chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8-15-01 pt was given his first dose of Heb.B two hours later at home he told me his heart was beating very fast,his face was very pale,I chech his heart and it was pounding, he said his legs were so weak and the about 5minutes he said he was very dizzness thet the room was spinning.  I put in a called to the doctor , she said not to worry just give him some Tylenol. I had him lay down and about 1hour later the heart started beating the regular beats. But he still complain of leg weakness and dizzness.  I would have to help him go back and forth to the bathroom,he  had to miss school the next day because of the weakness and dizzzness,he said it was not as bad as the night of Aug.15,2001. But just looking at him he still was having some problems.  He was able to go back to school two days after the shot.
first dose on 26-FEB-2021. The second dose was administered today on 26-AUG-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old female patient who received HAB (Twinrix) (batch number 9RT94, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th February 2021).   On 26th August 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. The action taken with Twinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the drug dose administration interval too long 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 reported as the age at vaccination was not reported. A patient received 2nd dose of Twinrix, which was later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.  Note included in structured field batch number was reported as 9RT94 but in description of source document batch number reported as 95T9R.
injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm; doctor diagnosed with cellulitis; swelling of the entire L arm; injection site circle; Swelling arm and finger; Injection site itchiness; rash at the right side of the waist; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (doctor diagnosed with cellulitis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash at the right side of the waist). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itchiness). On 07-Jan-2021, the patient experienced CELLULITIS (doctor diagnosed with cellulitis) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling of the entire L arm), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm). On 31-Dec-2020, RASH (rash at the right side of the waist) had resolved. On 08-Jan-2021, PERIPHERAL SWELLING (swelling of the entire L arm) had resolved. At the time of the report, CELLULITIS (doctor diagnosed with cellulitis), INJECTION SITE PRURITUS (Injection site itchiness), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger) had not resolved and INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Antibiotics and steroids used as a Treatment medication; Sender'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.
I am a healthcare worker that received my 2nd Covid vaccine on 2/17. I am now on day 13 days of fevers (up to 102 daily). I have had multiple infectious workups completed by my primary care provider and the emergency department with only etiology coming back with a UTI. Due to my continued fever, I am now being referred to Infectious Disease.
Beginning in April 2021, menstrual cycle has been  different. Symptoms include: increased pain and bleeding, more than one period in a month. Outcome: symptoms have continued for 4 weeks and not yet subsided.
my lymph node under my right arm is still swollen; my arm is still hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "my lymph node under my right arm is still swollen"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my arm is still hurting".  Additional information: After 3 months, the patient's lymph node under her right arm was still swollen, and her arm was still hurting.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received 1st Covid vaccine on 01/30/2021. Per our record of the assessment form, the patient received Pfizer (Lot # EL9261) on 01/30/2021. On 02/27/2021, the patient was scheduled for his 2nd dose and received the Moderna vaccine (Lot# 004M20A). The patient's assessment form that he signed and our record indicate that he did receive Moderna on 02/27/21. The patient was notified on 03/01/2021 around 3:30pm of incident. The patient stated that his vaccine card had listed Moderna as 1st dose on 01/30/21. The patient was notified that he received the Pfizer vaccine on 01/30/2021 and the Moderna vaccine on 02/27/2021. The patient was informed that the card was mislabeled and he may return to clinic for updated vaccine card for his record. I also discussed with patient that both vaccines serve as the Covid vaccine and both of the doses he received will still be counted as his Covid vaccination status. The patient verbalized understanding.
Pt developed multiple lesions of scalp, back and chest. Red and raised "pimple like."
Day one September 8 1:30 PM - Shingrix vaccine administered by a pharmacist at Pharmacy   3:30 sore stomach becoming increasingly worse and nausea   6:00 ate a sandwich   7:00 extreme abdominal pain and extremely nauseous   8:00 PM to 3:30 AM vomiting every 20-30 minutes and dizzy  The pain was so severe if we weren't under Covid crisis at the hospitals, I would have gone to the emergency room. The pain brought tears to my eyes.   Day 2 September 9 Very weak- in bed all day Stomach gut punches Foggy and light headed Pounding headache  Diarrhea all day and night  Day 3 September 10 Headache  Foggy Abdominal pain Diarrhea   I messaged my internist at the Clinic through MyChart with daily updates
patient tested postive for covid and hospitalizied on 09/07/2021 . Patient expired 9/11/2021. unable to complete section 21 for patient died will not allow me to enter date.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-FEB-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JAN-2015, the patient was treated by a physician for a persistent and blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 is unknown. Additional information has been requested.
PATIENT'S MOM SAYS DAUGHTER HAD ABNORMALLY HEAVY MENSTRUAL BLEEDING FOR THE PAST 4 DAYS.
Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included acetaminophen.  Company Comment  There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe.  However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history was not reported. On an unspecified dates in February 2016 (reported as since 02-FEB-2016), an unspecified number of unspecified patients had been administered with doses of ROTATEQ vial (strength unspecified) lot # L027726 with expiration date 10-MAY-2017, via oral route (dose number and dosage unspecified), which were improperly stored. The vaccine ROTATEQ was exposed to a temperature of 9.3 degrees C with the time frame of 1 hour and 15 minutes. Outcome of excursion was reported as supported. The vaccine did not undergo previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Small (less than pencil eraser) open blister appeared approx. 1-2 inches to the left of the injection site. Area became itchy. Treated with Neosporin. Still present 2 days after injection.
pt said they developed a red swollen area a day after their shot. Pt says the injection site appears more swollen and painful on day 3
This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions and concomitant medications were not provided. The patient had allergy to bovine products. On 07-MAY-2018, the patient was vaccinated with properly stored GARDASIL 9) (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On 07-MAY-2018, the patient experienced injection site rash. The outcome of injection site rash was not reported. The relatedness between the event and suspected vaccine was not reported.
Evaluated for a~2 week history of episodes of altered mental status/confusion and with new-onset seizures. initial evaluation, on day of seizures was in a clinic. She then was transferred to a hospital. Admitted to hospital 4-2-10.
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA006597: US-009507513-2206USA000873: US-009507513-2206USA006599: US-009507513-2206USA006600:
LEFT OCCULAR CONJUNCTIVITIS WITH DRAINAGE REQUIRING TREATMENT WITH ANTIBIOTIC AND STEROID OCCULAR DROPS FOR TEN DAYS.   RESOLVED AFTER TREATMENT
urticaria at right deltoid injection site and multiple urticaria developing on chest and abdomen one week after shot. Mild pruritis no other symptoms
Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The dose administered after 30-day Use by Date or after manufacturer date of expiry. The date the vial was initially stored in the refrigerator was unknown. It was also reported that the vial didn't undergo any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non-significant information.
14 hrs after the vaccine, developed flu symptoms.  beginning at 14 hrs, started taking temperature and did so every half-hour.   At hour 18, temp was 100.9, 30 min later, 101.5, 30 min later, 102.0, 30 min later, 102.7.  when temp reached 1019, spouse began to administer cold-wet cloth to heated areas, e.g., stomach and lower back, spouse continued until for 45 min, until temp dropped to 101.5.  checked temp every hour after that, until dropped below 100.0.  Temp returned to normal roughly 25 hrs after vaccine administration. 68 hrs after vaccine administration, developed cold sores.  Normally, the cold sore would manifest in an area no more than 5% of upper lip area,  After the COVID vaccine, the cold sore covered 35% of upper lip area, and lasted about 24 hours longer than it normally would.  lasted 5 days vice 3 - 4 days, normally.
I had taken my my Booster shot in November 2021. In the month of February 2022, I started noticing tat I have been starting to breakout in Hives.  It started off that there  few hives...fast forward to today. I have spent the last two months going back and forth to the doctor and the emergency room due to an increase breakout of hives.  I haven't experienced a constant break out of hives that is covered throughout my entire body. where I have to repeatly go the the Emergency Room to get some relief
Runny Nose; Itchy Nose; Feeling Sick; Missed dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny Nose), PRURITUS (Itchy Nose), MALAISE (Feeling Sick) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LV014) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (High) and Allergy NOS. Concomitant products included METOPROLOL SUCCINATE, LOSARTAN, ATORVASTATIN, ESTRADIOL, SERTRALINE HCL, CLONAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CETIRIZINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 05-Mar-2021, the patient experienced RHINORRHOEA (Runny Nose), PRURITUS (Itchy Nose) and MALAISE (Feeling Sick). At the time of the report, RHINORRHOEA (Runny Nose), PRURITUS (Itchy Nose), MALAISE (Feeling Sick) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 antibody test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications also included unspecified  glaucoma eye drops and nasal drops.  Treatment medication included corticosteroids for her allergy. Patient was on  antibiotic treatment
Twenty-four hours after the PPV vaccine (administered at 2:00 PM Thursday, 6/18 PCT)or Friday, 6/19 around 5:00 PM my temperature dropped perceptably and I began to shiver and shake so much that my teeth chattered.  I immediately went to bed with socks, bathrobe, and knit cap and did not stop shaking for three hours having finally warmed up. I had a slight rise in temperature and slept fitfully through the night.  The next day, 6/20, at 11:30 AM I am  feeling better and capable of writing this note.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient with diabetes. On 06-SEP-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (strength: 0.65 ml, route unknown lot J003805) that had an expiration date of 03-JUL-2014 (also reported as an unknown indication). The patient's concomitant medications and relevant past drug history were unknown. It was unknown was there relevant lab data. As of 06-SEP-2014, it was unknown if the patient was still on ZOSTAVAX and the outcome of receiving expired ZOSTAVAX was unknown. Additional information has been requested.
Went backward develomentally; High fever; This spontaneous report was received from an other reporter, concerning an unspecified child of unknown age and gender. Information regarding patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient presented high fever, the parents swear that the child went backward developmentally after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), however the physician did not agree with the parents assessment.   At the time of reporting, the outcome of high fever and backward developmentally was unknown.   The causal relationship between the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the adverse event was not provided by the reporter.
This is a spontaneous report from a Pfizer-sponsored program [Pfizer RXPathways]. A non-contactable consumer reported that a female patient of an unspecified age started to receive PREVNAR 13 (Solution for injection in pre-filled syringe), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose and frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported that patient had allergies with the ingredients. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was unknown. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.