chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: RIGHT LEG DEEP VEIN THROMBOSIS; PERIPHERAL VEIN OCCLUSION; This spontaneous report received from a patient via VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1201107) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and chronic obstructive pulmonary disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ferrous sulfate, ipratropium bromide/salbutamol sulfate, montelukast, salbutamol sulfate, budesonide, ipratropium, olodaterol hydrochloride/tiotropium bromide monohydrate and prednisone for chronic obstructive pulmonary disease.  On 07-APR-2021, the patient experienced right leg deep vein thrombosis. Patient was hospitalized for 4 days. On 07-APR-2021, the patient experienced peripheral vein occlusion. On 07-APR-2021, the patient had ultrasound scan abnormal. Laboratory data included: Ultrasound Doppler (NR: not provided) unknown, and right leg duplex Ultrasound Scan confirms right leg occlusive DVT involving common femoral, superficial femoral, and popliteal vein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg deep vein thrombosis, and peripheral vein occlusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210447773-Covid-19 vaccine ad26.cov2.s-Right leg deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral vein occlusion, Ultrasound Doppler, Ultrasound scan
Clinical narrative: RIGHT LEG DEEP VEIN THROMBOSIS; PERIPHERAL VEIN OCCLUSION; This spontaneous report received from a patient via VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1201107) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and chronic obstructive pulmonary disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ferrous sulfate, ipratropium bromide/salbutamol sulfate, montelukast, salbutamol sulfate, budesonide, ipratropium, olodaterol hydrochloride/tiotropium bromide monohydrate and prednisone for chronic obstructive pulmonary disease.  On 07-APR-2021, the patient experienced right leg deep vein thrombosis. Patient was hospitalized for 4 days. On 07-APR-2021, the patient experienced peripheral vein occlusion. On 07-APR-2021, the patient had ultrasound scan abnormal. Laboratory data included: Ultrasound Doppler (NR: not provided) unknown, and right leg duplex Ultrasound Scan confirms right leg occlusive DVT involving common femoral, superficial femoral, and popliteal vein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg deep vein thrombosis, and peripheral vein occlusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210447773-Covid-19 vaccine ad26.cov2.s-Right leg deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Palpitations, Panic attack, Vertigo
Clinical narrative: constant panic attacks; feeling like I'm going to pass out; vertigo; racing heart beat; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 V ACCINE, lot number EP7533), administered in right arm on 10Apr2021 01:30 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Vaccine facility type was reported as other. The patient's medical history included panic disorder, agoraphobia, generalised anxiety disorder (GAD), depression and known allergy to penicillin. Patient had not COVID prior vaccination. The patient's concomitant medications included diazepam (VALIUM), promethazine (PHENERGAN) and hydroxyzine, all from unspecified date. Patient did not receive any other vaccine in four weeks. The patient previously received alpha-galactosidase (ALPHA-GA) and it was reported as known allergy. Two days after shot on 12Apr2021 06:00 AM the patient experienced vertigo, constant panic attacks, dizziness, racing heart beat, feeling like he was going to pass out, all reported as non-serious. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was not resolved.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Panic attack, Presyncope, Vertigo
Clinical narrative: constant panic attacks; feeling like I'm going to pass out; vertigo; racing heart beat; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 V ACCINE, lot number EP7533), administered in right arm on 10Apr2021 01:30 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Vaccine facility type was reported as other. The patient's medical history included panic disorder, agoraphobia, generalised anxiety disorder (GAD), depression and known allergy to penicillin. Patient had not COVID prior vaccination. The patient's concomitant medications included diazepam (VALIUM), promethazine (PHENERGAN) and hydroxyzine, all from unspecified date. Patient did not receive any other vaccine in four weeks. The patient previously received alpha-galactosidase (ALPHA-GA) and it was reported as known allergy. Two days after shot on 12Apr2021 06:00 AM the patient experienced vertigo, constant panic attacks, dizziness, racing heart beat, feeling like he was going to pass out, all reported as non-serious. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was not resolved.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pallor, Syncope
Clinical narrative: Loss of consciousness; Seizure; Drowsiness, couldn't stay awake; Vomiting; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 12Apr2021 (11:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included peanut and penicillin allergy. The patient's concomitant medications were not reported. On12Apr2021 (11:45), the patient had loss of consciousness; seizure; drowsiness/could not stay awake; and vomiting. The events had resulted in an emergency room/department for urgent care, and were assessed as serious (medically significant). The patient was hospitalized in Apr2021 due to loss of consciousness. The patient had received epinephrine (EPIPEN) as treatment for the reported events. The outcome of the events was recovered in Apr2021. The patient did no have COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Seizure, Somnolence, Vomiting
Clinical narrative: Loss of consciousness; Seizure; Drowsiness, couldn't stay awake; Vomiting; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 12Apr2021 (11:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included peanut and penicillin allergy. The patient's concomitant medications were not reported. On12Apr2021 (11:45), the patient had loss of consciousness; seizure; drowsiness/could not stay awake; and vomiting. The events had resulted in an emergency room/department for urgent care, and were assessed as serious (medically significant). The patient was hospitalized in Apr2021 due to loss of consciousness. The patient had received epinephrine (EPIPEN) as treatment for the reported events. The outcome of the events was recovered in Apr2021. The patient did no have COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler
Clinical narrative: diagnosed with DVT/slight pain in right calf/severe pain in right calf (unable to weight bear); This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 02Apr2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included retinoblastoma, menorrhagia and fibroids from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestrel (OGESTREL-28) taken for menorrhagia, uterine leiomyoma; iron taken for an unspecified indication, start and stop dates for both were not reported. On 03Apr2021, the patient woke up with slight pain in right calf. On 04Apr2021, she woke up with severe pain in right calf (unable to weight bear), then went to Urgent Care and was diagnosed with deep vein thrombosis (DVT) 7cm. Started apixaban (ELIQUIS) for 3 months, stopped low norgestrel. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Full blood count, Pain in extremity, Ultrasound scan
Clinical narrative: diagnosed with DVT/slight pain in right calf/severe pain in right calf (unable to weight bear); This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 02Apr2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included retinoblastoma, menorrhagia and fibroids from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestrel (OGESTREL-28) taken for menorrhagia, uterine leiomyoma; iron taken for an unspecified indication, start and stop dates for both were not reported. On 03Apr2021, the patient woke up with slight pain in right calf. On 04Apr2021, she woke up with severe pain in right calf (unable to weight bear), then went to Urgent Care and was diagnosed with deep vein thrombosis (DVT) 7cm. Started apixaban (ELIQUIS) for 3 months, stopped low norgestrel. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: diagnosed with DVT/slight pain in right calf/severe pain in right calf (unable to weight bear); This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 02Apr2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included retinoblastoma, menorrhagia and fibroids from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestrel (OGESTREL-28) taken for menorrhagia, uterine leiomyoma; iron taken for an unspecified indication, start and stop dates for both were not reported. On 03Apr2021, the patient woke up with slight pain in right calf. On 04Apr2021, she woke up with severe pain in right calf (unable to weight bear), then went to Urgent Care and was diagnosed with deep vein thrombosis (DVT) 7cm. Started apixaban (ELIQUIS) for 3 months, stopped low norgestrel. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic occlusion, Arthralgia, Blood test, Cerebrovascular accident, Electrocardiogram ambulatory
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, 1 in total administered to left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced stroke and was hospitalized 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0: 20210442759 Covid-19 vaccine ad26.cov2.s-stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Illiteracy, Laboratory test, Nausea, Ophthalmological examination
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, 1 in total administered to left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced stroke and was hospitalized 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0: 20210442759 Covid-19 vaccine ad26.cov2.s-stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech rehabilitation, Vision blurred
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, 1 in total administered to left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced stroke and was hospitalized 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0: 20210442759 Covid-19 vaccine ad26.cov2.s-stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, 1 in total administered to left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced stroke and was hospitalized 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0: 20210442759 Covid-19 vaccine ad26.cov2.s-stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes normal, Blood pressure decreased, Computerised tomogram normal, Condition aggravated, Dizziness
Clinical narrative: Passed out; Felt strange/weird; Nauseous; Dizzy; ears rang; Blood pressure drop; This is a spontaneous report from a contactable consumer, reporting for himself. A 33-year-old male patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6208), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 at a single dose for covid-19 immunisation. The patient received the vaccination in the pharmacy. There was no medical history or concomitant medications. There were no other vaccines administered in the last four weeks. On 25Mar2021 at 23:30, the patient experienced passed out, felt strange/weird, nauseous, dizzy, ears rang, and blood pressure drop. The clinical course was as follows: the patient was advised to wait 15 minutes before leaving. He set an alarm. He bought some food to eat (potatoes and jerky) and waited to leave the site until 11:22. He felt strange/weird, but this was not an unusual feeling after receiving any kind of shot/vaccine for the patient. He was driving to work and started to get a little nauseous but nothing too bad. Thirty seconds later, he started to get dizzy, ears rang, felt blood pressure drop, and passed out going freeway speeds. He was treated in the emergency department and released the same day. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Impaired driving ability, Injury, Loss of consciousness
Clinical narrative: Passed out; Felt strange/weird; Nauseous; Dizzy; ears rang; Blood pressure drop; This is a spontaneous report from a contactable consumer, reporting for himself. A 33-year-old male patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6208), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 at a single dose for covid-19 immunisation. The patient received the vaccination in the pharmacy. There was no medical history or concomitant medications. There were no other vaccines administered in the last four weeks. On 25Mar2021 at 23:30, the patient experienced passed out, felt strange/weird, nauseous, dizzy, ears rang, and blood pressure drop. The clinical course was as follows: the patient was advised to wait 15 minutes before leaving. He set an alarm. He bought some food to eat (potatoes and jerky) and waited to leave the site until 11:22. He felt strange/weird, but this was not an unusual feeling after receiving any kind of shot/vaccine for the patient. He was driving to work and started to get a little nauseous but nothing too bad. Thirty seconds later, he started to get dizzy, ears rang, felt blood pressure drop, and passed out going freeway speeds. He was treated in the emergency department and released the same day. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Presyncope, Road traffic accident, Troponin normal
Clinical narrative: Passed out; Felt strange/weird; Nauseous; Dizzy; ears rang; Blood pressure drop; This is a spontaneous report from a contactable consumer, reporting for himself. A 33-year-old male patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6208), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 at a single dose for covid-19 immunisation. The patient received the vaccination in the pharmacy. There was no medical history or concomitant medications. There were no other vaccines administered in the last four weeks. On 25Mar2021 at 23:30, the patient experienced passed out, felt strange/weird, nauseous, dizzy, ears rang, and blood pressure drop. The clinical course was as follows: the patient was advised to wait 15 minutes before leaving. He set an alarm. He bought some food to eat (potatoes and jerky) and waited to leave the site until 11:22. He felt strange/weird, but this was not an unusual feeling after receiving any kind of shot/vaccine for the patient. He was driving to work and started to get a little nauseous but nothing too bad. Thirty seconds later, he started to get dizzy, ears rang, felt blood pressure drop, and passed out going freeway speeds. He was treated in the emergency department and released the same day. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Passed out; Felt strange/weird; Nauseous; Dizzy; ears rang; Blood pressure drop; This is a spontaneous report from a contactable consumer, reporting for himself. A 33-year-old male patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6208), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 at a single dose for covid-19 immunisation. The patient received the vaccination in the pharmacy. There was no medical history or concomitant medications. There were no other vaccines administered in the last four weeks. On 25Mar2021 at 23:30, the patient experienced passed out, felt strange/weird, nauseous, dizzy, ears rang, and blood pressure drop. The clinical course was as follows: the patient was advised to wait 15 minutes before leaving. He set an alarm. He bought some food to eat (potatoes and jerky) and waited to leave the site until 11:22. He felt strange/weird, but this was not an unusual feeling after receiving any kind of shot/vaccine for the patient. He was driving to work and started to get a little nauseous but nothing too bad. Thirty seconds later, he started to get dizzy, ears rang, felt blood pressure drop, and passed out going freeway speeds. He was treated in the emergency department and released the same day. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Passed out; Felt strange/weird; Nauseous; Dizzy; ears rang; Blood pressure drop; This is a spontaneous report from a contactable consumer, reporting for himself. A 33-year-old male patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6208), via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 at a single dose for covid-19 immunisation. The patient received the vaccination in the pharmacy. There was no medical history or concomitant medications. There were no other vaccines administered in the last four weeks. On 25Mar2021 at 23:30, the patient experienced passed out, felt strange/weird, nauseous, dizzy, ears rang, and blood pressure drop. The clinical course was as follows: the patient was advised to wait 15 minutes before leaving. He set an alarm. He bought some food to eat (potatoes and jerky) and waited to leave the site until 11:22. He felt strange/weird, but this was not an unusual feeling after receiving any kind of shot/vaccine for the patient. He was driving to work and started to get a little nauseous but nothing too bad. Thirty seconds later, he started to get dizzy, ears rang, felt blood pressure drop, and passed out going freeway speeds. He was treated in the emergency department and released the same day. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Laboratory test, Rash, SARS-CoV-2 test, Skin reaction
Clinical narrative: Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low energy; digestive symptoms; skin problems; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 05Feb2021 at 12:00 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and known allergies to sulfur and intravenous (IV) contrast; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; atenolol; and omeprazole (PROTONIX); all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 12:00 PM (lot number: EK9231) at the age of 49 years, administered on the right arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no prior vaccination. On an unspecified date in Mar2021 at 12:00 PM, the patient experienced severe 'chicken-pox' like rash began on arms; face pustules, eruct, infection; scarring result; low energy; and digestive symptoms in correlation with skin problems. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; and had also led to disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test via nasal swab: inconclusive on 20Mar2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included topical corticosteroids, oral steroids, and oral antibiotic (antib). The patient was not recovered from all the events.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Eructation, Gastrointestinal disorder, Infection, Pustule
Clinical narrative: Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low energy; digestive symptoms; skin problems; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 05Feb2021 at 12:00 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and known allergies to sulfur and intravenous (IV) contrast; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; atenolol; and omeprazole (PROTONIX); all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 12:00 PM (lot number: EK9231) at the age of 49 years, administered on the right arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no prior vaccination. On an unspecified date in Mar2021 at 12:00 PM, the patient experienced severe 'chicken-pox' like rash began on arms; face pustules, eruct, infection; scarring result; low energy; and digestive symptoms in correlation with skin problems. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; and had also led to disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test via nasal swab: inconclusive on 20Mar2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included topical corticosteroids, oral steroids, and oral antibiotic (antib). The patient was not recovered from all the events.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash vesicular, SARS-CoV-2 test, Scar, Skin disorder
Clinical narrative: Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low energy; digestive symptoms; skin problems; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 05Feb2021 at 12:00 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and known allergies to sulfur and intravenous (IV) contrast; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; atenolol; and omeprazole (PROTONIX); all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 12:00 PM (lot number: EK9231) at the age of 49 years, administered on the right arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no prior vaccination. On an unspecified date in Mar2021 at 12:00 PM, the patient experienced severe 'chicken-pox' like rash began on arms; face pustules, eruct, infection; scarring result; low energy; and digestive symptoms in correlation with skin problems. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; and had also led to disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test via nasal swab: inconclusive on 20Mar2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included topical corticosteroids, oral steroids, and oral antibiotic (antib). The patient was not recovered from all the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site extravasation
Clinical narrative: a lot of fluid inside of the bandage; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that a female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. When the patient got home and removed the bandage, she noticed that there's a lot of fluid inside of the bandage. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discharge
Clinical narrative: a lot of fluid inside of the bandage; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that a female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. When the patient got home and removed the bandage, she noticed that there's a lot of fluid inside of the bandage. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anti-RNA polymerase III antibody, Bell's palsy, Cardiac murmur, Chest discomfort, Computerised tomogram
Clinical narrative: lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8733) via an unspecified route of administration, administered on the left arm on 29Mar2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 10Apr2021 09:00 AM, patient woke up with lower right side of his face drooping and unable to move it. Urgent care advised going to ER, he was put in a stroke protocol, MRI proved it to be Bell's Palsy; ruled out stroke, brain tumors, all blood work normal, echocardiogram normal. No Lyme. No other events or health issues, only change was taking the vaccine. The event resulted in emergency room/department or urgent care visit and hospitalization for 1 day. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and prednisone (and lots of tests). COVID test post vaccination on 10Apr2021: nasal swab negative. The facility where the vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Outcome of the event was not recovered.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Facial paralysis, Laboratory test, Magnetic resonance imaging
Clinical narrative: lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8733) via an unspecified route of administration, administered on the left arm on 29Mar2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 10Apr2021 09:00 AM, patient woke up with lower right side of his face drooping and unable to move it. Urgent care advised going to ER, he was put in a stroke protocol, MRI proved it to be Bell's Palsy; ruled out stroke, brain tumors, all blood work normal, echocardiogram normal. No Lyme. No other events or health issues, only change was taking the vaccine. The event resulted in emergency room/department or urgent care visit and hospitalization for 1 day. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and prednisone (and lots of tests). COVID test post vaccination on 10Apr2021: nasal swab negative. The facility where the vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Outcome of the event was not recovered.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Echocardiogram, Investigation, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: lower right side of his face drooping and unable to move it/ Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8733) via an unspecified route of administration, administered on the left arm on 29Mar2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 10Apr2021 09:00 AM, patient woke up with lower right side of his face drooping and unable to move it. Urgent care advised going to ER, he was put in a stroke protocol, MRI proved it to be Bell's Palsy; ruled out stroke, brain tumors, all blood work normal, echocardiogram normal. No Lyme. No other events or health issues, only change was taking the vaccine. The event resulted in emergency room/department or urgent care visit and hospitalization for 1 day. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and prednisone (and lots of tests). COVID test post vaccination on 10Apr2021: nasal swab negative. The facility where the vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Outcome of the event was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Contusion, Dizziness, Gait disturbance
Clinical narrative: headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse.  A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation.  Medical history included osteoarthritis, and migraines.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination.  The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Joint swelling, Nausea, SARS-CoV-2 test negative
Clinical narrative: headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse.  A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation.  Medical history included osteoarthritis, and migraines.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination.  The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse.  A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation.  Medical history included osteoarthritis, and migraines.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination.  The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Swelling
Clinical narrative: headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse.  A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation.  Medical history included osteoarthritis, and migraines.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination.  The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis 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.