chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Vaccination complication
Clinical narrative: Passed out; Abdominal pain; Trouble breathing; Sweats; Didn't feel well; Fatigue; death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) and LOSS OF CONSCIOUSNESS (Passed out) in a male 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.     The patient's past medical history included No adverse event.    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, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue). The patient died on 26-Apr-2021. The reported cause of death was Passed out. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Passed out), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue) outcome was unknown.            No treatment information provided by the reporter and no history of concomitant medication was reported  Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: passed out
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abortion induced, Crohn's disease, Dyspepsia, Malaise, Maternal exposure during pregnancy
Clinical narrative: Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date.  At the time of the report, CROHN'S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect.  No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Retinal vein occlusion, Visual impairment
Clinical narrative: possible central retinal vein ablasion; left eye vision was only like 5% of his vision; severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) (seriousness criterion hospitalization). At the time of the report, RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) had not resolved and HEADACHE (severe headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.  Company Comment: 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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Thrombosis, Urticaria, Vertigo
Clinical narrative: Blood clot; Couldn't breathe; Heart palpitations; Hives; vertigo; This spontaneous case was reported by a health care professional and describes the occurrence of THROMBOSIS (Blood clot) 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.     Medical History not reported.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo). At the time of the report, THROMBOSIS (Blood clot), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15 Mar 2021, within 1 hour of receiving first dose of the Moderna COVID-19 vaccine, the patient couldn't breathe, she had heart palpitations, hives, vertigo, and a blood clot. The patient stated that she was able to fell the blood clot.  At the time of the report it was unclear if the patient had seen a physician for the events.  Treatment for the event was cetirizine, and the patient stated that she has no hives when she takes cetirizine, but once  she stops the cetirizine the hives return.  Treatment provided with cetirizine for hives.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Electrocardiogram, Feeling abnormal, Incomplete course of vaccination, Pruritus
Clinical narrative: Pacemaker Surgery; patient did end up missing the date of her second vaccination and has not received it; feel itchy; feeling very funny and real strange; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange). On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it). At the time of the report, CARDIAC PACEMAKER INSERTION (Pacemaker Surgery), PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Electrocardiogram: normal (normal) heart was operating properly.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking unspecified blood pressure medication concomitantly.  Following the administration while the patient was in the clinic, she began to feel itchy, very funny and real strange. At this time the EMS on site were concerned and preformed an electrocardiogram (EKG) on the patient to make sure that the heart was operating properly. It was deemed that it was and the patient was then sent home. After that time no other side effects were present but the patient did eventually have to go into the hospital for a Pacemaker Surgery that was believed to be unrelated. The date of this surgery could not be remembered at the time of the call.  No treatment information was provided.  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.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Haemorrhage, Inflammatory bowel disease
Clinical narrative: Bleeding; IBD; Diarrhoea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion hospitalization), INFLAMMATORY BOWEL DISEASE (IBD) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported.No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event(s) is not applicable  Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; reconstituted the MMR II vaccine with normal saline instead of the supplied STERILE DILUENT; This spontaneous report was received from a pharmacist, referring to a 23-year-old male, at the time of the report. The patient concurrent conditions,relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 14-APR-2021, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (lot number T006166 has been verified to be valid, expiration date 19-FEB-2022)  (anatomical site of vaccination was not reported), as prophylaxis. This vaccine was administered with normal saline (dose, frequency, lot number, expiration date were not reported) instead of  sterile diluent (manufacturer unknown) (Product preparation error).  No additional adverse event reported. It was reported that the patient would repeat dose in 4 weeks (28 days).   Moreover, the dose was single use vaccine, operator of device was an healthcare professional. There was no product quality complaint and no excursion ocurred, the vaccine was not available for return/evaluation. The operator was trained and vaccine was purchased with funds.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE. No PQC. No further information available.; Patient was administered expired MMRll on 04/16/2021; This spontaneous report has been received from a nurse practitioner, referring to a 41-year-old female patient. Information about her pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.  On 16-APR-2021, the patient was vaccinated with and expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Therapy type: rHA), lot number S007814 and expiration date 14-MAR-2021, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).  The nurse practitioner requested medical information for expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccines and was provided with outcome response. No additional events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional adverse events reported; The VAQTA expired on 10APR2021 and was administered 16APR2021; This spontaneous report was received from other reporter referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.   On 16-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis at a dose of 0.5 milliliter (concentration, number of administered dose, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number S037574 and expiration date 10-APR-2021) (expired product administered). No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administration of PROQUAD to a patient which had expired on 25MAR2021 and was administered, today, 27APR2021; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 27-APR-2021, the patient was vaccinated with and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number S030211, expiration date 25-MAR-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional information provided; Primary care Physician has assured to the patient he will write a prescription of gardasil9; This spontaneous report was received from a 60-year-old male physician assistant reporting on himself. The patient's, concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant therapies were not reported .   The physician assistant stated that his primary care physician had assured to he that the physician would write with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot#, expiration date and route were not reported) prescriptionon on 27-APR-2021, when the phisician would see him. No additional adverse event information reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA001494:
Sex: M
Vaccine: VARZOS
Symptoms: Feeling jittery, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain at the injection site/arm pain; Fever; Jitteriness/Jittery; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, jitteriness and general body pain. On an unknown date, the outcome of the injection site pain, fever, jitteriness and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, jitteriness and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 55 or 56 years old. The patient received Shingrix and was experiencing pain at the injection site (arm pain), fever, jitteriness and body aches. All symptoms were ongoing at the time of reporting. The reporter did not consent to follow-up and declined to provide date of birth.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old non-pregnant female patient received BNT162B2 first dose (Pfizer-Biontech Covid19 vaccine, Batch/Lot no: EL3247) via an unspecified route of administration and administrated in left arm on 26Jan2021 at 9:30 as single dose for COVID-19 immunization at workplace clinic facility. The patient medical history included high blood pressure. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR), mirabegron (MYRBETRIC) and amlodipine besilate (NORVASC). Patient not had covid prior vaccination. On 27Jan2021 at 12:00, patient experienced headache. Patient not tested for covid post vaccination. Patient not received treatment for the event. At the time of this report event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable Other HCP (Patient) via Medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously took 1 mg of Prednisone up until 6 months ago because she had an anaphylaxis reaction to a vitamin drip. On unspecified date in Jan2021 (about 2 days after vaccination), the patient doesn't have any side effects except arm soreness. She got nervous the morning before getting her vaccine of a reaction and took a very small amount of prednisone before getting the vaccine. Her second dose was scheduled for 25 days. The seriousness of the event was reported as non-serious. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature abnormal, Cough, Decreased appetite, Dysphonia
Clinical narrative: No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Irritability, Nausea
Clinical narrative: been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; This is a spontaneous report from a contactable consumer (patient). A 89-year-old female patient received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unknown date (at the age of 89-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the vaccine last Friday and it had been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed. The outcome of the events were not recovered.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Dizziness
Clinical narrative: feeling very, very  dizzy/dizziness; diarrhea; This is a spontaneous report received from a contactable consumer. A 80-year-old female consumer (patient) received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), (Batch/lot number: EL3249) on 20Jan2021 at single dose for COVID-19 immunisation. The medical history of the patient included genito arthritis and asthma. The concomitant medication was not provided. On 20-JAN-2021 patient was feeling very, very dizzy and diarrhea. Patient was concerned about diarrhea as she got a shot 20Jan2021 and on 27Jan2021 she was still experiencing diarrhea. The patient took the vaccine on last Wednesday and had side effects or dizziness and 2 days later I started with diarrhea which is going on now. Patient did not received any treatment. Patient had some blood work done. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: tiny bit of dizziness, felt like everything was going dark; This is a spontaneous report from a contactable Consumer. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021) via intramuscular route administered in left deltoid on 14Jan2021 12:41 as single dose (0.3mL) for COVID-19 immunization. Medical history included atrial fibrillation and blood pressure high. She was on medication for this condition. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient experienced tiny bit of dizziness, felt like everything was going dark on 14Jan2021. Caller stated that she received the second COVID-19 vaccine. She was scheduled to receive her second vaccine and she doesn't know whether or not to do it. Caller explains she had the shot, and her facility had her wait 15 minutes. She didn't think much about it. She went to the bathroom to kill some time. It was about 1 minute until it was time to leave, and she was getting her husband gathered up so by the time they got to the door, she could probably leave. Very quickly she had this tiny bit of dizziness and it felt like everything was going dark. She states this episode was very quick and didn't last long at all. After that, she was totally fine. She doesn't know whether to have her second vaccine or not. No relevant tests done. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Palpitations
Clinical narrative: Red lump 0.5 inches on anteromedial edge of axilla, Painful to touch and raise right arm; Red lump 0.5 inches on anteromedial edge of axilla, Painful to touch and raise right arm; Firm palpitation; This is a spontaneous report from a non-contactable other Health Professional (patient). A 30-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EK5730) via intramuscularly, administered in left arm on 19Jan2021 (at the age of 30-year-old) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. 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 vaccination, patient had not tested for COVID-19. The patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) on an unspecified date as a single dose for Covid-19 immunization. On 26Jan2021, the patient experienced red lump 0.5 inches on anteromedial edge of axilla, painful to touch and raise right arm and Firm palpitation. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body rash/Rash was noted by caller on her right and left arms, back of her legs, entire abdomen and back/full body rash; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date on Jan2021 at 14:00 about 48hrs after vaccination, the patient got body rash, her right and left arms, back of her legs, entire abdomen and back was full of body rash. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Muscle spasms, Pain in extremity
Clinical narrative: back pain; legs, calves, feet extreme pain; cramping; extreme fatigue for 6 days and nights better 7th day; headache; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 75-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3246; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:15 as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, cardiac failure, atrial fibrillation, renal failure, rheumatoid arthritis, gastroesophageal reflux disease, irritable bowel syndrome, hypertension from an unknown date. Concomitant medications included apixaban (ELIQUIS), metoprolol, pravastatin sodium, indapamide for an unspecified indication. The patient previously took morphine and experienced drug hypersensitivity. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Jan2021 at 7:00PM, the patient experienced back pain, legs, calves, feet extreme pain, cramping, extreme fatigue for 6 days and nights better 7th day, headache. The clinical outcome of the events was recovering.  No follow-up attempts are possible, no information is required.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Headache, Nausea
Clinical narrative: Nausea; 20 hrs after second shot severe shaking chills; fever 103F; chest burning; severe headache; severe weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: unknown) via unspecified route of administration on right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history includes chronic lymphocytic leukemia, hypertension, type 2 diabetes, metastatic thyroid cancer, pulmonary metastases and allergic to Keflex and clindamycin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1263) in right arm on 07Jan2021 15:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 27Jan2021 at 03:00, 20 hours after second shot, the patient experienced severe shaking chills, fever 103F, chest burning, severe headache, severe weakness and nausea. The patient did not receive any treatment for the events. The outcome of events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; 20 hrs after second shot severe shaking chills; fever 103F; chest burning; severe headache; severe weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: unknown) via unspecified route of administration on right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history includes chronic lymphocytic leukemia, hypertension, type 2 diabetes, metastatic thyroid cancer, pulmonary metastases and allergic to Keflex and clindamycin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1263) in right arm on 07Jan2021 15:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 27Jan2021 at 03:00, 20 hours after second shot, the patient experienced severe shaking chills, fever 103F, chest burning, severe headache, severe weakness and nausea. The patient did not receive any treatment for the events. The outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on the upper part of my arm/Small rash circles, not red raised skincolor circles like a bunch of pea sizes circles or smaller; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 26Jan2021 at 10:15 (at the age of 37-year-old), as single dose in right arm for COVID-19 immunisation at Doctor's office/urgent care. The patient's medical history included allergic to eggs, seasonal allergies and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 27Jan2021 at 06:15, the patient woke up with a rash on the upper part of her arm. Small rash circles, not red raised skin colour, circles like a bunch of pea sizes circles or smaller. They did not itch, but they seemed to be closer to the injection site with less on the outer arm area. Patient continued to monitor. There was no treatment received for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (reporting himself). A 53 -year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 26Jan2021 at 12:00 as a single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks. The patient's concomitant medication included losartan, armodafinil, baby asprin, multivitamin. The patient was not diagnosed with COVID prior vaccination. On 26Jan2021 at 12:30, the patient experienced headache. The patient did not received treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Feeling abnormal
Clinical narrative: temperature went up to 99; Feeling dragged out; This is a spontaneous report from a contactable consumer.   A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: not reported), dose 1 intramuscular, administered in Arm Left on 22Jan2021 at single dose for covid-19 immunisation.  Medical history included ongoing atrial fibrillation diagnosed about 5 years ago. None Prior Vaccinations within 4 weeks. AE(s) following prior vaccinations: Sore arm with flu shot that she got in Sep2020, she does not know the name or have lot number to provide. Concomitant medication(s) included apixaban, 5mg tablet twice a day by mouth (ELIQUIS) metoprolol, 25mg tablet, half tablet once a day by mouth (METOPROLOL) and flecainide, 50mg, one tablet every twelve hours by mouth taken for atrial fibrillation. The patient experienced feeling dragged out on 24Jan2021, temperature went up to 99. The patient underwent lab tests and procedures which included body temperature: around 97 or 98 on, body temperature: up to 99 on 26Jan2021 little bit of temperature hike/usually temperature was around 97 or 98 and her temperature went up to 99. Additional Context included She was calling about the Pfizer first dose of covid shot. She was asking when you get a reaction from the shot, is it immediate or it does it take a while to have a reaction. She clarifies it is the Pfizer sars-cov2 vaccine. Her second dose was scheduled for 12Feb2021. She clarifies that she was not know if she has a sinus infection or a reaction to the shot since the symptoms are similar. She was felt dragged out for a couple of days, today she was feeling a little bit better but not 100%. She got the first dose on Friday afternoon and she did not have any problems right after receiving it. She had to wait there for 15 minutes after receiving the shot. Reports she started feeling dragged out Sunday night but it was not that bad and it started getting bad Monday afternoon, Yesterday was bad, and today she was a tiny bit better, but still feels dragged out. She had a little bit of temperature hike but nothing major, her usually temperature was around 97 or 98 and her temperature went up to 99 yesterday. The outcome of the event(Feeling abnormal) was recovering and event (Body temperature abnormal) was recovered on 27Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Headache, Pyrexia
Clinical narrative: temperature of 99.8; lower back pain; severe headache; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) (Age at Time of Vaccination was 45 years) via unspecified route of administration on 24Jan2021 around 9-9:15 a.m. in the left arm as a single dose for COVID-19 immunization. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and Concomitant medication was not reported. It was reported that on Sunday, the caller and his wife received the vaccine. He does not have any symptoms. However, his wife had a severe headache and feels like the veins in her head are getting inflamed. Caller wants to know was this kind of a normal side effect or does she need to go to the hospital. Caller stated that his wife also had a temperature of 9.8 degrees (later clarified as 99.8 degrees). Caller tried to call the doctor, but no one answered. Caller confirmed that his wife received her first vaccine Sunday, 24Jan2021. That same night, she had a headache. She took pills for the headache and the headache went away. Monday, 25Jan2021, she had a light headache. Yesterday afternoon (26Jan2021), she had a really bad headache. The pain was getting bigger, she felt more pain in her head. It was confirmed that his wife's temperature was checked yesterday morning and it was 99.8 degrees. Today, she just took it and her temperature has gone up to 100 degrees. It was stated that his wife was also noticing some pain in her lower back. This pain started on Monday and it was not as strong as the pain in her head, but she was starting to feel more discomfort. The patient did not visit emergency Room/Physician Office. The outcome of the events was not recovered/not resolved.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after 2nd dose for 1 day; This is a spontaneous report from contactable physician via Pfizer sales representative. This Physician (Patient) reported that an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced fatigue after 2nd dose for 1 day. The reporter stated that event took place after use of product. The clinical outcome of the event was recovered on an unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: have cold symptoms; Cough; Fever; Stuffiness/Congestion; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 15:00 (at the age of 40-years) as single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included jardiance, atorvastatin, unspecified vitamins and some unspecified prebiotics. On 28Jan2021, the patient had cold symptoms, cough, stuffiness/congestion and fever. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nasopharyngitis, Oropharyngeal pain, Pain in extremity
Clinical narrative: Continue to have a sore throat; a cold with massive amounts of mucous since injection.; tiredness; joint pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3248), dose 1 via an unspecified route of administration at left arm on 27Jan2021 07:15 as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included Lisinopril 20 mg, Atorvastatin calcium 10 mg, Sildenafil 100 mg taken for an unspecified indication. Patient did not suffer any Allergies to medications, food, or other products. Prior to vaccination patient was not diagnosed with COVID-19. Even after vaccination, patient has not tested for COVID-19. On 27Jan2021 10:00 am, the patient experienced continue to have a sore throat and a cold with massive amounts of mucous since injection. Has subsided a bit, but it continues today. Also had usual side effects (joint pain, arm pain, tiredness, etc). The outcome of the event was not recovered.   Follow-up attempts have been completed and no further information is expected.