chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hyperthyroid; This is a spontaneous report received from a contactable other HCP (patient, self-reported). A 49-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 31Dec2020 at 14:30 PM (age at vaccination: 49 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included AFib, hypertension, and percocet allergy. Concomitant medications included colchicine, apixaban (ELIQUIS), flecainide, olmesartan, and omeprazole (OMEPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 01Jul2021, she experienced hyperthyroid. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included pending endocrinology appt. Outcome of the event was not recovered.  Information about batch/Lot number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event hyperthyroidism cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Patient was erroneously given Tdap vaccine ID in the left forearm instead of IM in the deltoid.  The tech who administered the shot realized something was not right while giving the injection, therefore pulled the needle out, stating he only gave half the syringe (.25cc).  Initially there was redness at the injection site, but we followed up with the patient later in the day and he denied any other reactions or complications.  Spoke to the Military Vaccine Agency physician on call and he advised patient of possible signs/symptoms to look out for.  Our clinic will also be following up with patient at next month's drill and patient will notify us in the meantime if he notices any changes in his status.
Received high dose flu vaccine 9/19/19. Urgent care visit 9/27/19 w rash/vasculitis LE feet to upper calf areas, palpable purpura, decreased hgb and hct
This case was reported by a consumer and described the occurrence of insomnia in a 3 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The reporter is the mother of the pt. A physician or other health care professional has not verified this report. The pt's past medical history included gastric reflux. Concurrent medications included Zantac. The pt received previous doses of vaccine which may have included hep B vaccine and then experienced irritability and insomnia. On an unspecified date, the pt reportedly received a dose of Pediarix as the third dose in the hep B immunization series. The mother stated that, the doctor had accidentally given the pt the third hep B shot within 2 weeks of the second shot. The mother was not sure what vaccine was used for the third hep B dose, but she thinks it was Pediarix. The dates of the vaccinations were not provided. This is sooner than the recommended interval of five month between the second and third dose of hep B vaccine recombinant (Engerix B). At an unspecified time following the admin of Pediarix, the pt experienced insomnia, irritability and crying. The events were ongoing at the time of initial reporting, 14Jan05.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of accidental overdose in a 15-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), Dtap vaccine. Concurrent vaccination included pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 7 September 2011. On 7 September 2011 the subject inadvertently received unspecified dose of PEDIARIX (details unknown) and unspecified dose of Dtap vaccine (details unknown), and experienced accidental overdose. The subject received two doses of the Dtap component of the vaccines. No further information was provided. Follow-up information received 22 November 2011 from a physician. The 15-month-old female subject had concurrent medical condition of otitis media. On 07 September the nurse mistakenly gave the subject a dose of PEDIARIX (.5 ml, intramuscular, left thigh) instead of varicella along with a regular dose of Dtap vaccine (non-GSK) (.5 ml, intramuscular, right thigh). The physician associated the accidental overdose of tetanus as an erroneous administration. Later the same day on 7 September 2011, the subject experienced red welts and leg knots. On 8 September 2011 the subject experienced fever. On 13 September 2011 the fever resolved. On 15 September 2011 the red welt and knot on thigh resolved. PEDIARIX and Dtap immunization series were not discontinued as a result of the events. The physician considered the events of red welt and knot on thigh as probably related to vaccination with PEDIARIX and the event of fever as possibly related to vaccination with PEDIARIX.
About 3 hrs after injection left arm hurt. Next day left thigh hurt - next day pain was so severe I could hardly walk. Visit to chiropractor - no relief - visit to doctor - referred to ortho Dr. - diagnosed as bursitis. Shot was ineffective. Finally had MRI, meanwhile living on VICODIN 24/7. MRI results attached. Physical therapy recommended and continued to date. Still some discomfort in thigh. In discussing this with many medical personnel, some have suggested the problem was caused by the needle, not necessarily the vaccine.
Information has been received from a physician concerning an 18 year old female stude3nt who on 30-JAN-2007 was vaccinated with her first dose of Gardasil there were no symptoms after the first dose. On 04-APR-2007 the patient was vaccinated with her second dose of Gardasil. On approximately 04-APR-2007 patient had swelling for 2 days and then resolved. On 25-APR-2007 when the patient experienced induration at injection site. Additional information has been requested.
The lymph node in "my" right arm pit swelled to the size of a peach and stayed swollen for 3 weeks.; "I" have sporadic (3-4 occurrences a week) chest pain in the area of "my" heart; Slightly left center mass; Bouts of lethargy; Extreme fatigue (1-2 times a week).; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to NSAIDs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH2602) via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. On 18Mar2021, the patient experienced lymph node in her right arm pit swelled to the size of a peach and stayed swollen for 3 weeks. She had sporadic (3-4 occurrences a week) chest pain in the area of her heart, slightly left centre mass, bouts of lethargy and extreme fatigue (1-2 times a week). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node in her right arm pit swelled to the size of a peach and stayed swollen for 3 weeks was resolved on an unknown date in Apr2021: whereas the events sporadic (3-4 occurrences a week) chest pain in the area of her heart, slightly left centre mass, bouts of lethargy and extreme fatigue (1-2 times a week) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse (R.N) concerning an 82 year old female patient with chronic obstructive pulmonary disease, hypertension and allergy to penicillin, prednisone and clindamycin who on 24-AUG-2010 was vaccinated subcutaneously with a 0.5mL dose of ZOSTAVAX (Merck) (lot number unknown). Concomitant therapy included LIPITOR, atenolol, SPIRIVA and lisinopril (Manufacturer unknown). The nurse reported that and on 26-AUG-2010 the patient got shingles. At the time of report, the patient had not recovered from shingles. Follow-up information was received from a registered nurse who stated the female patient with a history of chicken pox when was a child on 24-AUG-1010, was vaccinated SQ with 0.5 ml dose of ZOSTAVAX (Merck) (lot# 665528/0710Z). It was reported that on 26-AUG-2010 in the afternoon, the patient developed zoster like rash "4 days after the vaccine was administered". The blisters appeared on the right buttock, extended to the left labia following dermatome pattern. The distributions of blisters were above the legs. It was also reported that the pain was quantified in 5 in a scale from 1 to 10 were 10 was the most painful. There were no other systemic symptoms. There was not a recent exposure to chicken pox or herpes zoster. There was not a direct fluorescent antibody done and there was not a specimen collected for PCR. The patient was treated with VALTREX and the patient did very well. At the time of the report, the patient recovered. The patient did not seek medical attention. No further information is available.
Numb in hand, pain in arm that radiated to jaw and across the chest. Having trouble speaking, balance issues, extremely confused most of the time. Symptoms of heart attack or stroke.
Swollen, painful lymph nodes on both sides of neck right greater than left.  Immunization site was tender, no other symptoms.  No fever, no sore throat.
fever; Myalgia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and MYALGIA (Myalgia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (Myalgia). At the time of the report, PYREXIA (fever) and MYALGIA (Myalgia) outcome was unknown.
dizziness 15 minutes after receiving the shot . Not able to walk .  No shortness of breath, or ,chest pain or rash.  Noted to have a thready pulse.
Allergy; This spontaneous report was received from nurse prescriber and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy (unspecified). At the time of reporting, the outcome of the event was unknown.  The causal relationship between allergy and zoster vaccine live (ZOSTAVAX) was unknown.
pt had recent hosp admission with positive COVID test, was improved and dc'd to home; back to hosp again with severe hypoxemia; COVID test negative this time; O2 sats 71% on RA; placed on 15L High-flow O2; AHRF, post acute sequelae of COVID infection; pulmonary fibrosis; emphysema COPD, paroxysmal A Fib; required intubation due to failing condition; suffered cardiac arrest and despite resuscitation efforts the pt died in the hospital
Red hot rash; Skin was hard; Red hematoma appeared near the eye; Sore arm in a different place than the injection site; Could not lift the arm; Left arm was sore and swollen in the injection site; Left arm was sore and swollen in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in a different place than the injection site), LIMB DISCOMFORT (Could not lift the arm), RASH (Red hot rash), SKIN INDURATION (Skin was hard) and HAEMATOMA (Red hematoma appeared near the eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urinary infection. Concomitant products included PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) for Urinary infection, ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore and swollen in the injection site) and VACCINATION SITE SWELLING (Left arm was sore and swollen in the injection site). On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in a different place than the injection site) and LIMB DISCOMFORT (Could not lift the arm). On 21-Mar-2021, the patient experienced RASH (Red hot rash), SKIN INDURATION (Skin was hard) and HAEMATOMA (Red hematoma appeared near the eye). On 29-Mar-2021, SKIN INDURATION (Skin was hard) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm in a different place than the injection site), LIMB DISCOMFORT (Could not lift the arm), RASH (Red hot rash), HAEMATOMA (Red hematoma appeared near the eye), VACCINATION SITE PAIN (Left arm was sore and swollen in the injection site) and VACCINATION SITE SWELLING (Left arm was sore and swollen in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
CHILLS; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; This spontaneous report received from a patient concerned a 47 year old male. 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.
Information has been received from a nurse referring to unspecified patients who on unspecified dates were vaccinated with doses of PROQUAD (Merck) (route, dose and lot # not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pharmacist who had a patient to report that they had redness and swelling at injection site.; Pharmacist who had a patient to report that they had redness and swelling at injection site.; This spontaneous report has been received from a pharmacist via company representative, concerning 68-year-old female patient. No information was provided regarding the patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions, or allergies.  On 01-MAR-2022, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided)  On 02-MAR-2022, the patient experienced redness and swelling at the injection site (vaccination site erythema, vaccination site swelling). The reporter stated that the patient also received on 17-FEB-2021 the first dose of COVID 19 vaccine (also reported as Pfizer vaccine), on 10-MAR-2021 with the second dose and finally on 19-DEC-2021 with a booster dose (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided), and did not know if there was a correlation on timing of getting vaccines.   The outcome of the event, and the causality assessment between the suspect therapies and the events were not provided.
Fast heart beat (105 BPM); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat (105 BPM)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart beat (105 BPM)). On 01-Mar-2021, HEART RATE INCREASED (Fast heart beat (105 BPM)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Heart rate: 105 (High) 105 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA258725 (same reporter). This case involves a 11 years old male patient who received a dose of MENACTRA lot U6152AA in the right arm on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that some vaccines that arrived after 72 hours rather than 48 and that vaccines should not be used. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Client complained solely of difficulty swallowing, throat feeling tight and swollen. Still able to speak and breathe normally. Gave total of 45mg BENADRYL. Declined epinephrine. For about 50 mins. continued with same feeling-no improvement or worsening of symptoms. Still breathing and speaking normal. Became increasingly anxious. Left in a gurney with paramedics.
Miscarriage Conceived 1 week after the second vaccine.; This is a spontaneous report from a contactable consumer (patient herself). This is a maternal report. A 35-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported at the age of 35-year-old), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 08:00 as single for COVID-19 immunisation. The patient had no medical history. The patient concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, on an unknown date as single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage conceived 1 week after the second vaccine on 16Jun2021. Doctor confirmed miscarriage at 7.5 weeks (8.5 weeks after second vaccine). The mother reported she became pregnant while taking bnt162b2. The mother was 7 weeks pregnant at the onset of the event. The mother was due to deliver on 27Jan2022. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the event. Since the vaccination, the patient had not tested for COVID-19. The outcome of the event was resolving.   Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Pt received smallpox vaccine at the beginning of Jan. around mid Jan pt reported 24 hrs of constant chest pain that worsened as he laid down. Labs show elevated cardiac enzymes.
On January 25, 2022 the patient presented himself at our pharmacy to administered the Pfizer Covid-19 vaccine booster. It was administered and while waiting 15 minutes in the recovery area patient passed out. He turned pale, began to sweat, and was unconscious for approximately 2 minutes. His blood pressure was taken and it was 133/97 and his pulse was 63. 911 was called, he was given oxygen, candy and drink to rule out hypoglycemia. When the ambulance arrived they took him on a stretcher to stabilize him.
body aches; chills; fatiquge; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatiquge". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient rapid test was negative, so she was waiting for results from her PCR test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.