chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Muscle twitching, Muscular weakness, Paraesthesia, Telangiectasia
Clinical narrative: Hemiparesis; legion on my left frontal temporal lobe; spinal fluid leak.; weakness in my right arm and leg; telangiectasia on my pons; Central nervous system lesion; Vitreous floaters; Epidural blood patch; shingle blisters; tingling; twitching in my arm and face; burning sensation; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249 and expiration date was not reported), intramuscular, administered in Arm Left on 20Jan2021 at dose 2, single for covid-19 immunization. The patient had no medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone; cyanocobalamin (VITAMIN B-12); fish oil (OMEGA 3 FISH OILS). The patient experienced hemiparesis on an unspecified date. On 02Feb2021, patient started experiencing tingling and twitching in her arm and face. On the 3feb2021, she developed shingle blisters on the left side of abdomen. A week later (Feb2021), she had the burning sensation of shingles all over her body. She continued to have weakness in right arm and leg, tingling in right hand and sparkling floaters in her vision. She also had Central nervous system lesion on an unspecified date. She had a MRI of brain and was identified telangiectasia on her pons and also found a legion on left frontal temporal lobe. Patient's neurologist ordered a MRI of her neck which came back clear. On 06Jul2021, she had a lumbar cap analysis of spinal fluid and on 12Jul2021, she had to have a blood patch because she had a spinal fluid leak. The patient underwent lab tests and procedures which included Lab Work, lumbar puncture, magnetic resonance imaging neck: unknown results, magnetic resonance imaging head: abnormal. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Hemiparesis; legion on my left frontal temporal lobe; spinal fluid leak.; weakness in my right arm and leg; telangiectasia on my pons; Central nervous system lesion; Vitreous floaters; Epidural blood patch; shingle blisters; tingling; twitching in my arm and face; burning sensation; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249 and expiration date was not reported), intramuscular, administered in Arm Left on 20Jan2021 at dose 2, single for covid-19 immunization. The patient had no medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone; cyanocobalamin (VITAMIN B-12); fish oil (OMEGA 3 FISH OILS). The patient experienced hemiparesis on an unspecified date. On 02Feb2021, patient started experiencing tingling and twitching in her arm and face. On the 3feb2021, she developed shingle blisters on the left side of abdomen. A week later (Feb2021), she had the burning sensation of shingles all over her body. She continued to have weakness in right arm and leg, tingling in right hand and sparkling floaters in her vision. She also had Central nervous system lesion on an unspecified date. She had a MRI of brain and was identified telangiectasia on her pons and also found a legion on left frontal temporal lobe. Patient's neurologist ordered a MRI of her neck which came back clear. On 06Jul2021, she had a lumbar cap analysis of spinal fluid and on 12Jul2021, she had to have a blood patch because she had a spinal fluid leak. The patient underwent lab tests and procedures which included Lab Work, lumbar puncture, magnetic resonance imaging neck: unknown results, magnetic resonance imaging head: abnormal. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dark circles under eyes, Hypomenorrhoea, Menstrual disorder, Postmenopausal haemorrhage
Clinical narrative: I got my second shot 2 days after the spotting increased along with some clotting; spotting increased along with some clotting; Light Period; I am noticing some weakness and Dark circles around my Eyes; I am noticing some weakness and Dark circles around my Eyes; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181 and expiration date was not reported), intramuscular, administered in Arm Left on 28Aug2021 12:00 at dose 2, single for covid-19 immunization. Medical history included ongoing HEPC (hepatitis c), ongoing asthma, only shows up during allergy season and patient had this since childhood; she had been post-menopausal for 6 years. Family Medical History was none. Concomitant medications included All day allergy relief for Allergies from 01Sep2021 to 03Sep2021. Patient did not receive any other vaccines prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was FA7584 and expiration date was not reported) on 07Aug2021 16:00 intramuscularly in left arm at dose 1, single for covid-19 immunization and experienced post-menopausal bleeding for 4 weeks. 2 days after second dose, patient's spotting increased along with some clotting, It has been 4 weeks at the time of report and she was still spotting to the point of a high period and no treatment was taken. Because of this she would be seeing a doctor. She also has noticed some weakness and dark circles around eyes. She wish she had known about this before the shot. The most recent vaccine was administered at Pharmacy or Drug store. The outcome of the events weakness and dark circles around Eyes was unknown and outcome of rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blindness, Cerebrospinal fluid leakage, Cisternogram, Epidural blood patch
Clinical narrative: I lost vision; everything was blurry for two weeks; CSF leak; migraine; Stiff neck; back aches; pain; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Colleague. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm on 06Apr2021 as dose 2, single for COVID-19 immunization. There was no patient's medical history. Current illnesses was reported as none. Concomitant medications included sumatriptan 50 mg as needed. On 13Ap2021, the patient developed a migraine and stiff neck and back aches exactly 1 week after the second COVID shot. the patient just woke up in pain and a week later, she lost her vision and everything was blurry for 2 weeks. It was reported that any time while she was walking, and couldn't drive. She went to two emergency rooms and was in the hospital for 2 days on 13Apr2021 for these events. On 13Apr2021, the patient had lab data which includes 3 magnetic resonance imaging (MRI's) on her brain and spine, a blood patch, a caffeine fusion, and a nuclear medicine cisternogram. These were done at hospital. The neurologist determined it was a cerebrospinal fluid (CSF) leak and had no idea how she got it. The patient was not in an accident and didn't get this at work. The patient was in and out of work for a month and had to use short term disability. The outcome of lost vision and blurred vision was recovered in Apr2021 since reported the duration as 2 weeks while the outcome of the other events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Migraine, Musculoskeletal stiffness
Clinical narrative: I lost vision; everything was blurry for two weeks; CSF leak; migraine; Stiff neck; back aches; pain; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Colleague. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm on 06Apr2021 as dose 2, single for COVID-19 immunization. There was no patient's medical history. Current illnesses was reported as none. Concomitant medications included sumatriptan 50 mg as needed. On 13Ap2021, the patient developed a migraine and stiff neck and back aches exactly 1 week after the second COVID shot. the patient just woke up in pain and a week later, she lost her vision and everything was blurry for 2 weeks. It was reported that any time while she was walking, and couldn't drive. She went to two emergency rooms and was in the hospital for 2 days on 13Apr2021 for these events. On 13Apr2021, the patient had lab data which includes 3 magnetic resonance imaging (MRI's) on her brain and spine, a blood patch, a caffeine fusion, and a nuclear medicine cisternogram. These were done at hospital. The neurologist determined it was a cerebrospinal fluid (CSF) leak and had no idea how she got it. The patient was not in an accident and didn't get this at work. The patient was in and out of work for a month and had to use short term disability. The outcome of lost vision and blurred vision was recovered in Apr2021 since reported the duration as 2 weeks while the outcome of the other events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vision blurred
Clinical narrative: I lost vision; everything was blurry for two weeks; CSF leak; migraine; Stiff neck; back aches; pain; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Colleague. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm on 06Apr2021 as dose 2, single for COVID-19 immunization. There was no patient's medical history. Current illnesses was reported as none. Concomitant medications included sumatriptan 50 mg as needed. On 13Ap2021, the patient developed a migraine and stiff neck and back aches exactly 1 week after the second COVID shot. the patient just woke up in pain and a week later, she lost her vision and everything was blurry for 2 weeks. It was reported that any time while she was walking, and couldn't drive. She went to two emergency rooms and was in the hospital for 2 days on 13Apr2021 for these events. On 13Apr2021, the patient had lab data which includes 3 magnetic resonance imaging (MRI's) on her brain and spine, a blood patch, a caffeine fusion, and a nuclear medicine cisternogram. These were done at hospital. The neurologist determined it was a cerebrospinal fluid (CSF) leak and had no idea how she got it. The patient was not in an accident and didn't get this at work. The patient was in and out of work for a month and had to use short term disability. The outcome of lost vision and blurred vision was recovered in Apr2021 since reported the duration as 2 weeks while the outcome of the other events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Head discomfort, Swollen tongue
Clinical narrative: I had a sudden pressure in my head; my tongue started swelling; I could not swallow very well at all.; This is a spontaneous report from a contactable consumer (patient herself).  This 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 17Sep2021 16:30 (at the age of 40-year-old) at single dose for COVID-19 immunization, administered at pharmacy/drug store. Historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3182), via an unspecified route of administration administered in the left arm, on 17Sep2021 16:30 (at the age of 40-year-old) for COVID-19 immunisation. The patient did not have known allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included bupropion hydrochloride (BUPROPION HCL XL). On 17Sep2021 at 18:00, the patient had a sudden pressure in head that lasted a minute or two and then her tongue started swelling and she could not swallowvery well at all. The events required Emergency room/department or urgent care. Therapeutic measures taken as result of the events included diphenhydramine hydrochloride (BENADRYL), prednisone, and famotidine (PEPCID AC). Post vaccination COVID-19 test was not done. The patient had recovered from sudden pressure in head on 17Sep2021 while the outcome of the remaining events was recovered in Sep2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Chills, Cough, Headache
Clinical narrative: myocarditis; fluttering in her heart; fever; headache; chills; chest pain; cough; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.   A 52-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FF8839; Expire Date: unknown) via an unspecified route of administration, administered in Arm Left on 26Sep2021, (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (she had COVID before and had that same feeling as when she had COVID in her chest that became cloudy and had that same feeling and had a little cough because of the discomfort in her chest; states she has the little pain in her chest and the fluttering; states she was diagnosed with COVID the end of Mar on 18Mar2021 or 20Mar2021 Caller states the cough, pain in her chest and fluttering are the same as when they began), little cough on March2021 to unknown date, discomfort in her chest on March2021 to unknown date, little pain in her chest on March2021 to unknown date, pain in her chest and fluttering on March2021 to unknown date, and cholesterol from unknown date unknown if ongoing. Concomitant medications included simvastatin taken for blood cholesterol, start and stop date were not reported and bisoprolol fumarate (EMCONCOR) taken for palpitations start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183) via an unspecified route of administration, on 05Sep2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. No investigation assessment was performed. No additional vaccines were administered. On unspecified date, the patient experienced fever, myocarditis, headache, chills, chest pain and fluttering in her heart, cough. she asked and was wondering if these are symptoms of myocarditis. At the time of this report, she did not have a fever and did not feel weak or have a headache but had a little discomfort in her chest and had that because she had COVID before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (she was diagnosed with covid the end of March on 18Mar2021 or 20Mar2021) on 18Mar2021 and 20Mar2021. The patient did not require emergency room and physician office visit. She did not have treatment or do anything about the reported events. The outcome of the events fever, headache and chills was recovered on unspecified date. The outcome of the events fluttering in her heart, chest pain, myocarditis, cough was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pyrexia, SARS-CoV-2 test
Clinical narrative: myocarditis; fluttering in her heart; fever; headache; chills; chest pain; cough; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.   A 52-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FF8839; Expire Date: unknown) via an unspecified route of administration, administered in Arm Left on 26Sep2021, (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (she had COVID before and had that same feeling as when she had COVID in her chest that became cloudy and had that same feeling and had a little cough because of the discomfort in her chest; states she has the little pain in her chest and the fluttering; states she was diagnosed with COVID the end of Mar on 18Mar2021 or 20Mar2021 Caller states the cough, pain in her chest and fluttering are the same as when they began), little cough on March2021 to unknown date, discomfort in her chest on March2021 to unknown date, little pain in her chest on March2021 to unknown date, pain in her chest and fluttering on March2021 to unknown date, and cholesterol from unknown date unknown if ongoing. Concomitant medications included simvastatin taken for blood cholesterol, start and stop date were not reported and bisoprolol fumarate (EMCONCOR) taken for palpitations start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183) via an unspecified route of administration, on 05Sep2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. No investigation assessment was performed. No additional vaccines were administered. On unspecified date, the patient experienced fever, myocarditis, headache, chills, chest pain and fluttering in her heart, cough. she asked and was wondering if these are symptoms of myocarditis. At the time of this report, she did not have a fever and did not feel weak or have a headache but had a little discomfort in her chest and had that because she had COVID before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (she was diagnosed with covid the end of March on 18Mar2021 or 20Mar2021) on 18Mar2021 and 20Mar2021. The patient did not require emergency room and physician office visit. She did not have treatment or do anything about the reported events. The outcome of the events fever, headache and chills was recovered on unspecified date. The outcome of the events fluttering in her heart, chest pain, myocarditis, cough was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Hypersensitivity, Palpitations
Clinical narrative: allergy (hives); allergy (hives); breathing weird; palpitations; tachycardia to 130-140/Heart rate increased; chest got tight; This is a spontaneous report from a contactable consumer. A 74-year-old female patient reported that she received the first dose of BNT162b2 (COMIRNATY, Lot number unclearly reported as EP or EF and then 7533) via an unspecified route of administration in left arm on 02Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Relevant medical history included dizziness (for numbers of years), arrhythmia (using BiPAP), sleep apnea and general aches. Concomitant medications were not reported. The patient did not have any prior vaccination within 4 weeks. About 5-6 hours after receiving the vaccine her chest got tight, heart pounding out of chest, palpitations, heart beat elevated, tachycardia to 130-140 and she stayed that way for an about an hour before it got better. Also the next day the caller reported looking at her home security footage and noticed that she was breathing weird, although she did not feel this side effect the previous day as she was more concerned about her heart rate. The patient had also allergy (hives). The patient took metoprolol and Zyrtec. Tachycardia, chest got tight, heart rate increased and palpitations were resolving, while outcome of the other events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: allergy (hives); allergy (hives); breathing weird; palpitations; tachycardia to 130-140/Heart rate increased; chest got tight; This is a spontaneous report from a contactable consumer. A 74-year-old female patient reported that she received the first dose of BNT162b2 (COMIRNATY, Lot number unclearly reported as EP or EF and then 7533) via an unspecified route of administration in left arm on 02Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Relevant medical history included dizziness (for numbers of years), arrhythmia (using BiPAP), sleep apnea and general aches. Concomitant medications were not reported. The patient did not have any prior vaccination within 4 weeks. About 5-6 hours after receiving the vaccine her chest got tight, heart pounding out of chest, palpitations, heart beat elevated, tachycardia to 130-140 and she stayed that way for an about an hour before it got better. Also the next day the caller reported looking at her home security footage and noticed that she was breathing weird, although she did not feel this side effect the previous day as she was more concerned about her heart rate. The patient had also allergy (hives). The patient took metoprolol and Zyrtec. Tachycardia, chest got tight, heart rate increased and palpitations were resolving, while outcome of the other events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Bone pain, Cardiac flutter
Clinical narrative: my blood pressure was 129 over 70; my blood pressure was 129 over 70; I get episodes of racing; I get episodes of fast-beating heartbeat; I continued to have pain at the point of each injection; The pain has now begun to radiate now from the injection site down to my right and left elbows; My Right-Collar bone has discomfort; I have recurring days of diarrhea; Recurring headaches; slight dizziness; An overall feeling of weakness and tiredness; An overall feeling of weakness and tiredness; I get episodes of fluttering; Second dose same date 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 15Jun2021 (Lot Number: EWOP6) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at Public Health Clinic. The patient had not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Known allergies: Not confirmed, Possible Penicillin. Other medical history included high blood pressure and sticky heart valve. There were no concomitant medications. The patient reported: 'When I went to the doctor's office on 21Sep2021, my blood pressure was 129 over 70. The blood pressure has been at around 110 over 68 for years. It was 110 over 68 this past Jan2021 when I when to my doctor for an annual examination. I get episodes of racing, fluttering, fast beating heartbeat; I continued to have pain at the point of each injection; the pain has now begun to radiate now from the injection site down to my right and left elbows, I have difficulty working with my arms above my shoulders. My Right-Collar bone has discomfort. I have recurring days of diarrhea, recurring headaches and slight dizziness (the last dizziness was on 27 and 28Sep2021; an overall feeling of weakness and tiredness)'. Onset date of blood pressure increased was 21Sep2021, while onset date of other events was 20Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events had not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: my blood pressure was 129 over 70; my blood pressure was 129 over 70; I get episodes of racing; I get episodes of fast-beating heartbeat; I continued to have pain at the point of each injection; The pain has now begun to radiate now from the injection site down to my right and left elbows; My Right-Collar bone has discomfort; I have recurring days of diarrhea; Recurring headaches; slight dizziness; An overall feeling of weakness and tiredness; An overall feeling of weakness and tiredness; I get episodes of fluttering; Second dose same date 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 15Jun2021 (Lot Number: EWOP6) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at Public Health Clinic. The patient had not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Known allergies: Not confirmed, Possible Penicillin. Other medical history included high blood pressure and sticky heart valve. There were no concomitant medications. The patient reported: 'When I went to the doctor's office on 21Sep2021, my blood pressure was 129 over 70. The blood pressure has been at around 110 over 68 for years. It was 110 over 68 this past Jan2021 when I when to my doctor for an annual examination. I get episodes of racing, fluttering, fast beating heartbeat; I continued to have pain at the point of each injection; the pain has now begun to radiate now from the injection site down to my right and left elbows, I have difficulty working with my arms above my shoulders. My Right-Collar bone has discomfort. I have recurring days of diarrhea, recurring headaches and slight dizziness (the last dizziness was on 27 and 28Sep2021; an overall feeling of weakness and tiredness)'. Onset date of blood pressure increased was 21Sep2021, while onset date of other events was 20Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events had not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inappropriate schedule of product administration, Pain, Palpitations
Clinical narrative: my blood pressure was 129 over 70; my blood pressure was 129 over 70; I get episodes of racing; I get episodes of fast-beating heartbeat; I continued to have pain at the point of each injection; The pain has now begun to radiate now from the injection site down to my right and left elbows; My Right-Collar bone has discomfort; I have recurring days of diarrhea; Recurring headaches; slight dizziness; An overall feeling of weakness and tiredness; An overall feeling of weakness and tiredness; I get episodes of fluttering; Second dose same date 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 15Jun2021 (Lot Number: EWOP6) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at Public Health Clinic. The patient had not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Known allergies: Not confirmed, Possible Penicillin. Other medical history included high blood pressure and sticky heart valve. There were no concomitant medications. The patient reported: 'When I went to the doctor's office on 21Sep2021, my blood pressure was 129 over 70. The blood pressure has been at around 110 over 68 for years. It was 110 over 68 this past Jan2021 when I when to my doctor for an annual examination. I get episodes of racing, fluttering, fast beating heartbeat; I continued to have pain at the point of each injection; the pain has now begun to radiate now from the injection site down to my right and left elbows, I have difficulty working with my arms above my shoulders. My Right-Collar bone has discomfort. I have recurring days of diarrhea, recurring headaches and slight dizziness (the last dizziness was on 27 and 28Sep2021; an overall feeling of weakness and tiredness)'. Onset date of blood pressure increased was 21Sep2021, while onset date of other events was 20Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events had not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my blood pressure was 129 over 70; my blood pressure was 129 over 70; I get episodes of racing; I get episodes of fast-beating heartbeat; I continued to have pain at the point of each injection; The pain has now begun to radiate now from the injection site down to my right and left elbows; My Right-Collar bone has discomfort; I have recurring days of diarrhea; Recurring headaches; slight dizziness; An overall feeling of weakness and tiredness; An overall feeling of weakness and tiredness; I get episodes of fluttering; Second dose same date 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 15Jun2021 (Lot Number: EWOP6) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at Public Health Clinic. The patient had not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Known allergies: Not confirmed, Possible Penicillin. Other medical history included high blood pressure and sticky heart valve. There were no concomitant medications. The patient reported: 'When I went to the doctor's office on 21Sep2021, my blood pressure was 129 over 70. The blood pressure has been at around 110 over 68 for years. It was 110 over 68 this past Jan2021 when I when to my doctor for an annual examination. I get episodes of racing, fluttering, fast beating heartbeat; I continued to have pain at the point of each injection; the pain has now begun to radiate now from the injection site down to my right and left elbows, I have difficulty working with my arms above my shoulders. My Right-Collar bone has discomfort. I have recurring days of diarrhea, recurring headaches and slight dizziness (the last dizziness was on 27 and 28Sep2021; an overall feeling of weakness and tiredness)'. Onset date of blood pressure increased was 21Sep2021, while onset date of other events was 20Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events had not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 24Sep2021 at 12:30 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 on 02Sep2021 at 12:00. The patient had no relevant medical history. There were no concomitant medications.  The patient experienced hives on 26Sep2021 at 12:00. The event was treated with Benedryl. The outcome of event was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid on 17Sep2021; Tested positive for Covid on 17Sep2021; This is a spontaneous report received directly from a contactable pharmacist and also via the Program.  A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 02Mar2021, as 2nd single dose, and via an unspecified route of administration on 03Feb2021 as 1st single dose, for COVID-19 immunisation. The patient's age at the time of both vaccinations with BNT162b2 was 66 years old. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks, while 8 weeks prior to vaccination (unspecified if 1st or 2nd). The patient had received pneumonia vaccine. The pharmacist stated that the patient tested positive for Covid on 17Sep2021. No hospitalization, ER visit or physician office visit was needed due to the event. At the time of the reporting the patient was at a rehab facility and where rehab tests were being done. The outcome of the event was not specified.   According to the reporting pharmacist the event was unrelated to BNT162b2.  This lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up. Based on information in the case, a possible causal association between the reported events COVID-19, vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hallucination, Nausea, Oral discomfort, Oral pain
Clinical narrative: roof of my mouth was burned; hallucinations; extreme vomiting; dizzy; fever; nausea; roof of my mouth was burned; have been unable to eat anything due to the pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 24Sep2021 11:00 (at the age of 29years) as dose number unknown, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included anemia, blood clots, ectopic pregnancy, Known allergy: Eggs, Mushrooms. The patient's concomitant medications were not reported. The patient previously took Tylenol and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25Sep2021 (also reported as the 2nd day)), the patient experienced extreme vomiting, dizzy, hallucinations, fever were all expected until day 3. The patient sought medical attention for the nausea. On day 3 (reported as 27Sep2021), the roof of mouth was burned, and patient had not eaten anything, have been unable to eat anything due to the pain. On Day 4 other symptoms dissipated, the remaining symptom is that of the burn on the roof of mouth that does not ease with saltwater rinses or anything. The patient scheduled dentist appointment to see if there is anything that can be done on 28Sep2021. Dentist visit scheduled for 29Sep2021 at 10:30 a.m. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. AE treatment: nausea medication, pending dentist visit at 10:30. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Stomatitis, Vomiting
Clinical narrative: roof of my mouth was burned; hallucinations; extreme vomiting; dizzy; fever; nausea; roof of my mouth was burned; have been unable to eat anything due to the pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 24Sep2021 11:00 (at the age of 29years) as dose number unknown, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included anemia, blood clots, ectopic pregnancy, Known allergy: Eggs, Mushrooms. The patient's concomitant medications were not reported. The patient previously took Tylenol and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25Sep2021 (also reported as the 2nd day)), the patient experienced extreme vomiting, dizzy, hallucinations, fever were all expected until day 3. The patient sought medical attention for the nausea. On day 3 (reported as 27Sep2021), the roof of mouth was burned, and patient had not eaten anything, have been unable to eat anything due to the pain. On Day 4 other symptoms dissipated, the remaining symptom is that of the burn on the roof of mouth that does not ease with saltwater rinses or anything. The patient scheduled dentist appointment to see if there is anything that can be done on 28Sep2021. Dentist visit scheduled for 29Sep2021 at 10:30 a.m. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. AE treatment: nausea medication, pending dentist visit at 10:30. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: double pneumonia; double pneumonia; This is a spontaneous report received from a non-contactable nurse via Medical information team. This nurse reported different events for 3 patients. This is first of three reports.   A 74-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. However, it was also reported that the patient received "PREVNAR 20" (pending query). The patient's medical history and concomitant medications were not reported. The patient died 3 years ago in 2018 because of double pneumonia in the hospital after getting a pneumococcal shot. The patient died in 2018. It was unknown if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101284946 same reporter/drug, different /AE/patient;US-PFIZER INC-202101284945 same reporter/drug, different /AE/patient; Reported Cause(s) of Death: double pneumonia; double pneumonia
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Right upper extremity deep venous thrombosis in the brachial, basilic, and median cubital veins.; This is a spontaneous report from a contactable other hcp.  A 34-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) intramuscular in Arm Right on 11Sep2021 (at 34 years)as single dose for covid-19 immunisation .  Medical history included smoker, anxiety, depression. No Known allergies. No covid prior vaccination and not covid tested post vaccination.Concomitant medications included sertraline hydrochloride (ZOLOFT) and  gabapentin, both  taken for an unspecified indication, start and stop date were not reported.  On 14Sep2021 patient experienced right upper extremity deep venous thrombosis in the brachial, basilic, and median cubital veins. Event resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated with Eliquis 10 mg. The outcome of the event was recovering.The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Deep vein thrombosis cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Blood iron, Blood magnesium, Blood thyroid stimulating hormone, Dizziness
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Gait inability, Head discomfort, Headache
Clinical narrative: Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.