chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient with generalized body flushing advancing to numbness and tingling to right side of mouth, lips and cheek. Diffuse flushing over body. Vaccine given at 8:15a - and symptoms began 10 minutes post injection. Patient requested 911. HR120. Able to speak and breath without difficulty. Benadryl administered IM x 1. No throat tightness.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: she developed a brachial deep venous thrombosis 9 days after the vaccine on the same side
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: she developed a brachial deep venous thrombosis 9 days after the vaccine on the same side
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Ultrasound scan
Clinical narrative: she developed a brachial deep venous thrombosis 9 days after the vaccine on the same side
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Intentional dose omission, Ultrasound scan
Clinical narrative: she developed a brachial deep venous thrombosis 9 days after the vaccine on the same side
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given benadryl, sx's started improving a couple hours later.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Paraesthesia oral, Sensation of foreign body
Clinical narrative: numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given benadryl, sx's started improving a couple hours later.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 14Jan2021 14:30 in left arm at single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies-pollen/dust and other medical history was none. No other vaccine was received in four weeks. Concomitant medication in two weeks included cetirizine, quercetin, ascorbic acid, sodium ascorbate (LIPOSOMAL VITAMIN C). Facility type vaccine was public health clinic/veterans administration facility. 7 minutes post injection, patient had hives/severe itching about 1x1 inch patch above left elbow. 40 minutes post injection, patient experienced swelling of left arm and both calves and facial flushing, mild rash on day 3- 4 on both arms. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Patient received the treatment of oral diphenhydramine hydrochloride (BENADRYL) 50 MG; famoditine IV (intravenous) for events. Outcome of events were recovered with sequel in Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 14Jan2021 14:30 in left arm at single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies-pollen/dust and other medical history was none. No other vaccine was received in four weeks. Concomitant medication in two weeks included cetirizine, quercetin, ascorbic acid, sodium ascorbate (LIPOSOMAL VITAMIN C). Facility type vaccine was public health clinic/veterans administration facility. 7 minutes post injection, patient had hives/severe itching about 1x1 inch patch above left elbow. 40 minutes post injection, patient experienced swelling of left arm and both calves and facial flushing, mild rash on day 3- 4 on both arms. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Patient received the treatment of oral diphenhydramine hydrochloride (BENADRYL) 50 MG; famoditine IV (intravenous) for events. Outcome of events were recovered with sequel in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Intensive care, Laboratory test, Nausea
Clinical narrative: Pt had complained of dizziness, itching, throat/chest tightness, nausea and shortness of breath. No hives, no hemodynamic instability. She got 1 mg epinephrine, duoneb, benadryl then sent to ED. She was admitted to hospital for monitoring - required 2nd dose EpiPen, intermittent albuterol nebs, diphenhydramine, cetrizine and dexamethasone/prednisone. Discharged after 2days.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Throat tightness, Wheezing
Clinical narrative: Pt had complained of dizziness, itching, throat/chest tightness, nausea and shortness of breath. No hives, no hemodynamic instability. She got 1 mg epinephrine, duoneb, benadryl then sent to ED. She was admitted to hospital for monitoring - required 2nd dose EpiPen, intermittent albuterol nebs, diphenhydramine, cetrizine and dexamethasone/prednisone. Discharged after 2days.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Nausea, Pruritus
Clinical narrative: Pt had complained of dizziness, itching, throat/chest tightness, nausea and shortness of breath. No hives, no hemodynamic instability. She got 1 mg epinephrine, duoneb, benadryl then sent to ED. She was admitted to hospital for monitoring - required 2nd dose EpiPen, intermittent albuterol nebs, diphenhydramine, cetrizine and dexamethasone/prednisone. Discharged after 2days.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Pt had complained of dizziness, itching, throat/chest tightness, nausea and shortness of breath. No hives, no hemodynamic instability. She got 1 mg epinephrine, duoneb, benadryl then sent to ED. She was admitted to hospital for monitoring - required 2nd dose EpiPen, intermittent albuterol nebs, diphenhydramine, cetrizine and dexamethasone/prednisone. Discharged after 2days.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Continuously headache  (something like poking inside head, heaviness in head)
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Continuously headache  (something like poking inside head, heaviness in head)
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Continuously headache  (something like poking inside head, heaviness in head)
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Fatigue, Flushing, Injection site erythema, Injection site pain
Clinical narrative: Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP.   A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Physical examination, Rash, SARS-CoV-2 test positive, Tachycardia, Vital signs measurement
Clinical narrative: Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP.   A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Flushing, Pain in extremity, Peripheral swelling
Clinical narrative: Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP.   A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP.   A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Computerised tomogram, Electrocardiogram, Facial paralysis
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Laboratory test, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Pyrexia, SARS-CoV-2 test negative, Vocal cord disorder
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adductor vocal cord weakness, Adverse event, Chills, Facial paralysis, Fatigue
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Viral test negative, Vocal cord disorder
Clinical narrative: enlarged painful lymph nodes left axilla; fever; aches; chills; facial paralysis; vocal cord weakness; fatigue; Brain fog; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at Left arm on 05Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination was reported as 'No'. Medical history included breast cancer from 2008 to an unknown date, the patient had known allergies to Phenergan, Reglan, morphine. The patient's concomitant medications were not reported (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination).  The patient previously took first dose of bnt162b2 (lot number: Ej1685) at Left arm on 17Dec2020 07:15 AM for covid-19 immunisation. The patient previously received promethazine (PHENERGAN), metoclopramide hydrochloride (REGLAN), morphine and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab for COVID-19 on 15Jan2021 with negative result. 9 hours post 2nd dose, the patient had enlarged painful lymph nodes left axilla, fever, aches, chills, severe lasting 24 hours, 1 week post facial paralysis, vocal cord weakness, fatigue, Brain fog. The events started on 12Jan2021 07:30 AM and serious due to Disabling/Incapacitating. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment drugs prednisone 60mg x 5 days, valacyclovir (VALTREX) 1 gram 3xper day. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "enlarged painful lymph nodes left axilla, fever, aches, chills, post facial paralysis, vocal cord weakness, fatigue, Brain fog" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test, Cyanosis, Differential white blood cell count, Dizziness, Dyspnoea
Clinical narrative: This is a 27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. At the time of my visit she felt anxious, denies SOB, palpitation, or chest pain. Vitals in the ER  Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation. She did well overnight on telemetry with stable vitals and no further evidence of respiratory compromise. Patient was counseled about her allergy to covid moderna vaccine and to list it as an allergy with anaphylaxis.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Tachycardia
Clinical narrative: This is a 27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. At the time of my visit she felt anxious, denies SOB, palpitation, or chest pain. Vitals in the ER  Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation. She did well overnight on telemetry with stable vitals and no further evidence of respiratory compromise. Patient was counseled about her allergy to covid moderna vaccine and to list it as an allergy with anaphylaxis.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Cyanosis, Dizziness, Dyspnoea
Clinical narrative: This is a 27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. At the time of my visit she felt anxious, denies SOB, palpitation, or chest pain. Vitals in the ER  Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation. She did well overnight on telemetry with stable vitals and no further evidence of respiratory compromise. Patient was counseled about her allergy to covid moderna vaccine and to list it as an allergy with anaphylaxis.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Tachycardia
Clinical narrative: This is a 27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. At the time of my visit she felt anxious, denies SOB, palpitation, or chest pain. Vitals in the ER  Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation. She did well overnight on telemetry with stable vitals and no further evidence of respiratory compromise. Patient was counseled about her allergy to covid moderna vaccine and to list it as an allergy with anaphylaxis.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Dizziness
Clinical narrative: Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Full blood count normal, Headache, Metabolic function test
Clinical narrative: Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Vertigo
Clinical narrative: Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.