chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Computerised tomogram head normal, Dizziness, Feeling abnormal, Full blood count normal
Clinical narrative: BPPV; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in arm right on 10Mar2021 10:30 (at the age of 54-years-old) as a single dose  for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma  and allergies from an unknown date. The patient had known allergies with Sulfa. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), administered in arm right on 17Feb2021 10:00 AM (at the age of 54-years-old) for covid-19 immunization. Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. On 16Mar2021 06:00 AM, the patient experienced extreme vertigo and dizziness. She was diagnosed with BPPV  by an ENT and ended up in the emergency room on 18Mar2021 and had brainMRI and CT scan along with other blood work. She have also undergone vestibular therapy with a physical therapist 3 times and despite this therapy, she continue to have severe dizziness. The patient received treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event of BPPV 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, SARS-CoV-2 test negative, Urine analysis normal, Vertigo, Vertigo positional
Clinical narrative: BPPV; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in arm right on 10Mar2021 10:30 (at the age of 54-years-old) as a single dose  for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma  and allergies from an unknown date. The patient had known allergies with Sulfa. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), administered in arm right on 17Feb2021 10:00 AM (at the age of 54-years-old) for covid-19 immunization. Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. On 16Mar2021 06:00 AM, the patient experienced extreme vertigo and dizziness. She was diagnosed with BPPV  by an ENT and ended up in the emergency room on 18Mar2021 and had brainMRI and CT scan along with other blood work. She have also undergone vestibular therapy with a physical therapist 3 times and despite this therapy, she continue to have severe dizziness. The patient received treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event of BPPV 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Magnetic resonance imaging head, Vertigo positional
Clinical narrative: BPPV; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in arm right on 10Mar2021 10:30 (at the age of 54-years-old) as a single dose  for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma  and allergies from an unknown date. The patient had known allergies with Sulfa. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), administered in arm right on 17Feb2021 10:00 AM (at the age of 54-years-old) for covid-19 immunization. Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. On 16Mar2021 06:00 AM, the patient experienced extreme vertigo and dizziness. She was diagnosed with BPPV  by an ENT and ended up in the emergency room on 18Mar2021 and had brainMRI and CT scan along with other blood work. She have also undergone vestibular therapy with a physical therapist 3 times and despite this therapy, she continue to have severe dizziness. The patient received treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event of BPPV 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: have developed 2 massive blood clots; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 for COVID-19 immunisation. Since then, the patient had developed 2 massive blood clots. The patient did not have a history of blood clots. The outcome of the event was unknown. There was no doubt this was related. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: On 06Apr2021, diagnosed at ER with Bell's Palsy, Woke up with no left side facial function.; This is a spontaneous report from a contactable consumer, reporting for herself. A non-pregnant 71-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 02Mar2021 at 09:30 at a single dose for covid-19 immunisation. Medical history included liver/kidney transplant, thyroid nodules, and high blood pressure. Concomitant medications included tacrolimus (PROGRAF); levothyroxine (MANUFACTURER UNKNOWN); prednisone (MANUFACTURER UNKNOWN); bupropion (MANUFACTURER UNKNOWN). The patient previously received the first dose of the bnt162b2 on 09Feb2021 at 9:30am at 71 years of age in the left arm for covid-19 immunisation. The patient did not receive other vaccines in four weeks. There were no known allergies. On 04Apr2021 (as reported), the patient was diagnosed at the emergency room with Bell's palsy, woke up with no left side facial function on 06Apr2021 (as reported). Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1000mg three times a daily and prednisone 60mg three times a day. There was no COVID prior to or post vaccination. The clinical outcome of the event was not recovered.  The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: On 06Apr2021, diagnosed at ER with Bell's Palsy, Woke up with no left side facial function.; This is a spontaneous report from a contactable consumer, reporting for herself. A non-pregnant 71-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 02Mar2021 at 09:30 at a single dose for covid-19 immunisation. Medical history included liver/kidney transplant, thyroid nodules, and high blood pressure. Concomitant medications included tacrolimus (PROGRAF); levothyroxine (MANUFACTURER UNKNOWN); prednisone (MANUFACTURER UNKNOWN); bupropion (MANUFACTURER UNKNOWN). The patient previously received the first dose of the bnt162b2 on 09Feb2021 at 9:30am at 71 years of age in the left arm for covid-19 immunisation. The patient did not receive other vaccines in four weeks. There were no known allergies. On 04Apr2021 (as reported), the patient was diagnosed at the emergency room with Bell's palsy, woke up with no left side facial function on 06Apr2021 (as reported). Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1000mg three times a daily and prednisone 60mg three times a day. There was no COVID prior to or post vaccination. The clinical outcome of the event was not recovered.  The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pulmonary embolism
Clinical narrative: PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH, EVIDENCE OF PULMONARY EMBOLISM 2 DAYS AFTER 2ND SHOT OF MODERNA VACCINATION. DISCOMFORT WAS MOSTLY PLEURITIC ON THE LEFT SIDE. PATIENT ALSO HAD SOME SWELLING OF RIGHT LOWER EXTREMITY.  HE WAS DIAGNOSED WITH ACUTE RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS AND BILATERAL (LEFT GREATER THAN RIGHT) PULMONARY EMBOLISM. PATIENT WAS HOSPITALIZED FOR 3 DAYS. HE WAS STARTED ON ANTICOAGULATION WITH LOVENOX INPATIENT AND WAS TRANSITIONED TO PRADAXA OUTPATIENT. HE RETURNED TO THE HOSPITAL 11 DAYS LATER WITH NEW LEFT LEG SWELLING AND PERSISTENT SHORTNESS OF BREATH. COMBINED PAST ADMISSION AND MOST RECENT ADMISSION, PATIENT WAS IN THE HOSPITAL FOR 5 DAYS
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Discomfort, Dyspnoea, Peripheral swelling
Clinical narrative: PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH, EVIDENCE OF PULMONARY EMBOLISM 2 DAYS AFTER 2ND SHOT OF MODERNA VACCINATION. DISCOMFORT WAS MOSTLY PLEURITIC ON THE LEFT SIDE. PATIENT ALSO HAD SOME SWELLING OF RIGHT LOWER EXTREMITY.  HE WAS DIAGNOSED WITH ACUTE RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS AND BILATERAL (LEFT GREATER THAN RIGHT) PULMONARY EMBOLISM. PATIENT WAS HOSPITALIZED FOR 3 DAYS. HE WAS STARTED ON ANTICOAGULATION WITH LOVENOX INPATIENT AND WAS TRANSITIONED TO PRADAXA OUTPATIENT. HE RETURNED TO THE HOSPITAL 11 DAYS LATER WITH NEW LEFT LEG SWELLING AND PERSISTENT SHORTNESS OF BREATH. COMBINED PAST ADMISSION AND MOST RECENT ADMISSION, PATIENT WAS IN THE HOSPITAL FOR 5 DAYS
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Pulmonary embolism
Clinical narrative: PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH, EVIDENCE OF PULMONARY EMBOLISM 2 DAYS AFTER 2ND SHOT OF MODERNA VACCINATION. DISCOMFORT WAS MOSTLY PLEURITIC ON THE LEFT SIDE. PATIENT ALSO HAD SOME SWELLING OF RIGHT LOWER EXTREMITY.  HE WAS DIAGNOSED WITH ACUTE RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS AND BILATERAL (LEFT GREATER THAN RIGHT) PULMONARY EMBOLISM. PATIENT WAS HOSPITALIZED FOR 3 DAYS. HE WAS STARTED ON ANTICOAGULATION WITH LOVENOX INPATIENT AND WAS TRANSITIONED TO PRADAXA OUTPATIENT. HE RETURNED TO THE HOSPITAL 11 DAYS LATER WITH NEW LEFT LEG SWELLING AND PERSISTENT SHORTNESS OF BREATH. COMBINED PAST ADMISSION AND MOST RECENT ADMISSION, PATIENT WAS IN THE HOSPITAL FOR 5 DAYS
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hypertension, Lymphadenopathy
Clinical narrative: Metallic taste in mouth. Bp 172/89, gums numb, O2 sats 95% Pulse 60.per EMS monitor, lungs clear.advised pt to call 911 if gets worse advised next dose at Pcp.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: Metallic taste in mouth. Bp 172/89, gums numb, O2 sats 95% Pulse 60.per EMS monitor, lungs clear.advised pt to call 911 if gets worse advised next dose at Pcp.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Asthenia, Dizziness, Electrocardiogram, Headache
Clinical narrative: SEIZURES LIKE SHAKING; DIFFICULTY BREATHING; FEELING FAINT/DIZZINESS; DIFFICULTY FEELING EXTREMITIES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: unknown) dose was not reported, 1 total dose administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Electrocardiogram (NR: not provided) not reported. Patient was hospitalized for 2 days after receiving the vaccine. Patient reported that, the reaction appeared approximately 16 hours after vaccination, patients had to seek from the emergency room and it was result of the vaccination based on bodily reactions On 26-MAR-2021, dizziness ,difficulty breathing/feeling faint, difficulty feeling extremities, seizures like shaking, experienced and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures like shaking, difficulty breathing, feeling faint/dizziness, nausea, and difficulty feeling extremities. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210440664-COVID-19 VACCINE AD26.COV2.S-seizures like shaking, difficulty breathing, feeling faint/dizziness and difficulty feeling extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210440664-COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Nausea
Clinical narrative: SEIZURES LIKE SHAKING; DIFFICULTY BREATHING; FEELING FAINT/DIZZINESS; DIFFICULTY FEELING EXTREMITIES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: unknown) dose was not reported, 1 total dose administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Electrocardiogram (NR: not provided) not reported. Patient was hospitalized for 2 days after receiving the vaccine. Patient reported that, the reaction appeared approximately 16 hours after vaccination, patients had to seek from the emergency room and it was result of the vaccination based on bodily reactions On 26-MAR-2021, dizziness ,difficulty breathing/feeling faint, difficulty feeling extremities, seizures like shaking, experienced and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures like shaking, difficulty breathing, feeling faint/dizziness, nausea, and difficulty feeling extremities. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210440664-COVID-19 VACCINE AD26.COV2.S-seizures like shaking, difficulty breathing, feeling faint/dizziness and difficulty feeling extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210440664-COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Hypoaesthesia, Nausea
Clinical narrative: SEIZURES LIKE SHAKING; DIFFICULTY BREATHING; FEELING FAINT/DIZZINESS; DIFFICULTY FEELING EXTREMITIES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: unknown) dose was not reported, 1 total dose administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Electrocardiogram (NR: not provided) not reported. Patient was hospitalized for 2 days after receiving the vaccine. Patient reported that, the reaction appeared approximately 16 hours after vaccination, patients had to seek from the emergency room and it was result of the vaccination based on bodily reactions On 26-MAR-2021, dizziness ,difficulty breathing/feeling faint, difficulty feeling extremities, seizures like shaking, experienced and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures like shaking, difficulty breathing, feeling faint/dizziness, nausea, and difficulty feeling extremities. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210440664-COVID-19 VACCINE AD26.COV2.S-seizures like shaking, difficulty breathing, feeling faint/dizziness and difficulty feeling extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210440664-COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: SEIZURES LIKE SHAKING; DIFFICULTY BREATHING; FEELING FAINT/DIZZINESS; DIFFICULTY FEELING EXTREMITIES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: unknown) dose was not reported, 1 total dose administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Electrocardiogram (NR: not provided) not reported. Patient was hospitalized for 2 days after receiving the vaccine. Patient reported that, the reaction appeared approximately 16 hours after vaccination, patients had to seek from the emergency room and it was result of the vaccination based on bodily reactions On 26-MAR-2021, dizziness ,difficulty breathing/feeling faint, difficulty feeling extremities, seizures like shaking, experienced and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures like shaking, difficulty breathing, feeling faint/dizziness, nausea, and difficulty feeling extremities. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210440664-COVID-19 VACCINE AD26.COV2.S-seizures like shaking, difficulty breathing, feeling faint/dizziness and difficulty feeling extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210440664-COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infection, Platelet count decreased, Portal vein thrombosis
Clinical narrative: portal vein thrombosis; thrombocytopenia; This is a spontaneous report from a contactable consumer (former colleague). A 6-decade-old (in her 50s) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 09Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 around 09Mar2021 and was hospitalized 2 weeks later. It was reported that the patient experienced portal vein thrombosis and thrombocytopenia in 2021. The patient died in 2021 due to portal vein thrombosis and thrombocytopenia at a State hospital. No autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Thrombocytopenia; portal vein thrombosis
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Portal vein thrombosis, Thrombocytopenia
Clinical narrative: portal vein thrombosis; thrombocytopenia; This is a spontaneous report from a contactable consumer (former colleague). A 6-decade-old (in her 50s) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 09Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 around 09Mar2021 and was hospitalized 2 weeks later. It was reported that the patient experienced portal vein thrombosis and thrombocytopenia in 2021. The patient died in 2021 due to portal vein thrombosis and thrombocytopenia at a State hospital. No autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Thrombocytopenia; portal vein thrombosis
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Autoimmune haemolytic anaemia, Blood immunoglobulin G, Dizziness, Dyspnoea
Clinical narrative: Autoimmune Hemolytic Anemia due to IgG; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prescribed medications (unspecified). The patient previously took atenolol and experienced allergies with bradycardia and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809) in the left arm on 14Feb2021, 03: 45 PM for COVID-19 immunisation. The patient did not receive any vaccine in 4 weeks. On an unspecified date in Mar2021, the patient developed weakness, severe shortness of breath, dizziness, became very pale, and so on. He visited PCP. His blood work showed 4.8 Hemoglobin and Hemolysis. He was hospitalized on an unspecified date for 7 days with diagnosis of Autoimmune Hemolytic Anemia due to IgG. It was unknown if treatment was given in response to the event. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. The patient has not been tested for COVID post vaccination. The outcome of the event was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin decreased, Pallor, Pyrexia
Clinical narrative: Autoimmune Hemolytic Anemia due to IgG; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prescribed medications (unspecified). The patient previously took atenolol and experienced allergies with bradycardia and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809) in the left arm on 14Feb2021, 03: 45 PM for COVID-19 immunisation. The patient did not receive any vaccine in 4 weeks. On an unspecified date in Mar2021, the patient developed weakness, severe shortness of breath, dizziness, became very pale, and so on. He visited PCP. His blood work showed 4.8 Hemoglobin and Hemolysis. He was hospitalized on an unspecified date for 7 days with diagnosis of Autoimmune Hemolytic Anemia due to IgG. It was unknown if treatment was given in response to the event. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. The patient has not been tested for COVID post vaccination. The outcome of the event was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood test, Haemoglobin
Clinical narrative: Autoimmune Hemolytic Anemia due to IgG; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prescribed medications (unspecified). The patient previously took atenolol and experienced allergies with bradycardia and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809) in the left arm on 14Feb2021, 03: 45 PM for COVID-19 immunisation. The patient did not receive any vaccine in 4 weeks. On an unspecified date in Mar2021, the patient developed weakness, severe shortness of breath, dizziness, became very pale, and so on. He visited PCP. His blood work showed 4.8 Hemoglobin and Hemolysis. He was hospitalized on an unspecified date for 7 days with diagnosis of Autoimmune Hemolytic Anemia due to IgG. It was unknown if treatment was given in response to the event. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. The patient has not been tested for COVID post vaccination. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Clumsiness, Computerised tomogram, Echocardiogram
Clinical narrative: sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was sick (hospitalization, life threatening) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging, Muscular weakness
Clinical narrative: sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was sick (hospitalization, life threatening) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was sick (hospitalization, life threatening) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Intensive care, Ischaemic stroke, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was sick (hospitalization, life threatening) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Body temperature increased, Chest discomfort, Chest pain
Clinical narrative: Myocarditis; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; having pain in my shoulder and left arm; having pain in my shoulder and left arm; body aches; headache; fever; chills; shortness of breath; chest pains; shooting pain in back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (Pfizer BioNTech Covid 19), dose 2 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient has no known allergies and has no other medical history. Concomitant medications were not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient previously received 1st dose of bnt162b2 (Pfizer BioNTech Covid 19, lot number EL9264) on 21Mar2021 03:00 PM in the right arm for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination. It was confirmed that after receiving the second dose, the patient experienced chills, fever, headache, body aches. Those symptoms went away about 24-36 hours later. The patient started experiencing shortness of breath and chest pains. The pain increased over time and started having pain in shoulder and left arm. Fever began off and on. Experienced chest pains, when tried to lie down, had shooting pain in back. The patient went to the emergency room and was subsequently admitted to the hospital where he was diagnosed with myocarditis. Heart ejection fraction was in 30s (reduced to 35-40 percent) and had a troponin level that spiked to 11. Angiogram did not indicate tears or blockages. Vital checks good as of 15Apr2021. Initial COVID-19 test on 14Apr2021 (unsure of type) was positive; plan to retest today (15Apr2021) for confirmation. It was also reported on 23Apr2021 that Nasal Swab on 14Apr2021 was negative. Onset of events reported as 13Apr2021 07:30 PM. The patient underwent lab tests and procedures which included angiogram: did not indicate tears or blockages on 13Apr2021, electrocardiogram (EKG): unknown result on unspecified date, heart function/heart ejection fraction: 30s on 13Apr2021 (reduced to 35-40 percent), COVID-19 test (unsure of type): positive on 14Apr2021, vital checks: good on 15Apr2021, nasal swab COVID-19 test: negative on 14Apr2021, troponin: spiked to 11 on 13Apr2021, ultrasound: unknown result on unspecified date. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days for the events. The patient received treatment for events. Outcome of events was reported as recovering.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cold sweat, Discomfort, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Myocarditis; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; having pain in my shoulder and left arm; having pain in my shoulder and left arm; body aches; headache; fever; chills; shortness of breath; chest pains; shooting pain in back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (Pfizer BioNTech Covid 19), dose 2 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient has no known allergies and has no other medical history. Concomitant medications were not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient previously received 1st dose of bnt162b2 (Pfizer BioNTech Covid 19, lot number EL9264) on 21Mar2021 03:00 PM in the right arm for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination. It was confirmed that after receiving the second dose, the patient experienced chills, fever, headache, body aches. Those symptoms went away about 24-36 hours later. The patient started experiencing shortness of breath and chest pains. The pain increased over time and started having pain in shoulder and left arm. Fever began off and on. Experienced chest pains, when tried to lie down, had shooting pain in back. The patient went to the emergency room and was subsequently admitted to the hospital where he was diagnosed with myocarditis. Heart ejection fraction was in 30s (reduced to 35-40 percent) and had a troponin level that spiked to 11. Angiogram did not indicate tears or blockages. Vital checks good as of 15Apr2021. Initial COVID-19 test on 14Apr2021 (unsure of type) was positive; plan to retest today (15Apr2021) for confirmation. It was also reported on 23Apr2021 that Nasal Swab on 14Apr2021 was negative. Onset of events reported as 13Apr2021 07:30 PM. The patient underwent lab tests and procedures which included angiogram: did not indicate tears or blockages on 13Apr2021, electrocardiogram (EKG): unknown result on unspecified date, heart function/heart ejection fraction: 30s on 13Apr2021 (reduced to 35-40 percent), COVID-19 test (unsure of type): positive on 14Apr2021, vital checks: good on 15Apr2021, nasal swab COVID-19 test: negative on 14Apr2021, troponin: spiked to 11 on 13Apr2021, ultrasound: unknown result on unspecified date. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days for the events. The patient received treatment for events. Outcome of events was reported as recovering.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Headache, Liver function test increased, Malaise
Clinical narrative: Myocarditis; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; having pain in my shoulder and left arm; having pain in my shoulder and left arm; body aches; headache; fever; chills; shortness of breath; chest pains; shooting pain in back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (Pfizer BioNTech Covid 19), dose 2 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient has no known allergies and has no other medical history. Concomitant medications were not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient previously received 1st dose of bnt162b2 (Pfizer BioNTech Covid 19, lot number EL9264) on 21Mar2021 03:00 PM in the right arm for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination. It was confirmed that after receiving the second dose, the patient experienced chills, fever, headache, body aches. Those symptoms went away about 24-36 hours later. The patient started experiencing shortness of breath and chest pains. The pain increased over time and started having pain in shoulder and left arm. Fever began off and on. Experienced chest pains, when tried to lie down, had shooting pain in back. The patient went to the emergency room and was subsequently admitted to the hospital where he was diagnosed with myocarditis. Heart ejection fraction was in 30s (reduced to 35-40 percent) and had a troponin level that spiked to 11. Angiogram did not indicate tears or blockages. Vital checks good as of 15Apr2021. Initial COVID-19 test on 14Apr2021 (unsure of type) was positive; plan to retest today (15Apr2021) for confirmation. It was also reported on 23Apr2021 that Nasal Swab on 14Apr2021 was negative. Onset of events reported as 13Apr2021 07:30 PM. The patient underwent lab tests and procedures which included angiogram: did not indicate tears or blockages on 13Apr2021, electrocardiogram (EKG): unknown result on unspecified date, heart function/heart ejection fraction: 30s on 13Apr2021 (reduced to 35-40 percent), COVID-19 test (unsure of type): positive on 14Apr2021, vital checks: good on 15Apr2021, nasal swab COVID-19 test: negative on 14Apr2021, troponin: spiked to 11 on 13Apr2021, ultrasound: unknown result on unspecified date. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days for the events. The patient received treatment for events. Outcome of events was reported as recovering.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pericarditis, Pyrexia, Troponin
Clinical narrative: Myocarditis; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; having pain in my shoulder and left arm; having pain in my shoulder and left arm; body aches; headache; fever; chills; shortness of breath; chest pains; shooting pain in back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (Pfizer BioNTech Covid 19), dose 2 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient has no known allergies and has no other medical history. Concomitant medications were not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient previously received 1st dose of bnt162b2 (Pfizer BioNTech Covid 19, lot number EL9264) on 21Mar2021 03:00 PM in the right arm for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination. It was confirmed that after receiving the second dose, the patient experienced chills, fever, headache, body aches. Those symptoms went away about 24-36 hours later. The patient started experiencing shortness of breath and chest pains. The pain increased over time and started having pain in shoulder and left arm. Fever began off and on. Experienced chest pains, when tried to lie down, had shooting pain in back. The patient went to the emergency room and was subsequently admitted to the hospital where he was diagnosed with myocarditis. Heart ejection fraction was in 30s (reduced to 35-40 percent) and had a troponin level that spiked to 11. Angiogram did not indicate tears or blockages. Vital checks good as of 15Apr2021. Initial COVID-19 test on 14Apr2021 (unsure of type) was positive; plan to retest today (15Apr2021) for confirmation. It was also reported on 23Apr2021 that Nasal Swab on 14Apr2021 was negative. Onset of events reported as 13Apr2021 07:30 PM. The patient underwent lab tests and procedures which included angiogram: did not indicate tears or blockages on 13Apr2021, electrocardiogram (EKG): unknown result on unspecified date, heart function/heart ejection fraction: 30s on 13Apr2021 (reduced to 35-40 percent), COVID-19 test (unsure of type): positive on 14Apr2021, vital checks: good on 15Apr2021, nasal swab COVID-19 test: negative on 14Apr2021, troponin: spiked to 11 on 13Apr2021, ultrasound: unknown result on unspecified date. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days for the events. The patient received treatment for events. Outcome of events was reported as recovering.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Wall motion score index abnormal
Clinical narrative: Myocarditis; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; My heart ejection fraction was reduced to 35-40 percent and had a troponin level that spiked to 11; having pain in my shoulder and left arm; having pain in my shoulder and left arm; body aches; headache; fever; chills; shortness of breath; chest pains; shooting pain in back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (Pfizer BioNTech Covid 19), dose 2 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient has no known allergies and has no other medical history. Concomitant medications were not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient previously received 1st dose of bnt162b2 (Pfizer BioNTech Covid 19, lot number EL9264) on 21Mar2021 03:00 PM in the right arm for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination. It was confirmed that after receiving the second dose, the patient experienced chills, fever, headache, body aches. Those symptoms went away about 24-36 hours later. The patient started experiencing shortness of breath and chest pains. The pain increased over time and started having pain in shoulder and left arm. Fever began off and on. Experienced chest pains, when tried to lie down, had shooting pain in back. The patient went to the emergency room and was subsequently admitted to the hospital where he was diagnosed with myocarditis. Heart ejection fraction was in 30s (reduced to 35-40 percent) and had a troponin level that spiked to 11. Angiogram did not indicate tears or blockages. Vital checks good as of 15Apr2021. Initial COVID-19 test on 14Apr2021 (unsure of type) was positive; plan to retest today (15Apr2021) for confirmation. It was also reported on 23Apr2021 that Nasal Swab on 14Apr2021 was negative. Onset of events reported as 13Apr2021 07:30 PM. The patient underwent lab tests and procedures which included angiogram: did not indicate tears or blockages on 13Apr2021, electrocardiogram (EKG): unknown result on unspecified date, heart function/heart ejection fraction: 30s on 13Apr2021 (reduced to 35-40 percent), COVID-19 test (unsure of type): positive on 14Apr2021, vital checks: good on 15Apr2021, nasal swab COVID-19 test: negative on 14Apr2021, troponin: spiked to 11 on 13Apr2021, ultrasound: unknown result on unspecified date. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days for the events. The patient received treatment for events. Outcome of events was reported as recovering.