chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an unspecified reporter concerning an approximately 66 year old female patient. Weight of the patient was reported as 150 (units unspecified). On an unknown date in September 2009, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant medications included TORADOL (reported as TOREDOL (start date unspecified) and unspecified hypertension medicine. On 29-DEC-2009, 2 months after receiving the vaccine, the patient experienced a case of the shingles, redness all over her body and her skin would start peeling. No treatment was given. The outcome of all the events was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested
10/09/2021 I woke up and felt fine day after the vaccine, however around 2pm I was overrun by a feeling of fatigue and had to lay down immediately and slept through the rest of the day, Sunday I began to feel a sore throat, body aches, and on Monday it then developed into a cough with the following day's symptoms. I went to the doctor that stated I may be having an adverse reaction to the vaccine. Symptoms were continuous for about a week and then began to improve. 5 weeks forward I received the flu vaccine and symptoms seem to have returned with body aches. My teeth have also been hurting as well.
Flu-like symptoms: headache, body ache, chills, runny nose, fatigue. Symptoms started at 11pm on day of injection, were very bad for next 3 days, then subsided. Almost back to normal after 7 days. "Very bad" means I had difficulty working at a computer. I work remotely, I wouldn't have been able to commute during the first three days  of symptoms.
This spontaneous report was received from a veterinarian and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 31-JAN-2019, the patient was inadvertently vaccinated with dose of PROQUAD (exact dose, route and site of administration, lot# and expiration date were not reported) instead of M-M-R II, concomitantly with a dose of VARIVAX (exact dose, route, site of administration, lot# and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
pt recv vax & exp a temp of 103, aches, & general malaise;pt was taken to ER;also noted that pt had been given hep p immune globulin every three months for 4 years up to 2 year before hep b vax given; This is in follow-up to report(s) previously submitted on 03/01/1999. Information has been received from a registered nurse concerning a female who in approximately 1989 was vaccinated with the first dose of RECOMBIVAX HB (Merck). Subsequently, the patient experienced a temperature of 103 degrees F, aches and general malaise. She was taken to emergency room. It was also noted that the patient had been administered hepatitis B immune globulin every three months for three years up to two years before she was administered the RECOMBIVAX HB. Follow-up was received which indicated the patient's primary concern was if there was any possible interaction between RECOMBIVAX HB and hepatitis B immune globulin to cause her to have a reaction after vaccination with the first dose of RECOMBIVAX HB. No further information is available.
On 4/16/02, body stiff, arms jerking, reddened face, gasping for air and heaving from stomach for approx. 2 minutes. On 4/17/02, body stiff, arms jerking, reddened face, gasping for air and heaving from stomach. On 4/18/02, hospitalized for observation with no dx.
Flu; Rashes; Arms swelled up; Hairs started to shed off; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu), RASH (Rashes), PERIPHERAL SWELLING (Arms swelled up) and ALOPECIA (Hairs started to shed off) in a male patient of an unknown age 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 13-Jul-2021, the patient experienced ALOPECIA (Hairs started to shed off). On an unknown date, the patient experienced INFLUENZA (Flu), RASH (Rashes) and PERIPHERAL SWELLING (Arms swelled up). At the time of the report, INFLUENZA (Flu), RASH (Rashes), PERIPHERAL SWELLING (Arms swelled up) and ALOPECIA (Hairs started to shed off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Patient began to flush immediately. Complained of tightness in the chest and pain in her back. Clinic nurse and pharmacist observed and monitored pulse and breathing. 911 was called and patient was transported to the ER.
expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information was received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot U7183AA, expiration date: 24-Sep-2023 , unknown strength) via unknown route in unknown administration site for Immunization and expired dose of tenivac was administered to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Fluzone Quadrivalent 0.5 mL was administered in error when Hepatitis A vaccine was prescribed, no AE; Fluzone Quadrivalent 0.5 mL was administered in error when Hepatitis A vaccine was prescribed only 9 days after it's initial dose, no AE; Initial information received on 06-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 month old male patient who received the second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] within nine days of the first dose instead of HEPATITIS A VACCINE (wrong product administered and extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA TETANUS ACELLULAR PERTUSSIS, PNEUMOCOCCAL VACCINE and HIB VACCINE   On 26-Feb-2020, the patient received the first dose of INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 06-Mar-2020, the patient received the 0.5 mL second dose of INFLUENZA QUADRIVAL A-B VACCINE (lot number UT6695NA, expiry date 30-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
3 days p/shot, high fever 102-103 lasted 5 days, no other sx @ this time, 8 days p/shot rash covering head, neck & torso, lasted 2 days, severe irritability throughout fever & rash;
no adverse event; temperature excursion on V ARlV AX; This spontaneous report was received from a medical assistant regarding a 25 year old male patient.No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 25-APR-2021 the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot S025910 and expiration date 20-AUG-2021 (dose number, route of administration, anatomical location, vaccination scheme was not reported.)  The vaccine underwent a temperature excursion of 14 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (37.5F) for 1440 hours; a data logger was involved and there were no previous temperature excursions. No additional adverse events were reported. The outcome for the event was unknown.
Pt complained of increasing arm pain & shoulder & neck pain to daughter. Daughter took pt to see MD, who diagnosed pt with "frozen shoulder syndrome as a result of vaccine".
Needle malfunction. Small amount of vaccine exuded from vaccination site upon withdrawal of the needle. It was determined that patient received greater than half of the dose. Therefore, per CDC guidelines, no further action was taken.
Developed pain in arm and shoulder after injection patient perceived as being  injected "very high."  Pain progressed and began to radiate down arm after several days.  No loss in range of motion.  referred for physical therapy.  Follow up 1 month later,  improving.
Patient went to his primary care office on Monday 9/26/22 and reported a large indurated reaction around the vaccine injection site. Clinic nurse practitioner assessed patient. The site is warm to the touch, but not painful. Does not appear infected. Patient given instructions to return to clinic or ED if symptoms worsen.
On 3/23/2021, Patient became ill, vomiting uncontrollably, throughout the day.  On 3/24/2021, he continued his vomiting episodes, and developed a fever with chills. At about 2100 hrs, patient was extremely weak, he went to the bathroom, urinated, and attempted to crawl back to his bedroom, less than 10 steps away. His wife, called 911, and went down stairs to allow entry for the fire department, The fire department, found patient unresponsive, not breathing, and no pulse.  He was pronounced dead in his home.
Shortly after vaccination, patient began to feel light-headed and pale. Patient was given some water and ice pack and placed on observation for an additional 15 minutes. Patient's symptoms shortly resolved and was discharged.
I tested negative for the first 2 days. I had symptoms of a head cold. By that night I had a fever of 102.0 and body aches. I also had a headache. I had not appetite for a couple of days. The fever lasted a day and a half. I was taking Tylenol. The head cold remained for about a week and a half. I was prescribed Paxlovid on the 3rd day. I have since recovered from all my symptoms.
No additional AEs or PQC reported; expired dose of PNEUMOVAX 23 administered; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-NOV-2021 the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, lot # T007383, expiration date 23-AUG-2021, anatomical location not reported) for prophylaxis (Expired product administered). No additional adverse events(AEs) or product quality complaints (PQC) were reported.
Low grade 99 degree-102.4 degree temps, watery eyes, loss of appetite, fatigue.  Also, reddened, hard, warm to touch 3 "diameter circle around injection site for 5 days on left thigh.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4407176-00.  A 63-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19".  Clinical information: It was unknown if patient was enrolled in COVID-19 Vaccine trial.   The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira (Adalimumab). The reporters causality for the event(s) of little sluggish after second COVID-19 Vaccination, Psoriasis in groin area, and under breast, COVID and Hidradenitis suppurativa flare ups with Humira (Adalimumab) was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
pt recvd vax 25FEB93 & devel lt sided parotitis 15MAR93;
PCV 23 and FLUZONE given on 10/14/15 right deltoid. Redness 40x60cm. Hot to the touch.
This spontaneous report as received from a pharmacist refers to her son, a male patient of unknown age with eczema. The patient had no drug reactions or allergies. Approximately on 2013 (reported as: about a year and a half ago) the patient was vaccinated with M-M-R II (Albumin status HSA; route, dosage, dose number and lot number unknown). The pharmacist also stated that her son received a flu vaccine she "thinks" it was FLUZONE, manufacturer unspecified) on an unspecified date and he "may have" also received (Oka/Merck) VARIVAX (route, dosage, dose number and lot number unknown), on an unspecified date, but she is "not exactly sure about the (Oka/Merck) VARIVAX". On July 2014 the patient was diagnosed with autism by an unspecified pediatrician. The pharmacist also reported that the eczema his son had, prior to receiving M-M-R II had "gotten better since receiving the M-M-R II". The patient sought medical attention and received occupational therapy and "ABA" the rapy for the autism since an unspecified date. The pharmacist reported that her son had a hearing test on an unspecified date in August 2014. The outcome of autism was unknown. Additional information is not expected because there is no authorization to contact physician.
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment information was provided.
Very high fever (103.5); vomiting; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Right Arm, on 09Apr2021 at 16:15 (at the age of 39-years-old), as dose 2, single dose for COVID-19 immunization. The patient's medical history included currently breast feeding. The patient had no known allergies to medications, food or other products. Concomitant medications included prenatal vitamins (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Right Arm, on 17Mar2021 at 16:30 (at the age of 39-years-old), as dose 1, single dose for COVID-19 immunization. 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. On 10Apr2021 at 02:00, the patient experienced very high fever (103.5 UNSPECIFIED UNITS) and vomiting. It was not reported if the patient received any treatment for the re-ported events. There was an off label use and drug use in unapproved population as the patient had a maternal exposure during breast feeding since an un-known date in 2021. On 10Apr2021, the patient underwent body temperature measurement, and the result was found to be 103.5 (UNSPECIFIED UNITS). The events did not result in doctor or other healthcare professional office/clinic vis-it, emergency room/department or urgent care. The clinical outcome of the events very high fever (103.5), vomiting was recovering at the time of this re-port. The clinical outcome of the events off label use and drug use in unapproved population was unknown at the time of this report.  Follow-up attempts are completed. No further information is expected.
Please note that I am the patient in question here, but also an physician, so I will write this in technical terms as best as I understand what happened.  For background, my cardiac history is important. I had a work-up for palpitations performed more than a year ago that revealed normal cardiac function (EF > 65% by NM myocardial perfusion study), normal coronary arteries, and significant exercise tolerance (I maxed out the treadmill test).  Usuallly I have to engage in vigorous exercise to raise my heart rate > 160 bpm. My resting heart rate is typically in the 50s or less.   On Jan 15, 2021 I had an elective cerebral angiography and embolization procedure performed. I was asymptomatic prior to this procedure.  The procedure requires general anesthesia for several hours.  I have had the procedure conducted a few months previously and it typically has an unremarkable recovery, one night required in the hospital.   After the procedure and following extubation, I had hypoxia on room air, tachycardia, wheezing and fatigue.  The working cause for this was suspected atelectasis due to general anesthesia and I was given bronchodilators.  While my breathing improved overnight, I was very tachycardic even while sleeping ? pulse greater than 130.  Overnight telemetry noted arrhythmias with sinus tachycardia.   The tachycardia persisted long after prior albuterol use so I had CTA chest on 1/16.  No PTE was noted, though some basilar atelectasis and mild upper lobe ground glass opacities.  I was discharged but due to continued mild hypoxia overnight, low grade fever (< 101F), and persistent tachycardia with any movement, I went to the ED on 1/17 for additional evaluation.   In the ED, I had tachycardia with arrhythmias noted (rate up to 160). Sinoatrial exit block noted on EKG and telemetry.  COVID-19 testing was negative by nasopharyngeal PCR and antigen testing.  Resting heart rate was > 90 even when sleeping.   Follow-up echocardiogram on 1/21/21 revealed depressed ejection fraction (40-45%).  Cardia MRI on 2/1 was performed to evaluate for cardiomyopathy.  Symptoms at this point were fatigue, dyspnea with even mild activity (e.g. walking), and tachycardia  > 140 bpm with even just walking.  My resting heart rate improved to 40s-50s.  It showed normal wall motion and ventricle size with slightly reduced ejection fraction. Cardiology recommended cardiac event monitoring which I wore for 28 days. It only revealed sinus tachycardia and bradycardia.   I still don?t feel great but able to do more physically than a couple of months ago.  I await further f/u cardiac imaging to see if there has been improvement in the heart function.
Approx. 35-45 min. after vaccine, mom alerted nurse child's cheeks red. Nurse noted hives on cheeks, erythematous patches of skin on chest and back. No distress or swelling noted. BENADRYL liquid 12.5mg given. Child observed for 30 minutes. All symptoms completely subside and child sent home with mother.