chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was 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 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was 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 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was 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 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was 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 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering.  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Areflexia, CSF glucose normal, CSF protein increased, CSF red blood cell count, CSF white blood cell count increased
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Bacterial test negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF red blood cell count positive, CSF white blood cell count increased, Cytomegalovirus test, Cytomegalovirus test negative, Demyelinating polyneuropathy
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram abnormal, Enterovirus test negative, Epstein-Barr virus test negative, Fungal test, Guillain-Barre syndrome
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes simplex test negative, Lumbar puncture, Magnetic resonance imaging spinal abnormal, Motor dysfunction, Sensory disturbance
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Treponema test negative
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Electromyogram, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging, Movement disorder
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: 56 y.o. right handed man with no prior medical history prior to recent hospitalization who had COVID vaccine on 3/13/21, with onset of lower back pain and ascending sensory and motor complaints since 3/19, found to have GBS, admitted starting 3/23
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood glucose, Computerised tomogram, Dysarthria, Facial paralysis
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Muscle strength abnormal, Syncope
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hyperhidrosis, Hypoaesthesia, Intensive care
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Syncope
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral normal, Anxiety, Condition aggravated, Conversion disorder, Dizziness
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysarthria, Facial paralysis, Facial paresis, Hemiparesis, Hyperhidrosis
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Malaise, Nausea, Pallor
Clinical narrative: Sweating/tempature within 5 minutes of shot Headache within 7 minutes of shot fainting 10 minutes of shot Blood pressure dropped within 13 minutes Slurred speech, right-side face drooping and right side tingling and numbing within 17 minutes Ambulance called within 20 minutes Arrived to Emergency within 30 to 40 minutes.  ER nurse called stroke alert within 60 minutes TPA blood clot buster administered within 75 to 95 minutes
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature decreased, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Felt like passing out at 12:30p the next afternoon; temperature of 95 degrees; Headaches; fatigue; dizziness; minor chest pain; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 24Mar2021 16:30 PM (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, patient diagnosed with COVID-19. On 25Mar2021 at 12:30 PM, the patient experienced felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath. Felt like passing out at 12:30 PM the next afternoon, temperature of 95 degrees at that time and experienced headaches, fatigue, dizziness, minor chest pain and shortness of breath since that day. The patient did not receive any treatment for the events. The clinical outcomes of the felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath were resolved with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Felt like passing out at 12:30p the next afternoon; temperature of 95 degrees; Headaches; fatigue; dizziness; minor chest pain; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 24Mar2021 16:30 PM (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, patient diagnosed with COVID-19. On 25Mar2021 at 12:30 PM, the patient experienced felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath. Felt like passing out at 12:30 PM the next afternoon, temperature of 95 degrees at that time and experienced headaches, fatigue, dizziness, minor chest pain and shortness of breath since that day. The patient did not receive any treatment for the events. The clinical outcomes of the felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath were resolved with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness
Clinical narrative: Felt like passing out at 12:30p the next afternoon; temperature of 95 degrees; Headaches; fatigue; dizziness; minor chest pain; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 24Mar2021 16:30 PM (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, patient diagnosed with COVID-19. On 25Mar2021 at 12:30 PM, the patient experienced felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath. Felt like passing out at 12:30 PM the next afternoon, temperature of 95 degrees at that time and experienced headaches, fatigue, dizziness, minor chest pain and shortness of breath since that day. The patient did not receive any treatment for the events. The clinical outcomes of the felt like passing out, temperature of 95 degrees, headaches, fatigue, dizziness, minor chest pain and shortness of breath were resolved with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Right sided facial numbness and tingling that started 5 hours after injection.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right sided facial numbness and tingling that started 5 hours after injection.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: My mother had her shot Friday. I was with her Saturday and she was fine, I spoke with her Sunday she was fine. Monday she passed without warning. My mother did not indicate that she was having any type of reaction to shot but aside from her existing health condition she was very much her happy & well self.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Full body rash, not at injection site, 10 days after 2nd vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EP6955), via an unspecified route of administration, administered on right arm on 18Mar2021 (at the age of 56-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination. Concomitant medications included lisinopril, hydrochlorothiazide, vitamin b, c, d and zinc within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205) administered on 24Feb2021 at 10:00 AM on right arm, single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. The patient experienced full body rash, not at injection site on 28Mar2021 08:00, 10 days after second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab test COVID-19 test which had a negative result on 29Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Full body rash, not at injection site, 10 days after 2nd vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EP6955), via an unspecified route of administration, administered on right arm on 18Mar2021 (at the age of 56-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination. Concomitant medications included lisinopril, hydrochlorothiazide, vitamin b, c, d and zinc within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205) administered on 24Feb2021 at 10:00 AM on right arm, single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. The patient experienced full body rash, not at injection site on 28Mar2021 08:00, 10 days after second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab test COVID-19 test which had a negative result on 29Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: Full body rash, not at injection site, 10 days after 2nd vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EP6955), via an unspecified route of administration, administered on right arm on 18Mar2021 (at the age of 56-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination. Concomitant medications included lisinopril, hydrochlorothiazide, vitamin b, c, d and zinc within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205) administered on 24Feb2021 at 10:00 AM on right arm, single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. The patient experienced full body rash, not at injection site on 28Mar2021 08:00, 10 days after second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab test COVID-19 test which had a negative result on 29Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Swelling, Throat irritation
Clinical narrative: No issues during the 15 minutes at pharmacy, went back to work and about 45 min later went into anaphylaxis.  Called 911 and went to emergency room
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: No issues during the 15 minutes at pharmacy, went back to work and about 45 min later went into anaphylaxis.  Called 911 and went to emergency room
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, Pulmonary thrombosis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Drug ineffective; contracted Covid with complications after receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced contracted covid with complications after receiving on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test was contracted covid with complications on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; contracted Covid with complications after receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced contracted covid with complications after receiving on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test was contracted covid with complications on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Syncope
Clinical narrative: 4/1/21: Per EMS on site during observation after COVID vaccine administration client had altered level of consciousness. Client had stable vital signs except for slightly elevated pulse rate. Client with history of reactions to vaccines. Client care transferred to ambulance for transport to Hospital for further evaluation of altered level of consciousness.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Heart rate increased
Clinical narrative: 4/1/21: Per EMS on site during observation after COVID vaccine administration client had altered level of consciousness. Client had stable vital signs except for slightly elevated pulse rate. Client with history of reactions to vaccines. Client care transferred to ambulance for transport to Hospital for further evaluation of altered level of consciousness.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Fatigue, Heart rate increased, Hot flush, Immediate post-injection reaction
Clinical narrative: Patient received the first dose of Pfizer Covid-19 vaccine and about 5 minutes after complained of numbness and tingling in her face and felt her throat was closing up.  Patient was medicated with 0.3mg epinephrine one dose, 911 called. EMS inserted IV line and Benadryl 50mg was administered once. The patient was transferred to the Emergency department where she was observed for 4 hours and given prescriptions for Prednisone and Benadryl for an additional 3 days on discharge.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Patient received the first dose of Pfizer Covid-19 vaccine and about 5 minutes after complained of numbness and tingling in her face and felt her throat was closing up.  Patient was medicated with 0.3mg epinephrine one dose, 911 called. EMS inserted IV line and Benadryl 50mg was administered once. The patient was transferred to the Emergency department where she was observed for 4 hours and given prescriptions for Prednisone and Benadryl for an additional 3 days on discharge.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat tightness
Clinical narrative: Patient received the first dose of Pfizer Covid-19 vaccine and about 5 minutes after complained of numbness and tingling in her face and felt her throat was closing up.  Patient was medicated with 0.3mg epinephrine one dose, 911 called. EMS inserted IV line and Benadryl 50mg was administered once. The patient was transferred to the Emergency department where she was observed for 4 hours and given prescriptions for Prednisone and Benadryl for an additional 3 days on discharge.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Rash, Swelling, Swelling face
Clinical narrative: NECK SWELLING; ITCHING; REDNESS; FACIAL SWELLING (CHEEKS, FOREHEAD, AROUND EYES); RASH; FACE IS HOT; COLD COMPRESS FOR 30 MINUTES, RESOLVED BUT RETURN IN A COUPLE OF HOUR; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 13:30 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced face is hot. On APR-2021, the subject experienced cold compress for 30 minutes, resolved but return in a couple of hour. On 01-APR-2021 18:00, the subject experienced neck swelling. On 01-APR-2021 18:00, the subject experienced itching. On 01-APR-2021 18:00, the subject experienced redness. On 01-APR-2021 18:00, the subject experienced facial swelling (cheeks, forehead, around eyes). On 01-APR-2021 18:00, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck swelling, itching, redness, rash, facial swelling (cheeks, forehead, around eyes), face is hot, and cold compress for 30 minutes, resolved but return in a couple of hour. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hot flush, Pruritus, Rash, Swelling
Clinical narrative: NECK SWELLING; ITCHING; REDNESS; FACIAL SWELLING (CHEEKS, FOREHEAD, AROUND EYES); RASH; FACE IS HOT; COLD COMPRESS FOR 30 MINUTES, RESOLVED BUT RETURN IN A COUPLE OF HOUR; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 13:30 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced face is hot. On APR-2021, the subject experienced cold compress for 30 minutes, resolved but return in a couple of hour. On 01-APR-2021 18:00, the subject experienced neck swelling. On 01-APR-2021 18:00, the subject experienced itching. On 01-APR-2021 18:00, the subject experienced redness. On 01-APR-2021 18:00, the subject experienced facial swelling (cheeks, forehead, around eyes). On 01-APR-2021 18:00, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck swelling, itching, redness, rash, facial swelling (cheeks, forehead, around eyes), face is hot, and cold compress for 30 minutes, resolved but return in a couple of hour. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: NECK SWELLING; ITCHING; REDNESS; FACIAL SWELLING (CHEEKS, FOREHEAD, AROUND EYES); RASH; FACE IS HOT; COLD COMPRESS FOR 30 MINUTES, RESOLVED BUT RETURN IN A COUPLE OF HOUR; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 13:30 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced face is hot. On APR-2021, the subject experienced cold compress for 30 minutes, resolved but return in a couple of hour. On 01-APR-2021 18:00, the subject experienced neck swelling. On 01-APR-2021 18:00, the subject experienced itching. On 01-APR-2021 18:00, the subject experienced redness. On 01-APR-2021 18:00, the subject experienced facial swelling (cheeks, forehead, around eyes). On 01-APR-2021 18:00, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck swelling, itching, redness, rash, facial swelling (cheeks, forehead, around eyes), face is hot, and cold compress for 30 minutes, resolved but return in a couple of hour. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Magnetic resonance imaging head, Superior sagittal sinus thrombosis
Clinical narrative: SAGITTAL SINUS THROMBOSIS; CEREBRAL HEMORRHAGE; SEIZURES; THROMBOCYTOPENIA; This spontaneous report was received from a pharmacist and concerned an 18-year-old female. Initial information was received on 03-APR-2021, with additional information obtained via telephone follow up from a physician on 07-APR-2021. The patient's height and weight were not reported. The patient had no known allergies, was a non-smoker, was not on oral contraceptives and was not on any medications. There was no history of clotting disorders for the patient and no family history of a clotting disorder. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number and expiration date were not reported) on 16-MAR-2021. The batch number has been requested.  On 01-APR-2021, patient developed headaches, vomiting and mental status changes. The mother of the patient noted that she was "staring" or "spacey". She was brought to the hospital where CT scan (computerized tomogram) and MRI (magnetic resonance imaging) of the brain revealed sagittal sinus thrombosis and hemorrhage. The patient was admitted to the intensive care unit. Platelet count on presentation was 18,000 (units unspecified), fibrinogen was noted to be low (value not provided), fibrin D-dimer was elevated (specific levels not provided). The platelet counts remained 22,000 to 24,000. In the evening of 01-APR-2021, the patient developed seizures, was intubated, sedated and placed on unspecified anti-epileptics. The patient was treated using a platelet transfusion in preparation for thrombectomy, and was anticoagulated (specific agents not provided). Following platelet transfusion and thrombectomy, patient's platelet count rose to 160,000, fibrinogen normalized (value not provided), and both remained stable for 1-2 days. Treatment with unspecified anti-epileptics was continued. The patient remained intubated and sedated, and thus her mental and neurologic status was not re-evaluated. She was transferred to a tertiary care hospital in the evening of 06-APR-2021. The patient recovered from thrombocytopenia, and the outcome of sagittal sinus thrombosis, cerebral hemorrhage, and seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of an 18-year-old female who experienced cerebral venous sinus thrombosis with thrombocytopenia and low fibrinogen levels 16 days after receipt of the Janssen COVID-19 vaccine. The patient was treated with platelet transfusion and underwent thrombectomy, and remains in intensive care. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood fibrinogen, Cerebral haemorrhage, Computerised tomogram head, Fibrin D dimer, Magnetic resonance imaging head
Clinical narrative: SAGITTAL SINUS THROMBOSIS; CEREBRAL HEMORRHAGE; SEIZURES; THROMBOCYTOPENIA; This spontaneous report was received from a pharmacist and concerned an 18-year-old female. Initial information was received on 03-APR-2021, with additional information obtained via telephone follow up from a physician on 07-APR-2021. The patient's height and weight were not reported. The patient had no known allergies, was a non-smoker, was not on oral contraceptives and was not on any medications. There was no history of clotting disorders for the patient and no family history of a clotting disorder. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number and expiration date were not reported) on 16-MAR-2021. The batch number has been requested.  On 01-APR-2021, patient developed headaches, vomiting and mental status changes. The mother of the patient noted that she was "staring" or "spacey". She was brought to the hospital where CT scan (computerized tomogram) and MRI (magnetic resonance imaging) of the brain revealed sagittal sinus thrombosis and hemorrhage. The patient was admitted to the intensive care unit. Platelet count on presentation was 18,000 (units unspecified), fibrinogen was noted to be low (value not provided), fibrin D-dimer was elevated (specific levels not provided). The platelet counts remained 22,000 to 24,000. In the evening of 01-APR-2021, the patient developed seizures, was intubated, sedated and placed on unspecified anti-epileptics. The patient was treated using a platelet transfusion in preparation for thrombectomy, and was anticoagulated (specific agents not provided). Following platelet transfusion and thrombectomy, patient's platelet count rose to 160,000, fibrinogen normalized (value not provided), and both remained stable for 1-2 days. Treatment with unspecified anti-epileptics was continued. The patient remained intubated and sedated, and thus her mental and neurologic status was not re-evaluated. She was transferred to a tertiary care hospital in the evening of 06-APR-2021. The patient recovered from thrombocytopenia, and the outcome of sagittal sinus thrombosis, cerebral hemorrhage, and seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of an 18-year-old female who experienced cerebral venous sinus thrombosis with thrombocytopenia and low fibrinogen levels 16 days after receipt of the Janssen COVID-19 vaccine. The patient was treated with platelet transfusion and underwent thrombectomy, and remains in intensive care. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Seizure, Superior sagittal sinus thrombosis, Thrombocytopenia
Clinical narrative: SAGITTAL SINUS THROMBOSIS; CEREBRAL HEMORRHAGE; SEIZURES; THROMBOCYTOPENIA; This spontaneous report was received from a pharmacist and concerned an 18-year-old female. Initial information was received on 03-APR-2021, with additional information obtained via telephone follow up from a physician on 07-APR-2021. The patient's height and weight were not reported. The patient had no known allergies, was a non-smoker, was not on oral contraceptives and was not on any medications. There was no history of clotting disorders for the patient and no family history of a clotting disorder. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number and expiration date were not reported) on 16-MAR-2021. The batch number has been requested.  On 01-APR-2021, patient developed headaches, vomiting and mental status changes. The mother of the patient noted that she was "staring" or "spacey". She was brought to the hospital where CT scan (computerized tomogram) and MRI (magnetic resonance imaging) of the brain revealed sagittal sinus thrombosis and hemorrhage. The patient was admitted to the intensive care unit. Platelet count on presentation was 18,000 (units unspecified), fibrinogen was noted to be low (value not provided), fibrin D-dimer was elevated (specific levels not provided). The platelet counts remained 22,000 to 24,000. In the evening of 01-APR-2021, the patient developed seizures, was intubated, sedated and placed on unspecified anti-epileptics. The patient was treated using a platelet transfusion in preparation for thrombectomy, and was anticoagulated (specific agents not provided). Following platelet transfusion and thrombectomy, patient's platelet count rose to 160,000, fibrinogen normalized (value not provided), and both remained stable for 1-2 days. Treatment with unspecified anti-epileptics was continued. The patient remained intubated and sedated, and thus her mental and neurologic status was not re-evaluated. She was transferred to a tertiary care hospital in the evening of 06-APR-2021. The patient recovered from thrombocytopenia, and the outcome of sagittal sinus thrombosis, cerebral hemorrhage, and seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of an 18-year-old female who experienced cerebral venous sinus thrombosis with thrombocytopenia and low fibrinogen levels 16 days after receipt of the Janssen COVID-19 vaccine. The patient was treated with platelet transfusion and underwent thrombectomy, and remains in intensive care. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Aspartate aminotransferase increased, Beta-2 glycoprotein antibody positive, Blood culture negative
Clinical narrative: SAGITTAL SINUS THROMBOSIS; CEREBRAL HEMORRHAGE; SEIZURES; THROMBOCYTOPENIA; This spontaneous report was received from a pharmacist and concerned an 18-year-old female. Initial information was received on 03-APR-2021, with additional information obtained via telephone follow up from a physician on 07-APR-2021. The patient's height and weight were not reported. The patient had no known allergies, was a non-smoker, was not on oral contraceptives and was not on any medications. There was no history of clotting disorders for the patient and no family history of a clotting disorder. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number and expiration date were not reported) on 16-MAR-2021. The batch number has been requested.  On 01-APR-2021, patient developed headaches, vomiting and mental status changes. The mother of the patient noted that she was "staring" or "spacey". She was brought to the hospital where CT scan (computerized tomogram) and MRI (magnetic resonance imaging) of the brain revealed sagittal sinus thrombosis and hemorrhage. The patient was admitted to the intensive care unit. Platelet count on presentation was 18,000 (units unspecified), fibrinogen was noted to be low (value not provided), fibrin D-dimer was elevated (specific levels not provided). The platelet counts remained 22,000 to 24,000. In the evening of 01-APR-2021, the patient developed seizures, was intubated, sedated and placed on unspecified anti-epileptics. The patient was treated using a platelet transfusion in preparation for thrombectomy, and was anticoagulated (specific agents not provided). Following platelet transfusion and thrombectomy, patient's platelet count rose to 160,000, fibrinogen normalized (value not provided), and both remained stable for 1-2 days. Treatment with unspecified anti-epileptics was continued. The patient remained intubated and sedated, and thus her mental and neurologic status was not re-evaluated. She was transferred to a tertiary care hospital in the evening of 06-APR-2021. The patient recovered from thrombocytopenia, and the outcome of sagittal sinus thrombosis, cerebral hemorrhage, and seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of an 18-year-old female who experienced cerebral venous sinus thrombosis with thrombocytopenia and low fibrinogen levels 16 days after receipt of the Janssen COVID-19 vaccine. The patient was treated with platelet transfusion and underwent thrombectomy, and remains in intensive care. Additional information has been requested.