chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 84 year old male with ischaemic cardiomyopathy and diabetes and a history of defibrillator insertion who on 20-APR-2009 was vaccinated with ZOSTAVAX (lot number 663637/1705X). Concomitant therapy included METFORMIN, GLIMEPIRIDE, HUMULIN, DIOVAN, TOPROL XL TABLETS and VIAGRA. There were no drug reactions and allergies. On 16-MAY-2009 the patient had shingles which was a "rash located around the patient's defibrillator on the left side on the bottom". On 18-MAY-2009, the patient had sought medical attention in the office. Lab diagnostics studies were not performed. At the time of reporting, the patient was recovering. Additional information has been requested.
I BEGAN TO HAVE NECK PAIN AND HEADACHES ONE MONTH FOLLOWING, BOTH OF WHICH I NEVER HAD BEFORE.  I HAD A SUDDEN CHANGE IN MY VISION, RESULTING IN PROGRESSIVE LENSES.   I HAVE DEVELOPED HEART PALPITATIONS, LIGHTHEADEDNESS, DIZZINESS, HAND TREMORS, A MUSCULAR MASS IN MY NECK WHICH IS CAUSING DIFFICULTIES SWALLOWING.  I HAVE LOST OVER 20LBS, AND HAVE BEEN SEEN BY MY PCP, AN EYE DOCTOR, AN ENDOCRINOLOGIST, A CARDIOLOGIST, AN ENT, AND I AM ON A WAITING LIST TO BE SEEN BY A NEUROLOGIST IN 2022.  I WAS HEALTHY BEFORE THE VACCINE, AND SO I HAVE REASON TO BELIEVE THIS MAY HAVE CAUSED THE ONSET OF THESE SYMPTOMS.
Pregnant; A spontaneous report was received from a consumer concerning a 29-years old pregnant female patient who experienced exposure to vaccine during pregnancy.   The patient's medical history was not reported. Concomitant medication reported mentions prenatal vitamins, unisom, promethazine and vitamin b-12.   The patient received their first of the two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm on 30 Jan 2021 for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient received the second of the two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient had a positive pregnancy test on 04 Dec 2020. Her last menstrual period was in 06 Nov 2020 and estimated date of conception was 06 Nov 2020. The patients estimated due date is 13 Aug 2021. On 30 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable as patient took both doses of the vaccine.
Projectile vomiting and/or excessive spit up (pouring out of mouth and nose)
Nighttime drooling since the second COVID vaccine was received, still ongoing at the time of this report
Burning sensation from tummy to toes / Still gets burning sensation today; Similar side effects as the first shot, after booster; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster). At the time of the report, BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) had not resolved and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided. She still got burning sensation on 14JAN2021.   This case was linked to MOD-2021-106680, MOD-2021-246781 (Patient Link).
No actual adverse event transpired. Third dose of vaccine was given less than 6 months after first dose. This was discovered 12 months later on a routine followup of patients records. CDC advised that another third dose be administered to assure adequate immunity. Patient contacted and will come in to repeat third dose of the ENGERIX-B.
Sniffles, body aches and pains, nausea, diarrhea,  light headed, profuse sweating,  headache and increased BP for 7+ days
3 days fever, chills, muscle aches & pains, Migraine Headaches, Nausea, Diarrhea, UTI, Dizziness, lethargic, sore throat
Right middle toe started with severe itching. It turned red and slightly swollen. 2 days later, 2 small pustules appeared on top of the toe. Only 1 toe has ever been affected.
Several hours after the injection I developed soreness at the injection site. 11 Hours later I felt warm, achy. I checked my temperature at 3:30 PM  and it was 100.2.
This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot numbers: K026247, L011846, L013429, L020015, L024993, L026602, M009378, M017983 and M028323 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis. It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of GARDASIL 9 were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001209: US-009507513-1705USA001211: US-009507513-1705USA001212.
After receiving the vaccine I felt sick, which I thought was normal. The issue I?m having is still pain at injection site that I can still feel down my left arm. This is two weeks AFTER the injection.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm".  Additional information: Reporter stated, the only thing we had was sore arm for a day and half and nothing else.  No follow-up attempts are possible. No further information is expected.
vaccine didn't work for me/suspected vaccination failure; vaccine didn't work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccine didn't work for me/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: vaccine didn't work for me). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that the vaccine did not work for him or her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
experienced a very high fever; seizures and convulsions; he was never the same; legionnaires disease; appendicitis; itching,; overweight; not much hair; "lots of body complaints," and is emotionally challenged; This spontaneous report refers to a currently 60-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in the late 1960s, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was hospitalized due to very high fever, seizures and convulsions. The patient was put on phenobarbital as a treatment. After that, "he was never the same". On an unspecified date, the patient experienced lifelong health issues, including legionnaires disease, appendicitis, itching, overweight, not much hair, "lots of body complaints" and was emotionally challenged. On an unknown date, the patient sought medical attention. The outcome of the events was reported as not recovered.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of appendicitis and pneumonia legionella were considered to be medically significant.
Hot flashes (mild but frequent) that have continued into second week so far.  My LMP was Dec 16 2020 (I am 58 y.o. and still having semi-regular cycles every month or two).  I have never had hot flashes before. They started a few hours after the vaccine and continue.
Information has been received from a physician concerning a patient who on 07-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663889/0632Y).  On 07-DEC-2009 the patient had a temperature of 103F.  The patient's arm was swollen a few hours after vaccination, and the arm became more blotchy.  On 09-DEC-2009 the patient was seen at the office and the area was blotchy and itchy.  At the time of the report, the patient's outcome was unknown.  This is one of two reports from the same source.  No further information is available.
50 year old female was vaccinated with a booster 30 days before the recommended interval following the Moderna primary two (2) series of six months.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported) and MMR II lot # K024035, expiration date 26-NOV-2016 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient given a dose of Moderna by the pharmacy (per patient report) on 09/13/2021. This was a full dose Moderna because it was before boosters were authorized. Moderna batch/lot# 020F21A. He then went to a clinic and asked for a second Moderna to meet requirements for travel to another country. Moderna 2nd dose given.
myocarditis; cardiac related problems; chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 20:00 (Lot number: 33036BD) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: PREMARIN; CELEBREX; VYVANSE; NURTEC ODT; SYNTHROID. The following information was reported: MYOCARDITIS (medically significant) with onset 10Jan2022 12:00, outcome "not recovered", described as "myocarditis"; CARDIAC DISORDER (non-serious) with onset 10Jan2022 12:00, outcome "not recovered", described as "cardiac related problems"; CHEST PAIN (non-serious) with onset 10Jan2022 12:00, outcome "not recovered", described as "chest pain". The events "myocarditis", "cardiac related problems" and "chest pain" were evaluated at the physician office visit. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID-19 post vaccination. The patient has no known allergies.
On 4/27/2021 around 3am,  I woke up in a sweat and I was having severe chest pains.  I took 2 aspirins right away.  At 9am,  I decided to go to the ER.  They did blood work and  EKG and it showed I was having a heart attack.  I did an emergency surgery and a stent was place.  I was admitted and was in the ICU for 5 days.  I was discharged with new medications and to follow up with a cardiologist.  On 5/28/2021, I had another stent place.  I now have SOB and breathing issues that I have never had before.
a patient was inadvertently given an expired dose of Pentacel vaccine with no adverse event; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Agency (Reference number: 00328024).  This case involves an 14 months male patient who was vaccinated inadvertently with an expired 0.5 mL fourth dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (lot number: UJ058ABA and expiration date 13-Oct-2020) via intramuscular route in the left thigh on 16-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HEPATITIS A VACCINE and INFLUENZA VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event reported.  Caller would like to know information regarding this incident and adverse reactions to look for.  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.
not been able to sleep; not been able to stand up; sitting up was hard; COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 027b21) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed). On an unknown date, the patient experienced INSOMNIA (not been able to sleep), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test positive: positive (Positive) positive.         No concomitant medication was reported.  No treatment medication was reported.  It was reported patient was good except for the upper congestion that won't go away.  Company Comment: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Large red area several inches wide from injection site down to elbow of left arm, no discomfort, area has not gotten worse or better after 7 days post vaccination.
A 16-year-old received Moderna as his booster shot (3rd dose) at the request of his grandmother, who is also his guardian. The age was missed at the time of check-in. Consent form was picked up by the nurse and vaccine administered before the RPh had a chance to check it. The nurse also missed the birthday/age of the patient. Patient is fine. No adverse reactions reported.
Member returned to clinic on 6/8 to report the following: she was given a typhoid shot on 6/6 and started experiencing symptoms of facial swelling and shortness of breath that afternoon. She self-medicated and went to bed. Her symptoms were milder the next morning and began to escalate throughout the day. On 6/8 she returned to the clinic with symptoms at their worse to include lightheadedness, shortness of breath, and the sensation that her face was swelling. Member was seen at the clinic, EMS was called anf member was transported to hospital where she was evaluated and released 24 hrs later.
Information has been received from a doctor of pharmacist refers to a female patient of unknown age who on 13-NOV-2013 was vaccinated with an expired dose of ZOSTAVAX (lot # 669746/0356AA, exp 09-JUN-2012) (dose and route not provided). No known adverse effects. Additional information has been requested.
Patient received COVID-19 vaccine 3 months ago per patient. Admitted to the hospital on 6/27/2021 with dyspnea on exertion. Myocarditis possible from COVID-19 vaccine. Treatment given was IVIG on 07/02/2021 and after therapy, patient has been clinically stable with no complaints.
Pain in legs and joints.  A week later, left knee is painful, feels like it has locked up.  Struggled to walk on it  due to pain for about a week.  Taken Tylenol, Ibuprofen,  Naproxen but doesn't seem to be effective.  Massage helps for a little while.   Pain present for 24 hours after first dose.  Have not sought care from PCP but will if pain does not resolve soon.
On May 17th around 1-2am, I woke up with nausea, vomiting, and severe dizziness. I did not have these symptoms when I went to bed around 11pm May 16th. I stayed in bed a full day May 17th and was unable to keep down fluids or food. I went to the emergency room the morning of the 18th. I was diagnosed with gallstones and treated for nausea and dehydration. I began taking  prednisone prescribed by neurologist on May 19th, as I was having a flare-up of multiple sclerosis. My gallbladder was surgically removed May 24. I am currently waiting on multiple sclerosis MRIs.
pt recv vax & devel an inj site rxn characterized by swelling & erythema;pt recovered p/2wk;this is 1 of 6 pt from this site to have an adverse exp following vax lot# 4968173
Prizer Vaccine on 3/19/2021 or 4/9/2021.  No reactions developed after two vaccinations.   7.8.21: Patient comes in to ER for abodminal Pain, Fever, cough, low back pain for 3 days radiating into her hips, Headache, fatigue, hypersomina, lightheadedness and cold intolerance.   Diagnosed with: COVID-19 disease, febrile neutropenia (resolved during stay). Started remdesivir 7.12.21: completed 5-day course of remdesivir. 7.13.21: Patient was discharged home.
This spontaneous report as received from a pharmacist via a company representative refers to a 42 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M018766; dose, route of administration and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) in the same arm. On an unknown date, the patient developed a rash that started at the injection site and spread to his abdomen. It was unspecified if the rash started at the PNEUMOVAX 23 or influenza virus vaccine (unspecified) injection site. The outcome of the adverse events was unknown. The relatedness between the adverse events and PNEUMOVAX 23 and influenza virus vaccine (unspecified) was not provided). Additional information has been requested.
Large red raised wheal, pruritic, at injection site deltoid. 10 x 6 cm. Onset within 24 hrs of vaccine injection. Hot to touch. No fever.
Site soreness, fatigue, sore hip joint. Effects were moderate so no treatment was sought.