ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose) had resolved.        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.  No treatment information was provided. An Immunocompromised patient received a booster dose instead of the 3rd dose.
KNOTS ON HEAD, EARS, NECK; RASH/ALL OVER FACE BUMPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced knots on head, ears, neck, and rash/all over face bumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash/all over face bumps and knots on head, ears, neck was not reported. This report was non-serious.
felt to the floor once, he was conscious all the time; felt dizzy; Acid reflux; throwing up , most of the day; had nausea all the time; A spontaneous report  was received from a Consumer concerning a 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux.  The patient's medical history was not provided. Concomitant medications reported were simvastatin for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events, throwing up. most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux. Event felt to the floor once, he was conscious all the time was considered medically significant.  Treatment details included unspecified nausea pills, as needed, from the emergency room on 31Jan2021.  Action taken with mRNA-1273 in response to the events, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room, was told he had acid reflux was not reported.   The outcome of events include, throwing up , most of the day, had nausea all the time, felt dizzy, felt to the floor once, he was conscious all the time, went to emergency room was told he had acid reflux was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
VOMITING WITHIN 5-10 MIN AFTER SHOT, ABOUT 5 MIN AFTER DAUGHTER VOMITED.. MOM GOT VACCINATION FIRST, DAUGHTER SECOND, DAUGHTER VOMITED FIRST.
I had shingles twice on my face Very painful; They are so painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120535   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient developed shingles twice on face and it was very painful. The first episode was on left side of face about 12 years ago and second episode on right side of face 4 years ago. The patient received first shingle shot before the first episode, then another shingles shot 4 years later. The patient already received two injections of the new shingles medication and hopefully it would not get them again. They (Shingles) were so painful.  Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR120535, reported by same patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR120535:Same patient, other dose
Fever/chills, Fatigue, and body aches 10-12 hours after vaccine  Angioedema of the lips 30 hours after vaccine(had fillers two years ago)
Confirmed case of Shingles beginning 3 days after receiving vaccine. Open vesicle and nerve pain on back of head. Pt was started on Acyclovir 800mg five times a day beginning 10/26/2018 and symptoms are improving.
Vaccine admin on 2/14/16. C/0 progressive red, itching/burning rash over both arms, trunk and legs within 12 hours of PCV-13 vaccination.
Dizziness, mild throat tightening sensation, anxiety, claminess, hypertension
took Moderna on 5/18/21. on 5/19/21 nausea vomiting.  hard time eating. lost 30 lb in 2 months
Muscle aches in upper front thigh and hip , also right back - deep throbbing aches
Patient called and complained of weakness and fever 101.5. Patient told to take Tylenol for fever and seek medical care if condition worsened or continued > 3 days. Patient went to hospital. Currently on ICU in stable condition.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/7/2023 SHORTNESS OF BREATH J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 4/7/2023 SHORTNESS OF BREATH R09.02 HYPOXIA 4/7/2023 SHORTNESS OF BREATH
Patient reported having a rash between her thighs and on her forearms for 2 weeks following administration of Shingrix #1. Denied any pain associated with rash. Evaluated by MD and determined as possible reaction to vaccine and #2 was not given.
Serious neurological issues (shooting pains, tingling, muscle twitching, jerky movements of the leg muscles making it impossible to sleep, dizziness, tinnitus...)  Diarrhea (still going after 9 days) Nausea Tiredness Dizziness
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 06May2021 as dose 2, single (Lot number: EW0182), in right arm and on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Negative; (05Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included Paxlovid from 25Jun2022 to 29Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling bad; The fever was a 101.1; Dizzy/Started feeling like kind of lightheaded like we have a little joint or something; I was not able to sleep last night; Felt very weak; Nauseated; Whole body had joint pain; Vaccine site is hurting where they gave the injection; Exhaustion; Muscle pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Left arm on 16Mar2021 as dose 1, single for covid-19 immunization.  Medical history included osteoporosis and irritable bowel syndrome. Prior to vaccination patient previously had covid-19 in Aug2020. Patient concomitant medication included vitamins. The patient was feeling bad after the vaccination, she had the fever with temperature a 101.1 and was  dizzy ,started feeling like kind of lightheaded like we have a little joint or something, she was not able to sleep last night. The patient felt very weak and was nauseated. The whole body had joint pain and vaccine site is hurting where they gave the injection exhaustion. She had muscle pain. The patient underwent lab tests and procedures which included body temperature: 101.1 (units unspecified) and COVID-19 test with positive result in Aug2020. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Fever; no power; Pain at injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 36-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:45 (at the age of 36 years old) (Batch/Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. The patient has no known allergies. There were no concomitant medications. Previously the patient took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 36 years old) as single dose for COVID-19 immunisation. On 03Mar2021 20:00, the patient experienced Fever, no power, Pain at injection site. No other vaccines were received in four weeks. No treatment was received for the adverse events. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Mother states her son had palpitations, after 3 hours of his vaccine at about 4:30pm. She also states he also experienced SOB and he explained he missed a beat to his heart". The days after he had same symptoms, two times a day for the next three days.  Mother states he experienced his symptoms about ten times a day for about 15 seconds. On the second day I called the doctor, nurse told her to take his pulse after he had an episode, difference was very slight during the 15 second pule taken, normal was 20bpm in 15 seconds and then it changed to 22bpm in 15 seconds.  On Monday while talking to other classmates in school, another kid said he experienced the same thing like him.   On Tuesday 05-25-2021, his mother states her son told her her felt some palpitations but as of today he has not had any more palpitations.
Information has been received from a physician concerning a college age female who was vaccinated with her first and second dose of Gardasil vaccine. The patient experienced flu like symptoms after the second dose. Subsequently, the patient eventually recovered several days after the vaccination from the flu like symptoms. The patient had no reaction to the first dose. She received the first dose in the physician's office and the second dose at her college. The patient sought medical attention by calling the physician. Additional information has been requested.
13 year old administered with the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old administered with the Moderna vaccine) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old administered with the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old administered with the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.