chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Muscular weakness, Myalgia, SARS-CoV-2 test
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Treponema test negative, Urine analysis
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cluster headache, Confusional state, Dizziness, Drug hypersensitivity, Endometriosis
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Mobility decreased, Muscular weakness
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nausea, Ovarian cyst ruptured, SARS-CoV-2 test
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, Discomfort, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: HLA-B*27 assay, Human chorionic gonadotropin negative, Magnetic resonance imaging head normal, Metabolic function test, Muscle contractions involuntary
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Thyroxine normal, Tremor
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary tract disorder, Vitamin D decreased
Clinical narrative: ruptured ovarian cyst; allergic to naproxen; Muscle weakness; loss of some motor function; easy fatigue; muscle pain; cluster headache; endometriosis flare up; headaches; dizzy/ lightheaded; confusion; Brain fog; nauseaus; This is a spontaneous report received from a contactable Other HCP (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 11:00 (at 29-year-old) (Lot Number: EW0175) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included endometriosis (now been diagnosed with cluster headaches and a ruptured ovarian cyst. Other symptoms not diagnosed yet). She's never been allergic to anything before vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19 Concomitant medications included daily escitalopram and quetiapine fumarate (SEROQUEL) for years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 06:00 am, the patient experienced muscle weakness, loss of some motor function, easy fatigue, muscle pain, cluster headache, endometriosis flare up, ruptured ovarian cyst, headaches, lightheaded, dizzy, nauseaus, allergic to naproxen when she's never been allergic to anything before, brain fog, and confusion. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. No treatment received for events. Since the vaccination, the patient has been tested (nasal swab on 05May2021) negative for COVID-19. The outcomes of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available  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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site swelling, Lymphadenopathy, Peripheral swelling, Rash
Clinical narrative: Patient came in for 2nd dose---reported that approximately 7 to 8 days after 1st dose, she had hives on the arm vaccination was administered, also reported swollen lymph node in neck and armpit region---resolved on its own about 2 days afterwards
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Lymphadenopathy
Clinical narrative: Patient came in for 2nd dose---reported that approximately 7 to 8 days after 1st dose, she had hives on the arm vaccination was administered, also reported swollen lymph node in neck and armpit region---resolved on its own about 2 days afterwards
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Cardiomyopathy, Chest pain, Echocardiogram abnormal, Troponin increased
Clinical narrative: Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician.  A 20-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient had not known allergies. Medical history included, abdominal pain ongoing, the patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, On 23May2021, The patient experienced myocarditis, chest pain , shortness of breath with outcome of recovering. The patient was hospitalized for myocarditis for 5 days. The patient was hospitalized for chest pain for 5 days. The patient was hospitalized for shortness of breath for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23May2021. Therapeutic measures were taken as a result of myocarditis (myocarditis), chest pain (chest pain), shortness of breath.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis,chest pain,dyspnoea. The case will be reassessed once new information is available. 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: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician.  A 20-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient had not known allergies. Medical history included, abdominal pain ongoing, the patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, On 23May2021, The patient experienced myocarditis, chest pain , shortness of breath with outcome of recovering. The patient was hospitalized for myocarditis for 5 days. The patient was hospitalized for chest pain for 5 days. The patient was hospitalized for shortness of breath for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23May2021. Therapeutic measures were taken as a result of myocarditis (myocarditis), chest pain (chest pain), shortness of breath.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis,chest pain,dyspnoea. The case will be reassessed once new information is available. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Hypertension, Palpitations
Clinical narrative: Increased heart rate; Increased Blood Pressure; received 1st and 2nd dose on 08Apr2021 15:45; received 1st and 2nd dose on 08Apr2021 15:45; This is a spontaneous report. A contactable consumer (patient) reported a non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8736)(at the age of 53 years old) as 2nd dose, single dose for COVID-19 immunisation;  dose 1 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8734)(at the age of 53 years old) as 1st dose, single dose for COVID-19 immunisation. The vaccine was administered in a Public Health Clinic. Patient's medical history included hypertension, diabetes and sulfa allergy. Concomitant medications included other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 29Apr2021, the patient experienced increased heart rate and increased blood pressure. The event increased heart rate resulted in physician office visit. The patient received medication for increased blood pressure. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events increased heart rate and increased blood pressure was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Increased heart rate; Increased Blood Pressure; received 1st and 2nd dose on 08Apr2021 15:45; received 1st and 2nd dose on 08Apr2021 15:45; This is a spontaneous report. A contactable consumer (patient) reported a non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8736)(at the age of 53 years old) as 2nd dose, single dose for COVID-19 immunisation;  dose 1 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8734)(at the age of 53 years old) as 1st dose, single dose for COVID-19 immunisation. The vaccine was administered in a Public Health Clinic. Patient's medical history included hypertension, diabetes and sulfa allergy. Concomitant medications included other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 29Apr2021, the patient experienced increased heart rate and increased blood pressure. The event increased heart rate resulted in physician office visit. The patient received medication for increased blood pressure. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events increased heart rate and increased blood pressure was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Overdose
Clinical narrative: Increased heart rate; Increased Blood Pressure; received 1st and 2nd dose on 08Apr2021 15:45; received 1st and 2nd dose on 08Apr2021 15:45; This is a spontaneous report. A contactable consumer (patient) reported a non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8736)(at the age of 53 years old) as 2nd dose, single dose for COVID-19 immunisation;  dose 1 via an unspecified route of administration, administered on the left arm on 08Apr2021 03:45PM (Lot number: ER8734)(at the age of 53 years old) as 1st dose, single dose for COVID-19 immunisation. The vaccine was administered in a Public Health Clinic. Patient's medical history included hypertension, diabetes and sulfa allergy. Concomitant medications included other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 29Apr2021, the patient experienced increased heart rate and increased blood pressure. The event increased heart rate resulted in physician office visit. The patient received medication for increased blood pressure. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events increased heart rate and increased blood pressure was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Computerised tomogram abnormal, Echocardiogram abnormal
Clinical narrative: Shortness of breath Fatigue Nausea Chest pain Hard to breathe Chills Chest flutter and fast heart beat Burning chest pain Coughing  but no cold
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericardial effusion, Pleural effusion, Red blood cell sedimentation rate increased
Clinical narrative: Shortness of breath Fatigue Nausea Chest pain Hard to breathe Chills Chest flutter and fast heart beat Burning chest pain Coughing  but no cold
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aspiration pleural cavity, Cardiac disorder, Cardiac flutter, Chest pain, Chills
Clinical narrative: Shortness of breath Fatigue Nausea Chest pain Hard to breathe Chills Chest flutter and fast heart beat Burning chest pain Coughing  but no cold
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Heart rate increased, Lung disorder
Clinical narrative: Shortness of breath Fatigue Nausea Chest pain Hard to breathe Chills Chest flutter and fast heart beat Burning chest pain Coughing  but no cold
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Shortness of breath Fatigue Nausea Chest pain Hard to breathe Chills Chest flutter and fast heart beat Burning chest pain Coughing  but no cold
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Anticoagulant therapy, Atypical pneumonia, Bacterial test
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bicarbonate increased, Blood calcium decreased, Blood chloride normal, Blood creatinine increased, Blood culture negative
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood potassium normal, Blood sodium decreased, Blood urea normal, C-reactive protein increased
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.