chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Computerised tomogram, Drug ineffective, Dyspnoea
Clinical narrative: experiencing symptoms of COVID-19, tested positive for COVID; experiencing symptoms of COVID-19, tested positive for COVID; pulmonary embolism on lower left lung; shortness of breath; severe chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 14:00 (Lot number: ff2588) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Murmur" (unspecified if ongoing); "gastrointestinal issues" (unspecified if ongoing), notes: Unresolved. Concomitant medication(s) included: METHYLPHENIDATE. Vaccination history included: Tdap, reaction(s): "severe reaction"; Pertussis, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Oct2021 08:00, outcome "recovering" and all described as "experiencing symptoms of COVID-19, tested positive for COVID"; PULMONARY EMBOLISM (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "pulmonary embolism on lower left lung"; DYSPNOEA (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "shortness of breath"; CHEST PAIN (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "severe chest pains". The events "experiencing symptoms of covid-19, tested positive for covid", "experiencing symptoms of covid-19, tested positive for covid", "pulmonary embolism on lower left lung", "shortness of breath" and "severe chest pains" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (09Oct2021) diagnosed with a pulmonary embolism on lower left, notes: lung; sars-cov-2 test: (12Oct2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, pulmonary embolism, dyspnoea, chest pain and treatment included blood thinner. No other vaccine in four weeks. No covid prior vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: experiencing symptoms of COVID-19, tested positive for COVID; experiencing symptoms of COVID-19, tested positive for COVID; pulmonary embolism on lower left lung; shortness of breath; severe chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 14:00 (Lot number: ff2588) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Murmur" (unspecified if ongoing); "gastrointestinal issues" (unspecified if ongoing), notes: Unresolved. Concomitant medication(s) included: METHYLPHENIDATE. Vaccination history included: Tdap, reaction(s): "severe reaction"; Pertussis, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Oct2021 08:00, outcome "recovering" and all described as "experiencing symptoms of COVID-19, tested positive for COVID"; PULMONARY EMBOLISM (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "pulmonary embolism on lower left lung"; DYSPNOEA (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "shortness of breath"; CHEST PAIN (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "severe chest pains". The events "experiencing symptoms of covid-19, tested positive for covid", "experiencing symptoms of covid-19, tested positive for covid", "pulmonary embolism on lower left lung", "shortness of breath" and "severe chest pains" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (09Oct2021) diagnosed with a pulmonary embolism on lower left, notes: lung; sars-cov-2 test: (12Oct2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, pulmonary embolism, dyspnoea, chest pain and treatment included blood thinner. No other vaccine in four weeks. No covid prior vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Fatigue, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: Fainting; Weakness beyond control; Migraines; puking; Heart issues; Brain fog; Digestive issues; Major fatigue; Lung problems; Sick all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: Ew0153) at the age of 50 years as dose 2, single and administration date 12Mar2021 10:00 (Lot number: Er2613) as dose1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis failed c spine surgery" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VALACYCLOVIR HCL; FLUOXETINE. Other medications in two weeks also included Clariti (unspecified). No other vaccine in four weeks.  The following information was reported: SYNCOPE (disability, medically significant), outcome "not recovered", described as "Fainting"; ASTHENIA (disability, medically significant), outcome "not recovered", described as "Weakness beyond control"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "Migraines"; VOMITING (disability, medically significant), outcome "not recovered", described as "puking"; CARDIAC DISORDER (disability, medically significant), outcome "not recovered", described as "Heart issues"; FEELING ABNORMAL (disability, medically significant), outcome "not recovered", described as "Brain fog"; GASTROINTESTINAL DISORDER (disability, medically significant), outcome "not recovered", described as "Digestive issues"; FATIGUE (disability, medically significant), outcome "not recovered", described as "Major fatigue"; LUNG DISORDER (disability, medically significant), outcome "not recovered", described as "Lung problems"; ILLNESS (disability, medically significant), outcome "not recovered", described as "Sick all the time". The events "fainting", "weakness beyond control", "migraines", "puking", "heart issues", "brain fog", "digestive issues", "major fatigue", "lung problems" and "sick all the time" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Blood n nasal test. Therapeutic measures were taken as a result of syncope, asthenia, migraine, vomiting, cardiac disorder, feeling abnormal, gastrointestinal disorder, fatigue, lung disorder, illness. Ae treatment: They can't figure me out she was a hot mess. The patient had no covid prior vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lung disorder, Migraine, SARS-CoV-2 test, Syncope
Clinical narrative: Fainting; Weakness beyond control; Migraines; puking; Heart issues; Brain fog; Digestive issues; Major fatigue; Lung problems; Sick all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: Ew0153) at the age of 50 years as dose 2, single and administration date 12Mar2021 10:00 (Lot number: Er2613) as dose1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis failed c spine surgery" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VALACYCLOVIR HCL; FLUOXETINE. Other medications in two weeks also included Clariti (unspecified). No other vaccine in four weeks.  The following information was reported: SYNCOPE (disability, medically significant), outcome "not recovered", described as "Fainting"; ASTHENIA (disability, medically significant), outcome "not recovered", described as "Weakness beyond control"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "Migraines"; VOMITING (disability, medically significant), outcome "not recovered", described as "puking"; CARDIAC DISORDER (disability, medically significant), outcome "not recovered", described as "Heart issues"; FEELING ABNORMAL (disability, medically significant), outcome "not recovered", described as "Brain fog"; GASTROINTESTINAL DISORDER (disability, medically significant), outcome "not recovered", described as "Digestive issues"; FATIGUE (disability, medically significant), outcome "not recovered", described as "Major fatigue"; LUNG DISORDER (disability, medically significant), outcome "not recovered", described as "Lung problems"; ILLNESS (disability, medically significant), outcome "not recovered", described as "Sick all the time". The events "fainting", "weakness beyond control", "migraines", "puking", "heart issues", "brain fog", "digestive issues", "major fatigue", "lung problems" and "sick all the time" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Blood n nasal test. Therapeutic measures were taken as a result of syncope, asthenia, migraine, vomiting, cardiac disorder, feeling abnormal, gastrointestinal disorder, fatigue, lung disorder, illness. Ae treatment: They can't figure me out she was a hot mess. The patient had no covid prior vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fainting; Weakness beyond control; Migraines; puking; Heart issues; Brain fog; Digestive issues; Major fatigue; Lung problems; Sick all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: Ew0153) at the age of 50 years as dose 2, single and administration date 12Mar2021 10:00 (Lot number: Er2613) as dose1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis failed c spine surgery" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VALACYCLOVIR HCL; FLUOXETINE. Other medications in two weeks also included Clariti (unspecified). No other vaccine in four weeks.  The following information was reported: SYNCOPE (disability, medically significant), outcome "not recovered", described as "Fainting"; ASTHENIA (disability, medically significant), outcome "not recovered", described as "Weakness beyond control"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "Migraines"; VOMITING (disability, medically significant), outcome "not recovered", described as "puking"; CARDIAC DISORDER (disability, medically significant), outcome "not recovered", described as "Heart issues"; FEELING ABNORMAL (disability, medically significant), outcome "not recovered", described as "Brain fog"; GASTROINTESTINAL DISORDER (disability, medically significant), outcome "not recovered", described as "Digestive issues"; FATIGUE (disability, medically significant), outcome "not recovered", described as "Major fatigue"; LUNG DISORDER (disability, medically significant), outcome "not recovered", described as "Lung problems"; ILLNESS (disability, medically significant), outcome "not recovered", described as "Sick all the time". The events "fainting", "weakness beyond control", "migraines", "puking", "heart issues", "brain fog", "digestive issues", "major fatigue", "lung problems" and "sick all the time" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Blood n nasal test. Therapeutic measures were taken as a result of syncope, asthenia, migraine, vomiting, cardiac disorder, feeling abnormal, gastrointestinal disorder, fatigue, lung disorder, illness. Ae treatment: They can't figure me out she was a hot mess. The patient had no covid prior vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Acidosis, Blood test, Electrocardiogram, Heart rate
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Aug2021 15:00 (Lot number: FC3183) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Vaccination history included: Bnt162b2 (Dose 1 (Lot No: FA6780), administered in left arm at 05:00 PM), when the patient was 23 years old, for Covid-19 immunization. The following information was reported: ACIDOSIS (hospitalization, life threatening) with onset 27Aug2021 13:00, outcome "recovered with sequelae" (2021), described as "Acidosis". The patient was hospitalized for acidosis (start date: 27Aug2021, discharge date: 28Aug2021, hospitalization duration: 1 day). The event "acidosis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (27Aug2021) had "acidosis", notes: which was 5 times higher than normal; electrocardiogram: (27Aug2021) had "acidosis", notes: which was 5 times higher than normal; (30Aug2021) everything was normal; heart rate: (27Aug2021) about 130-150 and wouldn't go below 100; (27Aug2021) still didn't go below 120; (27Aug2021) between 90-110; (30Aug2021) shot up to 170. Therapeutic measures were taken as a result of acidosis. Clinical course: On 27Aug2021 around 1-2 pm (as reported), patient heart rate was about 130-150 and wouldn't go below 100, patient had numbness all over face, both hands and arms, felt like she was going to pass out then her spouse took her to the ER. They said if patient went there a little late, her heart could've given out. They gave her some kind of calm medicine but her heart still didn't go below 120, she was sweating a lot and really hot. While resting at night it stayed between 90-110. They kept giving patient fluids throughout the night, also did EKG and blood test - they said patient had "Acidosis" which was 5 times higher than normal that caused all of that. Patient stayed there overnight and left the next day, two days later, patient heart shot up to 170 while laying down in the couch so she had to went to another ER, when she was there, they did another EKG and said everything was normal so they gave her beta blocker to take in case her heart rate went up again.  Follow-up attempts are completed. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anaphylactic shock, Dysmenorrhoea, Headache, Heavy menstrual bleeding
Clinical narrative: Anaphylactic shock; did not receive her period; terrible period; bleeding is very heavy; cramping; terrible period; bleeding is very heavy; cramping; Headache; Vomiting; This is a spontaneous report received from a contactable nurse (parent). A 15 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left upper arm (Lot number: FD8448, Expiration Date: 21Oct2021) at the age of 15 years 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: ANAPHYLACTIC SHOCK (non-serious), outcome "unknown", described as "Anaphylactic shock"; AMENORRHOEA (non-serious), outcome "unknown", described as "did not receive her period"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "terrible period; bleeding is very heavy; cramping"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting". The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of anaphylactic shock, headache, vomiting. Nurse stated she had her 15 year old daughter vaccinated in Oct2021 with her first injection. She went into anaphylactic shock. Treatment for adverse event included 30 ml of liquid diphenhydramine (BENADRYL) for anaphylactic shock. Patient did not receive her period in Oct2021 after the injection. Patient just now received it and it is a terrible period with headache, the bleeding is very heavy, vomiting and cramping. Patient has never experienced periods like that. Therapeutic measures were taken as a result of anaphylactic shock.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Anaphylactic shock; did not receive her period; terrible period; bleeding is very heavy; cramping; terrible period; bleeding is very heavy; cramping; Headache; Vomiting; This is a spontaneous report received from a contactable nurse (parent). A 15 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left upper arm (Lot number: FD8448, Expiration Date: 21Oct2021) at the age of 15 years 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: ANAPHYLACTIC SHOCK (non-serious), outcome "unknown", described as "Anaphylactic shock"; AMENORRHOEA (non-serious), outcome "unknown", described as "did not receive her period"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "terrible period; bleeding is very heavy; cramping"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting". The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of anaphylactic shock, headache, vomiting. Nurse stated she had her 15 year old daughter vaccinated in Oct2021 with her first injection. She went into anaphylactic shock. Treatment for adverse event included 30 ml of liquid diphenhydramine (BENADRYL) for anaphylactic shock. Patient did not receive her period in Oct2021 after the injection. Patient just now received it and it is a terrible period with headache, the bleeding is very heavy, vomiting and cramping. Patient has never experienced periods like that. Therapeutic measures were taken as a result of anaphylactic shock.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101634632 (Pfizer).  A 33 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Date of last menstrual period: 02Oct2021. The patient was 4 weeks pregnant at the time of exposure to bnt162b2. The patient was 6 weeks pregnant at the event onset. The patient is expected to deliver a baby on 09Jul2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "I had a miscarriage two weeks later". The event "I had a miscarriage two weeks later" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of abortion spontaneous. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,  the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid Test Result Nov 16, 2021; Positive Covid Test Result Nov 16, 2021; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 08:30 (Lot number: EW0186) at the age of 43 years as dose 3 (booster), single, administered in arm right, administration date 25Mar2021 12:00 (Lot number: EK5730) as dose 2, single and administered in arm right, administration date 04Mar2021 11:45 (Lot number: EJ1785) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergy" (unspecified if ongoing), notes: Past drug event:, Drug name: No, Reaction: Allergy. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 16Nov2021, outcome "recovering" and all described as "Positive Covid Test Result Nov 16, 2021"; IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "dose number=3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  Additional information:- The patient did not have covid prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was public health clinic. Since the vaccination, the patient has been tested for COVID-19. The device date was 19Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Ischaemic stroke, SARS-CoV-2 test
Clinical narrative: Ischemic Stroke; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 91-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 14:15 (Batch/Lot number: FD8448) at the age of 91 years as dose 3 (booster), single for covid-19 immunisation, administered at Pharmacy or Drug Store.  The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right), administration date: 21Jan2021, when the patient was 90 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right), administration date: 11Feb2021, when the patient was 90 years old, for COVID-19 Immunization. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: ISCHAEMIC STROKE (hospitalization, disability, medically significant) with onset 17Oct2021, outcome "not recovered", described as "Ischemic Stroke"; IMMUNISATION (non-serious) with onset 24Sep2021 14:15, outcome "unknown", described as "dose received 3". The patient was hospitalized for ischaemic stroke (hospitalization duration: 5 day(s)). The event "ischemic stroke" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got Covid even after vaccination; I got Covid even after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 16:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single and administered in arm left, administration date 01Mar2021 16:00 (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 patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the has been patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Nov2021, outcome " recovering ", COVID-19 (medically significant) with onset 12Nov2021, outcome "recovering" and all described as "I got Covid even after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Nov2021) positive. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Confusional state, Dizziness, Lip swelling
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (consumer) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. The reporter is the patient.  A 32 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 18Nov2021 at 15:00 (Lot number: FH8028) at the age of 32 years as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies (NKA). The patient had no other vaccine in four weeks. It was unknown if the patient had COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 19Nov2021 17:00, outcome "not recovered", described as "mental brain fog"; LIP SWELLING (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "Lip swelling"; SWOLLEN TONGUE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "tongue swelling"; DIZZINESS (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lightheadedness"; CONFUSIONAL STATE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "some confusion"; BODY TEMPERATURE DECREASED (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lower body temperature". Therapeutic measures were not taken as a result of mental impairment, lip swelling, swollen tongue, dizziness, confusional state, and body temperature decreased.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Swollen tongue
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (consumer) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. The reporter is the patient.  A 32 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 18Nov2021 at 15:00 (Lot number: FH8028) at the age of 32 years as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies (NKA). The patient had no other vaccine in four weeks. It was unknown if the patient had COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 19Nov2021 17:00, outcome "not recovered", described as "mental brain fog"; LIP SWELLING (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "Lip swelling"; SWOLLEN TONGUE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "tongue swelling"; DIZZINESS (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lightheadedness"; CONFUSIONAL STATE (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "some confusion"; BODY TEMPERATURE DECREASED (non-serious) with onset 19Nov2021 17:00, outcome "not recovered", described as "lower body temperature". Therapeutic measures were not taken as a result of mental impairment, lip swelling, swollen tongue, dizziness, confusional state, and body temperature decreased.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID; Contracted COVID; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) (Pfizer employee) reported for an adult female patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering" and all described as "Contracted COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Nov2021, outcome "recovering", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, influenza like illness.  Clinical course: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Back pain, Gait inability, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Could not walk for minutes; Pins and needles in feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's relevant medical history and concomitant medications were not reported. There was no other vaccines within four weeks. Vaccination history included: Bnt162b2 (Dose: 1, single), administration date: 01Apr2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "low back/sacroiliac joint inflammation", "tingling in feet and pins and needles in feet", "could not walk for minutes", "severe sacroiliac joint pain". The following information was reported: GAIT INABILITY (disability) with onset Apr2021, outcome "recovering", described as "Could not walk for minutes"; PARAESTHESIA (disability) with onset Apr2021, outcome "recovering", described as "Pins and needles in feet". The events "could not walk for minutes" and "pins and needles in feet" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: x-ray: (2021) unknown results; magnetic resonance imaging: (2021) unknown results. Therapeutic measures were taken as a result of events which included physical therapy, X-ray, magnetic resonance imaging. Steadily improved over the course of 7 months. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Sacral pain, X-ray
Clinical narrative: Could not walk for minutes; Pins and needles in feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's relevant medical history and concomitant medications were not reported. There was no other vaccines within four weeks. Vaccination history included: Bnt162b2 (Dose: 1, single), administration date: 01Apr2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "low back/sacroiliac joint inflammation", "tingling in feet and pins and needles in feet", "could not walk for minutes", "severe sacroiliac joint pain". The following information was reported: GAIT INABILITY (disability) with onset Apr2021, outcome "recovering", described as "Could not walk for minutes"; PARAESTHESIA (disability) with onset Apr2021, outcome "recovering", described as "Pins and needles in feet". The events "could not walk for minutes" and "pins and needles in feet" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: x-ray: (2021) unknown results; magnetic resonance imaging: (2021) unknown results. Therapeutic measures were taken as a result of events which included physical therapy, X-ray, magnetic resonance imaging. Steadily improved over the course of 7 months. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Chest pain, Migraine, Pain
Clinical narrative: I can't see, I have like a blind spot; Ocular Migraine on both sides; little bit of chest pain; Having trouble of pain; affecting my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ocular migraine on both sides" (unspecified if ongoing), notes: I only have this once before when I had anesthesia long time ago (history). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization, reaction(s): "intermittent chest pain". The following information was reported: BLINDNESS (medically significant) with onset 20Nov2021, outcome "unknown", described as "I can't see, I have like a blind spot"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "unknown", described as "Ocular Migraine on both sides"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Having trouble of pain; affecting my vision"; CHEST PAIN (non-serious) with onset 20Nov2021, outcome "unknown", described as "little bit of chest pain". The reporter seriousness for the events was reported as unspecified. Stated that, the patient was having trouble of pain, had the Covid Vaccine the 2nd one last night (on 19Nov2021) and today was having ocular migraine on both sides, it happened twice so far today, it was affecting the vision and only had this once before when the patient had anesthesia long time ago (history). Stated that, the patient had a kind of intermittent chest pain with the first (dose) but it went away and the patient was wondered whether this was the side effect of this vaccine or should the patient be worried about this. Stated that, second shot the patient mean that had a little bit of chest pain today but it was kind of it came on and run away really suddenly and then the ocular migraine started about half an hour later, the first one lasted for about 30 minutes. Stated that, when probed for vaccine LOT#, the patient was not going to be able to seeing it and the patient couldn't see through that. Stated that, the patient had like a blind spot because of the (incomplete sentence). The patient was informed about Pfizer Medical Information Department. The response included was enquired that, did the patient needed to call somebody else. Stated that, could the patient try primary care either as the patient didn't know where was to call and didn't want to spend 1000 of dollars, they were not there they said, they were there or not. Stated that, if the patient was having some kind of blood clot or some kind of stroke, the patient didn't know whether the patient should be concerned or not. Stated that, the patient didn't know whatever the patient need to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Thrombocytopenia
Clinical narrative: he died of a brain hemorrhage after spending two weeks in the hospital; The same condition severe thrombocytopenia caused his death; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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: CEREBRAL HAEMORRHAGE (death, hospitalization, medically significant), outcome "fatal", described as "he died of a brain hemorrhage after spending two weeks in the hospital"; THROMBOCYTOPENIA (death, medically significant), outcome "fatal", described as "The same condition severe thrombocytopenia caused his death". The patient was hospitalized for cerebral haemorrhage (hospitalization duration: 14 days). Therapeutic measures were taken as a result of thrombocytopenia. The patient date of death was unknown. The reported cause of death was brain hemorrhage, severe thrombocytopenia. It was unknown if an autopsy was performed. Clinical course: "The same condition severe thrombocytopenia caused his death, whose symptoms appeared three days after receiving the Pfizer-BioNTech vaccine. Treatments failed to restore his platelets and he died of a brain hemorrhage after spending two weeks in the hospital."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: severe thrombocytopenia; brain hemorrhage
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient experienced: COVID; patient experienced: COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4484000 (Genentech).  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Transverse Myelitis" (not ongoing); "Exacerbations" (not ongoing); "Detached Retina" (not ongoing); "New Lesions" (ongoing); "Common Cold" (ongoing); "Blocked Sinuses" (ongoing); "Deviated Septum" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 10Nov2021, outcome "recovering" and all described as "patient experienced: COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Heart rate, Heart rate decreased, Investigation
Clinical narrative: Covid test result=Positive; Covid test result=Positive; syncopal episodes; Heart rate began dropping into the 40-50s range; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0169) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Shellfish" (unspecified if ongoing), Known allergies: Sulfa Notes,: sulfa Codiene Percocet Compazine Reglan Shellfish. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPAMAX; LEXAPRO; ROPINIROLE; BUSPAR. Past drug history included: Codiene, reaction(s): "Known allergies"; Percocet, reaction(s): "Known allergies"; Compazine, reaction(s): "Known allergies"; Reglan, reaction(s): "Known allergies", notes: Known allergies: Sulfa Codiene Percocet Compazine Reglan Shellfish. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, prev dose brand=Pfizer mRNA BNT, prev dose brand unknown=False, prev dose lot number=ER8733, prev dose lot unknown=False, prev dose administration date=05Apr2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Apr2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Sep2021, outcome "unknown" and all described as "Covid test result=Positive"; SYNCOPE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "syncopal episodes"; HEART RATE DECREASED (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Heart rate began dropping into the 40-50s range"; FATIGUE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "severe fatigue". The events "syncopal episodes", "heart rate began dropping into the 40-50s range" and "severe fatigue" were evaluated at the physician office visit and emergency room visit. It was unknown if patient had covid prior vaccination. The patient had covid tested post vaccination. The patient underwent the following laboratory tests and procedures: heart rate: (26Apr2021) dropping into the 40- 50s range, notes: Heart rate began dropping into the 40- 50s range; investigation: (unspecified date) unknown results; sars-cov-2 test: (27Sep2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of syncope, heart rate decreased, fatigue as multiple testing in progress.