chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Influenza virus test negative, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; This is a spontaneous report from contactable Other HCPs. A 60 years old female Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) administered mid-deltoid on the left side on 21Dec2020 9:15 am at single dose for covid-19 immunization. The only medical history she has was a Chiari malformation that was decompressed with no residuals, it was done around 2004. Concomitant drug was colecalciferol (VITAMIN D). Caller describe what she experienced after receiving the COVID-19 vaccine: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot, has numbness on the left side of her face, arm and leg was reported as worsened on 21Dec2020 with outcome was not recovered. Caller, reporting on COVID 19. After getting the shot her arm and leg are going numb, she wants to know what to do. It is explained that she called her doctor and was told to call us. She is a physical therapist. The product was administered at 9:15 am on 21Dec2020 and 2 hours later is when the events started. She has numbness on the left side of her face, arm and leg which is on the same side she got the shot. It started in face and has progressed now going farther down her leg. It was administered mid-deltoid on the left side. She is on no medication except for Vitamin D. No treatment or testing, she was instructed to call us related to the event by her doctor. No family history that is relevant. No other events or side effects experienced with vaccines in the past.   Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; This is a spontaneous report from contactable Other HCPs. A 60 years old female Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) administered mid-deltoid on the left side on 21Dec2020 9:15 am at single dose for covid-19 immunization. The only medical history she has was a Chiari malformation that was decompressed with no residuals, it was done around 2004. Concomitant drug was colecalciferol (VITAMIN D). Caller describe what she experienced after receiving the COVID-19 vaccine: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot, has numbness on the left side of her face, arm and leg was reported as worsened on 21Dec2020 with outcome was not recovered. Caller, reporting on COVID 19. After getting the shot her arm and leg are going numb, she wants to know what to do. It is explained that she called her doctor and was told to call us. She is a physical therapist. The product was administered at 9:15 am on 21Dec2020 and 2 hours later is when the events started. She has numbness on the left side of her face, arm and leg which is on the same side she got the shot. It started in face and has progressed now going farther down her leg. It was administered mid-deltoid on the left side. She is on no medication except for Vitamin D. No treatment or testing, she was instructed to call us related to the event by her doctor. No family history that is relevant. No other events or side effects experienced with vaccines in the past.   Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; This is a spontaneous report from contactable Other HCPs. A 60 years old female Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) administered mid-deltoid on the left side on 21Dec2020 9:15 am at single dose for covid-19 immunization. The only medical history she has was a Chiari malformation that was decompressed with no residuals, it was done around 2004. Concomitant drug was colecalciferol (VITAMIN D). Caller describe what she experienced after receiving the COVID-19 vaccine: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot, has numbness on the left side of her face, arm and leg was reported as worsened on 21Dec2020 with outcome was not recovered. Caller, reporting on COVID 19. After getting the shot her arm and leg are going numb, she wants to know what to do. It is explained that she called her doctor and was told to call us. She is a physical therapist. The product was administered at 9:15 am on 21Dec2020 and 2 hours later is when the events started. She has numbness on the left side of her face, arm and leg which is on the same side she got the shot. It started in face and has progressed now going farther down her leg. It was administered mid-deltoid on the left side. She is on no medication except for Vitamin D. No treatment or testing, she was instructed to call us related to the event by her doctor. No family history that is relevant. No other events or side effects experienced with vaccines in the past.   Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Hypoaesthesia, Influenza virus test negative, Meningitis, Protein total normal, SARS-CoV-2 test negative
Clinical narrative: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; This is a spontaneous report from contactable Other HCPs. A 60 years old female Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) administered mid-deltoid on the left side on 21Dec2020 9:15 am at single dose for covid-19 immunization. The only medical history she has was a Chiari malformation that was decompressed with no residuals, it was done around 2004. Concomitant drug was colecalciferol (VITAMIN D). Caller describe what she experienced after receiving the COVID-19 vaccine: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot, has numbness on the left side of her face, arm and leg was reported as worsened on 21Dec2020 with outcome was not recovered. Caller, reporting on COVID 19. After getting the shot her arm and leg are going numb, she wants to know what to do. It is explained that she called her doctor and was told to call us. She is a physical therapist. The product was administered at 9:15 am on 21Dec2020 and 2 hours later is when the events started. She has numbness on the left side of her face, arm and leg which is on the same side she got the shot. It started in face and has progressed now going farther down her leg. It was administered mid-deltoid on the left side. She is on no medication except for Vitamin D. No treatment or testing, she was instructed to call us related to the event by her doctor. No family history that is relevant. No other events or side effects experienced with vaccines in the past.   Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Streptococcus test negative
Clinical narrative: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot; This is a spontaneous report from contactable Other HCPs. A 60 years old female Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) administered mid-deltoid on the left side on 21Dec2020 9:15 am at single dose for covid-19 immunization. The only medical history she has was a Chiari malformation that was decompressed with no residuals, it was done around 2004. Concomitant drug was colecalciferol (VITAMIN D). Caller describe what she experienced after receiving the COVID-19 vaccine: numbness and tingling on the left side, from left arm to left pinky finger, through the leg and foot, has numbness on the left side of her face, arm and leg was reported as worsened on 21Dec2020 with outcome was not recovered. Caller, reporting on COVID 19. After getting the shot her arm and leg are going numb, she wants to know what to do. It is explained that she called her doctor and was told to call us. She is a physical therapist. The product was administered at 9:15 am on 21Dec2020 and 2 hours later is when the events started. She has numbness on the left side of her face, arm and leg which is on the same side she got the shot. It started in face and has progressed now going farther down her leg. It was administered mid-deltoid on the left side. She is on no medication except for Vitamin D. No treatment or testing, she was instructed to call us related to the event by her doctor. No family history that is relevant. No other events or side effects experienced with vaccines in the past.   Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Fever 101.1°F; Body Aches; This is a spontaneous report from a contactable physician, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) Lot: EJ1685, via an unspecified route of administration in the left arm on 21Dec2020 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included a diagnosis of COVID-19 (COVID positive) on 31Aug2020. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020, the patient experienced a fever of 101.1°F, body aches and chills. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the fever of 101.1°F, body aches and chills were recovered on an unspecified date in Dec2020.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Chills; Fever 101.1°F; Body Aches; This is a spontaneous report from a contactable physician, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) Lot: EJ1685, via an unspecified route of administration in the left arm on 21Dec2020 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included a diagnosis of COVID-19 (COVID positive) on 31Aug2020. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020, the patient experienced a fever of 101.1°F, body aches and chills. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the fever of 101.1°F, body aches and chills were recovered on an unspecified date in Dec2020.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in her tongue and in her arm; Tingling in her tongue and in her arm; This is a spontaneous report from a contactable other health professional (patient) from Pfizer-sponsored program. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Dec2020, the patient experienced tingling in her tongue and in her arm, the patient reported that: "after getting the vaccine but it looked like the tingling in my arm was probably within an hour and the tongue was all like that in evening". The patient outcome of the events was recovered.  Information on Lot/Batch number for the product has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516692 same reporter, different patient/drug/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in her tongue and in her arm; Tingling in her tongue and in her arm; This is a spontaneous report from a contactable other health professional (patient) from Pfizer-sponsored program. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Dec2020, the patient experienced tingling in her tongue and in her arm, the patient reported that: "after getting the vaccine but it looked like the tingling in my arm was probably within an hour and the tongue was all like that in evening". The patient outcome of the events was recovered.  Information on Lot/Batch number for the product has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516692 same reporter, different patient/drug/event
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chest pain, Chills, Cough
Clinical narrative: tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; This is a spontaneous report from a contactable Other HCP (patient). This 45-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 18Dec2020 18:00 at single dose on the right arm for COVID-19 immunization. Medical history included connective tissue disorder. No allergies to medications, food, or other products. Concomitant medications were not reported. Facility that the most recent COVID-19 vaccine was administered in 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, the patient has been tested for COVID-19. The patient experienced tested on 16Dec2020 for COVID on rapid he was negative. Patient went and got the COVID vaccine on Friday. On 21Dec2020 01:00, patient had symptom early Sunday morning or shortness of breath. Chills with low grade fever 100.7 and a rapid heartrate. The same day patient lost his taste and smell, nasal congestion with dryness. Patient tested nasal swab (antigen rapid) on 20Dec2020: positive for strep and COVID. Outcome of the events was not recovered. Patient received treatment for the adverse event included doxcycline 100 mg and abutertol inhaler.; Sender's Comments: 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Fatigue, Influenza virus test, Mucosal discolouration, Nasal dryness
Clinical narrative: tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; This is a spontaneous report from a contactable Other HCP (patient). This 45-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 18Dec2020 18:00 at single dose on the right arm for COVID-19 immunization. Medical history included connective tissue disorder. No allergies to medications, food, or other products. Concomitant medications were not reported. Facility that the most recent COVID-19 vaccine was administered in 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, the patient has been tested for COVID-19. The patient experienced tested on 16Dec2020 for COVID on rapid he was negative. Patient went and got the COVID vaccine on Friday. On 21Dec2020 01:00, patient had symptom early Sunday morning or shortness of breath. Chills with low grade fever 100.7 and a rapid heartrate. The same day patient lost his taste and smell, nasal congestion with dryness. Patient tested nasal swab (antigen rapid) on 20Dec2020: positive for strep and COVID. Outcome of the events was not recovered. Patient received treatment for the adverse event included doxcycline 100 mg and abutertol inhaler.; Sender's Comments: 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; This is a spontaneous report from a contactable Other HCP (patient). This 45-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 18Dec2020 18:00 at single dose on the right arm for COVID-19 immunization. Medical history included connective tissue disorder. No allergies to medications, food, or other products. Concomitant medications were not reported. Facility that the most recent COVID-19 vaccine was administered in 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, the patient has been tested for COVID-19. The patient experienced tested on 16Dec2020 for COVID on rapid he was negative. Patient went and got the COVID vaccine on Friday. On 21Dec2020 01:00, patient had symptom early Sunday morning or shortness of breath. Chills with low grade fever 100.7 and a rapid heartrate. The same day patient lost his taste and smell, nasal congestion with dryness. Patient tested nasal swab (antigen rapid) on 20Dec2020: positive for strep and COVID. Outcome of the events was not recovered. Patient received treatment for the adverse event included doxcycline 100 mg and abutertol inhaler.; Sender's Comments: 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chills, Dyspnoea, Heart rate increased
Clinical narrative: tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; This is a spontaneous report from a contactable Other HCP (patient). This 45-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 18Dec2020 18:00 at single dose on the right arm for COVID-19 immunization. Medical history included connective tissue disorder. No allergies to medications, food, or other products. Concomitant medications were not reported. Facility that the most recent COVID-19 vaccine was administered in 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, the patient has been tested for COVID-19. The patient experienced tested on 16Dec2020 for COVID on rapid he was negative. Patient went and got the COVID vaccine on Friday. On 21Dec2020 01:00, patient had symptom early Sunday morning or shortness of breath. Chills with low grade fever 100.7 and a rapid heartrate. The same day patient lost his taste and smell, nasal congestion with dryness. Patient tested nasal swab (antigen rapid) on 20Dec2020: positive for strep and COVID. Outcome of the events was not recovered. Patient received treatment for the adverse event included doxcycline 100 mg and abutertol inhaler.; Sender's Comments: 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nasal dryness, Pyrexia, SARS-CoV-2 test positive, Streptococcus test positive
Clinical narrative: tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; tested positive for strep and covid; shortness of breath; Chills with low grade fever 100.7; rapid heartrate; lost taste and smell, nasal congestion with dryness; This is a spontaneous report from a contactable Other HCP (patient). This 45-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 18Dec2020 18:00 at single dose on the right arm for COVID-19 immunization. Medical history included connective tissue disorder. No allergies to medications, food, or other products. Concomitant medications were not reported. Facility that the most recent COVID-19 vaccine was administered in 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, the patient has been tested for COVID-19. The patient experienced tested on 16Dec2020 for COVID on rapid he was negative. Patient went and got the COVID vaccine on Friday. On 21Dec2020 01:00, patient had symptom early Sunday morning or shortness of breath. Chills with low grade fever 100.7 and a rapid heartrate. The same day patient lost his taste and smell, nasal congestion with dryness. Patient tested nasal swab (antigen rapid) on 20Dec2020: positive for strep and COVID. Outcome of the events was not recovered. Patient received treatment for the adverse event included doxcycline 100 mg and abutertol inhaler.; Sender's Comments: 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El0140), via an unspecified route of administration in the left arm on 23Dec2020 at 19:15 (at the age of 39-years-old) as a single dose for Covid-19 vaccination. Medical history included Fibromyalgia from an unknown date. The patient did not have any allergies to medications, or other products, was allergic to milk. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 09:30, the patient experienced sore arm. Therapeutic measures were not taken for the sore arm. The clinical outcome of the event sore arm was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El0140), via an unspecified route of administration in the left arm on 23Dec2020 at 19:15 (at the age of 39-years-old) as a single dose for Covid-19 vaccination. Medical history included Fibromyalgia from an unknown date. The patient did not have any allergies to medications, or other products, was allergic to milk. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 09:30, the patient experienced sore arm. Therapeutic measures were not taken for the sore arm. The clinical outcome of the event sore arm was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: "Pfizer-BioNTech COVID-19 Vaccine":  left-sided facial bell's palsy; facial drooping mostly resolved, minimal eye drooping on left side;  headache; Tylenol taken for headache; headache has resolved;left-sided sensitivity to loud noises; hearing sensitivity resolved
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hyperacusis
Clinical narrative: "Pfizer-BioNTech COVID-19 Vaccine":  left-sided facial bell's palsy; facial drooping mostly resolved, minimal eye drooping on left side;  headache; Tylenol taken for headache; headache has resolved;left-sided sensitivity to loud noises; hearing sensitivity resolved
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Chest X-ray normal, Chest discomfort, Chest pain, Gingival pain
Clinical narrative: delayed anaphylactic reaction; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines on the same day.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced delayed anaphylactic reaction. The clinical outcome of delayed anaphylactic reaction was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The delayed anaphylactic reaction was possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and the event features.  This 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gingival pruritus, Throat tightness, Troponin normal
Clinical narrative: delayed anaphylactic reaction; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines on the same day.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced delayed anaphylactic reaction. The clinical outcome of delayed anaphylactic reaction was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The delayed anaphylactic reaction was possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and the event features.  This 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Chest discomfort, Gingival discomfort, Gingival pain
Clinical narrative: delayed anaphylactic reaction; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines on the same day.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced delayed anaphylactic reaction. The clinical outcome of delayed anaphylactic reaction was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The delayed anaphylactic reaction was possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and the event features.  This 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face, Throat tightness
Clinical narrative: delayed anaphylactic reaction; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines on the same day.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced delayed anaphylactic reaction. The clinical outcome of delayed anaphylactic reaction was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The delayed anaphylactic reaction was possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and the event features.  This 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: delayed anaphylactic reaction; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines on the same day.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced delayed anaphylactic reaction. The clinical outcome of delayed anaphylactic reaction was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The delayed anaphylactic reaction was possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and the event features.  This 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: Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; Sore arm; This is a spontaneous report from a contactable Other healthcare professional (patient). A 63-year-old female patient received BNT162B2 (lot number EL0140) on 21Dec2020 2:30"pm on arm left at single dose for COVID-19 immunization. Medical history was none. Concomitant medications included multivitamin. She doesn't know if it is a side effect but today she has had vertigo that she has never had before, and a little bit of dizziness on and off. The vertigo started about 4:30am this morning (23Dec2020) when she got up to go to the bathroom. Everything was just spinning so she didn't go to the bathroom, she just laid down. She had it 2 more times but not anymore after that. Now she is just having some dizziness from time to time (Dec2020). She also specified that soreness is "normal" for her to experience "after injection". She has takes multivitamin but nothing that would be related to this event. She has just never had this happen before. It was given in his left upper biceps area. With previous vaccines she has had a sore arm but with this vaccine the sore arm wasn't that bad. It was sore that day (21Dec2020) and yesterday but today there is nothing, no soreness. She received no other vaccines that day or within 4 weeks of the vaccine. There is no significant family history. There have been no treatments for the events. The outcome of event vertigo and sore arm recovered on 23Dec2020. The outcome of event Dizziness was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity, Vertigo
Clinical narrative: Vertigo; Dizziness; Sore arm; This is a spontaneous report from a contactable Other healthcare professional (patient). A 63-year-old female patient received BNT162B2 (lot number EL0140) on 21Dec2020 2:30"pm on arm left at single dose for COVID-19 immunization. Medical history was none. Concomitant medications included multivitamin. She doesn't know if it is a side effect but today she has had vertigo that she has never had before, and a little bit of dizziness on and off. The vertigo started about 4:30am this morning (23Dec2020) when she got up to go to the bathroom. Everything was just spinning so she didn't go to the bathroom, she just laid down. She had it 2 more times but not anymore after that. Now she is just having some dizziness from time to time (Dec2020). She also specified that soreness is "normal" for her to experience "after injection". She has takes multivitamin but nothing that would be related to this event. She has just never had this happen before. It was given in his left upper biceps area. With previous vaccines she has had a sore arm but with this vaccine the sore arm wasn't that bad. It was sore that day (21Dec2020) and yesterday but today there is nothing, no soreness. She received no other vaccines that day or within 4 weeks of the vaccine. There is no significant family history. There have been no treatments for the events. The outcome of event vertigo and sore arm recovered on 23Dec2020. The outcome of event Dizziness was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Dizziness, Haemoglobin decreased, Nausea, Palpitations
Clinical narrative: Minutes after vaccine I experienced Tachycardia, dizziness, nausea.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia
Clinical narrative: Minutes after vaccine I experienced Tachycardia, dizziness, nausea.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Tachycardia
Clinical narrative: Minutes after vaccine I experienced Tachycardia, dizziness, nausea.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Nausea, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit; Left arm sore; Left arm was just a little swollen; A little swollen in her left underarm and armpit; Started getting hot and cold and hot and cold; Achy; Nauseous/Feeling like she was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration in the left arm, first dose on 19Dec2020 07:30 at a single dose for vaccination. Medical history included ongoing colitis ulcerative when she was 23 years old (1993), POTS (Postural Orthostatic Tachycardia Syndrome) from 2017 and ongoing, had thyroid problem, with heart medication.  Concomitant medication included prednisone, levothyroxine sodium (SYNTHROID), irbesartan, bisoprolol fumarate, fluticasone and potassium. The patient stopped prednisone about 4-5 days before COVID-19 Vaccine administered. She talked to her doctor about prednisone use and getting COVID-19 Vaccine, doctor told her to go ahead and get COVID-19 Vaccine. The patient is a Certified Nursing Assistant who received the Pfizer COVID-19 Vaccine at her place of employment on 19Dec2020. This was her first dose of 2 dose series of the vaccine. She reported after she received the vaccine injection, she had onset of 'achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, she started getting hot and cold and hot and cold, feeling like she was going to throw up and was running a temperature. She added that at the night of 19Dec2020 she felt achy and a little nauseous but it was not bad so she took some TYLENOL and she was feeling fine. She stayed at work Saturday. Starting morning of 20Dec2020 she woke up and her left arm felt like she had gotten a tetanus shot, left arm was sore and just a little swollen and she was a little swollen in her left underarm and armpit; she felt achy all over again; so she took some more TYLENOL and went to work and was feeling fine until about lunch time on 20Dec2020. Around lunch time on 20Dec2020, she started getting hot and cold and hot and cold, feeling like she was going to throw up; by about 4:30pm on 20Dec2020 she was running a temperature of 100.3 degrees Fahrenheit. The highest her temperature got up to last night was 101.9 degrees Fahrenheit. She took a Tylenol PM to knock her out to sleep because she was achy. The outcome of the events achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, started getting hot and cold and hot and cold, feeling like she was going to throw up, and she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit was recovering.  Information about Batch/Lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Feeling of body temperature change, Nausea, Oedema peripheral, Pain
Clinical narrative: she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit; Left arm sore; Left arm was just a little swollen; A little swollen in her left underarm and armpit; Started getting hot and cold and hot and cold; Achy; Nauseous/Feeling like she was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration in the left arm, first dose on 19Dec2020 07:30 at a single dose for vaccination. Medical history included ongoing colitis ulcerative when she was 23 years old (1993), POTS (Postural Orthostatic Tachycardia Syndrome) from 2017 and ongoing, had thyroid problem, with heart medication.  Concomitant medication included prednisone, levothyroxine sodium (SYNTHROID), irbesartan, bisoprolol fumarate, fluticasone and potassium. The patient stopped prednisone about 4-5 days before COVID-19 Vaccine administered. She talked to her doctor about prednisone use and getting COVID-19 Vaccine, doctor told her to go ahead and get COVID-19 Vaccine. The patient is a Certified Nursing Assistant who received the Pfizer COVID-19 Vaccine at her place of employment on 19Dec2020. This was her first dose of 2 dose series of the vaccine. She reported after she received the vaccine injection, she had onset of 'achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, she started getting hot and cold and hot and cold, feeling like she was going to throw up and was running a temperature. She added that at the night of 19Dec2020 she felt achy and a little nauseous but it was not bad so she took some TYLENOL and she was feeling fine. She stayed at work Saturday. Starting morning of 20Dec2020 she woke up and her left arm felt like she had gotten a tetanus shot, left arm was sore and just a little swollen and she was a little swollen in her left underarm and armpit; she felt achy all over again; so she took some more TYLENOL and went to work and was feeling fine until about lunch time on 20Dec2020. Around lunch time on 20Dec2020, she started getting hot and cold and hot and cold, feeling like she was going to throw up; by about 4:30pm on 20Dec2020 she was running a temperature of 100.3 degrees Fahrenheit. The highest her temperature got up to last night was 101.9 degrees Fahrenheit. She took a Tylenol PM to knock her out to sleep because she was achy. The outcome of the events achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, started getting hot and cold and hot and cold, feeling like she was going to throw up, and she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit was recovering.  Information about Batch/Lot number has been requested.