chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I developed tinnitus".  Additional information: About 28 days after COVID vaccination patient developed tinnitus. This may be coincidental, but patient think not  hearing has been protected and patient was  a healthy adult.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Patient stated that her platelets dropped after she received Covid Vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US051773.  A 65-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Patient stated that her platelets dropped after she received Covid Vaccine.". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Head discomfort, Head injury, Pain, Tremor
Clinical narrative: small bumps on my head; left eye hurts; The left side of my body hurts; shakes after the vaccine; feeling like head was exploding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAD INJURY (non-serious) with onset Apr2021, outcome "unknown", described as "small bumps on my head"; EYE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "left eye hurts"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "The left side of my body hurts"; TREMOR (non-serious) with onset Apr2021, outcome "unknown", described as "shakes after the vaccine"; HEAD DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "feeling like head was exploding". Additional information: the patient received the vaccine on 22Apr2021 and started getting shakes after the vaccine that didn't last very long (as reported). Then after 3 days she started getting a lot of small bumps on head (left side) that were very painful and felt like they will burst open. The left side of body hurted and her left eye hurted. She got the vaccine in left arm. She felt like her head was going to explode.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Sleep disorder, Vomiting
Clinical narrative: Vomiting; chills; low grade fever; awaking the patient from sleep; malaise; nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 13:00 (Lot number: FL8094) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "low grade fever"; SOMNOLENCE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "awaking the patient from sleep"; MALAISE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "malaise"; NAUSEA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "nauseous"; VOMITING (non-serious) with onset 16Jan2022 07:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, somnolence, malaise, nausea, vomiting.  Additional Information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Vomiting; chills; low grade fever; awaking the patient from sleep; malaise; nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 13:00 (Lot number: FL8094) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "low grade fever"; SOMNOLENCE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "awaking the patient from sleep"; MALAISE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "malaise"; NAUSEA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "nauseous"; VOMITING (non-serious) with onset 16Jan2022 07:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, somnolence, malaise, nausea, vomiting.  Additional Information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Vomiting; chills; low grade fever; awaking the patient from sleep; malaise; nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 13:00 (Lot number: FL8094) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "low grade fever"; SOMNOLENCE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "awaking the patient from sleep"; MALAISE (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "malaise"; NAUSEA (non-serious) with onset 16Jan2022 01:00, outcome "recovering", described as "nauseous"; VOMITING (non-serious) with onset 16Jan2022 07:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, somnolence, malaise, nausea, vomiting.  Additional Information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Nasopharyngitis
Clinical narrative: high blood sugars are 600 for a week; cold like symptoms; runny nose; my eyes are stinging; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported: HYPERGLYCAEMIA (medically significant), outcome "unknown", described as "high blood sugars are 600 for a week"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; EYE PAIN (non-serious), outcome "unknown", described as "my eyes are stinging". The patient underwent the following laboratory tests and procedures: blood glucose: 600, notes: high blood sugars are 600 for a week. The clinical course of events was as follows: Patient got the booster Pfizer on the 23rd (month and year not indicated) and had high blood sugars are 600 for a week, patient had also since then had cold like symptoms caused a runny nose, eyes were stinging since the 23rd. Patient still was having all these symptoms. The lot number for bnt162b2 was not provided and will be requested during follo up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Eye pain, Hyperglycaemia, Nasopharyngitis, Rhinorrhoea
Clinical narrative: high blood sugars are 600 for a week; cold like symptoms; runny nose; my eyes are stinging; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported: HYPERGLYCAEMIA (medically significant), outcome "unknown", described as "high blood sugars are 600 for a week"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; EYE PAIN (non-serious), outcome "unknown", described as "my eyes are stinging". The patient underwent the following laboratory tests and procedures: blood glucose: 600, notes: high blood sugars are 600 for a week. The clinical course of events was as follows: Patient got the booster Pfizer on the 23rd (month and year not indicated) and had high blood sugars are 600 for a week, patient had also since then had cold like symptoms caused a runny nose, eyes were stinging since the 23rd. Patient still was having all these symptoms. The lot number for bnt162b2 was not provided and will be requested during follo up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Palpitations, Ventricular extrasystoles
Clinical narrative: Heart Palpitations; pre ventricular contractions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 15:00 (Lot number: FC 3183) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Plant molds allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; LISINOPRIL; FENOFIBRATE. The following information was reported: PALPITATIONS (medically significant) with onset 27Aug2021 07:00, outcome "not recovered", described as "Heart Palpitations"; VENTRICULAR EXTRASYSTOLES (medically significant) with onset 27Aug2021 07:00, outcome "not recovered", described as "pre ventricular contractions". The events "heart palpitations" and "pre ventricular contractions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Sep2021) negative, notes: Binax covid test. Therapeutic measures were taken as a result of palpitations, ventricular extrasystoles and included treatment with beta blockers. The patient took dose 2 of bnt162b2 (Lot Number: 30130BA) on 16Sep2021 10:30 AM at age of 34-year-old in left arm for COVID-19 immunisation. The patient experienced heart Palpitations, and later was diagnosed as pre ventricular contractions. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: Heart Palpitations; pre ventricular contractions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 15:00 (Lot number: FC 3183) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Plant molds allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; LISINOPRIL; FENOFIBRATE. The following information was reported: PALPITATIONS (medically significant) with onset 27Aug2021 07:00, outcome "not recovered", described as "Heart Palpitations"; VENTRICULAR EXTRASYSTOLES (medically significant) with onset 27Aug2021 07:00, outcome "not recovered", described as "pre ventricular contractions". The events "heart palpitations" and "pre ventricular contractions" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Sep2021) negative, notes: Binax covid test. Therapeutic measures were taken as a result of palpitations, ventricular extrasystoles and included treatment with beta blockers. The patient took dose 2 of bnt162b2 (Lot Number: 30130BA) on 16Sep2021 10:30 AM at age of 34-year-old in left arm for COVID-19 immunisation. The patient experienced heart Palpitations, and later was diagnosed as pre ventricular contractions. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Dyspnoea, Echocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: Diagnosed with myocarditis; Severe heart palpitations; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 05Apr2021 12:30, outcome "recovering", described as "Diagnosed with myocarditis"; PALPITATIONS (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "Severe heart palpitations"; DYSPNOEA (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "shortness of breath". The events "diagnosed with myocarditis", "severe heart palpitations" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac monitoring: (unspecified date) result unknown; magnetic resonance imaging: (unspecified date) result unknown; sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, palpitations, dyspnoea.  Clinical Course: Adverse event treatment included Heartmonitor, MRI, colchicine, metoprolol succinat. No covid prior vaccination and tested for covid test post vaccination, Nasal Swab. Covid test name post vaccination: NOVEL CORONAVIRUS (COVID-19) RNA, QL RT-PCR.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Diagnosed with myocarditis; Severe heart palpitations; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 05Apr2021 12:30, outcome "recovering", described as "Diagnosed with myocarditis"; PALPITATIONS (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "Severe heart palpitations"; DYSPNOEA (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "shortness of breath". The events "diagnosed with myocarditis", "severe heart palpitations" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac monitoring: (unspecified date) result unknown; magnetic resonance imaging: (unspecified date) result unknown; sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, palpitations, dyspnoea.  Clinical Course: Adverse event treatment included Heartmonitor, MRI, colchicine, metoprolol succinat. No covid prior vaccination and tested for covid test post vaccination, Nasal Swab. Covid test name post vaccination: NOVEL CORONAVIRUS (COVID-19) RNA, QL RT-PCR.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Dyspnoea, Magnetic resonance imaging, Myocarditis, Palpitations
Clinical narrative: Diagnosed with myocarditis; Severe heart palpitations; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 05Apr2021 12:30, outcome "recovering", described as "Diagnosed with myocarditis"; PALPITATIONS (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "Severe heart palpitations"; DYSPNOEA (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "shortness of breath". The events "diagnosed with myocarditis", "severe heart palpitations" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac monitoring: (unspecified date) result unknown; magnetic resonance imaging: (unspecified date) result unknown; sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, palpitations, dyspnoea.  Clinical Course: Adverse event treatment included Heartmonitor, MRI, colchicine, metoprolol succinat. No covid prior vaccination and tested for covid test post vaccination, Nasal Swab. Covid test name post vaccination: NOVEL CORONAVIRUS (COVID-19) RNA, QL RT-PCR.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diagnosed with myocarditis; Severe heart palpitations; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 05Apr2021 12:30, outcome "recovering", described as "Diagnosed with myocarditis"; PALPITATIONS (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "Severe heart palpitations"; DYSPNOEA (non-serious) with onset 05Apr2021 12:30, outcome "recovering", described as "shortness of breath". The events "diagnosed with myocarditis", "severe heart palpitations" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac monitoring: (unspecified date) result unknown; magnetic resonance imaging: (unspecified date) result unknown; sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, palpitations, dyspnoea.  Clinical Course: Adverse event treatment included Heartmonitor, MRI, colchicine, metoprolol succinat. No covid prior vaccination and tested for covid test post vaccination, Nasal Swab. Covid test name post vaccination: NOVEL CORONAVIRUS (COVID-19) RNA, QL RT-PCR.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Loss of consciousness, Pruritus
Clinical narrative: loss of consciousness; itchy; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2022 11:45 (Lot number: fk9896) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies : Aspirin"; Codeine, reaction(s): "Known allergies : Codeine"; Dilaudid, reaction(s): "Known allergies : Dilaudid"; Opioids, reaction(s): "Known allergies : Opioids". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: el9262, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: el3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 03Feb2022 11:45, outcome "unknown", described as "loss of consciousness"; PRURITUS (non-serious) with onset 03Feb2022 11:45, outcome "unknown", described as "itchy"; DIZZINESS (non-serious) with onset 03Feb2022 11:45, outcome "unknown", described as "dizziness". The events "loss of consciousness", "itchy" and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of loss of consciousness, pruritus, dizziness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Loss of consciousness, pruritis, dizziness and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Pruritus
Clinical narrative: loss of consciousness; itchy; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2022 11:45 (Lot number: fk9896) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies : Aspirin"; Codeine, reaction(s): "Known allergies : Codeine"; Dilaudid, reaction(s): "Known allergies : Dilaudid"; Opioids, reaction(s): "Known allergies : Opioids". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: el9262, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: el3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 03Feb2022 11:45, outcome "unknown", described as "loss of consciousness"; PRURITUS (non-serious) with onset 03Feb2022 11:45, outcome "unknown", described as "itchy"; DIZZINESS (non-serious) with onset 03Feb2022 11:45, outcome "unknown", described as "dizziness". The events "loss of consciousness", "itchy" and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of loss of consciousness, pruritus, dizziness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Loss of consciousness, pruritis, dizziness and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: how much may be behavioral; Severe headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Jan2022 14:00 (Lot number: FL8095) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 03Jan2022 02:15, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 03Jan2022 02:15, outcome "not recovered", described as "dizziness"; BEHAVIOUR DISORDER (non-serious), outcome "not recovered", described as "how much may be behavioral". The events "severe headache", "dizziness" and "how much may be behavioral" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, dizziness, behaviour disorder.  Additional Information: Adverse event reported was severe headache and dizziness within minutes of getting vaccine. Watched for an hour. Seemed to be lessening so was released to home and no other symptoms. The headache lasted several days and then became intermittent. It was relieved with OTC pain reliever. Has lessened in severity and frequency since but was still complaining of headaches several times a week. Dad had been slow to give pain medication as he wants him to tough it out. His headaches are more frequent at school or with homework so not clear how much may be behavioral at this point. Was seen in (withheld) on 19Jan2022 and follow up with me on 02Feb2022. Adverse events treated with Tylenol and ibuprofen. No covid prior vaccination. No covid tested post vaccination. No other vaccine taken in four weeks. No other medications taken in two weeks. No known allergies. other medical history was None
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Behaviour disorder, Dizziness, Headache
Clinical narrative: how much may be behavioral; Severe headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Jan2022 14:00 (Lot number: FL8095) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 03Jan2022 02:15, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 03Jan2022 02:15, outcome "not recovered", described as "dizziness"; BEHAVIOUR DISORDER (non-serious), outcome "not recovered", described as "how much may be behavioral". The events "severe headache", "dizziness" and "how much may be behavioral" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, dizziness, behaviour disorder.  Additional Information: Adverse event reported was severe headache and dizziness within minutes of getting vaccine. Watched for an hour. Seemed to be lessening so was released to home and no other symptoms. The headache lasted several days and then became intermittent. It was relieved with OTC pain reliever. Has lessened in severity and frequency since but was still complaining of headaches several times a week. Dad had been slow to give pain medication as he wants him to tough it out. His headaches are more frequent at school or with homework so not clear how much may be behavioral at this point. Was seen in (withheld) on 19Jan2022 and follow up with me on 02Feb2022. Adverse events treated with Tylenol and ibuprofen. No covid prior vaccination. No covid tested post vaccination. No other vaccine taken in four weeks. No other medications taken in two weeks. No known allergies. other medical history was None
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Chest pain, Dyspnoea, Incorrect dose administered, SARS-CoV-2 test
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Blood creatinine, Blood immunoglobulin E, Blood thyroid stimulating hormone, Brain natriuretic peptide
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram, Computerised tomogram thorax, Differential white blood cell count
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Extra dose administered, Fibrin D dimer
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Glomerular filtration rate, Laboratory test, Oxygen saturation decreased, Scan with contrast
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, White blood cell count
Clinical narrative: chest pains; shortness of breath; Asthma; Medication Error I recieved 2 booster shots on the same day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 4, single and administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Bnt162b2 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Oct2021, outcome "unknown", described as "Medication Error I recieved 2 booster shots on the same day"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "chest pains"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath"; ASTHMA (non-serious) with onset Nov2021, outcome "unknown", described as "Asthma". The events "chest pains", "shortness of breath" and "asthma" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, dyspnoea, asthma.  Additional Information: 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. Medication Error patient recieved 2 booster shots on the same day. About a month or so later I started having chest pains, shortness of breath. Recently diagnosis with Asthma with no cause, And chest pains continue. Since the vaccination, the patient had  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.