chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Fever of 100.2; swelling at the injection site; Vomiting; Diarrhea; redness at the injection site; injection site warm to touch; This is a spontaneous report from a contactable Nurse (patient mother). This is the second of four reports. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right arm on 31Aug2021 at 08:00 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number EW0182) on 10Aug2021 at around 11:00 am in the left arm for COVID-19 immunisation. The patient had none with the first dose. Medical history included profoundly autistic and non-verbal and non-communitive since he was 1 year old. The patient's concomitant medications were not reported. On 31Aug2021 at 08:45 the patient experienced fever of 100.2, extreme swelling and redness at the injection site and is warm to touch, vomiting and diarrhea. The events were reported as serious (medically significant) and related to suspect product. No treatments received for the events. The outcome of events was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pyrexia, Vaccination site swelling, Vomiting, Diarrhoea, Vaccination site erythema, and Vaccina-tion site warmth and BNT162B2.  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: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Fever of 100.2; swelling at the injection site; Vomiting; Diarrhea; redness at the injection site; injection site warm to touch; This is a spontaneous report from a contactable Nurse (patient mother). This is the second of four reports. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right arm on 31Aug2021 at 08:00 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number EW0182) on 10Aug2021 at around 11:00 am in the left arm for COVID-19 immunisation. The patient had none with the first dose. Medical history included profoundly autistic and non-verbal and non-communitive since he was 1 year old. The patient's concomitant medications were not reported. On 31Aug2021 at 08:45 the patient experienced fever of 100.2, extreme swelling and redness at the injection site and is warm to touch, vomiting and diarrhea. The events were reported as serious (medically significant) and related to suspect product. No treatments received for the events. The outcome of events was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pyrexia, Vaccination site swelling, Vomiting, Diarrhoea, Vaccination site erythema, and Vaccina-tion site warmth and BNT162B2.  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: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Fever; swelling redness at injection site; swelling redness at injection site; He was not able to move his arm as much as he was after the first shot; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is the 3rd of 4 reports. A 32-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in right arm on 31Aug2021 08:00, at 32 years of age, (Batch/Lot Number: EW0191) as single dose for COVID-19 immunization. Medical history included ongoing autism. There were no concomitant medications. Historical vaccine included the first dose of the BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot: EW0182, administered on 10Aug2021 at around 11:00 AM in the left arm. On 31Aug2021, about 45 minutes after getting the shot, the patient experienced fever of 100.9 and swelling and redness at injection site and he was not able to move his arm as much as he was after the first shot. On the same day and time, the patient also experienced vomiting and diarrhea. A visit to Emergency Room or Physician Office was not required. No relevant test was performed. No treatment was administered. At the time of the report the reported events had not resolved yet. All the events were assessed as related to BNT162B2 by the reporting nurse.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pyrexia , Vaccination site swelling, Vaccination site erythema, Vaccination site movement impairment, Vomiting, Diarrhoea cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; swelling redness at injection site; swelling redness at injection site; He was not able to move his arm as much as he was after the first shot; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is the 3rd of 4 reports. A 32-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in right arm on 31Aug2021 08:00, at 32 years of age, (Batch/Lot Number: EW0191) as single dose for COVID-19 immunization. Medical history included ongoing autism. There were no concomitant medications. Historical vaccine included the first dose of the BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot: EW0182, administered on 10Aug2021 at around 11:00 AM in the left arm. On 31Aug2021, about 45 minutes after getting the shot, the patient experienced fever of 100.9 and swelling and redness at injection site and he was not able to move his arm as much as he was after the first shot. On the same day and time, the patient also experienced vomiting and diarrhea. A visit to Emergency Room or Physician Office was not required. No relevant test was performed. No treatment was administered. At the time of the report the reported events had not resolved yet. All the events were assessed as related to BNT162B2 by the reporting nurse.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pyrexia , Vaccination site swelling, Vaccination site erythema, Vaccination site movement impairment, Vomiting, Diarrhoea cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vaccination site erythema, Vaccination site movement impairment
Clinical narrative: Fever; swelling redness at injection site; swelling redness at injection site; He was not able to move his arm as much as he was after the first shot; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is the 3rd of 4 reports. A 32-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in right arm on 31Aug2021 08:00, at 32 years of age, (Batch/Lot Number: EW0191) as single dose for COVID-19 immunization. Medical history included ongoing autism. There were no concomitant medications. Historical vaccine included the first dose of the BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot: EW0182, administered on 10Aug2021 at around 11:00 AM in the left arm. On 31Aug2021, about 45 minutes after getting the shot, the patient experienced fever of 100.9 and swelling and redness at injection site and he was not able to move his arm as much as he was after the first shot. On the same day and time, the patient also experienced vomiting and diarrhea. A visit to Emergency Room or Physician Office was not required. No relevant test was performed. No treatment was administered. At the time of the report the reported events had not resolved yet. All the events were assessed as related to BNT162B2 by the reporting nurse.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pyrexia , Vaccination site swelling, Vaccination site erythema, Vaccination site movement impairment, Vomiting, Diarrhoea cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Fever; swelling redness at injection site; swelling redness at injection site; He was not able to move his arm as much as he was after the first shot; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is the 3rd of 4 reports. A 32-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in right arm on 31Aug2021 08:00, at 32 years of age, (Batch/Lot Number: EW0191) as single dose for COVID-19 immunization. Medical history included ongoing autism. There were no concomitant medications. Historical vaccine included the first dose of the BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot: EW0182, administered on 10Aug2021 at around 11:00 AM in the left arm. On 31Aug2021, about 45 minutes after getting the shot, the patient experienced fever of 100.9 and swelling and redness at injection site and he was not able to move his arm as much as he was after the first shot. On the same day and time, the patient also experienced vomiting and diarrhea. A visit to Emergency Room or Physician Office was not required. No relevant test was performed. No treatment was administered. At the time of the report the reported events had not resolved yet. All the events were assessed as related to BNT162B2 by the reporting nurse.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pyrexia , Vaccination site swelling, Vaccination site erythema, Vaccination site movement impairment, Vomiting, Diarrhoea cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression, Asthenia, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Fever; he was more combative when he got home, unusually so; arm at injection site was warm to touch with edema and swelling that increased; Vomiting; Diarrhea; arm at injection site was warm to touch with edema and swelling that increased; arm at injection site was warm to touch with edema and swelling that increased; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is for 4 of 4 patients.   This nurse reported for a 25-year-old male patient that received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Aug2021 08:00 (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing autism spectrum disorder (autistic and non verbal). There were no concomitant medications.  Historical vaccine included First dose of Comirnaty, on 10Aug2021 given at around 11:00 am in the left arm, Lot: EW0182.  The patient experienced fever (medically significant) on 31Aug2021 with outcome of not recovered , aggression (he was more combative when he got home, unusually so) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was warm to touch (vaccination site warmth) (medically significant) on 31Aug2021 with outcome of not recovered , vomiting (medically significant) on 31Aug2021 with outcome of not recovered , diarrhea (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was with edema (vaccination site oedema) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was swelling that increased (vaccination site swelling) (medically significant) on 31Aug2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100.9  on 31Aug2021 Fever of 100.9- started about 45 minutes after getting the shot and is ongoing.    The reporter considered all adverse events related to Comirnaty; Sender's Comments: Based on the strong temporal relationship and known drug safety profile the causal association between the events fever, vomiting, diarrhea, vaccination site edema and vaccination site swelling were assessed as related to the usage of the vaccine BNT162B2 and the events aggression and vaccination site warmth were considered as related based on strong temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; he was more combative when he got home, unusually so; arm at injection site was warm to touch with edema and swelling that increased; Vomiting; Diarrhea; arm at injection site was warm to touch with edema and swelling that increased; arm at injection site was warm to touch with edema and swelling that increased; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is for 4 of 4 patients.   This nurse reported for a 25-year-old male patient that received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Aug2021 08:00 (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing autism spectrum disorder (autistic and non verbal). There were no concomitant medications.  Historical vaccine included First dose of Comirnaty, on 10Aug2021 given at around 11:00 am in the left arm, Lot: EW0182.  The patient experienced fever (medically significant) on 31Aug2021 with outcome of not recovered , aggression (he was more combative when he got home, unusually so) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was warm to touch (vaccination site warmth) (medically significant) on 31Aug2021 with outcome of not recovered , vomiting (medically significant) on 31Aug2021 with outcome of not recovered , diarrhea (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was with edema (vaccination site oedema) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was swelling that increased (vaccination site swelling) (medically significant) on 31Aug2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100.9  on 31Aug2021 Fever of 100.9- started about 45 minutes after getting the shot and is ongoing.    The reporter considered all adverse events related to Comirnaty; Sender's Comments: Based on the strong temporal relationship and known drug safety profile the causal association between the events fever, vomiting, diarrhea, vaccination site edema and vaccination site swelling were assessed as related to the usage of the vaccine BNT162B2 and the events aggression and vaccination site warmth were considered as related based on strong temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression, Body temperature, Diarrhoea, Pyrexia, Vaccination site oedema
Clinical narrative: Fever; he was more combative when he got home, unusually so; arm at injection site was warm to touch with edema and swelling that increased; Vomiting; Diarrhea; arm at injection site was warm to touch with edema and swelling that increased; arm at injection site was warm to touch with edema and swelling that increased; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is for 4 of 4 patients.   This nurse reported for a 25-year-old male patient that received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Aug2021 08:00 (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing autism spectrum disorder (autistic and non verbal). There were no concomitant medications.  Historical vaccine included First dose of Comirnaty, on 10Aug2021 given at around 11:00 am in the left arm, Lot: EW0182.  The patient experienced fever (medically significant) on 31Aug2021 with outcome of not recovered , aggression (he was more combative when he got home, unusually so) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was warm to touch (vaccination site warmth) (medically significant) on 31Aug2021 with outcome of not recovered , vomiting (medically significant) on 31Aug2021 with outcome of not recovered , diarrhea (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was with edema (vaccination site oedema) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was swelling that increased (vaccination site swelling) (medically significant) on 31Aug2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100.9  on 31Aug2021 Fever of 100.9- started about 45 minutes after getting the shot and is ongoing.    The reporter considered all adverse events related to Comirnaty; Sender's Comments: Based on the strong temporal relationship and known drug safety profile the causal association between the events fever, vomiting, diarrhea, vaccination site edema and vaccination site swelling were assessed as related to the usage of the vaccine BNT162B2 and the events aggression and vaccination site warmth were considered as related based on strong temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: Fever; he was more combative when he got home, unusually so; arm at injection site was warm to touch with edema and swelling that increased; Vomiting; Diarrhea; arm at injection site was warm to touch with edema and swelling that increased; arm at injection site was warm to touch with edema and swelling that increased; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients. This report is for 4 of 4 patients.   This nurse reported for a 25-year-old male patient that received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Aug2021 08:00 (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing autism spectrum disorder (autistic and non verbal). There were no concomitant medications.  Historical vaccine included First dose of Comirnaty, on 10Aug2021 given at around 11:00 am in the left arm, Lot: EW0182.  The patient experienced fever (medically significant) on 31Aug2021 with outcome of not recovered , aggression (he was more combative when he got home, unusually so) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was warm to touch (vaccination site warmth) (medically significant) on 31Aug2021 with outcome of not recovered , vomiting (medically significant) on 31Aug2021 with outcome of not recovered , diarrhea (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was with edema (vaccination site oedema) (medically significant) on 31Aug2021 with outcome of not recovered , arm at injection site was swelling that increased (vaccination site swelling) (medically significant) on 31Aug2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 100.9  on 31Aug2021 Fever of 100.9- started about 45 minutes after getting the shot and is ongoing.    The reporter considered all adverse events related to Comirnaty; Sender's Comments: Based on the strong temporal relationship and known drug safety profile the causal association between the events fever, vomiting, diarrhea, vaccination site edema and vaccination site swelling were assessed as related to the usage of the vaccine BNT162B2 and the events aggression and vaccination site warmth were considered as related based on strong temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysgeusia, Electrocardiogram ambulatory, Laboratory test, Palpitations
Clinical narrative: ER visit on 29Aug21 confirmed arrhythmia; Metallic taste in mouth within minutes of vaccine; followed by tachycardia on and off since then; This is a spontaneous report from a contactable other healthcare professional (HCP, patient) reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 (Batch/Lot Number: FD8448) as dose 2, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included migraines and scoliosis. Patient is not pregnant. No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Patient previously took the first dose of BNT162B2 (Lot number=EW0183) on left arm on 05Aug2021 at 42-year-old for COVID-19 immunisation. Patient experienced metallic taste in mouth within minutes of vaccine followed by tachycardia on and off since then. ER visit on 29Aug21 confirmed arrhythmia. Referred to cardiologist for follow up. events start date was 26Aug2021 and resulted in Emergency room/department or urgent care. No COVID prior vaccination, No COVID tested post vaccination. Treatment received for the event included IV Fluids and testing. Patient was not recovered from the events.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event Arrhythmia and the suspect drug BNT162B2 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: ER visit on 29Aug21 confirmed arrhythmia; Metallic taste in mouth within minutes of vaccine; followed by tachycardia on and off since then; This is a spontaneous report from a contactable other healthcare professional (HCP, patient) reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 (Batch/Lot Number: FD8448) as dose 2, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included migraines and scoliosis. Patient is not pregnant. No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Patient previously took the first dose of BNT162B2 (Lot number=EW0183) on left arm on 05Aug2021 at 42-year-old for COVID-19 immunisation. Patient experienced metallic taste in mouth within minutes of vaccine followed by tachycardia on and off since then. ER visit on 29Aug21 confirmed arrhythmia. Referred to cardiologist for follow up. events start date was 26Aug2021 and resulted in Emergency room/department or urgent care. No COVID prior vaccination, No COVID tested post vaccination. Treatment received for the event included IV Fluids and testing. Patient was not recovered from the events.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event Arrhythmia and the suspect drug BNT162B2 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Dysgeusia, Electrocardiogram, Tachycardia
Clinical narrative: ER visit on 29Aug21 confirmed arrhythmia; Metallic taste in mouth within minutes of vaccine; followed by tachycardia on and off since then; This is a spontaneous report from a contactable other healthcare professional (HCP, patient) reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 (Batch/Lot Number: FD8448) as dose 2, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included migraines and scoliosis. Patient is not pregnant. No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Patient previously took the first dose of BNT162B2 (Lot number=EW0183) on left arm on 05Aug2021 at 42-year-old for COVID-19 immunisation. Patient experienced metallic taste in mouth within minutes of vaccine followed by tachycardia on and off since then. ER visit on 29Aug21 confirmed arrhythmia. Referred to cardiologist for follow up. events start date was 26Aug2021 and resulted in Emergency room/department or urgent care. No COVID prior vaccination, No COVID tested post vaccination. Treatment received for the event included IV Fluids and testing. Patient was not recovered from the events.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event Arrhythmia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Pruritus, Urticaria
Clinical narrative: itching behind the neck/Itching continued, worsened and moved to arms, thighs, and face; At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat".; feeling like she has "frog in her throat".; Hives start to show on her face; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A non-pregnant 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 33 years, on 31Aug2021 18:45 (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes known allergies to sulfa. No COVID prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient historically received Flu vaccine for immunisation and experienced allergies on unspecified date. The patient previously received amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced known allergies. On 31Aug2021 07:00 PM, symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, (name withheld) who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl. Patient was taken to University of (Institution name withheld) hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat". Hives continued to worsen spreading to arms and neck area. AE resulted in emergency room/department or urgent care. Patient had evaluation in emergency room, IV/PO medications. COVID not tested post vaccination. Facility type vaccine was at pharmacy or drug store. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect product BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 (Batch/Lot Number: FC3182) to reported events, cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Pruritus, Speech disorder, Urticaria
Clinical narrative: itching behind the neck/Itching continued, worsened and moved to arms, thighs, and face; At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat".; feeling like she has "frog in her throat".; Hives start to show on her face; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A non-pregnant 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 33 years, on 31Aug2021 18:45 (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes known allergies to sulfa. No COVID prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient historically received Flu vaccine for immunisation and experienced allergies on unspecified date. The patient previously received amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced known allergies. On 31Aug2021 07:00 PM, symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, (name withheld) who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl. Patient was taken to University of (Institution name withheld) hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat". Hives continued to worsen spreading to arms and neck area. AE resulted in emergency room/department or urgent care. Patient had evaluation in emergency room, IV/PO medications. COVID not tested post vaccination. Facility type vaccine was at pharmacy or drug store. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect product BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 (Batch/Lot Number: FC3182) to reported events, cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: itching behind the neck/Itching continued, worsened and moved to arms, thighs, and face; At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat".; feeling like she has "frog in her throat".; Hives start to show on her face; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A non-pregnant 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 33 years, on 31Aug2021 18:45 (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes known allergies to sulfa. No COVID prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient historically received Flu vaccine for immunisation and experienced allergies on unspecified date. The patient previously received amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced known allergies. On 31Aug2021 07:00 PM, symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, (name withheld) who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl. Patient was taken to University of (Institution name withheld) hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat". Hives continued to worsen spreading to arms and neck area. AE resulted in emergency room/department or urgent care. Patient had evaluation in emergency room, IV/PO medications. COVID not tested post vaccination. Facility type vaccine was at pharmacy or drug store. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect product BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 (Batch/Lot Number: FC3182) to reported events, cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphonia, Headache, Hypersensitivity, Lymphadenopathy
Clinical narrative: itching behind the neck/Itching continued, worsened and moved to arms, thighs, and face; At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat".; feeling like she has "frog in her throat".; Hives start to show on her face; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A non-pregnant 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 33 years, on 31Aug2021 18:45 (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes known allergies to sulfa. No COVID prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient historically received Flu vaccine for immunisation and experienced allergies on unspecified date. The patient previously received amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced known allergies. On 31Aug2021 07:00 PM, symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, (name withheld) who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl. Patient was taken to University of (Institution name withheld) hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat". Hives continued to worsen spreading to arms and neck area. AE resulted in emergency room/department or urgent care. Patient had evaluation in emergency room, IV/PO medications. COVID not tested post vaccination. Facility type vaccine was at pharmacy or drug store. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect product BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 (Batch/Lot Number: FC3182) to reported events, cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching behind the neck/Itching continued, worsened and moved to arms, thighs, and face; At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat".; feeling like she has "frog in her throat".; Hives start to show on her face; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A non-pregnant 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 33 years, on 31Aug2021 18:45 (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes known allergies to sulfa. No COVID prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient historically received Flu vaccine for immunisation and experienced allergies on unspecified date. The patient previously received amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced known allergies. On 31Aug2021 07:00 PM, symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, (name withheld) who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl. Patient was taken to University of (Institution name withheld) hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has "frog in her throat". Hives continued to worsen spreading to arms and neck area. AE resulted in emergency room/department or urgent care. Patient had evaluation in emergency room, IV/PO medications. COVID not tested post vaccination. Facility type vaccine was at pharmacy or drug store. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect product BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 (Batch/Lot Number: FC3182) to reported events, cannot be excluded.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Erythema, Full blood count normal, Headache, Henoch-Schonlein purpura
Clinical narrative: HSP; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 04:45 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE, vaccinated at the age of 13 years old, for covid-19 immunisation. Medical history included asthma, attention deficit hyperactivity disorder, scoliosis. Concomitant medications included methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient experienced hsp (henoch-schonlein purpura) on 08Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included PCR: negative on 25Aug2021. Treatment included Steroids. Event resulted in Emergency room/department or urgent care.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Red blood cell sedimentation rate normal, Urine analysis, Vasculitic rash
Clinical narrative: HSP; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 04:45 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE, vaccinated at the age of 13 years old, for covid-19 immunisation. Medical history included asthma, attention deficit hyperactivity disorder, scoliosis. Concomitant medications included methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient experienced hsp (henoch-schonlein purpura) on 08Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included PCR: negative on 25Aug2021. Treatment included Steroids. Event resulted in Emergency room/department or urgent care.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Henoch-Schonlein purpura, Polymerase chain reaction
Clinical narrative: HSP; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 04:45 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE, vaccinated at the age of 13 years old, for covid-19 immunisation. Medical history included asthma, attention deficit hyperactivity disorder, scoliosis. Concomitant medications included methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient experienced hsp (henoch-schonlein purpura) on 08Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included PCR: negative on 25Aug2021. Treatment included Steroids. Event resulted in Emergency room/department or urgent care.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Feeling cold, Muscle fatigue, Pain in extremity
Clinical narrative: I had a very cold sensation in the middle of my chest/then my lower legs have a on and off cold sensation; tingling; numbness; irritating bilateral pain; This is a spontaneous report from a contactable consumer, other healthcare professional. This 35-year-old female consumer (patient) reported for herself. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3181), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 08:45 (at the age of 35-years-old) as a single dose for covid-19 immunization. Medical history included retinal detachment, chronic inflammatory demyelinating polyradiculoneuropathy CIDP, unevaluable event- reaction to Gardasil vaccine. There were no concomitant medications. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Aug2021 09:00, In the first 5 minutes, the patient had a very cold sensation in the middle of her chest with tingling and numbness down the left side of her arm to her fingertips. After 40 minutes that resolved and then her lower legs have a on and off cold sensation with irritating bilateral pains that have become worse each day. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Outcome of the event was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, X-ray
Clinical narrative: I had a very cold sensation in the middle of my chest/then my lower legs have a on and off cold sensation; tingling; numbness; irritating bilateral pain; This is a spontaneous report from a contactable consumer, other healthcare professional. This 35-year-old female consumer (patient) reported for herself. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3181), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 08:45 (at the age of 35-years-old) as a single dose for covid-19 immunization. Medical history included retinal detachment, chronic inflammatory demyelinating polyradiculoneuropathy CIDP, unevaluable event- reaction to Gardasil vaccine. There were no concomitant medications. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Aug2021 09:00, In the first 5 minutes, the patient had a very cold sensation in the middle of her chest with tingling and numbness down the left side of her arm to her fingertips. After 40 minutes that resolved and then her lower legs have a on and off cold sensation with irritating bilateral pains that have become worse each day. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Outcome of the event was not recovered.