chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hepatic enzyme abnormal, Intensive care, Migraine, Onychoclasis, Renal function test abnormal
Clinical narrative: anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Chest X-ray, Electrocardiogram, Magnetic resonance imaging, Paralysis
Clinical narrative: I had a blood clot on right side of brain resulting in stroke and not being able to use left side of body.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram, Hemiparesis
Clinical narrative: I had a blood clot on right side of brain resulting in stroke and not being able to use left side of body.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: I had a blood clot on right side of brain resulting in stroke and not being able to use left side of body.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tuberculin test
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Lethargy, Mobility decreased, Myalgia
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Headache
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; HEADACHE; JOINT PAIN; FELT MINOR LOCALIZED PAIN AT THE INJECTION; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, treatment medications included: ibuprofen. On 09-MAR-2021 10:00, the subject experienced felt minor localized pain at the injection. On 09-MAR-2021 10:00, the subject experienced dizziness. On 09-MAR-2021 10:00, the subject experienced weakness. On 09-MAR-2021 18:00, the subject experienced chills. On 09-MAR-2021 18:00, the subject experienced fever. On 09-MAR-2021 18:00, the subject experienced body aches. On 09-MAR-2021 18:00, the subject experienced headache. On 09-MAR-2021 18:00, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 106 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt minor localized pain at the injection, dizziness, weakness, chills, fever, body aches, headache and joint pain was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Paraesthesia, Rash macular
Clinical narrative: Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation.  The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination.   Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog.  Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store.   Follow up attempts are needed. Information on lot/batch number was requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Fatigue, Feeling abnormal, Rash macular
Clinical narrative: Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation.  The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination.   Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog.  Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store.   Follow up attempts are needed. Information on lot/batch number was requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation.  The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination.   Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog.  Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store.   Follow up attempts are needed. Information on lot/batch number was requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Unresponsive to stimuli
Clinical narrative: Approximately 5-10 minutes after receiving vaccine, patient felt nauseous, lightheaded, and she fainted and lost consciousness. EMS was called and due to patient's blood pressure being very low, she was transported to the clinic emergency department. Patient reports she received something by IV to help with blood pressure and given the patient's heart history they performed a chest x-ray and blood work, which came back normal. Patient also reports that she experienced a heaviness in her chest for a week following vaccination, but after one week it went away. Patient denies any difficulty breathing.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Dizziness, Hypotension
Clinical narrative: Approximately 5-10 minutes after receiving vaccine, patient felt nauseous, lightheaded, and she fainted and lost consciousness. EMS was called and due to patient's blood pressure being very low, she was transported to the clinic emergency department. Patient reports she received something by IV to help with blood pressure and given the patient's heart history they performed a chest x-ray and blood work, which came back normal. Patient also reports that she experienced a heaviness in her chest for a week following vaccination, but after one week it went away. Patient denies any difficulty breathing.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Approximately 5-10 minutes after receiving vaccine, patient felt nauseous, lightheaded, and she fainted and lost consciousness. EMS was called and due to patient's blood pressure being very low, she was transported to the clinic emergency department. Patient reports she received something by IV to help with blood pressure and given the patient's heart history they performed a chest x-ray and blood work, which came back normal. Patient also reports that she experienced a heaviness in her chest for a week following vaccination, but after one week it went away. Patient denies any difficulty breathing.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Magnetic resonance imaging, Nausea
Clinical narrative: Nausea; dizziness/ lightheaded; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Feb2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The first dose was received on 25Jan2021 12:00 on the left arm at age 31 years old. Patient was not pregnant. There were no other vaccine in four weeks. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and montelukast sodium (SINGULAIR). The patient experienced nausea, dizziness, lightheaded on 19Feb2021 16:00. Events resulted in physician clinic visit and emergency room care. Outcome of the events was recovering. Meclizine, IV fluids, ZOFRAN, steroids were given as treatments. Patient was diagnosed with covid prior to vaccination and had tested (nasal swab) post- vaccination with unknown results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and BNT162B2 use cannot be excluded. The case will be assessed upon receipt of additional information.    The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; dizziness/ lightheaded; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Feb2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The first dose was received on 25Jan2021 12:00 on the left arm at age 31 years old. Patient was not pregnant. There were no other vaccine in four weeks. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and montelukast sodium (SINGULAIR). The patient experienced nausea, dizziness, lightheaded on 19Feb2021 16:00. Events resulted in physician clinic visit and emergency room care. Outcome of the events was recovering. Meclizine, IV fluids, ZOFRAN, steroids were given as treatments. Patient was diagnosed with covid prior to vaccination and had tested (nasal swab) post- vaccination with unknown results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and BNT162B2 use cannot be excluded. The case will be assessed upon receipt of additional information.    The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: sensorineural hearing loss; tinnitus followed by sensation of ear fullness; tinnitus followed by sensation of ear fullness; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiration date not provided) via an unspecified route of administration administered in the left arm on 01Apr2021 10:00 as a single dose for COVID-19 immunization. Medical history included Gilbert syndrome. The patient is not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021, 08:30 for Covid-19 immunization. On 01Apr2021 17:00, the patient experienced 2 hours of tinnitus followed by sensation of ear fullness. She woke up the next day, 02Apr2021 with sensorineural hearing loss for which she was given a course of high dose steroids and requiring follow up with ENT and otoneurologist. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events includes 60 mg prednisone in emergency department and was prescribed 10 days. The outcome of the events was not recovered. The reporter assessed the events as serious (disabling/incapacitating).; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Tinnitus, sensation of ear fullness and Sensory Neural Hearing Loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Ear discomfort, Tinnitus
Clinical narrative: sensorineural hearing loss; tinnitus followed by sensation of ear fullness; tinnitus followed by sensation of ear fullness; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiration date not provided) via an unspecified route of administration administered in the left arm on 01Apr2021 10:00 as a single dose for COVID-19 immunization. Medical history included Gilbert syndrome. The patient is not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021, 08:30 for Covid-19 immunization. On 01Apr2021 17:00, the patient experienced 2 hours of tinnitus followed by sensation of ear fullness. She woke up the next day, 02Apr2021 with sensorineural hearing loss for which she was given a course of high dose steroids and requiring follow up with ENT and otoneurologist. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events includes 60 mg prednisone in emergency department and was prescribed 10 days. The outcome of the events was not recovered. The reporter assessed the events as serious (disabling/incapacitating).; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Tinnitus, sensation of ear fullness and Sensory Neural Hearing Loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: sensorineural hearing loss; tinnitus followed by sensation of ear fullness; tinnitus followed by sensation of ear fullness; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiration date not provided) via an unspecified route of administration administered in the left arm on 01Apr2021 10:00 as a single dose for COVID-19 immunization. Medical history included Gilbert syndrome. The patient is not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021, 08:30 for Covid-19 immunization. On 01Apr2021 17:00, the patient experienced 2 hours of tinnitus followed by sensation of ear fullness. She woke up the next day, 02Apr2021 with sensorineural hearing loss for which she was given a course of high dose steroids and requiring follow up with ENT and otoneurologist. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events includes 60 mg prednisone in emergency department and was prescribed 10 days. The outcome of the events was not recovered. The reporter assessed the events as serious (disabling/incapacitating).; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Tinnitus, sensation of ear fullness and Sensory Neural Hearing Loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dysarthria, Fall, Impaired driving ability, Posture abnormal
Clinical narrative: Pulmonary embolism/ blood clot/ passed out; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in arm, side unknown, on 24Mar2021 14:30 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Vaccination facility type was clinic. Medical history included colon cancer in 2011. He had cancer in 2011 but resolved that year without chemotherapy or radiation. His lab work was good. There were no concomitant medications. No prior vaccinations (within 4 weeks). No family medical history relevant to AE. The patient experienced pulmonary embolism on 26Mar2021 with fatal outcome. The reporter was reporting on the Pfizer COVID vaccine that her father received. She stated he died from a blood clot after receiving the first dose. Stated she needs help because he had no health issues and he died. She just wanted this information to be out there and for people to be aware. This morning they had been reading on the news that the Johnson and Johnson vaccine is on hold. It seems to be put on the market without research. She felt like her father was a guinea pig. Her mother didn't want to get her second dose. Stated there seems to be an issue with Pfizer too. Her father had no issues whatsoever. His death certificate stated the cause of death was a pulmonary embolism, but he had no history of blood clots. Passed away Friday 26Mar2021 at 11:33 am. The reporter stated when he went to Emergency Room they thought he was having a heart attack. All physicians were wondering what happened because he had no health issues. The event required a visit to the emergency room that day because he passed out at his job. The patient underwent lab tests and procedures which included lab work: good in 2011.  The patient died on 26Mar2021. An autopsy was performed that revealed pulmonary embolism.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism/ blood clot/ passed out; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in arm, side unknown, on 24Mar2021 14:30 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Vaccination facility type was clinic. Medical history included colon cancer in 2011. He had cancer in 2011 but resolved that year without chemotherapy or radiation. His lab work was good. There were no concomitant medications. No prior vaccinations (within 4 weeks). No family medical history relevant to AE. The patient experienced pulmonary embolism on 26Mar2021 with fatal outcome. The reporter was reporting on the Pfizer COVID vaccine that her father received. She stated he died from a blood clot after receiving the first dose. Stated she needs help because he had no health issues and he died. She just wanted this information to be out there and for people to be aware. This morning they had been reading on the news that the Johnson and Johnson vaccine is on hold. It seems to be put on the market without research. She felt like her father was a guinea pig. Her mother didn't want to get her second dose. Stated there seems to be an issue with Pfizer too. Her father had no issues whatsoever. His death certificate stated the cause of death was a pulmonary embolism, but he had no history of blood clots. Passed away Friday 26Mar2021 at 11:33 am. The reporter stated when he went to Emergency Room they thought he was having a heart attack. All physicians were wondering what happened because he had no health issues. The event required a visit to the emergency room that day because he passed out at his job. The patient underwent lab tests and procedures which included lab work: good in 2011.  The patient died on 26Mar2021. An autopsy was performed that revealed pulmonary embolism.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Life support
Clinical narrative: Pulmonary embolism/ blood clot/ passed out; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in arm, side unknown, on 24Mar2021 14:30 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Vaccination facility type was clinic. Medical history included colon cancer in 2011. He had cancer in 2011 but resolved that year without chemotherapy or radiation. His lab work was good. There were no concomitant medications. No prior vaccinations (within 4 weeks). No family medical history relevant to AE. The patient experienced pulmonary embolism on 26Mar2021 with fatal outcome. The reporter was reporting on the Pfizer COVID vaccine that her father received. She stated he died from a blood clot after receiving the first dose. Stated she needs help because he had no health issues and he died. She just wanted this information to be out there and for people to be aware. This morning they had been reading on the news that the Johnson and Johnson vaccine is on hold. It seems to be put on the market without research. She felt like her father was a guinea pig. Her mother didn't want to get her second dose. Stated there seems to be an issue with Pfizer too. Her father had no issues whatsoever. His death certificate stated the cause of death was a pulmonary embolism, but he had no history of blood clots. Passed away Friday 26Mar2021 at 11:33 am. The reporter stated when he went to Emergency Room they thought he was having a heart attack. All physicians were wondering what happened because he had no health issues. The event required a visit to the emergency room that day because he passed out at his job. The patient underwent lab tests and procedures which included lab work: good in 2011.  The patient died on 26Mar2021. An autopsy was performed that revealed pulmonary embolism.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pulmonary embolism
Clinical narrative: Pulmonary embolism/ blood clot/ passed out; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in arm, side unknown, on 24Mar2021 14:30 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Vaccination facility type was clinic. Medical history included colon cancer in 2011. He had cancer in 2011 but resolved that year without chemotherapy or radiation. His lab work was good. There were no concomitant medications. No prior vaccinations (within 4 weeks). No family medical history relevant to AE. The patient experienced pulmonary embolism on 26Mar2021 with fatal outcome. The reporter was reporting on the Pfizer COVID vaccine that her father received. She stated he died from a blood clot after receiving the first dose. Stated she needs help because he had no health issues and he died. She just wanted this information to be out there and for people to be aware. This morning they had been reading on the news that the Johnson and Johnson vaccine is on hold. It seems to be put on the market without research. She felt like her father was a guinea pig. Her mother didn't want to get her second dose. Stated there seems to be an issue with Pfizer too. Her father had no issues whatsoever. His death certificate stated the cause of death was a pulmonary embolism, but he had no history of blood clots. Passed away Friday 26Mar2021 at 11:33 am. The reporter stated when he went to Emergency Room they thought he was having a heart attack. All physicians were wondering what happened because he had no health issues. The event required a visit to the emergency room that day because he passed out at his job. The patient underwent lab tests and procedures which included lab work: good in 2011.  The patient died on 26Mar2021. An autopsy was performed that revealed pulmonary embolism.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Heart rate increased, Hyperhidrosis, Respiratory rate increased
Clinical narrative: Received first Covid 19 vaccine and was told to walk around by person who administered injection since they did not have enough chairs.  Approximately five minutes after injection I was standing in an aisle when my vision became blurry and I felt a wave of heat come over my body.  I began to crouch down and passed out hitting my head causing a concussion.