chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, HIV test negative, Hepatic cyst, Legionella test, Lymphadenopathy
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mononucleosis heterophile test negative, Night sweats, Oedema peripheral, Pain in extremity, Pelvic fluid collection
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Scrotal swelling
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Thyroid function test normal, Tuberculin test, Ultrasound Doppler, Weight decreased
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chills, Cough, Inflammation, Joint swelling
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Night sweats, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Swelling, Testicular swelling, Weight bearing difficulty
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amylase, Blood lactate dehydrogenase, Differential white blood cell count, Dyspnoea, Electrocardiogram
Clinical narrative: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Factor II mutation, Factor V deficiency, Fatigue, Full blood count, International normalised ratio
Clinical narrative: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Muscle spasms, N-terminal prohormone brain natriuretic peptide, Parosmia, Protein C
Clinical narrative: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Protein S, Prothrombin level, SARS-CoV-2 antibody test, Troponin T
Clinical narrative: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Directional Doppler flow tests normal, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram ST-T segment abnormal
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report from a contactable consumer (parent). A 16-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09Jun2021 12:00 (Batch/Lot Number: EW0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included mild asthma (not needing treatment in several years), Cholinergic urticaria - allergic to his own sweat, breaking out in hives. Prior to vaccination, the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient previously took morphine and experienced allergy and altered personality. The patient experienced myocarditis and pericarditis on 01Jul2021 05:30. The events required visit Emergency room/department or urgent care. The patient was hospitalized for events from in Jul2021 for 4 days. Treatment included buprofen, morphine, toridol. The events were reported as serious due to Life threatening and Caused/prolonged hospitalization. The patient underwent lab tests and procedures which included ekg: unknown results in Jul2021; echocardiogram: unknown results in Jul2021. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab: negative on 01Jul2021. The event outcome was recovering.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram T wave inversion, Troponin I increased
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report from a contactable consumer (parent). A 16-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09Jun2021 12:00 (Batch/Lot Number: EW0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included mild asthma (not needing treatment in several years), Cholinergic urticaria - allergic to his own sweat, breaking out in hives. Prior to vaccination, the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient previously took morphine and experienced allergy and altered personality. The patient experienced myocarditis and pericarditis on 01Jul2021 05:30. The events required visit Emergency room/department or urgent care. The patient was hospitalized for events from in Jul2021 for 4 days. Treatment included buprofen, morphine, toridol. The events were reported as serious due to Life threatening and Caused/prolonged hospitalization. The patient underwent lab tests and procedures which included ekg: unknown results in Jul2021; echocardiogram: unknown results in Jul2021. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab: negative on 01Jul2021. The event outcome was recovering.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Pericarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report from a contactable consumer (parent). A 16-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09Jun2021 12:00 (Batch/Lot Number: EW0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included mild asthma (not needing treatment in several years), Cholinergic urticaria - allergic to his own sweat, breaking out in hives. Prior to vaccination, the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient previously took morphine and experienced allergy and altered personality. The patient experienced myocarditis and pericarditis on 01Jul2021 05:30. The events required visit Emergency room/department or urgent care. The patient was hospitalized for events from in Jul2021 for 4 days. Treatment included buprofen, morphine, toridol. The events were reported as serious due to Life threatening and Caused/prolonged hospitalization. The patient underwent lab tests and procedures which included ekg: unknown results in Jul2021; echocardiogram: unknown results in Jul2021. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab: negative on 01Jul2021. The event outcome was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: The patient was inadvertently given the entire vial, 6 doses, of the vaccine; Patient is pregnant; This is a spontaneous report from a contactable nurse. A 37-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) (at the age of 37 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient was inadvertently given the entire vial, 6 doses, of the vaccine on 26Jul2021. The patient was pregnant at the time of vaccination who received a higher dose than recommended. The reporter confirmed that the vial was diluted. The mother was due to deliver on 20Oct2021. The reporter asked if patient should be hospitalized for observation after receiving an entire vial of the Covid-19 vaccine. The patient was advised not to take the second dose.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Maternal exposure during pregnancy
Clinical narrative: The patient was inadvertently given the entire vial, 6 doses, of the vaccine; Patient is pregnant; This is a spontaneous report from a contactable nurse. A 37-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) (at the age of 37 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient was inadvertently given the entire vial, 6 doses, of the vaccine on 26Jul2021. The patient was pregnant at the time of vaccination who received a higher dose than recommended. The reporter confirmed that the vial was diluted. The mother was due to deliver on 20Oct2021. The reporter asked if patient should be hospitalized for observation after receiving an entire vial of the Covid-19 vaccine. The patient was advised not to take the second dose.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Nausea, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Within 48 hours patient had red,  itchy arms and ankles, then spread to abdomen and eventually to entire body on 7/24/21. Benadryl and hydrocortisone cream did not help. Patient took Claritin 7/25/21 but still very itchy. Her doctor prescribed  Levocetirizine 5mg and Triamcinolone Cream 0.1% on 7/27/21.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Within 48 hours patient had red,  itchy arms and ankles, then spread to abdomen and eventually to entire body on 7/24/21. Benadryl and hydrocortisone cream did not help. Patient took Claritin 7/25/21 but still very itchy. Her doctor prescribed  Levocetirizine 5mg and Triamcinolone Cream 0.1% on 7/27/21.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Within 48 hours patient had red,  itchy arms and ankles, then spread to abdomen and eventually to entire body on 7/24/21. Benadryl and hydrocortisone cream did not help. Patient took Claritin 7/25/21 but still very itchy. Her doctor prescribed  Levocetirizine 5mg and Triamcinolone Cream 0.1% on 7/27/21.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccine she received was not stored at the proper temperature; Muscle spasms; Her arm is still sore; There is a bruise were the shot was administered; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0176)), dose 1 via an unspecified route of administration, administered in the left arm on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Allergic reaction to pain medication that starts with M. she had no pre-existing conditions. She never had an allergic reaction to anything other than Tramadol and another pain medication that starts with an M. No other issues. The allergic reaction to Tramadol and the pain medication that started with M was more than 5 years ago. Caller doesn't have NDC, lot, or expiry to provide for Tramadol or the pain medication that starts with M. With the flu shot she got sick. That lasted for 3 days. She got stuffy, runny nose. That was about 10 years ago. She doesn't have NDC, lot, and expiry for the flu shot. The patient's concomitant medications were not reported. The patient previously took tramadol and experienced drug hypersensitivity, flu vaccine vii and experienced illness, flu vaccine vii for nasal congestion, flu vaccine vii for rhinorrhoea. On an unknown date in 2021, the patient experienced vaccine she received was not stored at the proper temperature (expired product administered), muscle spasms, her arm was still sore, there was a bruise where the shot was administered. Received first dose of COVID vaccine two weeks ago. Pharmacy called her and said that the vaccine she received was not stored at the proper temperature and she needs to start the vaccine series over. Are there any possible side effects since it wasn't store properly. She ad muscle spasms since she was vaccinated on left arm. The vaccine was given in the left arm and that was the arm she was having muscle spasms in. The muscle spasms started 24 to 48 hours later. It was every day, but it was not continuous. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not go to it comes in spurts. The patient did not go to emergency room. She just had one not long ago, about 2 minutes ago. She could feel it and stretched her arm and rotated it. Her arm was still sore. There was a bruise where the shot was administered. The new variant was the number one reason. Caller had a minor child in the home who was going back into school face to face. There are a lot of people against it, and she got it to help protect everyone else. It would be better than not having it. The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Muscle spasms, Pain in extremity, Vaccination site bruising
Clinical narrative: vaccine she received was not stored at the proper temperature; Muscle spasms; Her arm is still sore; There is a bruise were the shot was administered; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0176)), dose 1 via an unspecified route of administration, administered in the left arm on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Allergic reaction to pain medication that starts with M. she had no pre-existing conditions. She never had an allergic reaction to anything other than Tramadol and another pain medication that starts with an M. No other issues. The allergic reaction to Tramadol and the pain medication that started with M was more than 5 years ago. Caller doesn't have NDC, lot, or expiry to provide for Tramadol or the pain medication that starts with M. With the flu shot she got sick. That lasted for 3 days. She got stuffy, runny nose. That was about 10 years ago. She doesn't have NDC, lot, and expiry for the flu shot. The patient's concomitant medications were not reported. The patient previously took tramadol and experienced drug hypersensitivity, flu vaccine vii and experienced illness, flu vaccine vii for nasal congestion, flu vaccine vii for rhinorrhoea. On an unknown date in 2021, the patient experienced vaccine she received was not stored at the proper temperature (expired product administered), muscle spasms, her arm was still sore, there was a bruise where the shot was administered. Received first dose of COVID vaccine two weeks ago. Pharmacy called her and said that the vaccine she received was not stored at the proper temperature and she needs to start the vaccine series over. Are there any possible side effects since it wasn't store properly. She ad muscle spasms since she was vaccinated on left arm. The vaccine was given in the left arm and that was the arm she was having muscle spasms in. The muscle spasms started 24 to 48 hours later. It was every day, but it was not continuous. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not go to it comes in spurts. The patient did not go to emergency room. She just had one not long ago, about 2 minutes ago. She could feel it and stretched her arm and rotated it. Her arm was still sore. There was a bruise where the shot was administered. The new variant was the number one reason. Caller had a minor child in the home who was going back into school face to face. There are a lot of people against it, and she got it to help protect everyone else. It would be better than not having it. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Discomfort
Clinical narrative: Patient started to experience chest discomfort the day after the vaccination.  Patient also experienced palpitations the day after, and it lasted for a few hours in the evening.  Her heartrate was at 130 upon checking with an at-home pulse oximeter.  Since then, the palpitations come and go, but are in lesser magnitude in comparison to the first episode.  Her heartrate is fluctuates from 80 to 130.  Patient took OTC Tylenol every 4 hours the day after the vaccination to treat the underarm lymph node pain she experienced.   Patient sought medical evaluation at the ER on 8/5/2021 at Community Hospital.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Chest X-ray abnormal, Chest discomfort, Dermatitis contact
Clinical narrative: Patient started to experience chest discomfort the day after the vaccination.  Patient also experienced palpitations the day after, and it lasted for a few hours in the evening.  Her heartrate was at 130 upon checking with an at-home pulse oximeter.  Since then, the palpitations come and go, but are in lesser magnitude in comparison to the first episode.  Her heartrate is fluctuates from 80 to 130.  Patient took OTC Tylenol every 4 hours the day after the vaccination to treat the underarm lymph node pain she experienced.   Patient sought medical evaluation at the ER on 8/5/2021 at Community Hospital.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Lymph node pain, Lymphadenopathy, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: Patient started to experience chest discomfort the day after the vaccination.  Patient also experienced palpitations the day after, and it lasted for a few hours in the evening.  Her heartrate was at 130 upon checking with an at-home pulse oximeter.  Since then, the palpitations come and go, but are in lesser magnitude in comparison to the first episode.  Her heartrate is fluctuates from 80 to 130.  Patient took OTC Tylenol every 4 hours the day after the vaccination to treat the underarm lymph node pain she experienced.   Patient sought medical evaluation at the ER on 8/5/2021 at Community Hospital.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Feeling hot, Nausea
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Aphonia, Blood test, Chest pain
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return