chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Magnetic resonance imaging
Clinical narrative: went home, became very dizzy, if gets up becomes very dizzy and had mri yesterday 07/05/2021
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Panic attack
Clinical narrative: Chest pain started 2 days after shot and continues at different levels of pain, intensifying to the point of my going to an urgent care facility because I thought I was having a heart attack.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Chest pain started 2 days after shot and continues at different levels of pain, intensifying to the point of my going to an urgent care facility because I thought I was having a heart attack.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Chest X-ray normal, Chest discomfort, Echocardiogram normal, Laboratory test normal
Clinical narrative: Pericarditis; Initial EKG does show some diffuse ST segment elevation; This is a spontaneous report from a contactable Physician. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167), intramuscular, administered in Arm Left on 10Jun2021 11:15 (at age of 22 years old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. This is a 22-year-old active duty male without significant past medical history presenting with several days of chest pressure after coronavirus vaccination.  His vital signs are stable and he was afebrile upon arrival to the ED with a benign and reassuring physical examination. His initial EKG does show some diffuse ST segment elevation/PR depression that was not as impressive on a repeat EKG. Bedside point-of-care echocardiogram shows grossly normal function without obvious pericardial effusion or other acute abnormalities. Chest x-ray unremarkable. Laboratory work-up with undetectable troponin and normal BNP, all on 11Jun2021. Ultimately diagnosed with pericarditis at emergency department. Adverse event start date was 11Jun2021 11:15 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. Treatment (Ibuprophen 800 mg TID x 3 weeks) received. The outcome of the events was Recovering.; Sender's Comments: Considering a plausible temporal relationship and a known product safety profile, a possible contributory role of suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167) to the reported "Pericarditis" and " EKG ST segment elevation" 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; Initial EKG does show some diffuse ST segment elevation; This is a spontaneous report from a contactable Physician. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167), intramuscular, administered in Arm Left on 10Jun2021 11:15 (at age of 22 years old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. This is a 22-year-old active duty male without significant past medical history presenting with several days of chest pressure after coronavirus vaccination.  His vital signs are stable and he was afebrile upon arrival to the ED with a benign and reassuring physical examination. His initial EKG does show some diffuse ST segment elevation/PR depression that was not as impressive on a repeat EKG. Bedside point-of-care echocardiogram shows grossly normal function without obvious pericardial effusion or other acute abnormalities. Chest x-ray unremarkable. Laboratory work-up with undetectable troponin and normal BNP, all on 11Jun2021. Ultimately diagnosed with pericarditis at emergency department. Adverse event start date was 11Jun2021 11:15 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. Treatment (Ibuprophen 800 mg TID x 3 weeks) received. The outcome of the events was Recovering.; Sender's Comments: Considering a plausible temporal relationship and a known product safety profile, a possible contributory role of suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167) to the reported "Pericarditis" and " EKG ST segment elevation" 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Brain natriuretic peptide, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Pericarditis; Initial EKG does show some diffuse ST segment elevation; This is a spontaneous report from a contactable Physician. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167), intramuscular, administered in Arm Left on 10Jun2021 11:15 (at age of 22 years old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. This is a 22-year-old active duty male without significant past medical history presenting with several days of chest pressure after coronavirus vaccination.  His vital signs are stable and he was afebrile upon arrival to the ED with a benign and reassuring physical examination. His initial EKG does show some diffuse ST segment elevation/PR depression that was not as impressive on a repeat EKG. Bedside point-of-care echocardiogram shows grossly normal function without obvious pericardial effusion or other acute abnormalities. Chest x-ray unremarkable. Laboratory work-up with undetectable troponin and normal BNP, all on 11Jun2021. Ultimately diagnosed with pericarditis at emergency department. Adverse event start date was 11Jun2021 11:15 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. Treatment (Ibuprophen 800 mg TID x 3 weeks) received. The outcome of the events was Recovering.; Sender's Comments: Considering a plausible temporal relationship and a known product safety profile, a possible contributory role of suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167) to the reported "Pericarditis" and " EKG ST segment elevation" 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Pericarditis, Troponin, Vital signs measurement
Clinical narrative: Pericarditis; Initial EKG does show some diffuse ST segment elevation; This is a spontaneous report from a contactable Physician. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167), intramuscular, administered in Arm Left on 10Jun2021 11:15 (at age of 22 years old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. This is a 22-year-old active duty male without significant past medical history presenting with several days of chest pressure after coronavirus vaccination.  His vital signs are stable and he was afebrile upon arrival to the ED with a benign and reassuring physical examination. His initial EKG does show some diffuse ST segment elevation/PR depression that was not as impressive on a repeat EKG. Bedside point-of-care echocardiogram shows grossly normal function without obvious pericardial effusion or other acute abnormalities. Chest x-ray unremarkable. Laboratory work-up with undetectable troponin and normal BNP, all on 11Jun2021. Ultimately diagnosed with pericarditis at emergency department. Adverse event start date was 11Jun2021 11:15 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. Treatment (Ibuprophen 800 mg TID x 3 weeks) received. The outcome of the events was Recovering.; Sender's Comments: Considering a plausible temporal relationship and a known product safety profile, a possible contributory role of suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0167) to the reported "Pericarditis" and " EKG ST segment elevation" 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: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dizziness postural, Meniere's disease
Clinical narrative: I have positional dizziness; The malaise and fatigue are new and debilitating; The malaise and fatigue are new and debilitating; The malaise and fatigue are new and debilitating; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female non-pregnant patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm left on 09Feb2021 (Batch/Lot Number: EN6198) for covid-19 immunisation at age of 63-year-old (non-pregnant). Medical history included Post Traumatic Meniere's disease diagnosed in 2016 (symptoms were not well managed, but they were predictable), post-traumatic stress disorder (PTSD), high cholesterol, osteoporosis, hearing issues related to Menieres. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received the first single dose of bnt162b2 (date reported at 09Feb2021 13:00) (lot number: EM9809) on left arm at age of 63-year-old and had no reaction. Concomitant medications included atorvastatin (LIPITOR); lisinopril; HCTZ; betahistine; venlafaxine hydrochloride (EFFEXOR). The patient had allergy to cefaclor (CECLOR), moxifloxacin hydrochloride (AVELOX) and erythromycin. Everything changed after the second Pfizer covid vaccine. In Mar2021,she had positional dizziness, which was new, and it was easily triggered by a normal head nod or shake. The malaise and fatigue were new and debilitating. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The treatment included added OTC gingko. Started round 2 of vestib and rehab. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness postural, Fatigue, Malaise
Clinical narrative: I have positional dizziness; The malaise and fatigue are new and debilitating; The malaise and fatigue are new and debilitating; The malaise and fatigue are new and debilitating; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female non-pregnant patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm left on 09Feb2021 (Batch/Lot Number: EN6198) for covid-19 immunisation at age of 63-year-old (non-pregnant). Medical history included Post Traumatic Meniere's disease diagnosed in 2016 (symptoms were not well managed, but they were predictable), post-traumatic stress disorder (PTSD), high cholesterol, osteoporosis, hearing issues related to Menieres. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received the first single dose of bnt162b2 (date reported at 09Feb2021 13:00) (lot number: EM9809) on left arm at age of 63-year-old and had no reaction. Concomitant medications included atorvastatin (LIPITOR); lisinopril; HCTZ; betahistine; venlafaxine hydrochloride (EFFEXOR). The patient had allergy to cefaclor (CECLOR), moxifloxacin hydrochloride (AVELOX) and erythromycin. Everything changed after the second Pfizer covid vaccine. In Mar2021,she had positional dizziness, which was new, and it was easily triggered by a normal head nod or shake. The malaise and fatigue were new and debilitating. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The treatment included added OTC gingko. Started round 2 of vestib and rehab. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cyanosis, Dizziness, Eye movement disorder, Hypoacusis
Clinical narrative: lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15  as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering.  Information on the lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Muscle rigidity, Nausea, Pallor, Paraesthesia
Clinical narrative: lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15  as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering.  Information on the lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cyanosis, Dizziness, Dry mouth, Eye movement disorder
Clinical narrative: lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15  as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering.  Information on the lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Loss of consciousness, Muscle rigidity, Nausea, Pallor
Clinical narrative: lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15  as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering.  Information on the lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15  as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering.  Information on the lot/batch has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 intramuscular, administered in arm left on 27Mar2021 14:00 (Batch/Lot Number: EP6955) as dose 2, single at the age of 54-year-old for covid-19 immunisation. Patient received first dose (lot number: EN6199) intramuscular in left arm on 05Mar2021, 10:00 am for COVID-19 immunization. No known allergies or other medical history. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood clot R (right) upper leg on 24Apr2021 17:00. L (left) leg pain x 1 week. R lower leg pain x 1 week about 10May2021 or 12May2021. Then redness started 31May2021 saw urgent care 01Jun2021 thought was lymph started abx bactrim then on 04Jun2021 to PMD (Withheld) clinic had us + blood clot r upper leg. The adverse event result in Doctor or other healthcare professional office/clinic visit. Event treatment included blood thinners. The outcome of event was recovering.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Thrombosis
Clinical narrative: thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 intramuscular, administered in arm left on 27Mar2021 14:00 (Batch/Lot Number: EP6955) as dose 2, single at the age of 54-year-old for covid-19 immunisation. Patient received first dose (lot number: EN6199) intramuscular in left arm on 05Mar2021, 10:00 am for COVID-19 immunization. No known allergies or other medical history. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood clot R (right) upper leg on 24Apr2021 17:00. L (left) leg pain x 1 week. R lower leg pain x 1 week about 10May2021 or 12May2021. Then redness started 31May2021 saw urgent care 01Jun2021 thought was lymph started abx bactrim then on 04Jun2021 to PMD (Withheld) clinic had us + blood clot r upper leg. The adverse event result in Doctor or other healthcare professional office/clinic visit. Event treatment included blood thinners. The outcome of event was recovering.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear discomfort, Head discomfort, Hypoacusis, Tinnitus
Clinical narrative: Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 48-year-old female patient received bnt162b2 (Pfizer Covid-19), dose 1 via an unspecified route of administration, administered in arm left on 11Mar2021 (Batch/Lot Number: Fn6208) as dose 1, single at the age of 48-year-old for covid-19 immunisation.  No relevant medical history and concurrent conditions. No relevant past drug history. No concomitant medications. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced ringing in ears, fullness and muffled sound like hearing loss, dizziness on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: blood test with unknown result on an unknown date. No treatment. Outcome of event was not recovered.  No Follow-up attempts completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Deafness, Dizziness, Hypoacusis, Tinnitus
Clinical narrative: Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; Ringing in ears, fullness and muffled sound like hearing loss, dizziness; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 48-year-old female patient received bnt162b2 (Pfizer Covid-19), dose 1 via an unspecified route of administration, administered in arm left on 11Mar2021 (Batch/Lot Number: Fn6208) as dose 1, single at the age of 48-year-old for covid-19 immunisation.  No relevant medical history and concurrent conditions. No relevant past drug history. No concomitant medications. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced ringing in ears, fullness and muffled sound like hearing loss, dizziness on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: blood test with unknown result on an unknown date. No treatment. Outcome of event was not recovered.  No Follow-up attempts completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: ?Patient without significant medical history presents with complaint of chest pain short of breath started about 1.5 hours before ED assessment, she awoke from sleep with the symptoms. She did receive her first maternal vaccination yesterday. She did have coronavirus infection this past January 5 months ago. Patient without any cough. She is had fatigue and low-grade fever since she awoke this morning. Had some mild chest discomfort that has improved. She does have shortness of breath. EMS found the patient tachypneic in the 30s and tachycardic to the 130s and anxious and tearful but this has improved on ED arrival. Patient will have supportive care with IV fluids, analgesic effect with IV Tylenol and its antipyretic effect in this patient will be helpful as well. Patient well-appearing, no concern for sepsis. Denies any UTI symptoms. Low suspicion tickborne illness. Disposition based on results of imaging?
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin, Urine analysis
Clinical narrative: ?Patient without significant medical history presents with complaint of chest pain short of breath started about 1.5 hours before ED assessment, she awoke from sleep with the symptoms. She did receive her first maternal vaccination yesterday. She did have coronavirus infection this past January 5 months ago. Patient without any cough. She is had fatigue and low-grade fever since she awoke this morning. Had some mild chest discomfort that has improved. She does have shortness of breath. EMS found the patient tachypneic in the 30s and tachycardic to the 130s and anxious and tearful but this has improved on ED arrival. Patient will have supportive care with IV fluids, analgesic effect with IV Tylenol and its antipyretic effect in this patient will be helpful as well. Patient well-appearing, no concern for sepsis. Denies any UTI symptoms. Low suspicion tickborne illness. Disposition based on results of imaging?
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Dyspnoea, Fatigue
Clinical narrative: ?Patient without significant medical history presents with complaint of chest pain short of breath started about 1.5 hours before ED assessment, she awoke from sleep with the symptoms. She did receive her first maternal vaccination yesterday. She did have coronavirus infection this past January 5 months ago. Patient without any cough. She is had fatigue and low-grade fever since she awoke this morning. Had some mild chest discomfort that has improved. She does have shortness of breath. EMS found the patient tachypneic in the 30s and tachycardic to the 130s and anxious and tearful but this has improved on ED arrival. Patient will have supportive care with IV fluids, analgesic effect with IV Tylenol and its antipyretic effect in this patient will be helpful as well. Patient well-appearing, no concern for sepsis. Denies any UTI symptoms. Low suspicion tickborne illness. Disposition based on results of imaging?
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tearfulness
Clinical narrative: ?Patient without significant medical history presents with complaint of chest pain short of breath started about 1.5 hours before ED assessment, she awoke from sleep with the symptoms. She did receive her first maternal vaccination yesterday. She did have coronavirus infection this past January 5 months ago. Patient without any cough. She is had fatigue and low-grade fever since she awoke this morning. Had some mild chest discomfort that has improved. She does have shortness of breath. EMS found the patient tachypneic in the 30s and tachycardic to the 130s and anxious and tearful but this has improved on ED arrival. Patient will have supportive care with IV fluids, analgesic effect with IV Tylenol and its antipyretic effect in this patient will be helpful as well. Patient well-appearing, no concern for sepsis. Denies any UTI symptoms. Low suspicion tickborne illness. Disposition based on results of imaging?
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ankle fracture, Dizziness, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after several minutes of the vaccine administration. She hit her head and twisted her ankle when she fainted according to witnesses/mother.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head injury, Joint injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after several minutes of the vaccine administration. She hit her head and twisted her ankle when she fainted according to witnesses/mother.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation, Troponin increased
Clinical narrative: Heart attack; Myocarditis (heart inflammation); Chest pain; Having breathing problems; dry cough; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year old male patient received bnt162b2 (Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:00 (Batch/Lot Number: GW0217) as single dose for covid-19 immunisation at Pharmacy or Drug Store. He had received bnt162b2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 14:00 (Batch/Lot Number: EW0191) for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 12 hours of 2nd shot on 17Jun2021, the patient experienced fever, chills, body aches. On 18Jun2021, started having breathing problems, chest pain, dry cough. On 19Jun2021 patient ended up in Hospital suffered heart attack and was suffering myocarditis (heart inflammation). Patient was hospitalized for 3 days. The events were reported as serious with seriousness criteria life threatening, caused/prolonged hospitalization. Adverse event (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events. Myocarditis treatment was taken. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Cough, Myocardial infarction, Myocarditis
Clinical narrative: Heart attack; Myocarditis (heart inflammation); Chest pain; Having breathing problems; dry cough; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year old male patient received bnt162b2 (Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:00 (Batch/Lot Number: GW0217) as single dose for covid-19 immunisation at Pharmacy or Drug Store. He had received bnt162b2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 14:00 (Batch/Lot Number: EW0191) for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 12 hours of 2nd shot on 17Jun2021, the patient experienced fever, chills, body aches. On 18Jun2021, started having breathing problems, chest pain, dry cough. On 19Jun2021 patient ended up in Hospital suffered heart attack and was suffering myocarditis (heart inflammation). Patient was hospitalized for 3 days. The events were reported as serious with seriousness criteria life threatening, caused/prolonged hospitalization. Adverse event (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events. Myocarditis treatment was taken. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Respiratory disorder
Clinical narrative: Heart attack; Myocarditis (heart inflammation); Chest pain; Having breathing problems; dry cough; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year old male patient received bnt162b2 (Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:00 (Batch/Lot Number: GW0217) as single dose for covid-19 immunisation at Pharmacy or Drug Store. He had received bnt162b2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 14:00 (Batch/Lot Number: EW0191) for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 12 hours of 2nd shot on 17Jun2021, the patient experienced fever, chills, body aches. On 18Jun2021, started having breathing problems, chest pain, dry cough. On 19Jun2021 patient ended up in Hospital suffered heart attack and was suffering myocarditis (heart inflammation). Patient was hospitalized for 3 days. The events were reported as serious with seriousness criteria life threatening, caused/prolonged hospitalization. Adverse event (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events. Myocarditis treatment was taken. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Electrocardiogram abnormal, Pain in extremity, Pericarditis
Clinical narrative: Her doctor now says she has pericarditis due to the shot.; she had felt real bad; all over pain; vomiting; This is a spontaneous report from two contactable consumers. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jun2021 as dose number unknown, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 prior vaccination and post vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 10Jun2021, the patient felt real bad after the injection with vomiting and all over pain. The doctor said she has pericarditis due to the shot. The patient visited emergency room/physician office due to the events. Therapeutic measures (unspecified) were taken as a result of the events. The outcome for the events were not recovered.  Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin normal
Clinical narrative: Her doctor now says she has pericarditis due to the shot.; she had felt real bad; all over pain; vomiting; This is a spontaneous report from two contactable consumers. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jun2021 as dose number unknown, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 prior vaccination and post vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 10Jun2021, the patient felt real bad after the injection with vomiting and all over pain. The doctor said she has pericarditis due to the shot. The patient visited emergency room/physician office due to the events. Therapeutic measures (unspecified) were taken as a result of the events. The outcome for the events were not recovered.  Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain, Pericarditis, Vomiting
Clinical narrative: Her doctor now says she has pericarditis due to the shot.; she had felt real bad; all over pain; vomiting; This is a spontaneous report from two contactable consumers. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jun2021 as dose number unknown, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 prior vaccination and post vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 10Jun2021, the patient felt real bad after the injection with vomiting and all over pain. The doctor said she has pericarditis due to the shot. The patient visited emergency room/physician office due to the events. Therapeutic measures (unspecified) were taken as a result of the events. The outcome for the events were not recovered.  Information on Lot/Batch information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Fatigue, Immunoglobulin therapy, Myalgia
Clinical narrative: Woke up  with fever the next morning. Sunday around 4pm complained of chest pains . was admitted to hospital and stayed 5 days . Heart inflammation. Myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Woke up  with fever the next morning. Sunday around 4pm complained of chest pains . was admitted to hospital and stayed 5 days . Heart inflammation. Myocarditis