chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever Nausea/Vomiting Cough Congestion Chest Pain  Headache Vaccine #1 22JAN2021 Vaccine #2 19FEB2021
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever 103 F, muscle aches, headache
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Hemiparesis, Hypoaesthesia
Clinical narrative: 2nd day - chills, fatigue numbness 3rd > 6th days  - increasing numbness ... left face, left finger, left foot 4th & 5th days - stumbling on left side, all symptoms serious enough for me to get doctor consults (3 doctors)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: 2nd day - chills, fatigue numbness 3rd > 6th days  - increasing numbness ... left face, left finger, left foot 4th & 5th days - stumbling on left side, all symptoms serious enough for me to get doctor consults (3 doctors)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Urticaria
Clinical narrative: Hive-type rash around the injection area.   Not necessarily at the injection point but around a circle, centered at the injection point,  about 2" - 3"  away..
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events; Expired dose of PNEUMOV AX-23 was inadvertently administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age. and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-FEB-2021, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, injected once, lot # S012246 with expiration date 10-FEB-2021, for prophylaxis (strength was not reported). No additional adverse events were reported. The product had never had a temperature excursion.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Not able to take her last dose on day 7; Spontaneous report received on 04FEB2020.  A pharmacist reported that a female consumer was "not able to take her last dose on day 7" (PT: Product dose omission) while being on Vivotif for immunisation. The consumer took her first, second and third dose of Vivotif on 29JAN2020, 31JAN2020 and 02FEB2020 respectively. She was unable to take her last dose on 04FEB2020; instead, she would be able to take the last dose on 05FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: experienced a sore arm; redness at the injection site which resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follow: The age at vaccination was not reported. The patient reported that after 1st dose of Shingrix, on an unknown date, she experienced a sore arm and redness at the injection site which was resolved.   The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021015599.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015599:Same patent 2nd dose, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This case was reported by a consumer and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient asked if it was ok to take aspirin to help with arm pain from the Shingrix vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Facial paralysis, Ultrasound foetal
Clinical narrative: Bells palsy; Pregnancy; A spontaneous report was received from a physician, who was also a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA- 1273) during pregnancy and the patient has been diagnosed with Bell's palsy after delivery.  The patient's medical history included exercise induced asthma. Products known to have been used by the patient, within two weeks prior to the event, included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide and omeprazole.  On 23 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for the prophylaxis of COVID-19 infection. On 20 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) for the prophylaxis of COVID-19 infection.  On an unknown date, an ultrasound and quad screen (levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), estriol and inhibin A in pregnant women's blood) were performed, and the results were normal. There were no complications during the pregnancy.  On 01 Feb 2021, the patient delivered the baby. No other delivery or infant details were reported.   On 10 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the reported event, Bell's Palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: feeling cold; achy; feverish; they gave vaccine to my 16 year old daughter; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient that received the vaccine/product delivered to a patient of inappropriate age and experienced feeling cold, feverish/pyrexia and achy/pain.  The patient's medical history was not provided. Concomitant medications were not provided.   On 09 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unreported) in the left arm for the prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient experienced feeling cold, feverish and achy. Treatment for these events was not provided. Caregiver inquiring as to what to do about second dose.  Caregiver REFUSED permission to contact and DOES NOT want the Centers for Disease Control notified.  Action taken with mRNA-1273 was not reported.   The outcome of the event,  received the vaccine/product delivered to a patient of inappropriate age was considered resolved. The events, experienced feeling cold, feverish/pyrexia and achy/pain, was unknown.; Reporter's Comments: This report refers to a case of Product administration error  Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with  associated  events of feeling cold, Pain ,Pyrexia .Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a 17 year old the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, a health care professional gave a 17-year-old the Moderna COVID-19 vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, gave a 17-year-old the vaccine/product administrated to patient of inappropriate age, was considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number not provided) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Out of specification product administered; A spontaneous report was received from a physician concerning a "couple" of patients of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273), who reported the event of "Out of specification product administered"/MedDRA PT: expired vaccine used.   The patients' medical histories were not provided. Concomitant medication use was not provided.   On an unspecified date, a "couple of patients received a dose (unknown which dose) of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection.   A physician reported that "a couple of patients received their dose at 7 hours". Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event of  "Out of specification product administered" was considered recovered/resolved (date unspecified).; Reporter's Comments: This report refers to a case of Out of specification product administered for mRNA-1273, lot # unknown with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HCP administered the vaccine to a patient under the age of 18; A spontaneous report from USA was received from reporter concerning a under 18 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) by a Health Care Profession.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 28 January 2021, prior to the onset of the events, the patient received their first  dose of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the  unknown anatomical location for prophylaxis of COVID-19 infection. There are no recorded events of symptoms experienced by the patient.  Laboratory details are unknown.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the given event is unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (under 18 year old female) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 Year old patient inadvertently received vaccine; A spontaneous report was received from a pharmacist concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age.  The pharmacist is concerned about 2nd dose recommendations.    The patient's medical history was not provided.    The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on a date not provided intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure abnormal, Dizziness, Heart rate, Hypersensitivity
Clinical narrative: Severe allergic reactions; Tachychardia; Hypertensive; Blood pressure shut down; Dizzy; Weak; A spontaneous report was received from a consumer concerning a 46 year old, female patient who experienced severe allergic reactions, hypertension, blood pressure shut down, dizzy, weak and tachycardia.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 19-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19-Jan-2021, the patient had tachychardia 130-140, was dizzy and weak, bp shut off.  The patient said she was also hypertensive.  Treatment for the event included IV fluids, nitroglycerin, aspirin and Benadryl.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a 46-year-old female hospitalized with serious unexpected events of severe allergic reaction, tachycardia, hypertension, dizziness, asthenia and blood pressure shut down. The events occurred the same day as the first dose of mRNA-1273. Treatment included IVF, nitroglycerin, aspirin and Benadryl.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia
Clinical narrative: Severe allergic reactions; Tachychardia; Hypertensive; Blood pressure shut down; Dizzy; Weak; A spontaneous report was received from a consumer concerning a 46 year old, female patient who experienced severe allergic reactions, hypertension, blood pressure shut down, dizzy, weak and tachycardia.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 19-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19-Jan-2021, the patient had tachychardia 130-140, was dizzy and weak, bp shut off.  The patient said she was also hypertensive.  Treatment for the event included IV fluids, nitroglycerin, aspirin and Benadryl.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a 46-year-old female hospitalized with serious unexpected events of severe allergic reaction, tachycardia, hypertension, dizziness, asthenia and blood pressure shut down. The events occurred the same day as the first dose of mRNA-1273. Treatment included IVF, nitroglycerin, aspirin and Benadryl.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Swelling in the upper lip (angioedema); A Spontaneous report received from a non-health care professional concerning  a unknown year of age male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced angioedema.  The patient had already known food and drug allergies. No relevant concomitant medications were reported.  On 06 Feb 2021 prior to onset of events the patient received second of two planned doses of COVID-19 (mRNA-1273) vaccine, for prophylaxis of COVID-19 infection.  On 09 Feb 2021 patient experienced swelling in upper lip (angioedema). He was in the hospital for a few hours and then discharged. The lip swelling has since subsided.  Treatment information was not provided.  Action taken in response to mRNA-1273 vaccine events the patient was not applicable.  The outcome of event was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's history of known food and drug allergies remains confounding factor.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Ear discomfort, Tinnitus
Clinical narrative: Next day lost hearing in left ear and getting worse; Feels pressure and ringing in her ear.; Feels pressure and ringing in her ear./ ringing was worsening; Next day lost hearing in left ear and getting worse; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246) at single dose at right arm on 03Feb2021 16:30 for covid-19 immunisation, because of her age and she had asthma and to protect her elderly and sick parents.  Medical history included ongoing ongoing asthma all of her life, ongoing tinnitus 10 years approximately, allergies to everything, environmental allergies, medication, food allergies, contact allergies, ongoing fibromyalgia a decade, ongoing gastrooesophageal reflux disease (GERD) 10-15 years. Family history: father had bladder cancer and going through bowel resection surgery, mother was immunocompromised with polymyalgia rheumatica. Concomitant medication included gabapentin (GABAPENTIN) 200 mg, 1x/day at bedtime) for Fibromyalgia, famotidine (PEPCID) OTC dose in morning and night FOR GERD.   After vaccination, towards 04Feb2021 evening, she started losing hearing in her left ear. That was late afternoon. It started with some pressure, and some loss of hearing. By 05Feb2021 it got worse. So she gave herself Sudafed because she was thinking it was normal allergies. By 06Feb2021, it wasn't better. The Sudafed did not seem to help. She went to the Urgent care on 06Feb2021, who told her to go to ENT. She has an ENT appointment on 09Feb2021. The Urgent care prescribed her a short dose of prednisone by mouth 10mg twice a day. She has looked, and not find loss of hearing as a side effect. She hasn't called the doctor yet. The hearing loss has persisted or worsened. It is not constant all day long, but it is there all day long. As of on 09Feb2021, it was pretty bad. On 04Feb2021 she was also experiencing ear ringing. It was a high pitched ring in the same ear. She had tinnitus in both ears, but it was usually low. This one since the pressure started building in her ear, the ringing was louder and bigger. The ringing was worsening. The outcome of events was not recovered.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Condition aggravated, Delirium, Fall, Fatigue
Clinical narrative: delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown.   Information on Lot/Batch has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown.   Information on Lot/Batch has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Cardiac monitoring, Echocardiogram, Electrocardiogram, Palpitations
Clinical narrative: heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (reporting for himself). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL3246, expiry date unknown), via an unspecified route of administration in the right arm on 05Jan2021, 10:30AM (at 46 years old),  at single dose for COVID-19 immunization. The patient's medical history included high cholesterol (treated with statin medications) and seasonal allergies, both from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, ashwagandha, and ergocalciferol (VIT D). At 46 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number and expiry date unknown), via an unspecified route of administration in the left arm on 15Dec2020, 10:00AM at single dose for COVID-19 immunization. The patient has not received other vaccine in four weeks prior to vaccination. Patient did not have COVID prior to vaccination and has not tested for COVID after vaccination. In the morning of 07Jan2021 (approximately 9 am), the patient experienced a period of palpitations, and heart dysrhythmia lasting for approximately 1 hour. The episode resolved on its own and has not returned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; patient had echocardiogram, EKG, and 7 days heart monitoring from an unspecified date. The patient recovered from "heart dysrhythmia" on 07Jan2021, 10:00AM, and recovered from a period of palpitations an unspecified date.  Information on lot/batch number (first dose) has been requested.; Sender's Comments: Based on the available information, a causal relationship between event heart dysrhythmia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  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.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Cardiac monitoring
Clinical narrative: heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (reporting for himself). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL3246, expiry date unknown), via an unspecified route of administration in the right arm on 05Jan2021, 10:30AM (at 46 years old),  at single dose for COVID-19 immunization. The patient's medical history included high cholesterol (treated with statin medications) and seasonal allergies, both from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, ashwagandha, and ergocalciferol (VIT D). At 46 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number and expiry date unknown), via an unspecified route of administration in the left arm on 15Dec2020, 10:00AM at single dose for COVID-19 immunization. The patient has not received other vaccine in four weeks prior to vaccination. Patient did not have COVID prior to vaccination and has not tested for COVID after vaccination. In the morning of 07Jan2021 (approximately 9 am), the patient experienced a period of palpitations, and heart dysrhythmia lasting for approximately 1 hour. The episode resolved on its own and has not returned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; patient had echocardiogram, EKG, and 7 days heart monitoring from an unspecified date. The patient recovered from "heart dysrhythmia" on 07Jan2021, 10:00AM, and recovered from a period of palpitations an unspecified date.  Information on lot/batch number (first dose) has been requested.; Sender's Comments: Based on the available information, a causal relationship between event heart dysrhythmia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: I couldn't re stand; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history included multiple sclerosis (MS). The patient's concomitant medications were not reported. The patient stated she has MS and have both of her Pfizer vaccine doses. She called her doctor and he said it was ok to get the vaccine, even though it had only been 48 days since her IV Immunotherapy. Then the next day his office sent a letter stating to wait 60 days after IV immunotherapy. On an unspecified date, after the first dose, she sat and she couldn't re stand with her Multiple sclerosis. She had to call to help to her with her my wheelchair. She called her HCP and he said to take acetaminophen (TYLENOL) 4x/day and it would get better and it did get better. The dose was similar reaction per caller and she stated she has reported this information to the Pfizer safety dept. The patient stated, she was not even sure it was the vaccine that caused  inability to stand for a few hours, with M.S. it could just flare up on it's own. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neutropenia
Clinical narrative: neutropenia after first dose; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed neutropenia after first dose on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported neutropenia cannot be excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Facial paralysis, Hypertension
Clinical narrative: Bell's palsy; chest pains; high blood pressure; This is a spontaneous report from a contactable consumer (patient).  A female consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 05Feb2021, the patient had bad chest pains (she was not sure if she was having a heart attack, as reported), high blood pressure, and Bell's palsy. She was scheduled to have her second dose on 14Feb2021. On unknown date, blood pressure resulted high. The outcome of the events. Information on the LOT/Batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Left side of face started to droop; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the left arm on 02Feb2021 14:25 at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported) via an unspecified route of administration on the left arm on 14Jan2021 at 0.3 mL, single for COVID-19 immunization.  The patient reported that when at work on Sunday 07Feb2021, the left side of his face started to droop at 23:00. No treatment was received for the event. The patient did not recover from the event.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pain in extremity, Syncope
Clinical narrative: fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself.  A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, International normalised ratio, SARS-CoV-2 test, Ventricular fibrillation
Clinical narrative: ventricular fibrillation; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for himself. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) , intramuscular in right arm on 06Jan2021 at 08:15 (at 39 years) at single dose for COVID-19 immunization. Medical history included mechanical tricuspid valve (as reported) from 2008 and had surgery in 2008 for a tricuspid valve replacement, had a pacemaker, had known allergies to penicillin and contrast dye and unknown blood clotting disorder (as reported, always in therapeutic International normalised ratio (INR) range). Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), lisinopril and warfarin sodium (JANTOVEN).  On 13Jan2021 at 09:45 the patient experienced ventricular fibrillation, serious as life threatening illness (immediate risk of death from the event) and due to hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and  Emergency room/department or urgent care . Nasal Swab on 06Jan2021 was negative. Blood tests done on 21Jan2021 and on 15Feb2021 were both negative. Clinical course was described as follows: Patient had an unknown blood clotting disorder. INR was always in the range of 2.5-3.5 and he took acetylsalicylic acid (BABY ASPIRIN) 3x/week. His heart was 100% paced via a pacemaker. He had surgery in 2008 for a tricuspid valve replacement. A week after he received the first dose of the vaccine, he had ventricular fibrillation that required 25 min of cardiopulmonary resuscitation (CPR) and 6 shocks via defibrillator. He was in the hospital to have a pacemaker replacement and replaced with a new pacemaker/ICD combo. Prolonged time in hospital related to significant trauma to heart, lungs, and liver from prolonged CPR and collapsed lung after initial procedure. Patient was hospitalized for 13 days. Final outcome of the event was not recovering.; Sender's Comments: Event ventricular fibrillation is more likely related to underlying heart disease and unrelated to BNT162B2 .  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.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza
Clinical narrative: Extremely severe flu symptoms; terrible testing cough in his chest; This is a spontaneous report from a non-contactable consumer (patient).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely severe flu symptoms, terrible testing cough in his chest, had to go to the emergency room (ER) on an unspecified date with outcome of unknown. The adverse event resulted in ER/ department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), hospitalization duration was 2 days. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac arrest, Coma
Clinical narrative: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "collapsed due to a cardiac arrest", "cardiac arrest was caused by an arrhythmia" and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.  The patient's pre-existing long history of congenital heart issues might have provided alternative explanations.   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 RA, IEC, as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: General achiness all over and soreness in her arm after receiving the vaccine; General achiness all over and soreness in her arm after receiving the vaccine; This spontaneous case was received on 08-Feb-2021 from other non-health professional via Med Communications (reference number: SEQW21-00439) and concerned a female patient of unspecified age. At the time of initial reporting the patient was in her 70s.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm after receiving the vaccine.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the case 202101374 (the same patient).  Company comment: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.; Sender's Comments: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itchy red round rash about the size of a tennis ball. Hard and warm to the touch
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Itchy red round rash about the size of a tennis ball. Hard and warm to the touch
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Nausea, Pain in extremity
Clinical narrative: 2/25 after 10 hours I woke up with a lot of soreness at injection site and 99.3 body temperature; 3:30 99.6 temperature, chills, achy arm; 4:47 100.5 temp; 2/26 5:00 AM: chills, 100.0 temp, nausea.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Myalgia, Nausea, Pyrexia
Clinical narrative: Increasing site soreness, increasing muscle soreness which is increasing in area involved, increasing warmth in muscle area, intermittent nausea, low grade fever (up to 100.9 F).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Micturition urgency, Mobility decreased, Muscle rigidity
Clinical narrative: On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine.  Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.