chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS; DIFFICULTY WALKING; BAD BODY PAIN; FAST HEART RATE; BAD HEADACHES; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and arrhythmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches, and fever. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Heart rate, Heart rate increased
Clinical narrative: DIZZINESS; DIFFICULTY WALKING; BAD BODY PAIN; FAST HEART RATE; BAD HEADACHES; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and arrhythmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches, and fever. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: DIZZINESS; DIFFICULTY WALKING; BAD BODY PAIN; FAST HEART RATE; BAD HEADACHES; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and arrhythmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches, and fever. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, difficulty walking, bad body pain, fast heart rate, bad headaches and fever was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Cough, Dizziness, Flushing, Sleep disorder
Clinical narrative: Ringing in ears; slight dizziness; Kinker sores in mouth; skin bumps on stomach; waking up at night in a cold sweat; waking up at night in a cold sweat; metal taste in mouth; flushed face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153), via an unspecified route of administration, administered in left arm on 06Apr2021 at 16:00 (at the age of 59 years old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were none reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ep6955) in left arm on 16Mar2021 (at the age of 59 years old) for covid-19 immunisation and experienced flushed face. On 23Apr2021 the patient experienced that slight dizziness (commenced with ringing in the ears), kinker sores in mouth, developed skin bumps on stomach, waking up at night in a cold sweat, metal taste in mouth. On unspecified date experienced flushed face began with 1st shot, experiencing this now daily. The patient visited physician office visit due to events. The patient did not receive any treatment for the events. The reporter reporting the events as non events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; slight dizziness; Kinker sores in mouth; skin bumps on stomach; waking up at night in a cold sweat; waking up at night in a cold sweat; metal taste in mouth; flushed face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153), via an unspecified route of administration, administered in left arm on 06Apr2021 at 16:00 (at the age of 59 years old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were none reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ep6955) in left arm on 16Mar2021 (at the age of 59 years old) for covid-19 immunisation and experienced flushed face. On 23Apr2021 the patient experienced that slight dizziness (commenced with ringing in the ears), kinker sores in mouth, developed skin bumps on stomach, waking up at night in a cold sweat, metal taste in mouth. On unspecified date experienced flushed face began with 1st shot, experiencing this now daily. The patient visited physician office visit due to events. The patient did not receive any treatment for the events. The reporter reporting the events as non events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Dysgeusia, Flushing, Hyperkeratosis
Clinical narrative: Ringing in ears; slight dizziness; Kinker sores in mouth; skin bumps on stomach; waking up at night in a cold sweat; waking up at night in a cold sweat; metal taste in mouth; flushed face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153), via an unspecified route of administration, administered in left arm on 06Apr2021 at 16:00 (at the age of 59 years old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were none reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ep6955) in left arm on 16Mar2021 (at the age of 59 years old) for covid-19 immunisation and experienced flushed face. On 23Apr2021 the patient experienced that slight dizziness (commenced with ringing in the ears), kinker sores in mouth, developed skin bumps on stomach, waking up at night in a cold sweat, metal taste in mouth. On unspecified date experienced flushed face began with 1st shot, experiencing this now daily. The patient visited physician office visit due to events. The patient did not receive any treatment for the events. The reporter reporting the events as non events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Stomatitis, Tinnitus
Clinical narrative: Ringing in ears; slight dizziness; Kinker sores in mouth; skin bumps on stomach; waking up at night in a cold sweat; waking up at night in a cold sweat; metal taste in mouth; flushed face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153), via an unspecified route of administration, administered in left arm on 06Apr2021 at 16:00 (at the age of 59 years old) as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were none reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ep6955) in left arm on 16Mar2021 (at the age of 59 years old) for covid-19 immunisation and experienced flushed face. On 23Apr2021 the patient experienced that slight dizziness (commenced with ringing in the ears), kinker sores in mouth, developed skin bumps on stomach, waking up at night in a cold sweat, metal taste in mouth. On unspecified date experienced flushed face began with 1st shot, experiencing this now daily. The patient visited physician office visit due to events. The patient did not receive any treatment for the events. The reporter reporting the events as non events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood test, Computerised tomogram, Fall, Gait disturbance
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); GUILLIAN BARRE SYNDROME (GBS); This spontaneous report received from a patient via a company representative concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD), and Guillian Barre Syndrome (GBS) after receiving the Covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic inflammatory demyelinating polyneuropathy (CIPD) and guillian barre syndrome (GBS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139987-COVID-19 VACCINE AD26.COV2.S- Chronic inflammatory demyelinating polyneuropathy (CIPD). This event(s) is considered unassessable. The event(s) 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(s).  20211139987-COVID-19 VACCINE AD26.COV2.S- Guillian-Barre syndrome (GBS)  This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Limb discomfort, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); GUILLIAN BARRE SYNDROME (GBS); This spontaneous report received from a patient via a company representative concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD), and Guillian Barre Syndrome (GBS) after receiving the Covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic inflammatory demyelinating polyneuropathy (CIPD) and guillian barre syndrome (GBS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139987-COVID-19 VACCINE AD26.COV2.S- Chronic inflammatory demyelinating polyneuropathy (CIPD). This event(s) is considered unassessable. The event(s) 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(s).  20211139987-COVID-19 VACCINE AD26.COV2.S- Guillian-Barre syndrome (GBS)  This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); GUILLIAN BARRE SYNDROME (GBS); This spontaneous report received from a patient via a company representative concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD), and Guillian Barre Syndrome (GBS) after receiving the Covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic inflammatory demyelinating polyneuropathy (CIPD) and guillian barre syndrome (GBS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139987-COVID-19 VACCINE AD26.COV2.S- Chronic inflammatory demyelinating polyneuropathy (CIPD). This event(s) is considered unassessable. The event(s) 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(s).  20211139987-COVID-19 VACCINE AD26.COV2.S- Guillian-Barre syndrome (GBS)  This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); GUILLIAN BARRE SYNDROME (GBS); This spontaneous report received from a patient via a company representative concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD), and Guillian Barre Syndrome (GBS) after receiving the Covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic inflammatory demyelinating polyneuropathy (CIPD) and guillian barre syndrome (GBS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139987-COVID-19 VACCINE AD26.COV2.S- Chronic inflammatory demyelinating polyneuropathy (CIPD). This event(s) is considered unassessable. The event(s) 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(s).  20211139987-COVID-19 VACCINE AD26.COV2.S- Guillian-Barre syndrome (GBS)  This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); GUILLIAN BARRE SYNDROME (GBS); This spontaneous report received from a patient via a company representative concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD), and Guillian Barre Syndrome (GBS) after receiving the Covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic inflammatory demyelinating polyneuropathy (CIPD) and guillian barre syndrome (GBS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139987-COVID-19 VACCINE AD26.COV2.S- Chronic inflammatory demyelinating polyneuropathy (CIPD). This event(s) is considered unassessable. The event(s) 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(s).  20211139987-COVID-19 VACCINE AD26.COV2.S- Guillian-Barre syndrome (GBS)  This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP, VARCEL, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Under 12 years of age; no adverse symptoms
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Impaired driving ability, Lacrimation increased, Ocular discomfort, Vision blurred
Clinical narrative: Double vision after having the vaccine shot; 10Oct first experienced, upon waking, double vision and blurred vision out of two eyes.; Extreme pressure in left eye; Dizziness; Vertigo; sensitivity to outdoor sunlight; This is a spontaneous report from a contactable consumer.   A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 09:15 (Batch/Lot Number: 301458A; Expiration Date: Nov2021) as DOSE 1, SINGLE (at unspecified age) for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 08Oct2021 (Batch/Lot number was not reported) to 08Oct2021, at DOSE NUMBER UNKNOWN, SINGLE (at unspecified age) for immunisation.  Patient received 1st Pfizer covid shot and 2 Flu shot recommended by pharmacy to take simultaneously.  Medical history included ongoing diabetes mellitus.  The patient had family history of High blood pressure and High Cholesterol.   The patient's concomitant medications were not reported.  The patient experienced upon waking, double vision and blurred vision out of two eyes (disability) on 10Oct2021 with outcome of not recovered, extreme pressure in left eye (disability) on 10Oct2021 with outcome of not recovered, dizziness (disability) on 10Oct2021 with outcome of not recovered, vertigo (disability) on 10Oct2021 with outcome of not recovered, sensitivity to outdoor sunlight (disability) on 10Oct2021 with outcome of not recovered.  Unspecified eyedrops were therapeutic measures taken as a result of diplopia, blurred vision, extreme pressure in left eye, dizziness, vertigo, and sensitivity to outdoor sunlight. No tests, including no Specific Relevant Test for thromboembolic events with thrombocytopenia were performed. Consulted with general practitioner; endocrinologist, eye doctor (who determined no anomalies in my eyes).  Vision specialist determined/discovered info regarding taking the flu shot with the 1st covid shot is reason for AE. Eye drops recommended. Gave timeline for 1 more month for 2nd appointment. After 2nd appointment to revisit whether there was any change from 1st visit: symptoms the same-Eye looked normal-referred to double vision specialist.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness, Ocular discomfort, Photophobia, Vertigo
Clinical narrative: Double vision after having the vaccine shot; 10Oct first experienced, upon waking, double vision and blurred vision out of two eyes.; Extreme pressure in left eye; Dizziness; Vertigo; sensitivity to outdoor sunlight; This is a spontaneous report from a contactable consumer.   A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 09:15 (Batch/Lot Number: 301458A; Expiration Date: Nov2021) as DOSE 1, SINGLE (at unspecified age) for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 08Oct2021 (Batch/Lot number was not reported) to 08Oct2021, at DOSE NUMBER UNKNOWN, SINGLE (at unspecified age) for immunisation.  Patient received 1st Pfizer covid shot and 2 Flu shot recommended by pharmacy to take simultaneously.  Medical history included ongoing diabetes mellitus.  The patient had family history of High blood pressure and High Cholesterol.   The patient's concomitant medications were not reported.  The patient experienced upon waking, double vision and blurred vision out of two eyes (disability) on 10Oct2021 with outcome of not recovered, extreme pressure in left eye (disability) on 10Oct2021 with outcome of not recovered, dizziness (disability) on 10Oct2021 with outcome of not recovered, vertigo (disability) on 10Oct2021 with outcome of not recovered, sensitivity to outdoor sunlight (disability) on 10Oct2021 with outcome of not recovered.  Unspecified eyedrops were therapeutic measures taken as a result of diplopia, blurred vision, extreme pressure in left eye, dizziness, vertigo, and sensitivity to outdoor sunlight. No tests, including no Specific Relevant Test for thromboembolic events with thrombocytopenia were performed. Consulted with general practitioner; endocrinologist, eye doctor (who determined no anomalies in my eyes).  Vision specialist determined/discovered info regarding taking the flu shot with the 1st covid shot is reason for AE. Eye drops recommended. Gave timeline for 1 more month for 2nd appointment. After 2nd appointment to revisit whether there was any change from 1st visit: symptoms the same-Eye looked normal-referred to double vision specialist.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Double vision after having the vaccine shot; 10Oct first experienced, upon waking, double vision and blurred vision out of two eyes.; Extreme pressure in left eye; Dizziness; Vertigo; sensitivity to outdoor sunlight; This is a spontaneous report from a contactable consumer.   A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 09:15 (Batch/Lot Number: 301458A; Expiration Date: Nov2021) as DOSE 1, SINGLE (at unspecified age) for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 08Oct2021 (Batch/Lot number was not reported) to 08Oct2021, at DOSE NUMBER UNKNOWN, SINGLE (at unspecified age) for immunisation.  Patient received 1st Pfizer covid shot and 2 Flu shot recommended by pharmacy to take simultaneously.  Medical history included ongoing diabetes mellitus.  The patient had family history of High blood pressure and High Cholesterol.   The patient's concomitant medications were not reported.  The patient experienced upon waking, double vision and blurred vision out of two eyes (disability) on 10Oct2021 with outcome of not recovered, extreme pressure in left eye (disability) on 10Oct2021 with outcome of not recovered, dizziness (disability) on 10Oct2021 with outcome of not recovered, vertigo (disability) on 10Oct2021 with outcome of not recovered, sensitivity to outdoor sunlight (disability) on 10Oct2021 with outcome of not recovered.  Unspecified eyedrops were therapeutic measures taken as a result of diplopia, blurred vision, extreme pressure in left eye, dizziness, vertigo, and sensitivity to outdoor sunlight. No tests, including no Specific Relevant Test for thromboembolic events with thrombocytopenia were performed. Consulted with general practitioner; endocrinologist, eye doctor (who determined no anomalies in my eyes).  Vision specialist determined/discovered info regarding taking the flu shot with the 1st covid shot is reason for AE. Eye drops recommended. Gave timeline for 1 more month for 2nd appointment. After 2nd appointment to revisit whether there was any change from 1st visit: symptoms the same-Eye looked normal-referred to double vision specialist.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site urticaria, Pain, Pain in extremity
Clinical narrative: Chest congestion; Difficulty breathing; Positive d-dine test; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Fe3590), via an unspecified route of administration, administered in arm left on 18Oct2021 at 16:45 (at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included known allergies: penicillin, wheat and almonds, grass, dust and trees. The patient's concomitant medications were not reported. The patient experienced chest congestion, difficulty breathing and positive d-dine test on 22Oct2021 at 21:30. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included fibrin d dimer: positive on an unspecified date. The event chest congestion was assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.     No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Chest congestion; Difficulty breathing; Positive d-dine test; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Fe3590), via an unspecified route of administration, administered in arm left on 18Oct2021 at 16:45 (at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included known allergies: penicillin, wheat and almonds, grass, dust and trees. The patient's concomitant medications were not reported. The patient experienced chest congestion, difficulty breathing and positive d-dine test on 22Oct2021 at 21:30. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included fibrin d dimer: positive on an unspecified date. The event chest congestion was assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.     No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Respiratory tract congestion
Clinical narrative: Chest congestion; Difficulty breathing; Positive d-dine test; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Fe3590), via an unspecified route of administration, administered in arm left on 18Oct2021 at 16:45 (at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included known allergies: penicillin, wheat and almonds, grass, dust and trees. The patient's concomitant medications were not reported. The patient experienced chest congestion, difficulty breathing and positive d-dine test on 22Oct2021 at 21:30. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included fibrin d dimer: positive on an unspecified date. The event chest congestion was assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.     No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Headache, Hypersomnia
Clinical narrative: fever; headache; chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest; difficulty breathing; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration, administered in arm left on 09Jul2021 at 12:00 (at the age of 12-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks were unknown. Any other medications the patient received within 2 weeks of vaccination was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 10Jul2021, the patient experienced fever, headache, chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest and difficulty breathing. The seriousness of the events was reported as serious. The patient underwent lab tests and procedures which included body temperature on 10Jul2021: unknown results. The patient takes rest for more than a week. Adverse events required emergency room visit and physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Neck pain, Pyrexia, Syncope
Clinical narrative: fever; headache; chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest; difficulty breathing; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration, administered in arm left on 09Jul2021 at 12:00 (at the age of 12-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks were unknown. Any other medications the patient received within 2 weeks of vaccination was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 10Jul2021, the patient experienced fever, headache, chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest and difficulty breathing. The seriousness of the events was reported as serious. The patient underwent lab tests and procedures which included body temperature on 10Jul2021: unknown results. The patient takes rest for more than a week. Adverse events required emergency room visit and physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Headache, Pyrexia
Clinical narrative: fever; headache; chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest; difficulty breathing; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration, administered in arm left on 09Jul2021 at 12:00 (at the age of 12-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks were unknown. Any other medications the patient received within 2 weeks of vaccination was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 10Jul2021, the patient experienced fever, headache, chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest and difficulty breathing. The seriousness of the events was reported as serious. The patient underwent lab tests and procedures which included body temperature on 10Jul2021: unknown results. The patient takes rest for more than a week. Adverse events required emergency room visit and physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Headache, Illness
Clinical narrative: fever; headache; chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest; difficulty breathing; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration, administered in arm left on 09Jul2021 at 12:00 (at the age of 12-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks were unknown. Any other medications the patient received within 2 weeks of vaccination was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 10Jul2021, the patient experienced fever, headache, chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest and difficulty breathing. The seriousness of the events was reported as serious. The patient underwent lab tests and procedures which included body temperature on 10Jul2021: unknown results. The patient takes rest for more than a week. Adverse events required emergency room visit and physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Pyrexia, Syncope
Clinical narrative: fever; headache; chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest; difficulty breathing; This is a spontaneous report received from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration, administered in arm left on 09Jul2021 at 12:00 (at the age of 12-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks were unknown. Any other medications the patient received within 2 weeks of vaccination was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 10Jul2021, the patient experienced fever, headache, chest pain/describes the chest pain as the two bullets shooting through the two sides of the chest and difficulty breathing. The seriousness of the events was reported as serious. The patient underwent lab tests and procedures which included body temperature on 10Jul2021: unknown results. The patient takes rest for more than a week. Adverse events required emergency room visit and physician office visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Headache, Hypersomnia
Clinical narrative: abdominal pain; ill; faints during the swimming practice/ faints during the swimming practice; chest pain; fever; headache; neck pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on unspecified date in Jul2021 (at the age of 12 years) as dose 2, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. No covid prior vaccination. No Known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously patient took first dose of BNT162B2 (lot number: EW0196) on 09Jul2021 24:00 PM (at the age of 12 years), administered in Left arm as dose 1, single for COVID-19 immunisation and experienced fever, headache, chest pain and difficulty in breathing. The patient experienced fever, headache and neck pain on 31Jul2021, chest pain on 01Aug2021, difficulty breathing on unspecified date in 2021, faints during the swimming practice/ faints during the swimming practice on 27Oct2021 18:00, abdominal pain and ill on 28Oct2021. Seriousness criteria-Disabling/Incapacitating. It was reported that on the second day 31Jul2021, patient had a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complained of chest pain and difficulty breathing. Since then he had chest pain and difficulty breathing till now. About 18:00 pm on 27Oct2021, he faints during the swimming practice/ faints during the swimming practice. At about 11:30 am on 28Oct2021, he experiences severe abdominal pain at school and is sent back home earlier. Since then he was very ill and has not been able to return to school. On the night of 05Nov2021, again he faints in the middle of the running 1/2 miles. Adverse events resulted in healthcare professional office visit and Emergency room visit. No covid tested post vaccination. No treatment was received. The clinical outcome of the events was unknown for fever, headache, neck pain, faints during the swimming practice/ faints during the swimming practice, abdominal pain, ill; not recovered for chest pain and difficulty breathing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Neck pain, Pyrexia, Syncope
Clinical narrative: abdominal pain; ill; faints during the swimming practice/ faints during the swimming practice; chest pain; fever; headache; neck pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on unspecified date in Jul2021 (at the age of 12 years) as dose 2, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. No covid prior vaccination. No Known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously patient took first dose of BNT162B2 (lot number: EW0196) on 09Jul2021 24:00 PM (at the age of 12 years), administered in Left arm as dose 1, single for COVID-19 immunisation and experienced fever, headache, chest pain and difficulty in breathing. The patient experienced fever, headache and neck pain on 31Jul2021, chest pain on 01Aug2021, difficulty breathing on unspecified date in 2021, faints during the swimming practice/ faints during the swimming practice on 27Oct2021 18:00, abdominal pain and ill on 28Oct2021. Seriousness criteria-Disabling/Incapacitating. It was reported that on the second day 31Jul2021, patient had a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complained of chest pain and difficulty breathing. Since then he had chest pain and difficulty breathing till now. About 18:00 pm on 27Oct2021, he faints during the swimming practice/ faints during the swimming practice. At about 11:30 am on 28Oct2021, he experiences severe abdominal pain at school and is sent back home earlier. Since then he was very ill and has not been able to return to school. On the night of 05Nov2021, again he faints in the middle of the running 1/2 miles. Adverse events resulted in healthcare professional office visit and Emergency room visit. No covid tested post vaccination. No treatment was received. The clinical outcome of the events was unknown for fever, headache, neck pain, faints during the swimming practice/ faints during the swimming practice, abdominal pain, ill; not recovered for chest pain and difficulty breathing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Headache, Pyrexia
Clinical narrative: abdominal pain; ill; faints during the swimming practice/ faints during the swimming practice; chest pain; fever; headache; neck pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on unspecified date in Jul2021 (at the age of 12 years) as dose 2, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. No covid prior vaccination. No Known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously patient took first dose of BNT162B2 (lot number: EW0196) on 09Jul2021 24:00 PM (at the age of 12 years), administered in Left arm as dose 1, single for COVID-19 immunisation and experienced fever, headache, chest pain and difficulty in breathing. The patient experienced fever, headache and neck pain on 31Jul2021, chest pain on 01Aug2021, difficulty breathing on unspecified date in 2021, faints during the swimming practice/ faints during the swimming practice on 27Oct2021 18:00, abdominal pain and ill on 28Oct2021. Seriousness criteria-Disabling/Incapacitating. It was reported that on the second day 31Jul2021, patient had a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complained of chest pain and difficulty breathing. Since then he had chest pain and difficulty breathing till now. About 18:00 pm on 27Oct2021, he faints during the swimming practice/ faints during the swimming practice. At about 11:30 am on 28Oct2021, he experiences severe abdominal pain at school and is sent back home earlier. Since then he was very ill and has not been able to return to school. On the night of 05Nov2021, again he faints in the middle of the running 1/2 miles. Adverse events resulted in healthcare professional office visit and Emergency room visit. No covid tested post vaccination. No treatment was received. The clinical outcome of the events was unknown for fever, headache, neck pain, faints during the swimming practice/ faints during the swimming practice, abdominal pain, ill; not recovered for chest pain and difficulty breathing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.