chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Diarrhoea, Dizziness, Flushing
Clinical narrative: 15 minutes following vaccine "I" started getting tingling in "my" 3 outer fingers on left hand.; little numbness in "my" left wrist, hand and forearm; numbness in teeth; That evening "I" also felt tingling in my mouth, lips, tongue; head flushing (about 5 days); diarrhea (one day); lightheaded (5 days); "I" have a burning sensation on both calves and ankles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 19Aug2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history included urticaria, allergy to dairy, egg and sesame. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), tocopherol (VITAMIN E), B-Complex (unspecified) and magnesium lactate/pyridoxine hydrochloride (MAGNES), all for unknown indications from unknown dates and unknown if ongoing. On 19Aug2021 at 15:15, 15 minutes following vaccine, the patient started getting tingling in her 3 outer fingers on left hand followed by a little numbness in her left wrist, hand and forearm and on that evening, she also felt tingling in her mouth, lips, tongue and numbness in teeth. On an unknown date in Aug2021, the patient had additional complaints which were head flushing (about 5 days), diarrhea (one day) and lightheaded (5 days). It had been almost two weeks and the tingling/numbness continues off and on in both hands, fingers, forearms, wrists and teeth. On an unknown date in Aug2021, the patient had a burning sensation on both calves and ankles. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, head flushing and lightheaded were resolved on an unknown date in Aug2021. The clinical outcome of the events burning sensation on both calves and ankles, tingling in 3 outer fingers on left hand, tingling in mouth, lips, tongue, numbness in left wrist, hand and forearm and numbness in teeth were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: 15 minutes following vaccine "I" started getting tingling in "my" 3 outer fingers on left hand.; little numbness in "my" left wrist, hand and forearm; numbness in teeth; That evening "I" also felt tingling in my mouth, lips, tongue; head flushing (about 5 days); diarrhea (one day); lightheaded (5 days); "I" have a burning sensation on both calves and ankles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 19Aug2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history included urticaria, allergy to dairy, egg and sesame. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), tocopherol (VITAMIN E), B-Complex (unspecified) and magnesium lactate/pyridoxine hydrochloride (MAGNES), all for unknown indications from unknown dates and unknown if ongoing. On 19Aug2021 at 15:15, 15 minutes following vaccine, the patient started getting tingling in her 3 outer fingers on left hand followed by a little numbness in her left wrist, hand and forearm and on that evening, she also felt tingling in her mouth, lips, tongue and numbness in teeth. On an unknown date in Aug2021, the patient had additional complaints which were head flushing (about 5 days), diarrhea (one day) and lightheaded (5 days). It had been almost two weeks and the tingling/numbness continues off and on in both hands, fingers, forearms, wrists and teeth. On an unknown date in Aug2021, the patient had a burning sensation on both calves and ankles. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, head flushing and lightheaded were resolved on an unknown date in Aug2021. The clinical outcome of the events burning sensation on both calves and ankles, tingling in 3 outer fingers on left hand, tingling in mouth, lips, tongue, numbness in left wrist, hand and forearm and numbness in teeth were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Diarrhoea, Dizziness, Flushing, Hypoaesthesia
Clinical narrative: 15 minutes following vaccine "I" started getting tingling in "my" 3 outer fingers on left hand.; little numbness in "my" left wrist, hand and forearm; numbness in teeth; That evening "I" also felt tingling in my mouth, lips, tongue; head flushing (about 5 days); diarrhea (one day); lightheaded (5 days); "I" have a burning sensation on both calves and ankles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 19Aug2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history included urticaria, allergy to dairy, egg and sesame. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), tocopherol (VITAMIN E), B-Complex (unspecified) and magnesium lactate/pyridoxine hydrochloride (MAGNES), all for unknown indications from unknown dates and unknown if ongoing. On 19Aug2021 at 15:15, 15 minutes following vaccine, the patient started getting tingling in her 3 outer fingers on left hand followed by a little numbness in her left wrist, hand and forearm and on that evening, she also felt tingling in her mouth, lips, tongue and numbness in teeth. On an unknown date in Aug2021, the patient had additional complaints which were head flushing (about 5 days), diarrhea (one day) and lightheaded (5 days). It had been almost two weeks and the tingling/numbness continues off and on in both hands, fingers, forearms, wrists and teeth. On an unknown date in Aug2021, the patient had a burning sensation on both calves and ankles. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, head flushing and lightheaded were resolved on an unknown date in Aug2021. The clinical outcome of the events burning sensation on both calves and ankles, tingling in 3 outer fingers on left hand, tingling in mouth, lips, tongue, numbness in left wrist, hand and forearm and numbness in teeth were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia teeth, Paraesthesia, Paraesthesia oral
Clinical narrative: 15 minutes following vaccine "I" started getting tingling in "my" 3 outer fingers on left hand.; little numbness in "my" left wrist, hand and forearm; numbness in teeth; That evening "I" also felt tingling in my mouth, lips, tongue; head flushing (about 5 days); diarrhea (one day); lightheaded (5 days); "I" have a burning sensation on both calves and ankles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 19Aug2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history included urticaria, allergy to dairy, egg and sesame. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), tocopherol (VITAMIN E), B-Complex (unspecified) and magnesium lactate/pyridoxine hydrochloride (MAGNES), all for unknown indications from unknown dates and unknown if ongoing. On 19Aug2021 at 15:15, 15 minutes following vaccine, the patient started getting tingling in her 3 outer fingers on left hand followed by a little numbness in her left wrist, hand and forearm and on that evening, she also felt tingling in her mouth, lips, tongue and numbness in teeth. On an unknown date in Aug2021, the patient had additional complaints which were head flushing (about 5 days), diarrhea (one day) and lightheaded (5 days). It had been almost two weeks and the tingling/numbness continues off and on in both hands, fingers, forearms, wrists and teeth. On an unknown date in Aug2021, the patient had a burning sensation on both calves and ankles. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, head flushing and lightheaded were resolved on an unknown date in Aug2021. The clinical outcome of the events burning sensation on both calves and ankles, tingling in 3 outer fingers on left hand, tingling in mouth, lips, tongue, numbness in left wrist, hand and forearm and numbness in teeth were not resolved at the time of this report.
Age: 82.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Back pain, Feeling abnormal, Hypertension
Clinical narrative: Low back pain; BP was too high; The patient felt weird; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1683196-1), reported by other health professional and concerned an 82-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies.  On 08-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312827.  On the same day, after receiving Fluad Quadrivalent, the patient felt weird. According to an associate on the salesfloor, she grabbed onto the shelf near the center aisle, while she was shopping around. Patient then moved quickly and sat down on a chair. She began complaining of low back pain and lifted her legs up on a chair. After a few minutes, she began to feel better. Store manager called the paramedics. When they arrived, they checked her blood pressure (BP) and said that it was too high for her to drive home and she would either had to call her doctor or go with them. She chose to go with the paramedics.She visited physician's office, however, further details were not reported.   The outcome for all the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: An 82-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced blood pressure increased and back pain. Reportedly, the patient felt weird (feeling abnormal). The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related back pain. Although chronology is plausible, causality is unassessable for evenet of feeling abnormal and blood pressure increased, due to lack of information regarding event and patient's medical history.; Sender's Comments: An 82-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced blood pressure increased and back pain. Reportedly, the patient felt weird (feeling abnormal). The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related back pain. Although chronology is plausible, causality is unassessable for evenet of feeling abnormal and blood pressure increased, due to lack of information regarding event and patient's medical history.
Age: 82.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Back pain, Hypertension
Clinical narrative: Low back pain; BP was too high; The patient felt weird; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1683196-1), reported by other health professional and concerned an 82-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies.  On 08-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312827.  On the same day, after receiving Fluad Quadrivalent, the patient felt weird. According to an associate on the salesfloor, she grabbed onto the shelf near the center aisle, while she was shopping around. Patient then moved quickly and sat down on a chair. She began complaining of low back pain and lifted her legs up on a chair. After a few minutes, she began to feel better. Store manager called the paramedics. When they arrived, they checked her blood pressure (BP) and said that it was too high for her to drive home and she would either had to call her doctor or go with them. She chose to go with the paramedics.She visited physician's office, however, further details were not reported.   The outcome for all the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: An 82-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced blood pressure increased and back pain. Reportedly, the patient felt weird (feeling abnormal). The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related back pain. Although chronology is plausible, causality is unassessable for evenet of feeling abnormal and blood pressure increased, due to lack of information regarding event and patient's medical history.; Sender's Comments: An 82-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced blood pressure increased and back pain. Reportedly, the patient felt weird (feeling abnormal). The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related back pain. Although chronology is plausible, causality is unassessable for evenet of feeling abnormal and blood pressure increased, due to lack of information regarding event and patient's medical history.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Erythema, Pityriasis rosea, Pruritus, Rash
Clinical narrative: I am on month 5 of an all body skin rash; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Small skin growths on my scalp, back and hairline; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 08Apr2021 at 11:30 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on an unknown date in 2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient was on month 5 of an all-body skin rash, severe blotchiness and itchiness with scales all over body. Never ever in life the patient had allergic to response to anything. The patient also had small skin growths on scalp, back and hairline. On an unknown date in 2021, the patient underwent two biopsy test and results were unknown at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 05Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was on month 5 of an all body skin rash, severe blotchiness and itchiness with scales all over body and small skin growths on scalp, back and hairline was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin burning sensation, Urticaria
Clinical narrative: I am on month 5 of an all body skin rash; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Small skin growths on my scalp, back and hairline; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 08Apr2021 at 11:30 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on an unknown date in 2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient was on month 5 of an all-body skin rash, severe blotchiness and itchiness with scales all over body. Never ever in life the patient had allergic to response to anything. The patient also had small skin growths on scalp, back and hairline. On an unknown date in 2021, the patient underwent two biopsy test and results were unknown at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 05Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was on month 5 of an all body skin rash, severe blotchiness and itchiness with scales all over body and small skin growths on scalp, back and hairline was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Neoplasm skin, Pruritus, Rash, Rash macular
Clinical narrative: I am on month 5 of an all body skin rash; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Small skin growths on my scalp, back and hairline; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 08Apr2021 at 11:30 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on an unknown date in 2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient was on month 5 of an all-body skin rash, severe blotchiness and itchiness with scales all over body. Never ever in life the patient had allergic to response to anything. The patient also had small skin growths on scalp, back and hairline. On an unknown date in 2021, the patient underwent two biopsy test and results were unknown at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 05Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was on month 5 of an all body skin rash, severe blotchiness and itchiness with scales all over body and small skin growths on scalp, back and hairline was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Skin exfoliation
Clinical narrative: I am on month 5 of an all body skin rash; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Severe blotchiness and itchiness with scales all over my body; Small skin growths on my scalp, back and hairline; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 08Apr2021 at 11:30 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on an unknown date in 2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient was on month 5 of an all-body skin rash, severe blotchiness and itchiness with scales all over body. Never ever in life the patient had allergic to response to anything. The patient also had small skin growths on scalp, back and hairline. On an unknown date in 2021, the patient underwent two biopsy test and results were unknown at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 05Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was on month 5 of an all body skin rash, severe blotchiness and itchiness with scales all over body and small skin growths on scalp, back and hairline was not resolved at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Cardiac disorder, Chest discomfort, Chest pain
Clinical narrative: Short of breath/ hard to breathe; Heart palpitations; Feel like throwing up; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control- iud from an unknown date and unknown if ongoing. On 12Sep2021 at 13:30, the patient experienced short of breath, hard to breathe, heart palpitations, felt like throwing up and dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events short of breath/ hard to breathe, heart palpitations, feel like throwing up and dizzy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Flatulence, Gastrointestinal disorder, Hypoaesthesia
Clinical narrative: Short of breath/ hard to breathe; Heart palpitations; Feel like throwing up; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control- iud from an unknown date and unknown if ongoing. On 12Sep2021 at 13:30, the patient experienced short of breath, hard to breathe, heart palpitations, felt like throwing up and dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events short of breath/ hard to breathe, heart palpitations, feel like throwing up and dizzy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle fatigue, Muscle spasms, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Short of breath/ hard to breathe; Heart palpitations; Feel like throwing up; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control- iud from an unknown date and unknown if ongoing. On 12Sep2021 at 13:30, the patient experienced short of breath, hard to breathe, heart palpitations, felt like throwing up and dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events short of breath/ hard to breathe, heart palpitations, feel like throwing up and dizzy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia, Sneezing, Vaginal discharge
Clinical narrative: Short of breath/ hard to breathe; Heart palpitations; Feel like throwing up; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control- iud from an unknown date and unknown if ongoing. On 12Sep2021 at 13:30, the patient experienced short of breath, hard to breathe, heart palpitations, felt like throwing up and dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events short of breath/ hard to breathe, heart palpitations, feel like throwing up and dizzy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Palpitations
Clinical narrative: Short of breath/ hard to breathe; Heart palpitations; Feel like throwing up; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control- iud from an unknown date and unknown if ongoing. On 12Sep2021 at 13:30, the patient experienced short of breath, hard to breathe, heart palpitations, felt like throwing up and dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events short of breath/ hard to breathe, heart palpitations, feel like throwing up and dizzy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Dizziness, Mobility decreased, Nausea
Clinical narrative: 'Could not ambulate' or get out of bed for a couple hours; Dizziness; Nausea; This spontaneous case was retrieved on 18-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1713958-1), reported by other healthcare professional and concerned a 79-year-old, male patient.  The patient's medical history and patient's concomitant medications were not provided.  On 17-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose reported as one, route of administration: intramuscular and anatomical location: right arm, indication: not reported). The batch number reported was 312832.   On 18-Sep-2021, one day after receiving Fluad Quadrivalent, the patient woke up around 5 am feeling severe dizziness, to the point where he 'could not ambulate' or get out of bed for a couple hours. Also, the patient was nauseous.    On the same date, five hours after the onset, the patient recovered from the events.   The reporter assessed the events as related to Fluad Quadrivalent, since the reporter referred to the events as side/adverse effects.   The case was assessed as non-serious.  Company comment: A 79-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced dizziness, nausea and mobility decreased (reported as "he could not ambulate or get out of bed for a couple hours") Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent, since the reporter referred to the events as side/adverse effects.; Sender's Comments: A 79-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced dizziness, nausea and mobility decreased (reported as "he could not ambulate or get out of bed for a couple hours") Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.
Age: 79.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Dizziness, Gait disturbance, Mobility decreased, Nausea
Clinical narrative: 'Could not ambulate' or get out of bed for a couple hours; Dizziness; Nausea; This spontaneous case was retrieved on 18-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1713958-1), reported by other healthcare professional and concerned a 79-year-old, male patient.  The patient's medical history and patient's concomitant medications were not provided.  On 17-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose reported as one, route of administration: intramuscular and anatomical location: right arm, indication: not reported). The batch number reported was 312832.   On 18-Sep-2021, one day after receiving Fluad Quadrivalent, the patient woke up around 5 am feeling severe dizziness, to the point where he 'could not ambulate' or get out of bed for a couple hours. Also, the patient was nauseous.    On the same date, five hours after the onset, the patient recovered from the events.   The reporter assessed the events as related to Fluad Quadrivalent, since the reporter referred to the events as side/adverse effects.   The case was assessed as non-serious.  Company comment: A 79-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced dizziness, nausea and mobility decreased (reported as "he could not ambulate or get out of bed for a couple hours") Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent, since the reporter referred to the events as side/adverse effects.; Sender's Comments: A 79-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced dizziness, nausea and mobility decreased (reported as "he could not ambulate or get out of bed for a couple hours") Causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Herpes zoster, Paraesthesia, Rash vesicular
Clinical narrative: Herpes zoster; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer and physician.  A 37-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 07Sep2021 as dose 1, single (age at vaccination 37 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient, 5-6 days after receiving the vaccine developed a rash on his right hip on an unknown date in Sep2021. Dermatologist confirmed that it was herpes zoster rash and that he had herpes zoster outbreak. The reporter was not sure if it was related to the COVID vaccine. The patient saw doctor at Urgent care and dermatologist. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer and physician.  A 37-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 07Sep2021 as dose 1, single (age at vaccination 37 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient, 5-6 days after receiving the vaccine developed a rash on his right hip on an unknown date in Sep2021. Dermatologist confirmed that it was herpes zoster rash and that he had herpes zoster outbreak. The reporter was not sure if it was related to the COVID vaccine. The patient saw doctor at Urgent care and dermatologist. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual Cycle lasting long than normal cycle; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 09Sep2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hashimoto's disease and allergy to latex adhesive(latex allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included semaglutide (RYBELSUS), sertraline (MANUFACTURER UNKNOWN) and levothyroxine sodium (MANUFACTURER UNKNOWN) started on unknown date for an unknown indication and unknown if ongoing. On 11Sep2021 at 05:00, the patient reported that menstrual cycle lasted long than normal cycle, currently 12 days past when it should have ended at the time of this report. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle lasted long than normal cycle was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Menstrual Cycle lasting long than normal cycle; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 09Sep2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hashimoto's disease and allergy to latex adhesive(latex allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included semaglutide (RYBELSUS), sertraline (MANUFACTURER UNKNOWN) and levothyroxine sodium (MANUFACTURER UNKNOWN) started on unknown date for an unknown indication and unknown if ongoing. On 11Sep2021 at 05:00, the patient reported that menstrual cycle lasted long than normal cycle, currently 12 days past when it should have ended at the time of this report. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle lasted long than normal cycle was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 11Sep2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported was not applicable (as per source doc). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Sep2021, the patient broke out with painful, itchy, blistery rashes all over both hands, palms, wrists and forearms. It was reported that this led the patient to the urgent care. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with antibiotic cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out with painful, itchy, blistery rashes all over both hands, palms, wrists and forearms was not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; Broke out with painful, itchy, blistery rashesall over both hands , palms, wrists , & forearms; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 11Sep2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported was not applicable (as per source doc). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Sep2021, the patient broke out with painful, itchy, blistery rashes all over both hands, palms, wrists and forearms. It was reported that this led the patient to the urgent care. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with antibiotic cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out with painful, itchy, blistery rashes all over both hands, palms, wrists and forearms was not resolved at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness transient, Blood test, Headache, Magnetic resonance imaging, Seizure
Clinical narrative: BLINDNESS TRANSIENT; SEIZURE; BLOOD TEST; MAGNETIC RESONANCE IMAGING; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority(VAER reference number 1756920) concerned a 30 year old female unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for drug used for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 09-APR-2021, the patient experienced blindness transient lasting for ten minutes, Subsequently a similar transient vision loss event occurred three additional times. The patient also experienced seizure and headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown, and MRI (NR: not provided) unknown. On 29-SEP-2021, patient visited hospital urgently for seizure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blindness transient, and had not recovered from blood test, headache, magnetic resonance imaging, and seizure. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 15-OCT-2021.Upon review following information was amended: Outcome of the event blindness transient to be changed to recovered/resolved.; Sender's Comments: V1: Version created to amend previously reported information. Outcome of the event blindness transient to be changed to recovered/resolved. This updated information does not alter the causality of previously reported events.  20211031880-covid-19 vaccine ad26.cov2.s-blindness transient, seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).