chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest X-ray normal, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: myocarditis; pericarditis; She is now bed ridden and unable to work.; Ill; This is a spontaneous report received from a Contactable Consumer or other non-health care professional (Parent). A 36-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient mother who was seeking data on the Pfizer COVID 19 vaccine - Comirnaty, and the reports of myocarditis and pericarditis. The patient was completely healthy with no issues prior to taking the vaccine. On an unknown date, patient experienced myocarditis and pericarditis after vaccine and she has been diagnosed with myocarditis and pericarditis since becoming ill. She was now bed ridden and unable to work. She has been to 3 cardiologists, a neurologist, and a rheumatologist. None were able to provide any treatment that helped, and they all had different opinions. Treatment taken for the events myocarditis and pericarditis. Parent wanted to know if there was any data that helped to treat the other patients who have had these reactions. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram normal, Impaired quality of life, Mobility decreased, Pain
Clinical narrative: myocarditis; pericarditis; She is now bed ridden and unable to work.; Ill; This is a spontaneous report received from a Contactable Consumer or other non-health care professional (Parent). A 36-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient mother who was seeking data on the Pfizer COVID 19 vaccine - Comirnaty, and the reports of myocarditis and pericarditis. The patient was completely healthy with no issues prior to taking the vaccine. On an unknown date, patient experienced myocarditis and pericarditis after vaccine and she has been diagnosed with myocarditis and pericarditis since becoming ill. She was now bed ridden and unable to work. She has been to 3 cardiologists, a neurologist, and a rheumatologist. None were able to provide any treatment that helped, and they all had different opinions. Treatment taken for the events myocarditis and pericarditis. Parent wanted to know if there was any data that helped to treat the other patients who have had these reactions. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pericardial effusion, Pericarditis, Scan with contrast abnormal
Clinical narrative: myocarditis; pericarditis; She is now bed ridden and unable to work.; Ill; This is a spontaneous report received from a Contactable Consumer or other non-health care professional (Parent). A 36-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient mother who was seeking data on the Pfizer COVID 19 vaccine - Comirnaty, and the reports of myocarditis and pericarditis. The patient was completely healthy with no issues prior to taking the vaccine. On an unknown date, patient experienced myocarditis and pericarditis after vaccine and she has been diagnosed with myocarditis and pericarditis since becoming ill. She was now bed ridden and unable to work. She has been to 3 cardiologists, a neurologist, and a rheumatologist. None were able to provide any treatment that helped, and they all had different opinions. Treatment taken for the events myocarditis and pericarditis. Parent wanted to know if there was any data that helped to treat the other patients who have had these reactions. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Illness, Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; She is now bed ridden and unable to work.; Ill; This is a spontaneous report received from a Contactable Consumer or other non-health care professional (Parent). A 36-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient mother who was seeking data on the Pfizer COVID 19 vaccine - Comirnaty, and the reports of myocarditis and pericarditis. The patient was completely healthy with no issues prior to taking the vaccine. On an unknown date, patient experienced myocarditis and pericarditis after vaccine and she has been diagnosed with myocarditis and pericarditis since becoming ill. She was now bed ridden and unable to work. She has been to 3 cardiologists, a neurologist, and a rheumatologist. None were able to provide any treatment that helped, and they all had different opinions. Treatment taken for the events myocarditis and pericarditis. Parent wanted to know if there was any data that helped to treat the other patients who have had these reactions. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Lacrimation increased, Pruritus, Rhinorrhoea
Clinical narrative: itchiness all over the body; cough; runny eyes; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for herself) communicated to Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Feb2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date in 2021, the patient experienced itchiness all over the body, cough, runny eyes and runny nose. It was reported that the patient wanted to report symptoms that she experienced after taking the 1st dose last 02Feb2021. She said that she was experiencing itchiness all over the body, cough, runny eyes and runny nose. She said that she was advised not to continue to take the 2nd dose of the vaccine due to these symptoms. There were no any unaddressed medical questions referred to medical information. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: Breakthrough case
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough case
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp.  A 79-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 26Aug2021 (Age at Vaccination: 79) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had earlier received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on unspecified dates for COVID-19 immunisation. The patient received his pfizer booster on august twenty six (26Aug2021) about four or five days later. he had red blotches up both arms (30Aug2021). The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp.  A 79-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 26Aug2021 (Age at Vaccination: 79) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had earlier received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on unspecified dates for COVID-19 immunisation. The patient received his pfizer booster on august twenty six (26Aug2021) about four or five days later. he had red blotches up both arms (30Aug2021). The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Psoriasis, Therapeutic product effect incomplete
Clinical narrative: JOINT PAIN GOT WORSE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, psoriatic arthritis, and latex allergy. The patient was previously treated with azithromycin; and experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced joint pain got worse. Laboratory data (dates unspecified) included: Erythrocyte sedimentation rate (NR: not provided) Increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain got worse. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Red blood cell sedimentation rate
Clinical narrative: JOINT PAIN GOT WORSE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, psoriatic arthritis, and latex allergy. The patient was previously treated with azithromycin; and experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced joint pain got worse. Laboratory data (dates unspecified) included: Erythrocyte sedimentation rate (NR: not provided) Increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain got worse. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Aphasia, Arteriogram carotid, Balance disorder, Disorientation
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Extra dose administered, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Nausea
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Urinary hesitation, Urinary retention
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Dysuria, Headache, Hypoaesthesia
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, SARS-CoV-2 test
Clinical narrative: disorientation; BLE weakness; numbness; difficulty urinating; dizziness; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Sep2021 14:45 (Lot Number: EW0151) (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia and rheumatoid arthritis. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included trazodone; bupropion; gabapentin; paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19 on 14Sep2021 with result as negative. On 14Sep2021 11:00, the patient experienced disorientation, bilateral lover extremities (BLE) weakness, and numbness, difficulty urinating, dizziness, headache, nausea. The events resulted hospitalization of patient for 3 days in Sep2021 and disability. The events led to emergency room/department or urgent care visit. The patient received treatment with steroids, physical therapy (PT), pain medication, nausea medication for the events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dysphagia, Dyspnoea, Electrocardiogram
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Hypoaesthesia, Laboratory test, Palpitations, Throat tightness
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Palpitations, Paraesthesia, SARS-CoV-2 test, Throat tightness
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Ultrasound chest, X-ray
Clinical narrative: left side of face numb/Left arm numb; Shortness of breath; feeling of throat closing; shakes; heart palpitations; Left chest pain and tightness; Left chest pain and tightness; left arm tingling; This is a spontaneous report from a contactable other hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FD8448, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 33-years-old) in Doctor's office/urgent care. Medical history included hypertension and hypothyroidism. Concomitant medications included escitalopram, losartan potassium and levothyroxine sodium (LEVOTHYROXIN) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took reglan [metoclopramide] and compazine [prochlorperazine edisylate], and experienced drug hypersensitivity. Patient did not took any other vaccine in 4 weeks prior to vaccination. On 01Sep2021 23:00 the patient experienced left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness and left arm tingling (medically significant). Therapeutic measures were taken as a result of left side of face numb/left arm numb, shortness of breath, feeling of throat closing, shakes, heart palpitations, left chest pain and tightness, left chest pain and tightness, and left arm tingling includes EKG x2, X ray x2, blood work, ultrasound of heart. Adverse event result in other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had not tested for covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient on 09Sep2021; underwent nasal swab lab tests and procedures which included sars-cov-2 test which was negative and on an unknown date had EKG x2, X ray x2, blood work, ultrasound of heart with result as unknown. The outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between suspect drug BNT162B2 and reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Mycobacterium tuberculosis complex test positive, Tuberculosis
Clinical narrative: TB Gold was POSITIVE; This is a spontaneous report from a contactable nurse. A non-pregnant 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 18Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and trazodone, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took LYRICA, EES and CELEBREX and known allergies.  The patient stated, "I have been a nurse 26 years. Never cared for a TB patient, have always had negative Mantoux and tb gold tests- last was Mar2021- negative. Last week (10Sep2021) I was required to obtain a TB Gold for preemployment screening and my TB Gold was POSITIVE. CXR negative". The patient received no treatment. No COVID prior to vaccination and no post vaccination test. The outcome of the event was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal relationship and previous lab data the role of the vaccine BNT162B2 in triggering TB cannot be completely excluded and also TB could be an intercurrent illness. The case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tuberculosis
Clinical narrative: TB Gold was POSITIVE; This is a spontaneous report from a contactable nurse. A non-pregnant 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 18Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and trazodone, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took LYRICA, EES and CELEBREX and known allergies.  The patient stated, "I have been a nurse 26 years. Never cared for a TB patient, have always had negative Mantoux and tb gold tests- last was Mar2021- negative. Last week (10Sep2021) I was required to obtain a TB Gold for preemployment screening and my TB Gold was POSITIVE. CXR negative". The patient received no treatment. No COVID prior to vaccination and no post vaccination test. The outcome of the event was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal relationship and previous lab data the role of the vaccine BNT162B2 in triggering TB cannot be completely excluded and also TB could be an intercurrent illness. The case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.