chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right eye pain when blinking.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FR8734) via an unspecified route of administration in the right arm on 29Mar2021 at 11:45 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and hydrochlorothiazide, lisinopril (LISINOPRIL HCT). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. One day after vaccination, on 30Mar2021, the patient experienced mild but definitely noticeable right eye pain when blinking and that was lasted for about 8 hours. It was felt like a hard contact lenses were in upper part of eye. After a few hours, it occurred to the patient to check the internet to see if that was related to the vaccine, and then she found many similar reports. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event right eye pain when blinking was resolved on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Information has been rec'd from a physician and a hlth care professional concerning a pt who on 6/29/00 was vaccinated with varicella virus vaccine live. In December 2000 (previously reported as December 1999), the pt developed breakthrough chicken pox on her abdomen, buttocks, and legs after exposure to her brother who had shingles, Subsequently, the patient recovered. The reporters provided information regarding the patient's brother (WAES00121480). additional information has been requested.
Patient received second DTaP (#2) and IPV #2 only 19 days after first/initial. Manufacturer was called by our office. We were advised to continue with routine vaccine schedule.
feverish 99.4 F.; Heart Racing; getting sick fast; light-headed; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (No reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache). At the time of the report, PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose increased: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL, 0.5 milliliter, intramuscular. Concomitant therapy included MENACTRA and tetanus toxoid. The physician reported the patient who received her first dose of GARDASIL was pregnant. The patient said she was not pregnant at the time of the office visit and refused a pregnancy test at that time. The patient's mother called the office later in the day and said the patient was pregnant and her last menstrual period was "2-3 weeks ago" which was on approximately 18-SEP-2008-25-SEP-2008. No adverse effect reported. The patient sought medical attention at office visit. Follow-up information was received from the physician who reported that the teenager and parent decided terminated pregnancy with parental consent. Upon internal review, terminated pregnancy was considered to be an other important medical event. Additional information has been requested.
patient received Twinrix then as a second dose received Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 55-year-old female patient who received HBV (Engerix B adult) (batch number 54A32, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Twinrix (received a dose of Twinrix on an unknown date).   On an unknown date, the patient received Engerix B adult and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B adult and hepatitis B vaccine pre-filled syringe device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Twinrix and then as a second dose received Engerix B 20MCG/ML, which led to wrong vaccine administered. The pharmacist asked information on how to proceed for the patient's vaccination series. The reporter did not consent to follow up.
pt received Tdap and Menactra vaccines to (L) Deltoid @ 16 yr. Hm on 9-27-07. Seen in office on 9-24 with 1 day 1x c/o swollen 3" x 3", painful, itchy, red at site. No fever.
Voice message received on 09OCT2022, outside of normal business hours, from a Merck employee who reported an adverse event on behalf of a HCP who was the patient. Caller explained the HCP had elevated liver enzymes after he was admini; This spontaneous report has been received from the patient who was also a health care professional (HCP) via company representative, referring to himself a male patient of unknown age.The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were unknown.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose, vaccination scheme, lot #, expiry date, and route of administration were unknown).  On an unknown date, after the vaccine administration the patient developed elevated liver enzymes.  The outcome, as well as the causality assessment between the hepatic enzyme increased event and hepatitis a vaccine, inactivated (VAQTA) were not provided.
The vaccine hit them very hard; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The vaccine hit them very hard) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION COMPLICATION (The vaccine hit them very hard). At the time of the report, VACCINATION COMPLICATION (The vaccine hit them very hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058154 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058154:Case for patient
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case was linked to 2018SA302869 (same reporter). This case involves a 19 years old female patient who received expired dose of vaccine, MENACTRA lot U5462AB via (Expiry date: 19-Jan-2018) unknown route in unknown administration site. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to issue with the imprint of expiration date (two digit year) on the vials which caused confusion (Product leaflet confusion) eventually led to administration of the expired vaccine (expired vaccine used). It was unknown whether patient experienced any adverse 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 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. Documents held by sender: none.
Within one hour of administration began with shortness of breath. Progressed to swelling of eyelids, lips. Due to history of asthma, admitted to ICU for monitoring. Given steroids and nebulizer treatments.
pt got vaccine at 11:30, went to the waiting area to wait out 15 mins. got light headed, slid out of chair into floor. pharmacist seen her draw up like she was about to seize. pt straightened out and came to. when pt woke up she did not know  how she got into the floor. 911 was called. pt was stabilized before 911 arrived. Pt states she had not ate before vaccine was given. Pt was gave a bottle of water and crackers. ems checked B/P, blood sugar, pulse, listened to lungs. all was normal. Pt was slightly light headed but remained instore for monitoring and until resolved.  family was called to pick pt up.
Swelling and redness of thigh started 1 day after receiving vaccine.  Erythema 12 cm X 14 cm with 4 cm diameter diff. between legs.
Hospitalized 1/17/22-1/21/22 weakness, nausea with vomiting, decreased oral intake, cough, elevated troponin, sepsis, a-fib, pressure ulcer
difficulty breathing during regular activity; This is a spontaneous report from a contactable other hcp (For himself). A 64-year-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included metoprolol, losartan and apixaban (ELIQUIS). The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. The patient experienced difficulty breathing during regular activity on 29Mar2021. The patient received second dose of (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported) on 21Apr2021 at 16:30 in the left arm for COID-19 Immunization. The patient had no other vaccine in four weeks: No. The patient has not tested for COVID-19 prior to vaccination and post vaccination. The patient has not received any treatment. The outcome of the event was not recovered.    Information about lot/batch number has been requested.
left room accompanied by family member, apparently fainted & hit back of head on floor;loss of consciousness approx 1min;EMS contacted & transported to ER for eval;
She said she had a little bit of injection site pain with her first COVID-19 Vaccine shot.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via intramuscular route of administration in Arm Left on 16Jan2021 17:15 (at the age of 76 years old) as dose 1, single for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Patient historical vaccine included Flu shot on an unspecified date and experienced flu for a day (about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. No further details provided). The patient experienced as, she said she had a little bit of injection site pain with her first covid-19 vaccine shot on an unspecified date on Jan2021. Outcome of the event was recovered on Jan2021.  Follow-up attempts completed. No further information expected.
I got sick with COVID; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161, expiration date: 31Jul2021), via an unspecified route of administration on 17Apr2021 (at the age of 47-years-old) at 1st dose, single in the left arm for COVID-19 immunization. Medical history included hypothyroidism. The patient's concomitant medications were not reported. The patient wanted to know if she was supposed to get her 2nd vaccine which was scheduled on 06May2021. The patient got her 1st vaccine on 17Apr2021. On 23Apr2021, the patient got sick with COVID. The patient reported that she and her husband both got the vaccine, and both got the virus. The patient did not receive any treatment but underwent home quarantine. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021502285 same reporter/drug/event, different patient
Patient was admitted due to loss of consciousness with shortness of breath and productive that started 4 days prior to presentation with fever and chills.  Found to be COVID-19 positive.  He was empirically placed on steroids antibiotics and Remdesivir. Seen in acute renal failure creatinine elevated to 2.2 was placed on IV hydration. He was asymptomatic at the time of discharge.
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
Pt is a 6 m male with irritability early this morning, had non-rhythmic shaking movements of upper and lower extremities without organization, seemed chilled to mother though body was hot; a pool of spittle nearby, but that is not abnl for him, as he is teething; Mother states eyes appeared somewhat glazed, period lasted about 2 minutes, and when ended, he seemed more placid and restful; he fell asleep shortly after and awakened his usual time of 6 AM and has seemed normal since, though felt a bit warm on awakening and given infant advil; he fed well at 6 AM; Pt seen yesterday for WB visit and was no ill; he was given flu, Pediarix, HIB and Prevnar, Rotateq, he had had all of these x2 prior, with exception of flu; At 3 months, prior to coming to this area, he had 103 documented temp within 24 hrs of 1st immunizations, consisting of Combivax, DTaP, Prevnar and Rotateq; no intervention required and no sequelae; Pt without perinatal or dev concerns and no fam hx of epilepsy or neurological problems
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. It was reported that "3 weeks after getting the second dose of GARDASIL" the patient experienced a seizure. The outcome of the patient was unknown. Upon internal review seizure was determined to be other important medical event. Additional information has been requested.
T102, lethargy 24 hrs p/vax observed in hosp; discharged in good condition;
1 hrs p/receiving MMR pt called & said had hives all over & difficult breathing; treatment in emergency dept included IV, adrenalin & DPH; sx improved rapidly; released p/45-60 minutes;
nurse brought to room and we were instrcuted to administer a bivalent moderna booster.  call the pts name and patient responded.  he rolled up sleeve and took the shot.  after it was given, he asked if his roommate was going to get one. Roommate was the pt who signed up for the vaccine and 1st patient did not.  he didnt have an AEs and his wife and the facility was notified of the error.  Both pt and wife were fine with it.
Pt was awake most of the night crying w/pain in area of inject; denies temp or redness pt not crying this AM;
A LITTLE BIT OF FATIGUE/TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced a little bit of fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little bit of fatigue/tired on 13-APR-2021. This report was non-serious.
CHILLS; HEADACHE; FEVER; MUSCLE ACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, headache, fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fever, chills, and muscle ache. This report was non-serious.
Information has been received from a health professional concerning a 30 year old Asian male with no known drug allergies who on 7/27/01 was vaccinated with MMRII (lot 637872/1517K). Concomitant therapy included varicella virus vaccine live (lot 637957/1882K) and tuberculin purified protein derivative test. It was noted that a family member reported to the health care professionals that soon after his vaccinations, he could not see at all out of his left eye. It was noted that the pt and family members spoke very little English. By 7/29/01, he was able to see again. It was reported that the PPD test was positive. Unspecified medical attention was sought. Upon internal review monocular blindness was considered an "Other Important Medical Event". Additional information has been requested.
9/22/21 PATIENT STATES  4 HOURS AFTER INJECTION SITE WAS  SORE / WARM . THE NEXT DAY  PATIENT STATES  LYMPH NODES UNDER VACCINATED ARM  AND NECK ARE SWOLLEN AND TENDER. PATIENT  STATES  "HER LEFT SIDE FELT NUMB"  WAS CONCERND  WENT TO EMERGENCY ROOM TO GET SYMPTOMS CHECK OUT. AT HOSPITAL PATIENT SAYS DOCTORS OBSERVED HER FOR 2 HOURS THEN SENT HER  HOME AND TOLD HER  THAT  WAS  A NORMAL  SIDE EFFECT FROM THE COVID VACCINE.. SHE WAS INSTRUCTED TO USE TYLENOL AND APPLY ICE TO SWOLLEN AREAS . 9/24/21 PATIENT SAYS FEELING A LITTLE BETTER BUT NOT YET FULLY RECOVERED
Patient asked about a rash on arm a few inches below injection site that extended to bend in arm. Rash appeared to be slightly larger than a dollar bill. They stated it was warm to touch but did not itch. They  were recommended to apply cold compress and follow up at scheduled visit with primary care next day 6/2/23.
I experienced red striations and a burning sensation on tongue and the sensation of a warm tooth. I was diagnosed with Burning Mouth Syndrome by my dentist a week after my first vaccine.  Severe symptoms lasted about a month. Minor symptoms still present. No treatment required. Never experienced this syndrome before.
Fully vaccinated with two doses of Moderna. Tested positive for Covid 19 on 1/4/2022. Admitted to hospital on 01/17/2022. Patient expired on 01/20/2022 while still hospitalized.
Large red oval below injection site, itching started 2 days after injection and continued for 6-7 days.
Post vax, the patient developed a bright red and swollen wound site on his left thigh. There was moderate tenderness and the patient was afebrile. The patient was treated with Rocephin, Benadryl, Motrin and Augmentin.
I had arm pain for 5 days I think; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself.  A female patient of an unspecified age first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain for 5 days she thinks on an unspecified date. The outcome of the event was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed covid on 8/2/22, took Paxlovid for 5 days, had a rebound and tested positive again for covid on 8/10/22.
PATIENT DEVELOPED SWEATY HANDS IMMEDIATELY AFTER THE SHOT WAS GIVEN, THEN SAT AND SAID SHE WAS SHAKEY, ABOUT 5 MINUTES LATER SHE SAID SHE WAS VERY COLD.  LASTED FOR ABOUT 30 MINUTES UNTIL SHE FELT BETTER AND HAD SOMEONE PICK HER UP
Muscle aches, chills, fever, headache, lymph nodes in upper chest and neck area appeared (pictures sent to doctor) and severe neck pain
redness, warmth, large enduration at injection site x 3+ wk, nausia, chills x 3d
Information has been received from a physician concerning a 70 year old female who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  It was reported that after vaccination, the patient developed soft tissue rash.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.