chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hot flush, Syncope, Tachycardia
Clinical narrative: syncope; Tachycardia; heat flash; dizziness; This is a spontaneous report from a contactable nurse.  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration into the right arm on 21Dec2020, at 08:45 as single dose for covid-19 immunization.  Medical history included allergies to medications, food, or other products: including sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), cobamamide (VITAMIN B12), melatonin (MELATOL).  The patient experienced syncope, tachycardia, heat flash, and dizziness on 21Dec2020, at 09:00.  No treatment was given. The outcome of syncope, tachycardia, heat flash, and dizziness was recovered in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the event syncope cannot be excluded based on a compatible temporal relation. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: I became nauseated and had abdominal cramps for three days.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: I became nauseated and had abdominal cramps for three days.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Computerised tomogram abdomen abnormal, Laparoscopic surgery
Clinical narrative: Severe Abdominal pain experienced on Friday morning went to ED and diagnosed with acute early appendicitis and had appendectomy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidaemia. No other vaccine administered in four weeks. No Covid prior vaccination. Concomitant medication included amlodipine besilate (NORVASC), vitamin C. The patient experienced severe abdominal pain experienced on Friday morning (18Dec2020 09:00) went to ED (emergency department) and diagnosed with acute early appendicitis, and had appendectomy on Saturday 19Dec2020. Event resulted in: Hospitalization for 1 day (18Dec2020-19Dec2020). The patient underwent lab tests and procedures which included nasal swab: negative on 18Dec2020. The outcome of event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully 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: M
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal
Clinical narrative: Severe Abdominal pain experienced on Friday morning went to ED and diagnosed with acute early appendicitis and had appendectomy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidaemia. No other vaccine administered in four weeks. No Covid prior vaccination. Concomitant medication included amlodipine besilate (NORVASC), vitamin C. The patient experienced severe abdominal pain experienced on Friday morning (18Dec2020 09:00) went to ED (emergency department) and diagnosed with acute early appendicitis, and had appendectomy on Saturday 19Dec2020. Event resulted in: Hospitalization for 1 day (18Dec2020-19Dec2020). The patient underwent lab tests and procedures which included nasal swab: negative on 18Dec2020. The outcome of event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully 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: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Culture negative, Laboratory test
Clinical narrative: Severe Abdominal pain experienced on Friday morning went to ED and diagnosed with acute early appendicitis and had appendectomy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidaemia. No other vaccine administered in four weeks. No Covid prior vaccination. Concomitant medication included amlodipine besilate (NORVASC), vitamin C. The patient experienced severe abdominal pain experienced on Friday morning (18Dec2020 09:00) went to ED (emergency department) and diagnosed with acute early appendicitis, and had appendectomy on Saturday 19Dec2020. Event resulted in: Hospitalization for 1 day (18Dec2020-19Dec2020). The patient underwent lab tests and procedures which included nasal swab: negative on 18Dec2020. The outcome of event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemorrhage, Platelet count decreased, SARS-CoV-2 test negative, Thrombocytopenia
Clinical narrative: TTP; This is a spontaneous report from a non-contactable pharmacist.  A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 17Dec2020 as a single dose for COVID-19 immunization.  The patient did not have any known relevant medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.   The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination.  On 21Dec2020, the patient experienced thrombotic thrombocytopenic purpura (TTP); which was serious for hospitalization. The clinical course was as follows: The patient went to the emergency room/urgent care and was admitted in the early morning of 21Dec2020 due to TTP. Work-up was ongoing with no known results.  On 21Dec2020, the patient also had a COVID-19 test which was negative. The patient was treated with unspecified corticosteroids and platelets. The clinical outcome of the TTP was unknown. The reporter assessed that it was unknown if the TTP was related to the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and diagnostic workups such as coagulation test,  Combs test, bacterial/virologic/immunological biomarkers to identify the etiology.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mouth haemorrhage, Rash, Stomatitis, Thrombocytopenia
Clinical narrative: TTP; This is a spontaneous report from a non-contactable pharmacist.  A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 17Dec2020 as a single dose for COVID-19 immunization.  The patient did not have any known relevant medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.   The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination.  On 21Dec2020, the patient experienced thrombotic thrombocytopenic purpura (TTP); which was serious for hospitalization. The clinical course was as follows: The patient went to the emergency room/urgent care and was admitted in the early morning of 21Dec2020 due to TTP. Work-up was ongoing with no known results.  On 21Dec2020, the patient also had a COVID-19 test which was negative. The patient was treated with unspecified corticosteroids and platelets. The clinical outcome of the TTP was unknown. The reporter assessed that it was unknown if the TTP was related to the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and diagnostic workups such as coagulation test,  Combs test, bacterial/virologic/immunological biomarkers to identify the etiology.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Platelet transfusion, SARS-CoV-2 test negative, Thrombotic thrombocytopenic purpura
Clinical narrative: TTP; This is a spontaneous report from a non-contactable pharmacist.  A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 17Dec2020 as a single dose for COVID-19 immunization.  The patient did not have any known relevant medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.   The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination.  On 21Dec2020, the patient experienced thrombotic thrombocytopenic purpura (TTP); which was serious for hospitalization. The clinical course was as follows: The patient went to the emergency room/urgent care and was admitted in the early morning of 21Dec2020 due to TTP. Work-up was ongoing with no known results.  On 21Dec2020, the patient also had a COVID-19 test which was negative. The patient was treated with unspecified corticosteroids and platelets. The clinical outcome of the TTP was unknown. The reporter assessed that it was unknown if the TTP was related to the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and diagnostic workups such as coagulation test,  Combs test, bacterial/virologic/immunological biomarkers to identify the etiology.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: ringing in the ear; unable to hear out of the right ear; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient (and nurse) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the left arm on 19Dec2020 at 08:00 at 53-year-old at a single dose for COVID-19 immunization. The vaccine was administered at a hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Medical history included asthma, mitral valve prolapse, Sulfonamide allergy, and allergies to tree nuts; all from an unknown date and unknown if ongoing.  Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO), fluticasone propionate (FLOVENT); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination). On 20Dec2020 at 14:00, the patient experienced: unable to hear out of the right ear (medically significant). On 21Dec2020 at 02:00, the patient experienced: ringing in the ear (non-serious). The clinical course was reported as follows: Approximately 30 hours post-vaccination, the patient was unable to hear out of her right ear. It progressively worsened; however, by 02:00, the patient's hearing returned, and the patient developed a ringing in her ear. By 14:00, all the symptoms had disappeared. There was no treatment received due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, unable to hear out of the right ear, was recovered on 21Dec2020 at 02:00. The clinical outcome of the event, ringing in the ear, was recovered on 21Dec2020 at 14:00.; Sender's Comments: A possible contribution role of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) to the onset of event deafness right ear cannot be excluded due to temporal relationship. 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cold sweat, Cough, Dyspnoea, Dyspnoea exertional
Clinical narrative: Shortness of breath; fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, Shortness of breath. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered not At Military Site. There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. Per (website name), patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the (website name) indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Shortness of breath cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Headache, Heart rate increased, Nausea
Clinical narrative: Shortness of breath; fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, Shortness of breath. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered not At Military Site. There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. Per (website name), patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the (website name) indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Shortness of breath cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Shortness of breath; fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, Shortness of breath. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered not At Military Site. There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. Per (website name), patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the (website name) indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Shortness of breath cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, SARS-CoV-2 test negative
Clinical narrative: Shortness of breath; fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, Shortness of breath. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered not At Military Site. There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. Per (website name), patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the (website name) indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Shortness of breath cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Pruritus, Urticaria
Clinical narrative: broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; throat pain, coughing; throat pain, coughing; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 57-year-old female patient received fist dose of bnt162b2 (BNT162B2, Brand Pfizer), via unknown route of administration in Left arm on 21Dec2020 12:00 PM at single dose for covid-19 immunisation. Medical history included Known allergies to medications, food, or other products: Azithromycin Flushing, Spinach-anaphylaxis, mild allergic reactions to the Ocrevus, azure and Seasonal allergies, Multiple Sclerosis, Irritable bowel syndrome (IBS-C), post herpactic neuralgia. Concomitant medications included other medications the patient received within 2 weeks of vaccination baclophen, clozapine (KLOPIN), ocrelizumab (OCREVUS), sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), mo. She is not pregnant at the time of vaccination. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced within 15 to twenty minutes of vaccine, broke out in hives on face and hoarseness, tightness in throat then sent to ED where hives continued to form on back the arms, throat pain, coughing, hoarseness increased from 21Dec2020 12:15 AM. AE resulted in: [Emergency room/department or urgent care]. Outcome of the events was unknown. Treatment received included Epinephrine, solumedrol, Benadryl IV. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination was Other, covid test name post vaccination was Nasopharyngeal Sofia2 SARS Antigen on 21Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, has the patient been tested for COVID-19. Test Name was Nasopharyngeal Sofia2 SARS Antigen. Vaccine Facility information available.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be completely excluded. Medical history of known allergies may have predisposed patient to react this way.  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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Oropharyngeal pain, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; throat pain, coughing; throat pain, coughing; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 57-year-old female patient received fist dose of bnt162b2 (BNT162B2, Brand Pfizer), via unknown route of administration in Left arm on 21Dec2020 12:00 PM at single dose for covid-19 immunisation. Medical history included Known allergies to medications, food, or other products: Azithromycin Flushing, Spinach-anaphylaxis, mild allergic reactions to the Ocrevus, azure and Seasonal allergies, Multiple Sclerosis, Irritable bowel syndrome (IBS-C), post herpactic neuralgia. Concomitant medications included other medications the patient received within 2 weeks of vaccination baclophen, clozapine (KLOPIN), ocrelizumab (OCREVUS), sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), mo. She is not pregnant at the time of vaccination. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced within 15 to twenty minutes of vaccine, broke out in hives on face and hoarseness, tightness in throat then sent to ED where hives continued to form on back the arms, throat pain, coughing, hoarseness increased from 21Dec2020 12:15 AM. AE resulted in: [Emergency room/department or urgent care]. Outcome of the events was unknown. Treatment received included Epinephrine, solumedrol, Benadryl IV. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination was Other, covid test name post vaccination was Nasopharyngeal Sofia2 SARS Antigen on 21Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, has the patient been tested for COVID-19. Test Name was Nasopharyngeal Sofia2 SARS Antigen. Vaccine Facility information available.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be completely excluded. Medical history of known allergies may have predisposed patient to react this way.  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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; broke out in hives on face and hoarseness, tightness in throat; throat pain, coughing; throat pain, coughing; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 57-year-old female patient received fist dose of bnt162b2 (BNT162B2, Brand Pfizer), via unknown route of administration in Left arm on 21Dec2020 12:00 PM at single dose for covid-19 immunisation. Medical history included Known allergies to medications, food, or other products: Azithromycin Flushing, Spinach-anaphylaxis, mild allergic reactions to the Ocrevus, azure and Seasonal allergies, Multiple Sclerosis, Irritable bowel syndrome (IBS-C), post herpactic neuralgia. Concomitant medications included other medications the patient received within 2 weeks of vaccination baclophen, clozapine (KLOPIN), ocrelizumab (OCREVUS), sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), mo. She is not pregnant at the time of vaccination. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced within 15 to twenty minutes of vaccine, broke out in hives on face and hoarseness, tightness in throat then sent to ED where hives continued to form on back the arms, throat pain, coughing, hoarseness increased from 21Dec2020 12:15 AM. AE resulted in: [Emergency room/department or urgent care]. Outcome of the events was unknown. Treatment received included Epinephrine, solumedrol, Benadryl IV. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination: covid test type post vaccination was Other, covid test name post vaccination was Nasopharyngeal Sofia2 SARS Antigen on 21Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, has the patient been tested for COVID-19. Test Name was Nasopharyngeal Sofia2 SARS Antigen. Vaccine Facility information available.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be completely excluded. Medical history of known allergies may have predisposed patient to react this way.  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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cold sweat, Orthostatic hypotension, Presyncope
Clinical narrative: lost vision and had intense cold sweats for about 2 minutes; Vasovagal response; had intense cold sweats for about 2 minutes until blood flow returned to normal in upper body; This is a spontaneous report from a contactable healthcare professional, the patient.  A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 16Dec2020 at 09:30 as a single dose for COVID-19 immunization.  Medical history included polycystic ovaries syndrome with diabetes, depression, anxiety, attention deficit hyperactivity disorder, iron deficiency anaemia, and vasovagal issues.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's received unspecified concomitant medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Dec2020 at 10:00 AM, the patient lost vision and had vasovagal response and intense cold sweats for about 2 minutes until blood flow returned to normal in upper body. The clinical course was as follows: The patient had a vasovagal response 30 minutes after the vaccine and had to lie down. She lost vision and had intense cold sweats for about 2 minutes until blood flow returned to normal in upper body. The entire episode lasted approximately 30 minutes. She felt it coming and knew to sit down so she would not "black out." She was unable to elevate her feet above her heart at the time; however, she was able to walk and stand afterward without dizziness. The patient did not receive any treatment. The clinical outcome of the vasovagal response, lost vision, and cold sweats were recovered on 16Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported vasovagal response with cold sweats and transient visual loss was possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship.  However, it is worth noting that the patient had medical history including vasovagal issues.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cold sweat, Presyncope
Clinical narrative: lost vision and had intense cold sweats for about 2 minutes; Vasovagal response; had intense cold sweats for about 2 minutes until blood flow returned to normal in upper body; This is a spontaneous report from a contactable healthcare professional, the patient.  A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 16Dec2020 at 09:30 as a single dose for COVID-19 immunization.  Medical history included polycystic ovaries syndrome with diabetes, depression, anxiety, attention deficit hyperactivity disorder, iron deficiency anaemia, and vasovagal issues.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's received unspecified concomitant medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Dec2020 at 10:00 AM, the patient lost vision and had vasovagal response and intense cold sweats for about 2 minutes until blood flow returned to normal in upper body. The clinical course was as follows: The patient had a vasovagal response 30 minutes after the vaccine and had to lie down. She lost vision and had intense cold sweats for about 2 minutes until blood flow returned to normal in upper body. The entire episode lasted approximately 30 minutes. She felt it coming and knew to sit down so she would not "black out." She was unable to elevate her feet above her heart at the time; however, she was able to walk and stand afterward without dizziness. The patient did not receive any treatment. The clinical outcome of the vasovagal response, lost vision, and cold sweats were recovered on 16Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported vasovagal response with cold sweats and transient visual loss was possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship.  However, it is worth noting that the patient had medical history including vasovagal issues.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Dysgeusia, Feeling abnormal, Flushing
Clinical narrative: elevated blood pressure/ elevation in blood pressure/ Highest BP 195/93 ranging 180s/90s/ Final BP 155/93; foggy headed/ less foggy; felt flushed/ feeling flushed; metallic taste in mouth; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 21Dec2020 15:30 at single dose on right arm for COVID-19 immunization. Medical history included Allergies to medications, food, or other products: IVP Dye, red ants. Concomitant medications received within 2 weeks of vaccination included celecoxib (CELEXA [CELECOXIB]) and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]). The most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 15:45, Initially patient felt flushed and foggy headed then developed metallic taste in mouth and elevated blood pressure, required extended monitoring period with continued elevation in blood pressure. Heart rate and respiratory rate stable, no respiratory distress noted. Highest BP 195/93 ranging 180s/90s, however denied need to be seen in ED. Final BP 155/93, less foggy, no dizziness or lightheadedness; feeling flushed remained. Total monitoring time: 83 mins, without significant distress. No treatment was received for the adverse events. The reporter reported the seriousness was no. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered (pending clarification) in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the event blood pressure increased and foggy feeling in head cannot be excluded based on a compatible temporal relation. 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dysgeusia, Feeling abnormal, Flushing
Clinical narrative: elevated blood pressure/ elevation in blood pressure/ Highest BP 195/93 ranging 180s/90s/ Final BP 155/93; foggy headed/ less foggy; felt flushed/ feeling flushed; metallic taste in mouth; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 21Dec2020 15:30 at single dose on right arm for COVID-19 immunization. Medical history included Allergies to medications, food, or other products: IVP Dye, red ants. Concomitant medications received within 2 weeks of vaccination included celecoxib (CELEXA [CELECOXIB]) and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]). The most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 15:45, Initially patient felt flushed and foggy headed then developed metallic taste in mouth and elevated blood pressure, required extended monitoring period with continued elevation in blood pressure. Heart rate and respiratory rate stable, no respiratory distress noted. Highest BP 195/93 ranging 180s/90s, however denied need to be seen in ED. Final BP 155/93, less foggy, no dizziness or lightheadedness; feeling flushed remained. Total monitoring time: 83 mins, without significant distress. No treatment was received for the adverse events. The reporter reported the seriousness was no. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered (pending clarification) in Dec2020.; Sender's Comments: A causal association between BNT162B2 and the event blood pressure increased and foggy feeling in head cannot be excluded based on a compatible temporal relation. 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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Presyncope, Vomiting
Clinical narrative: 12/21 SITTING IN CHAIR, FELT TINGLING IN EAR, 'FEELING FAINT'. MOVED TO CHAIR AGAINST THE WALL, TOLD MEDICAL STAFF. FAINTED, SWEATING PROFUSELY, 'WANTED TO GO TO SLEEP'. MONITORED HR, BP. VOMITED. BP WAS STILL ELEVATED 136/100. 'FELT BETTER' AFTER VOMITING, COLOR CAME BACK, 'CAME TO'.  ER: BASAL EVENT ABOUT TO DISCHARGE, TINGLING CAME BACK. NOTHING ON MONITOR INDICATED ANY PROBLEMS. EVENTUALLY DISCHARGED AS SYMPTOMS DECREASED.  DIAGNOSED; SYNCOPE
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Hyperhidrosis, Loss of consciousness
Clinical narrative: 12/21 SITTING IN CHAIR, FELT TINGLING IN EAR, 'FEELING FAINT'. MOVED TO CHAIR AGAINST THE WALL, TOLD MEDICAL STAFF. FAINTED, SWEATING PROFUSELY, 'WANTED TO GO TO SLEEP'. MONITORED HR, BP. VOMITED. BP WAS STILL ELEVATED 136/100. 'FELT BETTER' AFTER VOMITING, COLOR CAME BACK, 'CAME TO'.  ER: BASAL EVENT ABOUT TO DISCHARGE, TINGLING CAME BACK. NOTHING ON MONITOR INDICATED ANY PROBLEMS. EVENTUALLY DISCHARGED AS SYMPTOMS DECREASED.  DIAGNOSED; SYNCOPE
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Paraesthesia, Somnolence, Syncope, Tilt table test
Clinical narrative: 12/21 SITTING IN CHAIR, FELT TINGLING IN EAR, 'FEELING FAINT'. MOVED TO CHAIR AGAINST THE WALL, TOLD MEDICAL STAFF. FAINTED, SWEATING PROFUSELY, 'WANTED TO GO TO SLEEP'. MONITORED HR, BP. VOMITED. BP WAS STILL ELEVATED 136/100. 'FELT BETTER' AFTER VOMITING, COLOR CAME BACK, 'CAME TO'.  ER: BASAL EVENT ABOUT TO DISCHARGE, TINGLING CAME BACK. NOTHING ON MONITOR INDICATED ANY PROBLEMS. EVENTUALLY DISCHARGED AS SYMPTOMS DECREASED.  DIAGNOSED; SYNCOPE
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 12/21 SITTING IN CHAIR, FELT TINGLING IN EAR, 'FEELING FAINT'. MOVED TO CHAIR AGAINST THE WALL, TOLD MEDICAL STAFF. FAINTED, SWEATING PROFUSELY, 'WANTED TO GO TO SLEEP'. MONITORED HR, BP. VOMITED. BP WAS STILL ELEVATED 136/100. 'FELT BETTER' AFTER VOMITING, COLOR CAME BACK, 'CAME TO'.  ER: BASAL EVENT ABOUT TO DISCHARGE, TINGLING CAME BACK. NOTHING ON MONITOR INDICATED ANY PROBLEMS. EVENTUALLY DISCHARGED AS SYMPTOMS DECREASED.  DIAGNOSED; SYNCOPE