chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Mouth swelling, Paraesthesia oral, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling jittery, Gait disturbance, Headache, Heart rate increased
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Insomnia, Lip swelling, Oedema peripheral, Paraesthesia oral
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: CONFUSED; HARD TO WALK; MAYBE HARD TO BREATH OXYGEN HELPED; LIGHT HEADED; SWELLING LEGS/ANKLES; JITTERY; SLIGHT HAND TREMORS; WEAK; TIRED; HEADACHE; MOUTH WAS TINGLING; LIP SWELLING; THROAT TIGHTENING; WHISPER VOICE; HEART RATE INCREASED; DIFFICULTY SLEEPING; ACUTE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included isopropyl alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced mouth was tingling. On 20-MAY-2021, the subject experienced lip swelling. On 20-MAY-2021, the subject experienced throat tightening. On 20-MAY-2021, the subject experienced whisper voice. On 20-MAY-2021, the subject experienced heart rate increased. On 20-MAY-2021, the subject experienced difficulty sleeping. On 20-MAY-2021, the subject experienced acute allergic reaction. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced confused. On 22-MAY-2021, the subject experienced hard to walk. On 22-MAY-2021, the subject experienced maybe hard to breath oxygen helped. On 22-MAY-2021, the subject experienced light headed. On 22-MAY-2021, the subject experienced swelling legs/ankles. On 22-MAY-2021, the subject experienced jittery. On 22-MAY-2021, the subject experienced slight hand tremors. On 22-MAY-2021, the subject experienced weak. On 22-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and methylprednisolone acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mouth was tingling, throat tightening, whisper voice, and heart rate increased on 20-MAY-2021, lip swelling, acute allergic reaction, and headache on 21-MAY-2021, difficulty sleeping, and confused on 22-MAY-2021, hard to walk on 28-MAY-2021, light headed, and tired on 29-MAY-2021, and swelling legs/ankles, jittery, and slight hand tremors on 23-MAY-2021, and the outcome of maybe hard to breath oxygen helped and weak was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shaking almost fell of the chair; his arm is so hard and straight (on the left arm where the vaccine was injected); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old male patient received the 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 26May2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunization. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications the patient received within 2 weeks of vaccination. After seconds of injecting the vaccine, on 26May2021 at 10:00, the patient passed out or fainted. His father slightly slapped his face to keep him awake. The patient responded slightly and his face and lips became so pale. His father thought he was okay, then he fainted again and the seizure happened. The father was holding his body and his arm is so hard and straight (on the left arm where the vaccine was injected). His body was shaking, almost fell of the chair. Then they called for emergency assistance from the hospital. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was to schedule a visit to the primary doctor. The clinical outcome of the events passed out or fainted, face and lips became so pale, seizure, arm is so hard and straight, and body was shaking was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Seizure, Syncope
Clinical narrative: seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shaking almost fell of the chair; his arm is so hard and straight (on the left arm where the vaccine was injected); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old male patient received the 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 26May2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunization. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications the patient received within 2 weeks of vaccination. After seconds of injecting the vaccine, on 26May2021 at 10:00, the patient passed out or fainted. His father slightly slapped his face to keep him awake. The patient responded slightly and his face and lips became so pale. His father thought he was okay, then he fainted again and the seizure happened. The father was holding his body and his arm is so hard and straight (on the left arm where the vaccine was injected). His body was shaking, almost fell of the chair. Then they called for emergency assistance from the hospital. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was to schedule a visit to the primary doctor. The clinical outcome of the events passed out or fainted, face and lips became so pale, seizure, arm is so hard and straight, and body was shaking was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shaking almost fell of the chair; his arm is so hard and straight (on the left arm where the vaccine was injected); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old male patient received the 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 26May2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunization. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications the patient received within 2 weeks of vaccination. After seconds of injecting the vaccine, on 26May2021 at 10:00, the patient passed out or fainted. His father slightly slapped his face to keep him awake. The patient responded slightly and his face and lips became so pale. His father thought he was okay, then he fainted again and the seizure happened. The father was holding his body and his arm is so hard and straight (on the left arm where the vaccine was injected). His body was shaking, almost fell of the chair. Then they called for emergency assistance from the hospital. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was to schedule a visit to the primary doctor. The clinical outcome of the events passed out or fainted, face and lips became so pale, seizure, arm is so hard and straight, and body was shaking was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Bell's palsy, Ear pain, Facial paralysis, Hyperacusis
Clinical narrative: experienced Bell's palsy, her tongue was numb, could not taste on her right side, pain behind ear, sensitivity to loud noises,eye would not close; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non pregnant female patient (who was not pregnant at the time of vaccination), received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry dates were not provided), via an unspecified route of administration, administered in left arm on 13May2021 at 13:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation in school or student health clinic. The patient medical history was reported as none. No known allergies were reported. Concomitant medications received within 2 weeks of COVID vaccination included cannabis (CANNABIS); medroxyprogesterone acetate (DEPO PROVERA) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID, prior vaccination. She has not been tested for COVID, post vaccination. On 22May2021 at 09:00, the patient experienced Bell's palsy, her tongue was numb, and she could not taste on her right side, pain behind ear, sensitivity to loud noises and eye would not close. Next day (23May2021) her whole right side of face was weak. Third day (24May2021) right side of her face was almost fully paralyzed. Adverse events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient was treated with steroid and antiviral for the events. The patient reported events seriousness as serious (disability or permanent damage). The patient gave consent to contact her and her healthcare provider regarding events and about this report. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: experienced Bell's palsy, her tongue was numb, could not taste on her right side, pain behind ear, sensitivity to loud noises,eye would not close; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non pregnant female patient (who was not pregnant at the time of vaccination), received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry dates were not provided), via an unspecified route of administration, administered in left arm on 13May2021 at 13:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation in school or student health clinic. The patient medical history was reported as none. No known allergies were reported. Concomitant medications received within 2 weeks of COVID vaccination included cannabis (CANNABIS); medroxyprogesterone acetate (DEPO PROVERA) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID, prior vaccination. She has not been tested for COVID, post vaccination. On 22May2021 at 09:00, the patient experienced Bell's palsy, her tongue was numb, and she could not taste on her right side, pain behind ear, sensitivity to loud noises and eye would not close. Next day (23May2021) her whole right side of face was weak. Third day (24May2021) right side of her face was almost fully paralyzed. Adverse events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient was treated with steroid and antiviral for the events. The patient reported events seriousness as serious (disability or permanent damage). The patient gave consent to contact her and her healthcare provider regarding events and about this report. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: experienced Bell's palsy, her tongue was numb, could not taste on her right side, pain behind ear, sensitivity to loud noises,eye would not close; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non pregnant female patient (who was not pregnant at the time of vaccination), received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry dates were not provided), via an unspecified route of administration, administered in left arm on 13May2021 at 13:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation in school or student health clinic. The patient medical history was reported as none. No known allergies were reported. Concomitant medications received within 2 weeks of COVID vaccination included cannabis (CANNABIS); medroxyprogesterone acetate (DEPO PROVERA) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID, prior vaccination. She has not been tested for COVID, post vaccination. On 22May2021 at 09:00, the patient experienced Bell's palsy, her tongue was numb, and she could not taste on her right side, pain behind ear, sensitivity to loud noises and eye would not close. Next day (23May2021) her whole right side of face was weak. Third day (24May2021) right side of her face was almost fully paralyzed. Adverse events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient was treated with steroid and antiviral for the events. The patient reported events seriousness as serious (disability or permanent damage). The patient gave consent to contact her and her healthcare provider regarding events and about this report. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: Bell's Palsy on the right side of her face; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 16Apr2021 10:45 as single dose for covid-19 immunisation at pharmacy or drug store. The patient had no medical history and no known allergies. The patient's concomitant medication included vitamin D3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the patient took her first Pfizer shot on 16Apr2021 and on 08May2021 symptoms started and on 09May2021 she was diagnosed with having Bell's Palsy on the right side of her face. Doctor advised not to take her second Pfizer shot on 11May2021 until recovery which could take up to 8 weeks or longer. The adverse event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the unspecified medicine as treatment for the event and was still taking. The outcome of the event was reported as recovering.   No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy on the right side of her face; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 16Apr2021 10:45 as single dose for covid-19 immunisation at pharmacy or drug store. The patient had no medical history and no known allergies. The patient's concomitant medication included vitamin D3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the patient took her first Pfizer shot on 16Apr2021 and on 08May2021 symptoms started and on 09May2021 she was diagnosed with having Bell's Palsy on the right side of her face. Doctor advised not to take her second Pfizer shot on 11May2021 until recovery which could take up to 8 weeks or longer. The adverse event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the unspecified medicine as treatment for the event and was still taking. The outcome of the event was reported as recovering.   No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cardiac stress test, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: Three weeks after the vaccine I woke up during the night with chest pains. I was also having trouble breathing. I went to the ER and they found a Blood clot in my lung. Thrombosis in the left lung. I was hospitalized for three days. I have to take new medications Lipitor, blood thinner and diuretics. I also have some brain fog since that day and I am very tired all the time. I missed 22 days of work.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Pleural effusion, Productive cough, Pulmonary arterial hypertension, Pulmonary artery dilatation
Clinical narrative: Three weeks after the vaccine I woke up during the night with chest pains. I was also having trouble breathing. I went to the ER and they found a Blood clot in my lung. Thrombosis in the left lung. I was hospitalized for three days. I have to take new medications Lipitor, blood thinner and diuretics. I also have some brain fog since that day and I am very tired all the time. I missed 22 days of work.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Troponin
Clinical narrative: Three weeks after the vaccine I woke up during the night with chest pains. I was also having trouble breathing. I went to the ER and they found a Blood clot in my lung. Thrombosis in the left lung. I was hospitalized for three days. I have to take new medications Lipitor, blood thinner and diuretics. I also have some brain fog since that day and I am very tired all the time. I missed 22 days of work.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cardiovascular examination, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Three weeks after the vaccine I woke up during the night with chest pains. I was also having trouble breathing. I went to the ER and they found a Blood clot in my lung. Thrombosis in the left lung. I was hospitalized for three days. I have to take new medications Lipitor, blood thinner and diuretics. I also have some brain fog since that day and I am very tired all the time. I missed 22 days of work.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Impaired work ability, Pulmonary thrombosis
Clinical narrative: Three weeks after the vaccine I woke up during the night with chest pains. I was also having trouble breathing. I went to the ER and they found a Blood clot in my lung. Thrombosis in the left lung. I was hospitalized for three days. I have to take new medications Lipitor, blood thinner and diuretics. I also have some brain fog since that day and I am very tired all the time. I missed 22 days of work.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle rigidity, Syncope
Clinical narrative: syncopal episode; syncopal episode at 16:05, he was sitting down and slid out of his chair; This is a spontaneous report from a contactable consumer (patient).   An 18-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0187), intramuscular on 26May2021 at 16:01 as a single dose for COVID-19 immunization.  Medical history included syncope in the past while receiving other shots (unspecified). The patient's concomitant medications were not reported. The patient had a syncopal episode on 26May2021 at 16:05. He was sitting down and slid out of his chair with full extension of bilateral arms of legs, lasting about 30 seconds. Witnesses deny head strike or shaking during syncopal episode. The patient denies pain. He states that he only ate cereal the morning before and has experienced similar symptoms in the past while receiving other shots. The patient denies recent trauma or fall, HA, confusion, changes in vision/speech, changes in gait, fever, chills, n/v, abdominal pain, chest pain, SOB, palpitations, cough, hemoptysis, back pain, neck pain, dysuria, hematuria, recent sick contact or travel. Otherwise, the patient had no other complaints at the time of the report. The event required a visit to the emergency room. The patient underwent physical examination, vitals and 12 lead EKG all with unknown results. The patient was discharged at 16:54 and given educational materials on understanding vasovagal syncope. The outcome of the events was recovered.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fall, Physical examination, Syncope, Vital signs measurement
Clinical narrative: syncopal episode; syncopal episode at 16:05, he was sitting down and slid out of his chair; This is a spontaneous report from a contactable consumer (patient).   An 18-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0187), intramuscular on 26May2021 at 16:01 as a single dose for COVID-19 immunization.  Medical history included syncope in the past while receiving other shots (unspecified). The patient's concomitant medications were not reported. The patient had a syncopal episode on 26May2021 at 16:05. He was sitting down and slid out of his chair with full extension of bilateral arms of legs, lasting about 30 seconds. Witnesses deny head strike or shaking during syncopal episode. The patient denies pain. He states that he only ate cereal the morning before and has experienced similar symptoms in the past while receiving other shots. The patient denies recent trauma or fall, HA, confusion, changes in vision/speech, changes in gait, fever, chills, n/v, abdominal pain, chest pain, SOB, palpitations, cough, hemoptysis, back pain, neck pain, dysuria, hematuria, recent sick contact or travel. Otherwise, the patient had no other complaints at the time of the report. The event required a visit to the emergency room. The patient underwent physical examination, vitals and 12 lead EKG all with unknown results. The patient was discharged at 16:54 and given educational materials on understanding vasovagal syncope. The outcome of the events was recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram normal, Fibrin D dimer increased, Limb discomfort
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal pain, Myalgia, Myocarditis, Nausea, Oropharyngeal pain
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Troponin, Vomiting
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest pain, Electrocardiogram, Fatigue, Pain
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sluggishness, Troponin increased
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Troponin increased
Clinical narrative: He began to feel very tired in just a couple hours after the injection.  He had some body aches, but was very sluggish.  This did not improve on Saturday and by Saturday evening he started to notice some pain in his chest.  By Sunday morning there was no improvement and the pain in the chest was increasing.  This is when we decided to go to ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram normal, Fibrin D dimer increased, Limb discomfort
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal pain, Myalgia, Myocarditis, Nausea, Oropharyngeal pain
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Troponin, Vomiting
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest pain, Electrocardiogram, Fatigue, Pain
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sluggishness, Troponin increased
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Troponin increased
Clinical narrative: He started to feel very tired within a couple of hours.  He started to have body aches that evening.  This continued all day Saturday as well and then he started to complain about pain in his chest.  By Sunday morning we took him to the ER
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Third Pfizer vaccination was given in error.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: small stroke in the occipital lobe; headaches and partial vision loss due to the stroke; headaches and partial vision loss due to the stroke; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Right arm (at the age of 37-year-old) on 23Apr2021 09:30 (Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history was none. Concomitant medication included clomiphene [clomifene]; vitamin d [vitamin d nos]; phentermine. He was hospitalized for 3 days. They determined he had a small stroke in the occipital lobe. He currently experiencing headaches and partial vision loss due to the stroke. The events started from 27May2021 10:30. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Received the treatment (Currently undergoing treatment). The outcome of the events was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cerebrovascular accident, Headache
Clinical narrative: small stroke in the occipital lobe; headaches and partial vision loss due to the stroke; headaches and partial vision loss due to the stroke; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Right arm (at the age of 37-year-old) on 23Apr2021 09:30 (Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history was none. Concomitant medication included clomiphene [clomifene]; vitamin d [vitamin d nos]; phentermine. He was hospitalized for 3 days. They determined he had a small stroke in the occipital lobe. He currently experiencing headaches and partial vision loss due to the stroke. The events started from 27May2021 10:30. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Received the treatment (Currently undergoing treatment). The outcome of the events was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Myocarditis, Pneumonia viral, SARS-CoV-2 test positive
Clinical narrative: After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May).  Early June, patient experienced burning chest pain & difficulty breathing.  Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL).  Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion.  Patient was transferred to hospital for higher level of care.  Unknown if cardiac effects are related to vaccination or acute disease process.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May).  Early June, patient experienced burning chest pain & difficulty breathing.  Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL).  Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion.  Patient was transferred to hospital for higher level of care.  Unknown if cardiac effects are related to vaccination or acute disease process.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May).  Early June, patient experienced burning chest pain & difficulty breathing.  Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL).  Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion.  Patient was transferred to hospital for higher level of care.  Unknown if cardiac effects are related to vaccination or acute disease process.