chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in left arm on 26Apr2021 at 10:00 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation at pharmacy/drug store. The patient's medical history and concomitant medications. It was reported that day of 1st dose, no ailment, no medications, "exceptional" rating for health insurance every year, never ever had and never will have a single addiction, never an injury or hospitalization, fit and mindful of nutrition never overweight. After 1st dose, began slight dizziness and reported via "V-safe" coc website and weekly text check-ups. The patient did not receive any treatment for the events. The outcome of the event was reported as not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: two days later the glands under my arm were swollen; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at vaccination was 46 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, two days later the glands under my arm were swollen. The reporter reported that, two days later the glands under my arm were swollen, I went to the doctor and he told me to take ibuprofen and to wait, it would go away on its own. I was scheduled to receive the second dose today and at the vaccination center they recognized me, and they told me that they could not minister the vaccine, that I had to speak to Pfizer so that you could tell me if I can receive it or not.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, Chills, Dizziness, Electrocardiogram, Malaise
Clinical narrative: I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Near death experience, Pyrexia, Tachycardia, Weight
Clinical narrative: I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Blood cholesterol, Blood glucose, Cardiac function test
Clinical narrative: I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Electrocardiogram, Feeling abnormal, Headache, Influenza
Clinical narrative: I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Physical examination, Pyrexia, Tachycardia
Clinical narrative: I thought I was going to die; first dose of Pfizer two days ago and I got a very sick/Very ill; tachycardia; nausea; dizziness; weakness; chills; Fever; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Jul2021 14:00 (Batch/Lot Number: FA7485), at the age of 58-years-old, as dose 1, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient received her first dose on 25Jul2021. On the same day on 25Jul2021, she got very sick, she experienced tachycardia, nausea, dizziness, weakness, chills, fever, and she fell very ill. She thought she was going to die. The onset was quick. She received the dose around 2pm and felt chills at around 8pm or 9pm. She asked if she should get the second dose or not. She was a healthy person. She doesn't take any medication, she doesn't have any underlying disease, her blood pressure, sugar, cholesterol, height and weight were normal, she was very healthy. She was asking if it is safe to get another dose, two weeks from the time of report. She stated that being a medical person, she has a little bit of knowledge, she expected them to be a little later but it was very quick and very intense and she's scared if she will have the second dose, she's scared she'll die. She thought she was going to lose consciousness. She read online the CDC and Pfizer about side effects, but she thought she would only have side effects after the second dose. She didn't know if it was okay to have side effects after first, she knew after second but wasn't sure after the first. She reported that her patients who have been vaccinated didn't have many complaints after first dose and most of their side effects occurred after the second dose. She had her lab test in April, she thinks it was her annual physical, on April or May. Everything was normal: cardiogram, blood work, sugar, cholesterol and everything was normal. She was in a good shape, she looks young, she exercises, and she is very healthy. She feels better but she was weak, weak and dizziness and she feels much better. She missed one day of her work. She took vitamin C and stayed in bed; she didn't take anything else. The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events namely "Near death experience, Malaise, Tachycardia, Nausea, dizziness, asthenia, chills and pyrexia"  cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: cycle began again (that's 7 days earlier); This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. 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 not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 02Apr2021 18:00 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization and on 09Apr2021, the patient experienced Menstrual cycle dysregulated, Delayed period, and Bled very heavily and outcome was not recovered. On an unspecified date, the patient experienced cycle began again (that's 7 days earlier). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: cycle began again (that's 7 days earlier); This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. 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 not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 02Apr2021 18:00 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization and on 09Apr2021, the patient experienced Menstrual cycle dysregulated, Delayed period, and Bled very heavily and outcome was not recovered. On an unspecified date, the patient experienced cycle began again (that's 7 days earlier). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle dysregulated; Delayed period; Bled very heavily; This is a spontaneous report from a contactable other healthcare professional, the patient. This is the first of two reports.  A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021 at 18:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. No concomitant medications were reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 09Apr2021, the patient experienced menstrual cycle dysregulated. The patient reported that her cycle was due on the day of the first dose but it was delayed by 7 days and once it initiated, she bled very heavily on 09Apr2021. The patient reported that she had a regular 26-to-28-day cycle prior to the vaccine. The clinical outcome of the event menstrual cycle dysregulated, delayed period and bled very heavily was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: Menstrual cycle dysregulated; Delayed period; Bled very heavily; This is a spontaneous report from a contactable other healthcare professional, the patient. This is the first of two reports.  A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021 at 18:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. No concomitant medications were reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 09Apr2021, the patient experienced menstrual cycle dysregulated. The patient reported that her cycle was due on the day of the first dose but it was delayed by 7 days and once it initiated, she bled very heavily on 09Apr2021. The patient reported that she had a regular 26-to-28-day cycle prior to the vaccine. The clinical outcome of the event menstrual cycle dysregulated, delayed period and bled very heavily was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Photosensitivity reaction
Clinical narrative: she experienced a flare up of her arthritis after being in the sun.; sun sensitivity; This is a spontaneous report received from a contactable consumer. A 7-decade-old (in her 60s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. Patient declined to provide exact age. Reported that after she had received the first dose of her Pfizer BioNtech covid 19 almost three weeks ago she had experienced a flare up of her arthritis after being in the sun. Seeking information if sun sensitivity had been reported with the Pfizer BioNtech covid 19 vaccine and wanted information about pericarditis following the Pfizer BioNtech covid 19 vaccine, whether it was more common in males or females. Patient again stated that she wanted to know had there been any reaction towards the sun for people who had received the vaccine. Clarified patient have received first dose of the vaccine and said she had some type of reaction but not quite sure if it was from the sun. The events were assessed as non-serious. The clinical outcome of events was unknown.  Information on lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Sore lymph node under same arm vaccine was administered.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) via an unspecified route of administration in the right arm on 23Jul2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 05Jul2021, the patient experienced sore lymph node under same arm in which vaccine was administered. No therapeutic measures were taken as a result of the adverse event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event sore lymph node under same arm in which vaccine was administered was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Sore throat; Cold symptoms; Fever of 101; Throwing up; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 23Jul2021 at 15:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (Adhd) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Jul2021 at 02:45, the patient experienced fever of 101 (units unspecified), throwing up, sore throat and cold symptoms. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event fever 101 (units unspecified), throwing up, sore throat and cold symptoms were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza, Malaise, Nasal congestion, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a contactable nurse. A 72-year-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the arm on 26Mar2021 at 11:00 (at the age of 71-years-old) (Batch/Lot Number: ER8732) single, for COVID-19 immunization (also reported as so she wouldn't get COVID and die). Medical history included ongoing neurogenic bladder and frequent UTI's (from 3 years ago; she was incontinent but could only half trust the first urologist so she switched to a specialist which was at another hospital). The patient's concomitant medications were not reported. The patient had no additional vaccines administered on the same date as the Pfizer vaccine considered as suspect and had no prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) via an unspecified route of administration, administered in the arm on 05Mar2021 at 11:00 (Batch/Lot Number: EN6205) single for COVID-19 immunization. The patient experienced suspected COVID-19 in 2021, wheezing on an unknown date, and flu symptoms, nasal congestion, cough, and malaise on 25Jul2021. The patient got the Pfizer vaccine back in Mar2021 and right now, as of last Sunday, she had felt like she was sick. She hadn't been sick in years. She had the flu symptoms, the stuffed up nose, the coughing, the whole bit. She was better, but not perfect yet. The patient confirmed that symptoms have improved. According to the patient, she lived in an apartment building where a number of people did not get vaccinated and she thinks that may be the cause of her sickness. Also stated that she had no external reaction to either one of the vaccines. The patient kept in mind that the air quality had gone directly gone downhill since the fires even though she was on the east coast and apparently their air quality had gone down which could be contributed to her experience because she's having some wheezing on an unspecified date. The events did not require a visit to the Emergency Room or Physician's office (sent a message on Monday and haven't heard back). On 04Aug2021, the patient reported that she had the vaccine and was having COVID symptoms. Outcome of the events 'suspected COVID-19' and wheezing was unknown, while for the rest of the events was recovering (also reported as ongoing).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: This is a spontaneous report from a contactable nurse. A 72-year-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the arm on 26Mar2021 at 11:00 (at the age of 71-years-old) (Batch/Lot Number: ER8732) single, for COVID-19 immunization (also reported as so she wouldn't get COVID and die). Medical history included ongoing neurogenic bladder and frequent UTI's (from 3 years ago; she was incontinent but could only half trust the first urologist so she switched to a specialist which was at another hospital). The patient's concomitant medications were not reported. The patient had no additional vaccines administered on the same date as the Pfizer vaccine considered as suspect and had no prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) via an unspecified route of administration, administered in the arm on 05Mar2021 at 11:00 (Batch/Lot Number: EN6205) single for COVID-19 immunization. The patient experienced suspected COVID-19 in 2021, wheezing on an unknown date, and flu symptoms, nasal congestion, cough, and malaise on 25Jul2021. The patient got the Pfizer vaccine back in Mar2021 and right now, as of last Sunday, she had felt like she was sick. She hadn't been sick in years. She had the flu symptoms, the stuffed up nose, the coughing, the whole bit. She was better, but not perfect yet. The patient confirmed that symptoms have improved. According to the patient, she lived in an apartment building where a number of people did not get vaccinated and she thinks that may be the cause of her sickness. Also stated that she had no external reaction to either one of the vaccines. The patient kept in mind that the air quality had gone directly gone downhill since the fires even though she was on the east coast and apparently their air quality had gone down which could be contributed to her experience because she's having some wheezing on an unspecified date. The events did not require a visit to the Emergency Room or Physician's office (sent a message on Monday and haven't heard back). On 04Aug2021, the patient reported that she had the vaccine and was having COVID symptoms. Outcome of the events 'suspected COVID-19' and wheezing was unknown, while for the rest of the events was recovering (also reported as ongoing).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic Reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 07Apr2021 15:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history included drug allergy to iodine diagnostic agents. Concomitant medications the patient received within 2 weeks of vaccination included multivitamin and ipratropium bromide nasal spray. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and cefdinir, both had drug allergy; previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 12Mar2021 15:30 (at the age of 50-year-old) for COVID-19 immunization. The patient experienced anaphylactic reaction on 09Apr2021 07:00. Patient received treatment and caused emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tenderness in arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in left arm on 27Jul2021 at 15:00 (at the age of 28-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) and fish oil (OMEGA 3) pills; both for unknown indications from an unknown start date. The patient previously received minocycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Jul2021, the patient experienced tenderness in arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tenderness in arm was unknown at the time of this report.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: given a vaccine on 26Jul2021, it was undiluted; One of the patient at the pharmacy received an undiluted vaccine as the first dose on 26Jul2021; This is a spontaneous report received from a contactable consumer from a Pfizer-sponsored program. A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the right arm on 26Jul2021 at 14:45 (Batch/lot number: FA7485; Expiration Date: Oct 2021) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. Family medical history relevant to AE(s) was unknown. Relevant tests was none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Investigation assessment was unknown. The report was not related to a study or program. On 26Jul2021, the patient received an undiluted vaccine as the first dose. Reporter wanted to know if the patient need to restart vaccination series or not, and whether the patient would to be have a schedule for the 2nd dose. Reporter was looking for guidance. The reason of the patient taken Pfizer COVID 19 vaccine was unknown. Last time the patient was talked to yesterday, he was still feeling fine, and that was a few hours after the vaccine was given. The events were not required emergency room and physician office. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Illness, Malaise
Clinical narrative: allergic reaction to the cream; it made her sick for a while; was just not feeling well; This is a spontaneous report received from a contactable consumer (Patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. Medical history included ongoing skin cancer. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction to the cream, it made her sick for a while and was just not feeling well. She got her first Pfizer covid vaccine but then she had a lot of stuff come up physically like she has skin cancer and she had an allergic reaction to the cream she was given for it and it made her sick for a while, then she was just not feeling well. Now she felt better and wanted to get the second dose. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Plasma cell myeloma
Clinical narrative: multiple myeloma; This is a spontaneous report from a contactable consumer (patient's daughter). An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had both sets of Pfizer and was fine and had no reaction period. A couple weeks later, he was diagnosed with multiple myeloma. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph swelling in the breast; This is a spontaneous report from Pfizer sponsored program. A contactable Other HCP reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lymph swelling in the breast on an un-specified date. Reported as AE for reports of lymphadenopathy and extended menses in two female recipients of the Pfizer BioNTech Covid-19 Vaccine. Call received as transfer from (name withheld). she is a physical therapist with questions about the Pfizer BioNTech Covid-19 Vaccine. she just had a baby, and she has not gotten vaccinated yet. she knows two other health care providers who have received this vaccine; one of them had lymph swelling in the breast and one of them had an extended period. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve injury, Paraesthesia
Clinical narrative: tingling on the left side of his face and left fingers/numbness and tingling on the left side of my face; numbness and tingling on the left side of my face; nerve issue in my face / my nerve were damaged from a previous cavernoma bleed; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC, UPC number: Unknown), via an unspecified route of administration on 25Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cavernoma from an unknown date and unknown if ongoing, and reported as, I have a Cavernoma in my brain. I am getting the vaccine and let the vaccine that just causing some sort of nerve issue in my face where my nerve were damaged from a previous cavernoma bleed. No concomitant medications were reported. The patient reports he received the first dose of Pfizer covid vaccine 25Jul2021 and immediately started experiencing tingling on the left side of his face and left fingers. Caller reports he has a condition Cavernoma. The patient further stated as, "So, I got the Pfizer BioNTech (captured as COVID 19 Vaccine) on Sunday and on an unspecified date in Jul2021, the patient had some numbness and tingling on the left side of face. I have a Cavernoma in my brain, so it seems like these two might be related because it would be very hard for me to have a bleed from my cavernoma at the same time I am getting the vaccine and on an unknown date, let the vaccine 'that's' just causing some sort of nerve issue in my face where my nerve were damaged from a previous cavernoma bleed. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, Snoring
Clinical narrative: cough; lot of running nose with that medication; snore; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 23Jul2021 at age of 57 years old as single dose for COVID-19 immunisation. Medical history included blood pressure problems and cholesterol medicine. Concomitant medications included metoprolol for blood pressure, atorvastatin for cholesterol. The patient reported runny nose and cough (caller not sure if she noted symptoms on Saturday or Sunday after the vaccination) seemed to be getting worse, wanted to know if that was normal. The patient had lot of running nose with that medication. So, she needed to act on that. When probed for the side effect with the COVID-19 Vaccine: the patient stated, "I have been very snore and my nose were running a lot." The patient had runny nose and coughing on 24Jul2021. As it started a couple of days she will say it was between Saturday and Sunday. Somewhere roughly late now because she thought it's going to get better but it seen to be getting be worst to her with the running nose. It started with the running nose and coughing and now she had a lot of runny nose. The patient was supposed to go back at 20Aug for the 2nd shot. About treatment, the patient had nothing for the runny nose. The patient had been taking for cough, coughing, taking cough drops just taking regular the cough drops. The patient did not take any other vaccine prior to the first COVID-19 Vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2 ], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: feel so sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Pfizer sponsored program COVAX Support. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 30Jun2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient took first dose of covax on 30Jun2021 had not done second dose because she stated it made her feel so sick on an unspecified date in 2021. Medical Information included customer and/or medical inquiry was not forwarded or referred to MI. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia, Tremor
Clinical narrative: shaking in her hands that felt like she is nervous; shaking in her hands that felt like she is nervous; She also experience some hard tingling on her right ankle.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Jul2021 (Batch/Lot number: not reported) (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Jul2021, the patient experienced shaking in her hands that felt like she was nervous and also similar to that when she had a coffee. She also experienced some hard tingling on her right ankle. As of the moment, she had calmed down and had been okay. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: pt c/o fatigue and general decline in energy; pt c/o fatigue and general decline in energy; This is a spontaneous report from a contactable healthcare professional. A 88-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Feb2021 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as hypothyroid), hypertension (reported as htn), high cholesterol (reported as high chol), Gastro-oesophageal reflux disease (gerd) and osteoporosis. It was not reported if the patient received any medication within two weeks of vaccination. The patient previously took cefalexin (KEFLEX) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient complained of fatigue and general decline in energy on an an unknown date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fatigue and general decline in energy was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.