chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left ear canal is swollen; Left ear canal is swollen - there is some pain; muffled hearing; soreness at injection site; face tingling (possible partial numbness it's hard to tell).; Head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities; Left eye area feels like it's being pulled at, like the skin is being stretched; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 07Jun2021 11:45 as dose 1, single for COVID-19 immunization (at the age of 25-year-old, non-pregnant). Facility type was Public Health Clinic. Medical history included seasonal allergies and known allergies from Penicillin, levofloaxcin, clarithromycin, most fruits, celery, lettuce. Concomitant medication(s) included Multi Vitamin, cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen (MOTRIN [IBUPROFEN]); chlorphenamine maleate, paracetamol, phenylephrine. Patient did not receive any other vaccine in four weeks. Patient had no Covid prior vaccination and Covid was not tested post vaccination. The patient experienced tingling on left side of head after 3 mins after vaccine injection, left ear canal was swollen - there was some pain and the swelling was causing muffled hearing, soreness at injection site, face tingling (possible partial numbness it was hard to tell), head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities, left eye area feels like it's being pulled at, like the skin was being stretched on 07Jun2021 11:45. It was unknown if patient received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Injection given on left thigh. Rash on left thigh extending to the knee, warm to the touch. Hives.
The left arm where the shot was given was only sore for a short time, but my right are began to ache the next day.  It seems to be in the muscle between the elbow and shoulder.  I can use my arm, but grasping items and raising them above my shoulder are very painful (like holding my hair dryer and raising it to dry my hair).  I have debated with myself about reporting this, but with the current concern with the Johnson and Johnson - one shot, I thought maybe I should report it.
p/vax pt exp chickenpox w/50 to 60 itchy maculopapular vesicular lesions over trunk, face, neck & unspecified medical attention;
Arm is red, swelling and itching; Arm is red, swelling and itching; Arm is red, swelling and itching; This spontaneous case was reported by a consumer and describes the occurrence of   in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
low tiers for Hiberix; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 46-year-old male patient who received Hib (Hiberix) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The asplenic patient had low titers for Hiberix, which led to decreased therapeutic response. No lot number and expiration date provided. No vaccination date provided. The Vaccine Administration Facility is the same as Primary Reporter The reporter consented to follow up.
fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
He couldn't sleep; Dizziness; severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head) and INSOMNIA (He couldn't sleep) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 29-Mar-2021 to an unknown date for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head). On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced INSOMNIA (He couldn't sleep). At the time of the report, DIZZINESS (Dizziness) and TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head) had not resolved and INSOMNIA (He couldn't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were provided.    No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up information was received and the reporter information,  patient demographics, concomitant medications, new event, outcome of events were updated.; 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.
About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it was the left ear but the fact is both are ringing and the left side is worse. I was panicking and I didn't know what was going on. I went to urgent care three days later and they found nothing that was causing the ringing. They urgent care doctor made a phone call a specialist and she stated that the ringing in the ears is a rare side effect of the COVID vaccine and it should go away. I then went to my primary care doctor and she thought she saw some redness in my left ear and thus prescribed me methylPREDNISolone and an ear drop with the name Ofloxacin. They both did not work. She then prescribed me Azithromycin which also did not work. Since I was not responding to medication, I was diagnosed with tennitus by my primary care doctor. About a week later after the vaccine, I was been experiencing popping in my left ear as well as the noise. But on the right ear, there is only noise. Prior to vaccination, I never had any issue with my ears before. The tennitus is debilitating and life altering in so many ways. I'm still not getting more than four hours of sleep even with melatonin and I'm someone that has never used melatonin or had sleeping issues prior to vaccination.
shingles; This spontaneous report was received from a consumer referting to themselves, a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown.        The causal relationship between zoster vaccine live (ZOSTAVAX) and herpes zoster was unknown.
Marked drainage from vaccine site on day 8, status post vaccine administration erythema surrounding site, No edema, Positive palpable axillary node.  Denies fatigue, fever.  Levaquin 750mg by mouth daily given empirically.
Vaccine leaked out of the arm; Sore arm; A spontaneous report was received from a pharmacist concerning a 73-year-old male patient who was participating in the mRNA-1273 Emergency Use Program and Vaccine leaked out of the arm and the patient experienced sore arm.  The patient's medical history was not provided. Concomitant medications were not reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 11 Jan 2021, the vaccine leaked out of his arm and the patient experienced a sore arm for a couple of days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event incorrect dose administered was considered resolved on 11 Jan 2021. The outcome of the event sore arm was unknown on an unknown date.; Reporter's Comments: This case concerns a 73-year-old, male patient. The patient's medical history was not provided. The patient experienced a non serious event of vaccine leak and pain of arm. The event occurred the day the first dose of mRNA was administered. Based on the current available information and temporal association between the use of the product and the start date of the pain in arm, a causal relationship cannot be excluded.
Information has been received from a nurse through a Merck pregnancy registry concerning a 26 year old female patient with a history of 4 pregnancies and 2 live births who was on oral contraceptives in the first trimester, with gestational diabetes and insulin dependency, who on 31-MAY-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient was pregnant with a LMP of 09-Apr-2007. Follow up information indicated that on 09-Jan-2008 the patient delivered a normal liveborn male infant weeks from LMP 37 2/7 with a Apgar score 8/9. Follow up information has been received in the form of medical records. On 09-JAN-2008, the baby was born with hyperbilirubinemia and bilateral cephalohematomas. The weight was 8 lbs, the length 21 inches, head circumference 13.8 inch. On 12-JAN-2008 and 13-JAN-2008, the patient was admitted for phototherapy. Saturday, 12-JAN-2008, the patient's bilirubin was 19 and Sunday, 13-JAN-2008, rebound bilirubin was 11 (5 hours off phototherapy). A total bilirubin measurement with a heel stick was performed. The lab results were reported as: -12-JAN-2008: 18.0 mg /dl 19.2 mg /dl. -13-JAN-2008: 12.3 mg/dl 10.8 mg/dl 11.2 mg/dl 16.1 mg/dl. On 14-JAN-2008, the baby had a sick visit to the doctor and still had jaundice and cephalohematoma, with icteric sclera and hyperbilirubinemia. Some lab test was performed, which included a measurement of Total bilirubin with a heel stick. The results was : 12.2 mg/dl. On 18-JAN-2008, the baby had a sick visit date, and it was noted that the baby had jaundice from chest to upper abdomen (seedy yellow) and hyperbilirubinemia. The pediatrician was concerned about the baby's head swollen. The baby still had cephalohematoma. On examination on 25-JAN-2008, it was noted that the baby still had bilateral cephalohematoma; the left side greater the right side. It was also noticed that the baby had urine frequently, had jaundice in the face, and diaper rash. The baby was 15 days. A lab test was performed which included a PKU (result not reported). On examination on 08-FEB-2008, it was noted small cephalohematoma right. The baby was 1 month of age. On 07-MAR-2008, the baby's cephalohematomas was resolved. On an unspecified date, the baby recovered from diaper rash. The outcome of the baby's hyperbilirubinemia and frequent urination was unknown. No additional information is expected. It was also reported that the infant developed adverse experiences after vaccination with ROTATEQ (WAES # 809USA01659). All medical records will be provided upon request.
A FILLING NEEDLE WAS USED TO EXTRACT AND PREPARE 26 DOSES OUT OF A MODERNA VIAL SEQUENTIALLY UNDER 5 MINTUES TOTAL PREP TIME. MODERNA AND HEALTH AUTHORITY WERE NOTIFIED AND WE ARE AWAITING RESPONSE FROM MODERNA REGARDING STERILITY OF THE PRODUCT.  NONE OF THE POSSIBLY EFFECTED PATIENTS REPORTED ISSUES OR ADVERSE REACTIONS. AGENCY BEING FILED BECAUSE OF HEALTH AUTHORITY GUIDANCE.
12/24/2022 diagnosed with Covid, experienced vertigo. Medication prescribed were PAXLOVID and TESSALON. Also taking nexlosine.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 13-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. the patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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: 1822809 expiry: UNKNOWN) dose was not reported, administered on 19-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 19-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237053. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record describes a medication error regarding a potential temperature excursion with no product quality issue indicated, also janssen is not responsible for product storage in facilities out of janssen control) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220649045, 20220650111, 20220649488, 20220649417, 20220649421, 20220649137, 20220649884, 20220649803, 20220649915, 20220650185 and 20220650933.
pt recvd vax MAY92 & 6 hrs following vax exp severe gastrointestinal upset & was tired & achy; treated w/rest & fluids; reporter indicated that pt was switched to Recombivax for 2nd inject, & that the event did not re-appear;
Gradual onset of loss of taste early 2021, patient thinks after first COVID vaccine 2/26/2021. Continuous symptom. Worsened over first several weeks and then plateaued and has stayed stable. CHaracter is " everything tastes like metal" and "can't taste anything." No previous dysgeusia. COVID antigen test for these symptoms reported as negative twice. No headache, diplopia, new or worse dysphagia, dysarthria, numbness, tingling, lateralizing neurologic dysfunction, weight loss, or fever.
Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Heart attack". The patient date of death was unknown. Reported cause of death: "Heart attack". It was not reported if an autopsy was performed.  Clinical course: Caller stated that she had a friend whose brother died after the Pfizer shot, he died from a heart attack 7 days after and he was fine and in good health before that, but oh it could not be the shot, well that was the only thing that was different was the shot. Caller stated another friend's 19 years old son had a heart attack after the vaccine and now has myocarditis for the rest of his life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack
bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B219, 007B21A, and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced DIARRHOEA. At the time of the report, DIARRHOEA outcome was unknown.            The concomitant medication was unknown. The treatment information was not provided by the reporter.   This case was linked to MOD-2021-381347 (Patient Link).
No additional AE reported; Pharmacist reports a patient was administered PEDVAXHIB at 2 months, 4 months and at 6 months. Caller states the 6 month dose was administered on 27DEC2022.; This spontaneous report was received from a pharmacist and refers to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in August 2022, also reported as at 2 months, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) first dose (strength, dose, lot #, expiration date and route of administration were not provided) for prophylaxis. On an unknown date in October 2022, also reported as at 4 months, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) second dose (strength, dose, lot #, expiration date and route of administration were not provided) for prophylaxis. On 27-DEC-2022, also reported as at 6 mounts, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) third dose, lot#T030711, expiration date: 15-APR-2023 (strength, dose and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported (No adverse event).
2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.
Shortly after receiving the first dose of the vaccine, the patient started having profuse watery diarrhea on 2/11 and 2/12. She also stated she "fell out" on the same day. She was told to hydrate and then presented to the ED on 2/19 where she was found to be hypoxic down to the mid 80s. She was placed on 2L of O2 where her sat improved to 92%. She was febrile in the ED to 101.2 and had persistent fevers to 102.9 on the floor. COVID PCR testing negative x 2 and IgG positive. Patient received 6 days of antibiotics and supportive therapy.   On 3/2 - Patient reports feeling better overall but still overall fatigue and not back to baseline. On 2-3 L NC. patient is still admitted
Moderna COVID-19 Vaccine EUA   ? sore, hot, itchy arm ? sore at site and below, itchy and red just below (continuing through present)  ? chills and achy body 3a - 3p 2/7 and 4a - 9a 2/8  ? dull headache off and on 2/7 & 2/8
It was reported that an adult male pt received a Fluzone SV '01-'02 vaccination given at his workplace on the morning of 11/2/01. "At 10:00 on 11/3/01, he began vomiting violently and lost all hearing in her right ear and was extremely dizzy. He was admitted to the hospital where they were able to control the vomiting, however the deafness in his right ear and the extreme dizziness continues to this day; over 3 months later". Two specialists were consulted as well as an ENT. CT scans have been done and have found nothing that could cause this. The pt has been given oral steroids as well as an injection of steroids directly into the middle ear without any change in his condition.
Pt was mistakenly given an MMR 07/09/01, 10:30. No reaction occurred.
still gotten the flu after getting a shot.; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307940, 2020SA307941, 2020SA308033, 2020SA308034, 2020SA306301 and 2020SA302198.  This case involves a patient who still gotten the flu after getting a shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient still gotten the flu after getting a shot (influenza), (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.