chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Palpitations, Tachycardia
Clinical narrative: body flushing; Tachycardia; her heart was  pounding; This is a spontaneous report from a contactable nurse (patient). A 49-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 26Feb2021 15:00, at 49 years of age, (Batch/Lot Number: EN6202) as single dose for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 05Feb2021 15:00 (Batch/Lot Number: EL9266) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine in the previous 4 weeks. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and fexofenadine hydrochloride (ALLEGRA), both taken for an unspecified indication since an unknown date. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. On 26Feb2021 15:15 the patient felt whole body flushing, which became tachycardia, and her heart was pounding. It resolved in 5 minutes. 15 minutes later the same symptoms occurred again lasting 10 minutes. The patient required visit to Emergency room/department or urgent care but no treatment was administered. At the time of the report the reported events were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Nasopharyngitis, Nausea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: With my breathing I can hear a little wheezing in my chest area; I have got a really bad cold; I am very sick; Sneezing; congestion; she was now coughing; producing mucous; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number EL9266, not further confirmed, Expiry Date May2021) as single dose at the age of 51-year-old for COVID-19 immunisation, got through her job.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced with her breathing she can hear a little wheezing in her chest area, she has got a really bad cold, she was very sick, she was repeatedly sneezing, she was very congested, she was now coughing, the mucous was clear no infection or anything, she kept producing a lot of mucous on an unspecified date. The outcome of all events was unknown. Treatment received: Mucinex.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sneezing, Urticaria
Clinical narrative: With my breathing I can hear a little wheezing in my chest area; I have got a really bad cold; I am very sick; Sneezing; congestion; she was now coughing; producing mucous; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number EL9266, not further confirmed, Expiry Date May2021) as single dose at the age of 51-year-old for COVID-19 immunisation, got through her job.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced with her breathing she can hear a little wheezing in her chest area, she has got a really bad cold, she was very sick, she was repeatedly sneezing, she was very congested, she was now coughing, the mucous was clear no infection or anything, she kept producing a lot of mucous on an unspecified date. The outcome of all events was unknown. Treatment received: Mucinex.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Illness, Nasal congestion, Nasopharyngitis, Secretion discharge
Clinical narrative: With my breathing I can hear a little wheezing in my chest area; I have got a really bad cold; I am very sick; Sneezing; congestion; she was now coughing; producing mucous; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number EL9266, not further confirmed, Expiry Date May2021) as single dose at the age of 51-year-old for COVID-19 immunisation, got through her job.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced with her breathing she can hear a little wheezing in her chest area, she has got a really bad cold, she was very sick, she was repeatedly sneezing, she was very congested, she was now coughing, the mucous was clear no infection or anything, she kept producing a lot of mucous on an unspecified date. The outcome of all events was unknown. Treatment received: Mucinex.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing, Wheezing
Clinical narrative: With my breathing I can hear a little wheezing in my chest area; I have got a really bad cold; I am very sick; Sneezing; congestion; she was now coughing; producing mucous; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number EL9266, not further confirmed, Expiry Date May2021) as single dose at the age of 51-year-old for COVID-19 immunisation, got through her job.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced with her breathing she can hear a little wheezing in her chest area, she has got a really bad cold, she was very sick, she was repeatedly sneezing, she was very congested, she was now coughing, the mucous was clear no infection or anything, she kept producing a lot of mucous on an unspecified date. The outcome of all events was unknown. Treatment received: Mucinex.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Chills, Fatigue, Pain
Clinical narrative: fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6203) via an unspecified route in the left arm on 10Mar2021 at 13:00 pm as a single dose for COVID-19 immunisation. The patient medical history included migraine disease and slight hypertension since an unknown date. No allergies to medications food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included estradiol patch, liraglutide (SAXENDA), verapamil and colecalciferol (VITAMIN D). On day 6, patient experienced fatigue, chills, profound body aches, fever (around 100), insomnia, nausea, headache on 11Mar2021 at 12:45 am. The adverse reactions treatment done with rest, fluids, paracetamol (TYLENOL) and diazepam. The clinical outcome of the events was not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6203) via an unspecified route in the left arm on 10Mar2021 at 13:00 pm as a single dose for COVID-19 immunisation. The patient medical history included migraine disease and slight hypertension since an unknown date. No allergies to medications food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included estradiol patch, liraglutide (SAXENDA), verapamil and colecalciferol (VITAMIN D). On day 6, patient experienced fatigue, chills, profound body aches, fever (around 100), insomnia, nausea, headache on 11Mar2021 at 12:45 am. The adverse reactions treatment done with rest, fluids, paracetamol (TYLENOL) and diazepam. The clinical outcome of the events was not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6203) via an unspecified route in the left arm on 10Mar2021 at 13:00 pm as a single dose for COVID-19 immunisation. The patient medical history included migraine disease and slight hypertension since an unknown date. No allergies to medications food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included estradiol patch, liraglutide (SAXENDA), verapamil and colecalciferol (VITAMIN D). On day 6, patient experienced fatigue, chills, profound body aches, fever (around 100), insomnia, nausea, headache on 11Mar2021 at 12:45 am. The adverse reactions treatment done with rest, fluids, paracetamol (TYLENOL) and diazepam. The clinical outcome of the events was not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6203) via an unspecified route in the left arm on 10Mar2021 at 13:00 pm as a single dose for COVID-19 immunisation. The patient medical history included migraine disease and slight hypertension since an unknown date. No allergies to medications food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included estradiol patch, liraglutide (SAXENDA), verapamil and colecalciferol (VITAMIN D). On day 6, patient experienced fatigue, chills, profound body aches, fever (around 100), insomnia, nausea, headache on 11Mar2021 at 12:45 am. The adverse reactions treatment done with rest, fluids, paracetamol (TYLENOL) and diazepam. The clinical outcome of the events was not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Consciousness fluctuating, Hypertension, Lethargy
Clinical narrative: The vaccine was given at 11:30AM by 2:15 PM she was totally unconscious and unresponsive, Was taken to the hospital, evaluated in the Emergency Room and  admitted to the hospital. At 8:20 PM the charge nurse called a Stroke Alert and was taken to the Radiology Department for further testing. Dr said she had a stroke on the left side however he was not sure of the severity.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Loss of consciousness, Magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: The vaccine was given at 11:30AM by 2:15 PM she was totally unconscious and unresponsive, Was taken to the hospital, evaluated in the Emergency Room and  admitted to the hospital. At 8:20 PM the charge nurse called a Stroke Alert and was taken to the Radiology Department for further testing. Dr said she had a stroke on the left side however he was not sure of the severity.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: The vaccine was given at 11:30AM by 2:15 PM she was totally unconscious and unresponsive, Was taken to the hospital, evaluated in the Emergency Room and  admitted to the hospital. At 8:20 PM the charge nurse called a Stroke Alert and was taken to the Radiology Department for further testing. Dr said she had a stroke on the left side however he was not sure of the severity.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: cough; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; severe nausea; Headache; Diarrhea; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:33 (Batch/Lot Number: EN6202), at the age of 66-years-old, as 1st dose, single for COVID-19 immunization. The patient had no medical and family history. There were no concomitant medications. The patient received the first dose of the Pfizer COVID-19 vaccine on 02Mar2021. She stated that she did not feel well the next day (03Mar2021) after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day, 03Mar2021 she experienced severe nausea, headache, diarrhea and fatigue. The nausea and the headache are gone although she was unsure when the headache went away, and the diarrhea and fatigue are improved. A week later on 09Mar2021, they felt worse and was tested positive for COVID-19. The patient spoke with their doctor this last Friday and she advised them that she should wait to receive their second dose as it may be too soon. He treated the patient with zinc, vitamin C, vitamin A, vitamin D, and melatonin. Symptoms are all improving. Mentioned the fatigue was tremendous. The patient was scheduled to receive their second dose on 23Mar2021. The patient was asking if we can help them reschedule their second dose appointment. The patient's husband, on speaker phone, asks if fatigue and cough would be considered symptoms of COVID-19 and if they should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient had no additional vaccines administered on same date of the Pfizer suspect. The events did not require ER or hospitalization but did see a healthcare professional. The event nausea recovered on 11Mar2021, headache recovered on an Mar2021; malaise, diarrhea, fatigue, cough was recovering while event "tested positive for COVID-19" was unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314376 same reporter and drug, similar events, different patients
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: cough; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; severe nausea; Headache; Diarrhea; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:33 (Batch/Lot Number: EN6202), at the age of 66-years-old, as 1st dose, single for COVID-19 immunization. The patient had no medical and family history. There were no concomitant medications. The patient received the first dose of the Pfizer COVID-19 vaccine on 02Mar2021. She stated that she did not feel well the next day (03Mar2021) after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day, 03Mar2021 she experienced severe nausea, headache, diarrhea and fatigue. The nausea and the headache are gone although she was unsure when the headache went away, and the diarrhea and fatigue are improved. A week later on 09Mar2021, they felt worse and was tested positive for COVID-19. The patient spoke with their doctor this last Friday and she advised them that she should wait to receive their second dose as it may be too soon. He treated the patient with zinc, vitamin C, vitamin A, vitamin D, and melatonin. Symptoms are all improving. Mentioned the fatigue was tremendous. The patient was scheduled to receive their second dose on 23Mar2021. The patient was asking if we can help them reschedule their second dose appointment. The patient's husband, on speaker phone, asks if fatigue and cough would be considered symptoms of COVID-19 and if they should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient had no additional vaccines administered on same date of the Pfizer suspect. The events did not require ER or hospitalization but did see a healthcare professional. The event nausea recovered on 11Mar2021, headache recovered on an Mar2021; malaise, diarrhea, fatigue, cough was recovering while event "tested positive for COVID-19" was unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314376 same reporter and drug, similar events, different patients
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, SARS-CoV-2 antibody test
Clinical narrative: cough; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; severe nausea; Headache; Diarrhea; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:33 (Batch/Lot Number: EN6202), at the age of 66-years-old, as 1st dose, single for COVID-19 immunization. The patient had no medical and family history. There were no concomitant medications. The patient received the first dose of the Pfizer COVID-19 vaccine on 02Mar2021. She stated that she did not feel well the next day (03Mar2021) after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day, 03Mar2021 she experienced severe nausea, headache, diarrhea and fatigue. The nausea and the headache are gone although she was unsure when the headache went away, and the diarrhea and fatigue are improved. A week later on 09Mar2021, they felt worse and was tested positive for COVID-19. The patient spoke with their doctor this last Friday and she advised them that she should wait to receive their second dose as it may be too soon. He treated the patient with zinc, vitamin C, vitamin A, vitamin D, and melatonin. Symptoms are all improving. Mentioned the fatigue was tremendous. The patient was scheduled to receive their second dose on 23Mar2021. The patient was asking if we can help them reschedule their second dose appointment. The patient's husband, on speaker phone, asks if fatigue and cough would be considered symptoms of COVID-19 and if they should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient had no additional vaccines administered on same date of the Pfizer suspect. The events did not require ER or hospitalization but did see a healthcare professional. The event nausea recovered on 11Mar2021, headache recovered on an Mar2021; malaise, diarrhea, fatigue, cough was recovering while event "tested positive for COVID-19" was unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314376 same reporter and drug, similar events, different patients
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure
Clinical narrative: FAINTING SPELL; PASSED OUT; This spontaneous report received from a consumer (wife) concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease (diagnosed years ago), bee stings allergy, non smoker, non alcohol user, and marijuana abuse. The patient did not have primary care provider (PCP) and had not been to the doctor for 35 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  Five or ten minute after vaccination patient's eyes rolled back and he passed out at the vaccine centre. Reporter was not sure if he fainted or had a seizure. He came back for a bit but then started having the fainting spell again. The patient taken by the ambulance to the hospital. In hospital, did a few tests which included blood pressure, blood sugar, electrocardiogram (EKG) but everything came back fine. He had not eaten before getting the vaccine. Healthcare professional (HCP) could not find any reason for his symptom. He had not eaten before getting the vaccine but it was nothing unusual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting spell, and passed out on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210546973-covid-19 vaccine ad26.cov2.s-Fainting spell, passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Concussion, Heart rate decreased, Heart rate irregular, Intensive care
Clinical narrative: FAINTING SPELL; PASSED OUT; This spontaneous report received from a consumer (wife) concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease (diagnosed years ago), bee stings allergy, non smoker, non alcohol user, and marijuana abuse. The patient did not have primary care provider (PCP) and had not been to the doctor for 35 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  Five or ten minute after vaccination patient's eyes rolled back and he passed out at the vaccine centre. Reporter was not sure if he fainted or had a seizure. He came back for a bit but then started having the fainting spell again. The patient taken by the ambulance to the hospital. In hospital, did a few tests which included blood pressure, blood sugar, electrocardiogram (EKG) but everything came back fine. He had not eaten before getting the vaccine. Healthcare professional (HCP) could not find any reason for his symptom. He had not eaten before getting the vaccine but it was nothing unusual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting spell, and passed out on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210546973-covid-19 vaccine ad26.cov2.s-Fainting spell, passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Retinal tear, Syncope
Clinical narrative: FAINTING SPELL; PASSED OUT; This spontaneous report received from a consumer (wife) concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease (diagnosed years ago), bee stings allergy, non smoker, non alcohol user, and marijuana abuse. The patient did not have primary care provider (PCP) and had not been to the doctor for 35 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  Five or ten minute after vaccination patient's eyes rolled back and he passed out at the vaccine centre. Reporter was not sure if he fainted or had a seizure. He came back for a bit but then started having the fainting spell again. The patient taken by the ambulance to the hospital. In hospital, did a few tests which included blood pressure, blood sugar, electrocardiogram (EKG) but everything came back fine. He had not eaten before getting the vaccine. Healthcare professional (HCP) could not find any reason for his symptom. He had not eaten before getting the vaccine but it was nothing unusual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting spell, and passed out on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210546973-covid-19 vaccine ad26.cov2.s-Fainting spell, passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Electrocardiogram, Loss of consciousness, Syncope
Clinical narrative: FAINTING SPELL; PASSED OUT; This spontaneous report received from a consumer (wife) concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease (diagnosed years ago), bee stings allergy, non smoker, non alcohol user, and marijuana abuse. The patient did not have primary care provider (PCP) and had not been to the doctor for 35 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  Five or ten minute after vaccination patient's eyes rolled back and he passed out at the vaccine centre. Reporter was not sure if he fainted or had a seizure. He came back for a bit but then started having the fainting spell again. The patient taken by the ambulance to the hospital. In hospital, did a few tests which included blood pressure, blood sugar, electrocardiogram (EKG) but everything came back fine. He had not eaten before getting the vaccine. Healthcare professional (HCP) could not find any reason for his symptom. He had not eaten before getting the vaccine but it was nothing unusual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting spell, and passed out on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210546973-covid-19 vaccine ad26.cov2.s-Fainting spell, passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Acute hepatic failure, Acute kidney injury, Cardiac failure congestive, Cardiogenic shock
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiomyopathy, Jaundice, Malaise
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Acute kidney injury, Angiogram cerebral abnormal, Arteriogram coronary normal, Biopsy heart abnormal
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure acute, Cardiac hypertrophy, Cardiogenic shock, Cardiorenal syndrome, Catheterisation cardiac abnormal
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral artery occlusion, Cerebral infarction, Cerebral mass effect, Cerebrovascular accident, Coagulopathy
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Congestive hepatopathy, Craniectomy, Death, Dyspnoea, Ejection fraction decreased
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intracardiac thrombus, Lactic acidosis, Liver injury, Myocardial fibrosis, Myocardial oedema
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Right ventricular ejection fraction decreased, Ventricular assist device insertion
Clinical narrative: This is a English speaking male with a past medical history of well controlled asthma and former smoker, who received COVID 19 Pfizer vaccine on 3/24/21. Patient presented to outside hospital on 4/13/21  after 10 days of progressive abdominal bloating and SOB. Patient was transferred to our facility on 4/14/21 for acute care needs.   Found to have new biventricular HF (EF 20%) in cardiogenic shock with lactic acidosis, AKI, and acute liver injury with associated coagulopathy.  Admission was notable for  cardiogenic shock, cardiorenal syndrome, congestive hepatopathy, severe acute liver injury with associated coagulopathy and lactic acidosis with 2 weeks of HF symptoms s/p biVAD, stroke s/p craniotomy. He had a complicated admission and passed on 05/09/21 after family decided to withdraw care in the context of very poor neurological prognosis given the extent of strokes.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Red rash with burning appeared on arms, back, back of neck, ankles and knees starting 3 days after first injection. Started using ortezone10. still remained after a week. called doctor who started prednisone course and Triamcinolone Acetonide and Eucerin cream. Seemed to help a little. after full course not much change. Did another prednisone course, doubled zyrtec added benedryl 4 times daily. Referred to Spectrum Allergy.  No test available sent home suggested Sarna lotion, which helped burning sensation. Did biopsy, aside from edema result normal. Referred to Allergy specialist to be seen June 2 3PM
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Burning sensation, Rash erythematous
Clinical narrative: Red rash with burning appeared on arms, back, back of neck, ankles and knees starting 3 days after first injection. Started using ortezone10. still remained after a week. called doctor who started prednisone course and Triamcinolone Acetonide and Eucerin cream. Seemed to help a little. after full course not much change. Did another prednisone course, doubled zyrtec added benedryl 4 times daily. Referred to Spectrum Allergy.  No test available sent home suggested Sarna lotion, which helped burning sensation. Did biopsy, aside from edema result normal. Referred to Allergy specialist to be seen June 2 3PM
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscle spasms, Muscle tightness, Neuralgia
Clinical narrative: multible events shoulder injury tremors throughout her body body aches blood circulation problems she has seen multible doctors neurologist cardiologist gastro  were as the doctors feel the vaccination has triggered these series of events that is dibilitating her body.she has not been able to work since inception of covid vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Impaired work ability, Limb injury, Pain, Poor peripheral circulation
Clinical narrative: multible events shoulder injury tremors throughout her body body aches blood circulation problems she has seen multible doctors neurologist cardiologist gastro  were as the doctors feel the vaccination has triggered these series of events that is dibilitating her body.she has not been able to work since inception of covid vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: multible events shoulder injury tremors throughout her body body aches blood circulation problems she has seen multible doctors neurologist cardiologist gastro  were as the doctors feel the vaccination has triggered these series of events that is dibilitating her body.she has not been able to work since inception of covid vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PAIN; PITTING EDEMA; SWELLING; BLOOD CLOT LEFT AND RIGHT  LEG; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included factor 5 positive.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient  experienced pain, pitting edema, and swelling. The patient had an Ultrasound done on 02-MAY-2021 at the emergency room that showed a blood clot in her left leg. On 27-MAY-2021 she went to her doctor and had another ultrasound on her right leg that indicated a blood clot. She was started on Zorelto as a treatment for blood clot on 02-May-2021 15 mg BID Three times daily and is now taking 20mg 1 times daily, but that she may not be able to stay on Zorelto because it was not working. Also stated this vaccine had ruined her life and was very sorry that she ever got the vaccine. She was extremely frustrated and unhappy and had pain and swelling that has not allowed her to play tennis and experience inactivity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot left and right leg, and the outcome of pain, pitting edema and swelling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210556299-covid-19 vaccine ad26.cov2.s-Blood clot left and right leg. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema, Pain, Swelling, Thrombosis, Ultrasound scan
Clinical narrative: PAIN; PITTING EDEMA; SWELLING; BLOOD CLOT LEFT AND RIGHT  LEG; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included factor 5 positive.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient  experienced pain, pitting edema, and swelling. The patient had an Ultrasound done on 02-MAY-2021 at the emergency room that showed a blood clot in her left leg. On 27-MAY-2021 she went to her doctor and had another ultrasound on her right leg that indicated a blood clot. She was started on Zorelto as a treatment for blood clot on 02-May-2021 15 mg BID Three times daily and is now taking 20mg 1 times daily, but that she may not be able to stay on Zorelto because it was not working. Also stated this vaccine had ruined her life and was very sorry that she ever got the vaccine. She was extremely frustrated and unhappy and had pain and swelling that has not allowed her to play tennis and experience inactivity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot left and right leg, and the outcome of pain, pitting edema and swelling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210556299-covid-19 vaccine ad26.cov2.s-Blood clot left and right leg. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation test, Computerised tomogram, Deep vein thrombosis, Full blood count
Clinical narrative: PAIN; PITTING EDEMA; SWELLING; BLOOD CLOT LEFT AND RIGHT  LEG; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included factor 5 positive.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient  experienced pain, pitting edema, and swelling. The patient had an Ultrasound done on 02-MAY-2021 at the emergency room that showed a blood clot in her left leg. On 27-MAY-2021 she went to her doctor and had another ultrasound on her right leg that indicated a blood clot. She was started on Zorelto as a treatment for blood clot on 02-May-2021 15 mg BID Three times daily and is now taking 20mg 1 times daily, but that she may not be able to stay on Zorelto because it was not working. Also stated this vaccine had ruined her life and was very sorry that she ever got the vaccine. She was extremely frustrated and unhappy and had pain and swelling that has not allowed her to play tennis and experience inactivity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot left and right leg, and the outcome of pain, pitting edema and swelling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210556299-covid-19 vaccine ad26.cov2.s-Blood clot left and right leg. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: none known
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: none known
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: A vial that was previously punctured and stored at room temperature greater than the allowed 2 hours was used for this vaccination.  There were no known adverse reactions experienced by the patient.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: A vial that was previously punctured and stored at room temperature greater than the allowed 2 hours was used for this vaccination.  There were no known adverse reactions experienced by the patient.