chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cough, Fatigue, Headache, Pain
Clinical narrative: a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm with some force and I felt a jolt in my arm; fatigue; body aches; coughing; headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 15:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, exercise-induced asthma and penicillin allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), estradiol and progesterone, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 in the left arm on 23Mar2021 04:00 PM (at 58 years of age) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. The patient had no covid prior vaccination. She has not been tested for Covid post vaccination. The patient reported that the shot was put in the arm with some force and she felt a jolt in her arm and a big jolt immediately following in her heart. She mentioned that her heart felt sore off and on in that spot the following day 14Apr2021. No other unusual symptoms just the expected ones including fatigue, body aches and some coughing and headache. The events started on 13Apr2021 15:30 with outcome of recovering. The patient did not receive any treatment for the events.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information, and on a plausible temporal association, the Company considered that a reasonable possibility could not be completely excluded that the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to the occurrence of the reported event Big jolt immediately following in my heart. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm with some force and I felt a jolt in my arm; fatigue; body aches; coughing; headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 15:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, exercise-induced asthma and penicillin allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), estradiol and progesterone, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 in the left arm on 23Mar2021 04:00 PM (at 58 years of age) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. The patient had no covid prior vaccination. She has not been tested for Covid post vaccination. The patient reported that the shot was put in the arm with some force and she felt a jolt in her arm and a big jolt immediately following in her heart. She mentioned that her heart felt sore off and on in that spot the following day 14Apr2021. No other unusual symptoms just the expected ones including fatigue, body aches and some coughing and headache. The events started on 13Apr2021 15:30 with outcome of recovering. The patient did not receive any treatment for the events.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information, and on a plausible temporal association, the Company considered that a reasonable possibility could not be completely excluded that the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to the occurrence of the reported event Big jolt immediately following in my heart. 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.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced acute stroke on an unspecified date. The patient was still hospitalized in ICU. The outcome of the event was unknown.; Sender's Comments: Limited information can not support a complete medical assessment. A causal association between administration of BNT162B2 and the onset of acute stroke cannot be excluded, considering the temporal association. Case will be re-assessed upon the additional information provided. 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.,Linked Report(s) : US-PFIZER INC-2021415134 same reporter and drug, similar events, different patients
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient).   A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Hypoaesthesia, Peripheral coldness, Thyroid disorder
Clinical narrative: feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient).   A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Culture throat, Dysarthria, Electrocardiogram, Facial paralysis
Clinical narrative: Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Delirium, Headache
Clinical narrative: Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation.  Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021.  The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restlessness
Clinical narrative: Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation.  Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021.  The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Pancreatitis acute, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Acute pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunization. Medical history included cardiac, hypertension (HTN), and hyperlipidaemia (HLD). The patient had no known allergies. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ACETYLSALICYLIC ACID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; zolpidem (ZOLPIDEM) taken for an unspecified indication, start and stop date were not reported; and metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 01Apr2021 at 06:00AM, the patient had acute pancreatitis. It was reported that the patient had no history of pancreatitis and no other known cause of developing pancreatitis. The patient was hospitalized for acute pancreatitis for 2 days. The patient had no Covid prior vaccination and was tested for Covid post-vaccination. The patient underwent lab tests and procedures which included CT scans: unknown result, labs: unknown result, and Ultrasound: unknown result on unknown dates, and Nasal swab: negative on 01Apr2021. Treatment for the event included IV fluids, pain med, CT scan, ultrasound, and labs. The event resolved on an unknown date in 2021.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Necrotising retinitis
Clinical narrative: left retinal necrosis; This is a spontaneous report from a contactable physician. 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient medical history and concomitant medications were not reported. The patient experienced left retinal necrosis on 07Apr2021. The patient was hospitalized for the event on an unspecified date. The patient does not have COVID prior vaccination. The patient was did not test to covid post vaccination.. Outcome of the event was unknown.   Information about lot and batch number was requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Necrotising retinitis and the suspect drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reassessed once new information is available. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Dizziness, Nausea, Syncope
Clinical narrative: faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events.  Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events.  Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Diarrhoea, Dizziness
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered.   Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Migraine, Nausea, Pain
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered.   Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered.   Information about lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Choking, Cough, Epistaxis, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer.   A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks.  The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Vaccination site pain
Clinical narrative: Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer.   A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks.  The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After first shot continued ringing in both ears no-laterally started approx 2 days after and continued.; This is a spontaneous report from a contactable consumer (patient) reported that a 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECHC COVID-19 VACCINE, lot number: ER6204), via an unspecified route of administration, administered in arm left on 22Mar2021 (at the age of 52-years-old) as a single dose for covid-19 immunisation. The patient had known allergies with certain beta blockers and macadamias nuts. The patient had no covid-19 prior vaccination. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient's concomitant medications were not reported. After first shot continued ringing in both ears no-laterally started approximately 2 days after (24Mar2021) and continued. The event resulted in disability or permanent damage. The patient did not received any treatment for the event. The patient was not tested covid-19 post vaccination. The outcome of the event was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Palpitations, Paraesthesia
Clinical narrative: almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: blanked out and fell; blanked out and fell; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 15Apr2021 16:38:53  (Batch/Lot Number: EW0158) (age at vaccination: 69-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, coronary artery disease, blood cholesterol, Hay fever and diabetics. The patient's concomitant medications were not reported. The patient experienced blanked out and fell on 15Apr2021.  The patient got the vaccine on 15Apr2021 and they did it in her car and she waited 30 minutes and was fine. The caller was out and went into the bank and on the way out she did not know what happened. The caller got to where she went blank and fell on her face on the floor. She drove herself home. She got a daze and then she was down. The caller didn't get unconscious. The caller got up and didn't have to go to the hospital. This was within an hour of getting the vaccine. Caller states that she shrunk but was now 5 feet 3 inches. The caller mentions that she used to give injections for diabetics and as a rule they wiped the skin with alcohol before administering it. The lady administering the covid vaccine already had the vaccine into the syringe and the person administering it did not use alcohol. The vial with the rubber piece, the caller knows that they used to always wipe it off with alcohol and knock out the air bubbles in the vial. The caller is unsure if there were air bubbles in the syringe because she didn't see it being drawn up. This event was all outside in the car. Caller states they gave her a paper on the vaccine, it says they put some type of medication in the vaccine that has cholesterol in it. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Hyperhidrosis, Hyperventilation, Loss of consciousness
Clinical narrative: was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; he started getting dizzy; felt nauseated; This is a spontaneous report from a contactable consumer (patient's parent).    A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Apr2021 14:30 (Lot Number: EW0150) (age at vaccination: 16-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no. No COVID prior vaccination, no COVID tested post vaccination, no Known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).  Right after the patient was administered the vaccine, he started getting dizzy and felt nauseated, was sweating profusely and breathing heavy then he passed out. They were in the car so the nurse reclined his chair. He passed out and then woke up and then passed out (twice) -They gave him water and gum to chew and remained laying flat. After about 20 or so minutes he felt better and nurse checked his pulse and heart rate during the ordeal. The adverse events start date was reported as 11Apr2021 14:30. No treatment received for the events. The outcome of the events was recovered.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; was sweating profusely and breathing heavy then he passed out; he started getting dizzy; felt nauseated; This is a spontaneous report from a contactable consumer (patient's parent).    A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Apr2021 14:30 (Lot Number: EW0150) (age at vaccination: 16-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no. No COVID prior vaccination, no COVID tested post vaccination, no Known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks).  Right after the patient was administered the vaccine, he started getting dizzy and felt nauseated, was sweating profusely and breathing heavy then he passed out. They were in the car so the nurse reclined his chair. He passed out and then woke up and then passed out (twice) -They gave him water and gum to chew and remained laying flat. After about 20 or so minutes he felt better and nurse checked his pulse and heart rate during the ordeal. The adverse events start date was reported as 11Apr2021 14:30. No treatment received for the events. The outcome of the events was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hemiparesis, Neuralgia
Clinical narrative: extreme muscle weakness on his right side; nerve pain in his neck and shoulder; He feels very tired and like he's coming down with something; He feels very tired and like he's coming down with something; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (age: 58, unit: unspecified) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first Pfizer COVID vaccine on 07Apr2021. The next day (08Apr2021), he developed nerve pain in his neck and shoulder and extreme muscle weakness on his right side. He received his vaccination on his left side. He wanted to know if this was something that has been reported with the COVID vaccine. His condition has been worsening since his vaccination. He felt very tired and like he's coming down with something on Apr2021. The outcome of the event "he feels very tired and like he's coming down with something" was unknown and not recovered for all other events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Enlarged uvula, Pharyngeal swelling, Vertigo
Clinical narrative: she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT behind left knee detected at ER on 08Apr. Pain behind left knee started on 4Apr; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 12:00 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunization. Relevant medical history included prior deep vein thrombosis (DVT) behind right knee from an unspecified date in 2010 to an unknown date. Concomitant medication included finasteride (PROPECIA) taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen (ADVIL), acetylsalicylic acid (ASPIRIN), and unspecified salicylates, from which the patient had known allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 at 12:00 PM (lot number: EN6204) at the age of 47 years, administered in the left arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient had DVT behind left knee detected at the emergency room (ER) on 08Apr2021; the pain behind left knee started on 04Apr2021. The adverse event (AE) resulted in an emergency room/department or urgent care. Therapeutic measures were taken as a result of the event, which included that the patient was prescribed apixaban (ELIQUIS). The patient was not recovered from the event.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: left leg deepvein thrombosis; blood clot; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 12Feb2021 19:30 (7:30 pm) as single dose for COVID-19 immunization in a hospital. Medical history included high blood pressure and high cholesterol both from an unknown date. No known allergies. The patient took an unspecified medication. No other vaccines in four weeks. No COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (lot number: EL9261) on 22Jan2021 07:15 am on the right arm for COVID-19 immunization. On 25Feb2021 21:00 (9:00 pm), the patient experienced left leg deep vein thrombosis and blood clot which required a visit to the emergency room and subsequent hospital admission. The patient was given Eliquis as treatment. The patient was tested for COVID-19 post vaccination via nasal swab on 08Apr2021 with a negative result. The outcome of the events was reported as recovering.