chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Dysphagia, Hypoglycaemia
Clinical narrative: hypoglycemia; dizziness; This is a spontaneous report from a non-contactable Other HCP. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number HE9899, intramuscularly in the left arm on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously took spironolactone and experienced drug allergy. During her 15-minute waiting period after the vaccination, the patient began to experience feelings of hypoglycemia. She checked her blood glucose with her own monitor and had 77 at 11:04. She chewed 1 glucose tab that she had in her purse. She noted some difficulty with swallowing it and notified clinic staff. The patient also experienced dizziness and was escorted by clinic staff to the emergency bay. This provider was notified of patient reaction and she was then assessed in the emergency bay area. She denied difficulty breathing and chest pain, history of adverse reactions with prior vaccinations or allergies to medications with the exception of spironolactone. Patient had already been given a bottle of water by clinic staff and reported that the glucose tablet went down easier following the water. She took a second glucose tab sometime before 11:13. The event was assessed as non-serious. Outcome of the events hypoglycemia and dizziness was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Left sided lip numbness; Left hand and foot tingling; This is spontaneous report from a contactable physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular in left arm on 20Dec2020 17:45 at single dose for COVID-19 immunization. There was no medical history. The patient was not allergic to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left sided lip numbness, left hand and foot tingling on 20Dec2020 18:00. No treatment was received for the adverse events. Events outcome was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: Left sided lip numbness; Left hand and foot tingling; This is spontaneous report from a contactable physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular in left arm on 20Dec2020 17:45 at single dose for COVID-19 immunization. There was no medical history. The patient was not allergic to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left sided lip numbness, left hand and foot tingling on 20Dec2020 18:00. No treatment was received for the adverse events. Events outcome was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: R sided facial numbness; tingling; muscle weakness; This is a spontaneous report from a contactable pharmacist reporting for herself. This 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route at right arm on 21Dec2020 at single dose (lot number: EJ1685) for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient reported R sided facial numbness, tingling, and muscle weakness roughly 20 minutes after receiving the COVID-19 vaccine on 21Dec2020. The sensation was improving over the next 10-15 minutes. The patient was asked to monitor her signs and symptoms and report to her doctor if no improvement/worsening. Events were reported as non-serious. No treatment was received for events. Outcome of the events was recovering.   Information about lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; This is a spontaneous report from a contactable physician.  A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 16Dec2020 10:45 at single dose for COVID-19 immunisation.  Medical history included hypertension and dermal filler injections. Concomitant medication included losartan. The patient stated, "woke up 2 days later with painful swelling under both eyes and pain around my chin. These are all areas, and the only areas that I have had dermal filler injections. I started steroids and pain and swelling resolved in 3 days". The outcome of the events was recovered on Dec2020.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Periorbital pain, Periorbital swelling
Clinical narrative: Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; Woke up 2 days later with painful swelling under both eyes and pain around my chin. these are all areas, and the only areas that I have had dermal filler injections; This is a spontaneous report from a contactable physician.  A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 16Dec2020 10:45 at single dose for COVID-19 immunisation.  Medical history included hypertension and dermal filler injections. Concomitant medication included losartan. The patient stated, "woke up 2 days later with painful swelling under both eyes and pain around my chin. These are all areas, and the only areas that I have had dermal filler injections. I started steroids and pain and swelling resolved in 3 days". The outcome of the events was recovered on Dec2020.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbon dioxide decreased, Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Feeling abnormal, Full blood count normal, Haemoglobin normal, Headache
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Joint swelling, Lip swelling, Nausea
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Platelet count normal, Pruritus
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic, Tachycardia
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hypoaesthesia, Lip swelling
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Paraesthesia, Peripheral swelling, Rash erythematous
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: bilateral hand swelling; headache; bilateral upper extremity numbness/paresthesias; bilateral upper extremity numbness/paresthesias; waxing/waning reddish rash; palpitations and tachycardia; palpitations and tachycardia; two loose bowel movments; dizziness; nausea; Lip swelling; This is a spontaneous report from a contactable physician. A 29-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 18:00 at single dose in the right arm for immunization. Medical history included asthma, prediabetes, irritable bowel syndrome (IBS) and obesity. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included albuterol [salbutamol], paracetamol (TYLENOL), fluticasone propionate, salmeterol xinafoate (AIRDUO RESPICLICK), metformin and trazodone. The patient previously took mometasone and experienced allergies. On 21Dec2020 20:30, the patient experienced headache, then bilateral upper extremity numbness/paresthesias. Developed bilateral hand swelling. Developed dizziness, nausea and two loose bowel movements. This progressed to develop a waxing/waning reddish rash. This was followed by palpitations and tachycardia. As ED course went on developed lip swelling and then given this was given Epinephrine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events which includes Benadryl, Prednisone, Epinephrine. The outcome of the events was recovering.  The following information on the batch number has been requested.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Tongue disorder
Clinical narrative: Employee reported thickness of tongue and dry mouth.; Employee reported thickness of tongue and dry mouth.; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EJ1685, intramuscular in the right arm on 21Dec2020 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The employee reported thickness of tongue and dry mouth on 21Dec2020 12:30. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Soreness; Exhaustion; This is a spontaneous report from a contactable healthcare professional.  A 45-years-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on  21Dec2020 08:15 at a single dose for COVID-19 immunization at a hospital.  Medical history included breast cancer, blood pressure abnormal, blood cholesterol abnormal.  Concomitant medication included hydrochlorothiazide (HCTZ) and unspecified medications for blood pressure, cholesterol.  The patient experienced headache, soreness, and exhaustion on 21Dec2020, 10:15. with no treatment The patient was recovering from the events.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; Soreness; Exhaustion; This is a spontaneous report from a contactable healthcare professional.  A 45-years-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on  21Dec2020 08:15 at a single dose for COVID-19 immunization at a hospital.  Medical history included breast cancer, blood pressure abnormal, blood cholesterol abnormal.  Concomitant medication included hydrochlorothiazide (HCTZ) and unspecified medications for blood pressure, cholesterol.  The patient experienced headache, soreness, and exhaustion on 21Dec2020, 10:15. with no treatment The patient was recovering from the events.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Hyperhidrosis
Clinical narrative: "sweaty feeling"; Developed headache; flushing after injection; redness; This is a spontaneous report from a contactable nurse. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), intramuscularly on left arm at 12:00 PM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included exercise-induced asthma. The patient's concomitant medications were not reported.  The patient experienced headache, redness and flushing after injection, also reported "sweaty feeling" at 12:15 PM on 21Dec2020. Ae resulted in: Emergency room/department or urgent care. All events were reported as non-serious. The outcome of events was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Headache, Hyperhidrosis
Clinical narrative: "sweaty feeling"; Developed headache; flushing after injection; redness; This is a spontaneous report from a contactable nurse. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), intramuscularly on left arm at 12:00 PM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included exercise-induced asthma. The patient's concomitant medications were not reported.  The patient experienced headache, redness and flushing after injection, also reported "sweaty feeling" at 12:15 PM on 21Dec2020. Ae resulted in: Emergency room/department or urgent care. All events were reported as non-serious. The outcome of events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: PVCs developed about 20 mins after administration of vaccine; This is a spontaneous report from a contactable Pharmacist. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/ lot number: EL0140), intramuscularly on 21Dec2020 13:45 at right arm, at SINGLE DOSE for covid-19 immunization. Medical history included ongoing chronic back pain. Concomitant medication included escitalopram oxalate (LEXAPRO), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. The patient experienced PVCs about 20 mins after administration of vaccine. Placed on Zoll cardiac monitor on 21Dec2020. Vitals to include BP, heart rate, respiratory, pulse ox several times during additional monitoring period. No respiratory distress or other issues during this monitoring period. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered in Dec2020.No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring abnormal, Ventricular extrasystoles
Clinical narrative: PVCs developed about 20 mins after administration of vaccine; This is a spontaneous report from a contactable Pharmacist. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/ lot number: EL0140), intramuscularly on 21Dec2020 13:45 at right arm, at SINGLE DOSE for covid-19 immunization. Medical history included ongoing chronic back pain. Concomitant medication included escitalopram oxalate (LEXAPRO), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. The patient experienced PVCs about 20 mins after administration of vaccine. Placed on Zoll cardiac monitor on 21Dec2020. Vitals to include BP, heart rate, respiratory, pulse ox several times during additional monitoring period. No respiratory distress or other issues during this monitoring period. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered in Dec2020.No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dyspnoea, Hypopnoea, Intensive care, Throat clearing
Clinical narrative: Eight minutes after receiving the injection it felt like a tickle in my throat and then felt like I needed to keep clearing my throat, coughed a couple times and then there was stridor my airway was closing. I was given a shot of epinephrine and it subsided pretty quickly. I was taken to the ED to be watched. Still clearing my throat some so the ED physician had me take oral Benadryl. I developed stridor again and was given IV Benadryl and the symptoms still quickly advanced to complete airway closure. I was given another dose of epinephrine and the symptoms again resolved in probably about a minute. I was unable to swallow adequately and I was admitted to ICU for observation. I was  kept NPO till 0900 and at that time had no difficulty. I was released the following night. In the following days I have developed increased myasthenia gravis symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Eight minutes after receiving the injection it felt like a tickle in my throat and then felt like I needed to keep clearing my throat, coughed a couple times and then there was stridor my airway was closing. I was given a shot of epinephrine and it subsided pretty quickly. I was taken to the ED to be watched. Still clearing my throat some so the ED physician had me take oral Benadryl. I developed stridor again and was given IV Benadryl and the symptoms still quickly advanced to complete airway closure. I was given another dose of epinephrine and the symptoms again resolved in probably about a minute. I was unable to swallow adequately and I was admitted to ICU for observation. I was  kept NPO till 0900 and at that time had no difficulty. I was released the following night. In the following days I have developed increased myasthenia gravis symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood potassium decreased, Condition aggravated, Cough, Dysphagia
Clinical narrative: Eight minutes after receiving the injection it felt like a tickle in my throat and then felt like I needed to keep clearing my throat, coughed a couple times and then there was stridor my airway was closing. I was given a shot of epinephrine and it subsided pretty quickly. I was taken to the ED to be watched. Still clearing my throat some so the ED physician had me take oral Benadryl. I developed stridor again and was given IV Benadryl and the symptoms still quickly advanced to complete airway closure. I was given another dose of epinephrine and the symptoms again resolved in probably about a minute. I was unable to swallow adequately and I was admitted to ICU for observation. I was  kept NPO till 0900 and at that time had no difficulty. I was released the following night. In the following days I have developed increased myasthenia gravis symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Myasthenia gravis, Obstructive airways disorder, Stridor, Throat clearing
Clinical narrative: Eight minutes after receiving the injection it felt like a tickle in my throat and then felt like I needed to keep clearing my throat, coughed a couple times and then there was stridor my airway was closing. I was given a shot of epinephrine and it subsided pretty quickly. I was taken to the ED to be watched. Still clearing my throat some so the ED physician had me take oral Benadryl. I developed stridor again and was given IV Benadryl and the symptoms still quickly advanced to complete airway closure. I was given another dose of epinephrine and the symptoms again resolved in probably about a minute. I was unable to swallow adequately and I was admitted to ICU for observation. I was  kept NPO till 0900 and at that time had no difficulty. I was released the following night. In the following days I have developed increased myasthenia gravis symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Eight minutes after receiving the injection it felt like a tickle in my throat and then felt like I needed to keep clearing my throat, coughed a couple times and then there was stridor my airway was closing. I was given a shot of epinephrine and it subsided pretty quickly. I was taken to the ED to be watched. Still clearing my throat some so the ED physician had me take oral Benadryl. I developed stridor again and was given IV Benadryl and the symptoms still quickly advanced to complete airway closure. I was given another dose of epinephrine and the symptoms again resolved in probably about a minute. I was unable to swallow adequately and I was admitted to ICU for observation. I was  kept NPO till 0900 and at that time had no difficulty. I was released the following night. In the following days I have developed increased myasthenia gravis symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Neck also sore muscles; Neck also sore muscles; nausea; very bad HA, almost migraine; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), intramuscularly on left arm at 05:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications (No other-vaccine-in-four weeks, no other-medications-in-two weeks). 21 hours post injection (02:45 AM) on 22Dec2020, the patient experienced very bad HA (headache), almost migraine. Then added nausea. HA was bad for 3 hours, then slowly better. Neck also sore muscles. All events were reported as non-serious. Excedrine and advil taken intermittently. Slept/rested in dark for 8 hours. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of events was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscular weakness, Nausea, SARS-CoV-2 test
Clinical narrative: Neck also sore muscles; Neck also sore muscles; nausea; very bad HA, almost migraine; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), intramuscularly on left arm at 05:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications (No other-vaccine-in-four weeks, no other-medications-in-two weeks). 21 hours post injection (02:45 AM) on 22Dec2020, the patient experienced very bad HA (headache), almost migraine. Then added nausea. HA was bad for 3 hours, then slowly better. Neck also sore muscles. All events were reported as non-serious. Excedrine and advil taken intermittently. Slept/rested in dark for 8 hours. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Malaise, Paraesthesia
Clinical narrative: Midbottom of foot to toes is completely numb; tingling in toes of both feet; paresthesias (numbness, tingling) right arm; paresthesias (numbness, tingling) right arm; This is a spontaneous report from a contactable nurse practitioner, the patient.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left arm on 18Dec2020 (at the age of 56-years-old) as a single dose for COVID-19 immunization.   The patient did not have any relevant medical history.  Ongoing concomitant medications included levothyroxine sodium (SYNTHROID) and unspecified vitamins.  On 18Dec2020, the patent experienced paresthesia (numbness, tingling) in right arm. On 19Dec2020, the patient had tingling in the toes of both feet. On 21Dec2020, the mid bottom of foot to toes was completely numb. The clinical course was as follows: The patient received the vaccine in the left arm on 18Dec2020 and 9 hours later, she had paresthesias (tingling/numbness) in right arm. It was stemming from her shoulder down her arm. Around mid-morning on 19Dec2020, she had started having tingling in the toes of both feet.  On 21Dec2020, the mid bottom of foot to toes was completely numb. The patient reported that the paresthesias (tingling/numbness) in right arm was getting better and was more intermittent and the tingling in the toes was only in the left foot as of 22Dec2020. The clinical outcome of the paresthesia (numbness/tingling) in the right arm was recovering; while that of the numbness in mid foot to toes and tingling in the toes were not recovered. The reporter assessed the events as serious for being medically significant and assessed the events as related to the suspect vaccine.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported paresthesia (numbness, tingling) in right arm, tingling in the toes of both feet, the mid bottom of foot to toes was completely numb, and the administration of the BNT162B2 for COVID-19 immunization, based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Midbottom of foot to toes is completely numb; tingling in toes of both feet; paresthesias (numbness, tingling) right arm; paresthesias (numbness, tingling) right arm; This is a spontaneous report from a contactable nurse practitioner, the patient.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left arm on 18Dec2020 (at the age of 56-years-old) as a single dose for COVID-19 immunization.   The patient did not have any relevant medical history.  Ongoing concomitant medications included levothyroxine sodium (SYNTHROID) and unspecified vitamins.  On 18Dec2020, the patent experienced paresthesia (numbness, tingling) in right arm. On 19Dec2020, the patient had tingling in the toes of both feet. On 21Dec2020, the mid bottom of foot to toes was completely numb. The clinical course was as follows: The patient received the vaccine in the left arm on 18Dec2020 and 9 hours later, she had paresthesias (tingling/numbness) in right arm. It was stemming from her shoulder down her arm. Around mid-morning on 19Dec2020, she had started having tingling in the toes of both feet.  On 21Dec2020, the mid bottom of foot to toes was completely numb. The patient reported that the paresthesias (tingling/numbness) in right arm was getting better and was more intermittent and the tingling in the toes was only in the left foot as of 22Dec2020. The clinical outcome of the paresthesia (numbness/tingling) in the right arm was recovering; while that of the numbness in mid foot to toes and tingling in the toes were not recovered. The reporter assessed the events as serious for being medically significant and assessed the events as related to the suspect vaccine.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported paresthesia (numbness, tingling) in right arm, tingling in the toes of both feet, the mid bottom of foot to toes was completely numb, and the administration of the BNT162B2 for COVID-19 immunization, based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.