chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 007J21A-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing), notes: Hashimotos thyroiditis; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "Dose 4 Moderna/ dose 1,2 and 3 Pfizer" (unspecified if ongoing), notes: Dose 4 Moderna/ dose 1,2 and 3 Pfizer. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN, stop date: 12May2022. The following information was reported: IMMUNISATION (medically significant) with onset 05Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 05Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 12May2022, outcome "unknown", COVID-19 (medically significant) with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: Tested positive on an antigen test; (19May2022) Negative, notes: On day 7 I tested negative; (21May2022) Positive, notes: On day 9 tested positive again; (26May2022) Positive, notes: On day 14 still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2  to all the reported events cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product 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 began itching.  Developed what appeared to be hives all over trunk, then arms and neck and thighs.  She was seen the next day by physician who prescribed steroid dose pack and gave steroid injection.  Areas subsided quickly and reduced to very minimal by the following day.
Severe headache, fever to 103, shaking chills, nausea, unable to find words. Fever, chills, nausea resolved by about 18 hours post injection.  Headache gradually resolved over about 1 week
Swollen lymph nodes in right armpit  Extreme chills Both hands went numb for several hours
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 25-APR-2013 the patient was vaccinated with M-M-R II lot # 669672/0155AA,  0.5 ml, subcutaneous. This vaccine was expired on 01-FEB-2013. The patient was not experiencing any known symptoms. No further information was available. Additional information has been requested.
racing and irregular heart rate/irregular heartbeat; dizziness; vomiting; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; painful pressure in head (sensitive to touch)/severe pressure in her head/Feels like her head will explode; very severe headache/pain at the top of the head; wakes her up in the night; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in Arm Right on 05Feb2021 16:30 (age at vaccination was 49-year-old) as dose 1, single for COVID-19 immunization (at doctor's office). Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications rizatriptan within 2weeks prior to vaccination. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan (RIZATRIPTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies, patient was not diagnosed with covid prior to vaccination, patient was not tested for covid to post vaccination. On 05Feb2021 16:30 the patient experienced racing and irregular heart rate/irregular heartbeat, dizziness, vomiting, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, racing and irregular heart rate, painful pressure in head /severe pressure in her head/feels like her head will explode, very severe headache/pain at the top of the head, wakes her up in the night. Patient had physician office visits for the events. No therapeutic measures were taken for the events but labs ordered a heart monitor and used a heart monitor. The events were non-serious (not resulted in death, not life threatening, no hospitalization required or prolonged, no Disabling/Incapacitating and no Congenital anomaly/birth defect was reported). The outcome of the events heart rate irregular, dizziness, vomiting, trismus, ear pain, hyperaesthesia, heart rate increased, sensitive to touch, head discomfort, headache, middle insomnia was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician referring to an unspecified number of 11-18 years old male patients, 1 in 100 who were enrolled in a patient support program. There was no information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with first dose of GARDASIL (strength, dosage, frequency and route unspecified). Patients fainted when they received GARDASIL. Pediatrician would then have them elevate legs, recover, and watch the patients for 15-20 mins before letting them go. The physician reminded patients to eat before vaccine and had them sit in office for 15 (unit unspecified). The physician did not prevent administration of 2, 3 doses due to event. The outcome of syncope was reported as recovering/resolving. The causality was not reported. This is one of two cases received from the same reporter. Additional information is not expected as there was no consent to follow up.
The dose of ActHIB was reconstituted with sterile water instead of the diluent provided; Initial information was received on 13-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00680213).  This case involves a 12-month-old male patient who experienced the dose of HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the diluent provided (product preparation issue).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot number: UJ3999AAC, expiry date: 02-Oct-2021] via an unknown route at left thigh for prophylactic vaccination (product preparation issue) (latency: 1 day).  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  It was reported that "A patient received ActHIB on 08Jul2021 in the left thigh. The dose of ActHIB was reconstituted with sterile water instead of the diluent provided. Dose # if series #4--This was the first HIB the patient received that was ActHIB alone. Doses #1 through #3 of HIB received were as part of Pentacel."  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.
Specifically to PFIZER; 54 year old female presents with tongue swelling after 1st Pfizer covid vaccine. Vaccine was given around 1025. Tongue swelling around 1045. She was given a shot of benadryl and it resolved. No shortness of breath. No trouble swallowing. Feels well now. No pain. No history of medicaiton allergies. 1st dose receive on 3/22. Swelling as well too.
She called about 5pm and said she had just took bandaid off and there was dried bllod, and sall circular blue spot around the injection site,and a small knot about size of a pea. She said it was not really painful. When I gave the shot it bled quite a bit. I had put 2 bandaids on it. Sh e said she was taking tylenol for it, I had advised ibuprofen, but she said she could not take it due to stomach issues. SHe said she gets the flu shot every year and that has never happened. I told her to keep taking the tylenol q 6h, and I would follow up with her on 10/21 to make sure its not gotten any worse.
Received Phizer as booster shot yesterday. Heard ringing in my ears (both) laat night at 8:30pm (same day as vaccination shot). Heard ringing in my ears this morning about an hour after I woke up at 7:30am. I almost never experience ringing in my ears. Very unusual. Stiff, sore neck (20 hours after shot). Sore back muscles (20 hours after shot). Sore right arm (20 hours after shot)
also being treated for dialysis; Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of RENAL DISORDER (also being treated for dialysis) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 7164B) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery in August 2022.    On 27-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (also being treated for dialysis) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, RENAL DISORDER (also being treated for dialysis) was resolving and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Patient was being treated with dialysis.
break out on her chin that were blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUCELVAX QUADRIVALENT. In September 2020, less than a week after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and a Flucelvax Quadrivalent vaccine. Three to four days later, she had a break out on her chin that were blisters. The reporter consented to follow up.
A nurse reported that the day after receiving vaccines the patient developed an injection site reaction characterized by redness, swelling, and pain at the site of Acel-Imune administration. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-653.
Symptoms started early morning 5/23/22 noted around 5a. Bad cold symptoms - cough, congestion, sinus problems, generally felt sick stayed in bed all day
swelling of arm and hand; rashes on arm, lower legs, back on spline, itching, bleeding of rashes; rashes on arm, lower legs, back on spline, itching, bleeding of rashes; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 1573035), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 11:15 (Age at vaccination: 71 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Metoprolol Succinate; Losartan Potassium; Pravastatin. Patient did not receive other vaccines in four weeks. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient experienced swelling of arm and hand, rashes on arm, lower legs, back on spline, itching, bleeding of rashes on 27Apr2021 at 11:15.  The patient underwent lab tests and procedures which included sars-cov-2 test which was negative. Treatment received was unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
This spontaneous report as received from a female patient of unknown age regarding herself if who had no drug reactions or allergies. The patients current conditions included high blood pressure and cholesterol. On 22-Jul-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). Concomitant medications included: CRESTOR. Approximately on 29-JUL-2012 (reported as 1 week after getting the vaccine), the patient developed a raised red area at the injection site and the area itched for about 3 days and went away. No laboratory test was performed. The patient sought no medical attention and not treatment was given. Approximately on 01-AUG-2012 (reported as 10 days after getting vaccine) the patient recovered from all the reported events. Additional information is not expected.
started going downhill; sick; becoming slow; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) and ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) (seriousness criterion death), ILLNESS (sick) (seriousness criterion death) and BRADYKINESIA (becoming slow). The patient died on an unknown date. The reported cause of death was started going downhill and Illness. It is unknown if an autopsy was performed. At the time of death, BRADYKINESIA (becoming slow) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Caller reports the vaccine was Poison and the talked to so many people who have loved ones that are dead. Caller reports patient was perfectly fine then noticed becoming slow and sick overtime but caller states patient did not want to tell her exactly how patient was feeling.  Caller says patientr's blood was on Moderna's hands. Caller did not want to provide any information on the adverse event and hung up on the agent.  This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's  medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-354152 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's  medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: started going downhill; illness
The pt was brought in by mom for evaluation of what appears to have been some seizure activity yesterday. On 2/20/03, she received her first DTaP immunization. It consisted of the combination vaccine Pediarix. In addition to that she received the H. Influenza type B vaccine as well as the pneumococcal vaccine. She tolerated the vaccines well. They were administered approximately 10:30am on 2/20/03 and really for the rest of the day except for being maybe a little fussy, she did relatively well. At about 3:30 in the morning on 2/21/03 she developed some irritability with a high pitch cry and emesis, an episode of hypothermia where the mom measured the temperature down to 96.6 rectal. She became pale and somewhat listless with hypotonia but  no fever. It lasted about 5-10 mins. She did not have any apnea or cyanosis during that time. She was able to go back to sleep and then upon awakening the remainder of the day she seemed to be cranky with slight decrease in her breastfeeding patterns but otherwise seemed to be OK and then at about 2pm in the afternoon while they were at a store, again on 2/21/03, she became really fussy and irritable. Mom took her to the public restroom there to change her diaper and while she was there, laying on her back in a supine position, had what appeared to be some seizure activity. Mom described it as tonic-clonic acitvity with eye deviation and the pt was not responsive to verbal or tactile stimulus. The first episode lasted a few seconds and then she had recurring episodes, each one lasting only a few seconds but on a recurring pattern for about a 15 minute period of time. Between those short episodes she was crying and seemed to be in discomfort and stressed. After that 15 minute period she seemed to go into a post-ictal phase which lasted about one hour to 1- 1 1/2 hours. She did not have any apnea. No loss of consciousness. No cyanosis. When she contacted our office we did recommend that she take her to the ER for evaluation, which she did. Basic lab were unremarkable except for slightly decreased CO2 at 18. The rest of the examination was normal and the rest of the labs were normal. There is a strong family history of epilepsy. A maturnal aunt, the mother's sister, has absence seizures, and then two second cousins on the mother's side have seizures, one apparently grand mal seizures, the other one also absence seizures.
Patient reported to pharmacy on 10/8/2020 that she has experienced pain and soreness in the left shoulder since she was administered vaccination. Patient does not have PCP and was instructed to be evaluated at an urgent care clinic or emergency room. She states she waited to report incident hoping pain would subside, but it has not
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
This spontaneous report was received from a Registered Nurse concerning a 25 year old male patient. The patient's concurrent conditions, medical history and historical drugs were not reported.  On 10-MAR-2017 due to a computer error, the patient was vaccinated with M-M-R II expiration date of 11-MAR-2018 (dose, route and lot number were not reported), and VARIVAX expiration date of 23-NOV-2017 (dose, route and lot number were not reported) both for prophylaxis, and because he was ready to "go to school"; after the vaccination, it was discovered that the patient was already received doses of M-M-R II (dose, route and lot number and expiration date were not reported) on 03-DEC-1992, and VARIVAX expiration date of 18-APR-2015 (dose, route and lot number were not reported)on 31-DEC-2013; both for prophylaxis. The reporter did not have information about on the diluent used to prepared the doses, and it was reported that the patient did not received an extra dose of M-M-R II or VARIVAX, and had not experienced adverse effects. Additional information is not expected as there is no consent to contact the reporter.
sore throat; coughing; headache; soreness of injection site; tiredness; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine yesterday (26Dec2020) and is now experiencing headache, soreness of injection site and tiredness. Additionally, she is also experiencing sore throat and coughing which started today (27Dec2020). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Left arm started to have a red swollen area, had a fever.  Woke up 9/25/2010 with a "stiff right knee" could not bend knee. Called office 9-27-2010, also saw primary doctor who ordered an x-ray.  Patient report the x-ray showed mild degenerative arthritis.  Is on steroids for one week.
Received on 4-18-16. That evening he c/o redness, warm, swelling (L) deltoid. Pt did c/o discomfort to the injection site at that time. Was f/u by phone and then was seen on 4/20/16.