chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Pain in extremity, Pericarditis, White blood cell count increased
Clinical narrative: back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent's room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Discomfort, Headache
Clinical narrative: skin pain; Nausea; Unable to sleep; Stomach pain; Diarrhea; Passed out from pain; Very extreme joint, muscle, organ, skin pain in every cell of body; 40 hours later, joints are still nearly unbearably sore; Very extreme joint, muscle, organ, skin pain in every cell of body; Headache; This is a spontaneous report from a contactable consumer (patient)  A 28-years-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  via an unspecified route of administration, administered in Arm Right on 02May2021 (reported as at 15:30 ) (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunization.  The patient had no known medical history or allergies. Historical Vaccine includes 1st Dose of bnt162b2 on 11Apr2021 at 15:30 in right arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02May2021 at 02:00 the patient experienced passed out from pain,  very extreme joint, muscle, organ, skin pain in every cell of body, 40 hours later, joints are still nearly unbearably sore, headache, skin pain, nausea, unable to sleep, stomach pain, diarrhea.  Therapeutic measures were taken as a result of very extreme joint, muscle, organ, skin pain in every cell of body, headache. The clinical course was reported as follows  Very extreme joint, muscle, organ, skin pain in every cell of body. Passed out from pain, Headache,  Nausea. Pain only became slightly tolerable after taking 400 mg of both ibuprofen and acetaminophen nearly every 4 hours for the first 32 hours. Unable to sleep. Stomach pain. Diarrhea. 40 hours later, joints are still nearly unbearably sore. Continued stomach pain and diarrhea. The clinical outcome of the events was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Loss of consciousness, Myalgia, Nausea, Vascular pain
Clinical narrative: skin pain; Nausea; Unable to sleep; Stomach pain; Diarrhea; Passed out from pain; Very extreme joint, muscle, organ, skin pain in every cell of body; 40 hours later, joints are still nearly unbearably sore; Very extreme joint, muscle, organ, skin pain in every cell of body; Headache; This is a spontaneous report from a contactable consumer (patient)  A 28-years-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  via an unspecified route of administration, administered in Arm Right on 02May2021 (reported as at 15:30 ) (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunization.  The patient had no known medical history or allergies. Historical Vaccine includes 1st Dose of bnt162b2 on 11Apr2021 at 15:30 in right arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02May2021 at 02:00 the patient experienced passed out from pain,  very extreme joint, muscle, organ, skin pain in every cell of body, 40 hours later, joints are still nearly unbearably sore, headache, skin pain, nausea, unable to sleep, stomach pain, diarrhea.  Therapeutic measures were taken as a result of very extreme joint, muscle, organ, skin pain in every cell of body, headache. The clinical course was reported as follows  Very extreme joint, muscle, organ, skin pain in every cell of body. Passed out from pain, Headache,  Nausea. Pain only became slightly tolerable after taking 400 mg of both ibuprofen and acetaminophen nearly every 4 hours for the first 32 hours. Unable to sleep. Stomach pain. Diarrhea. 40 hours later, joints are still nearly unbearably sore. Continued stomach pain and diarrhea. The clinical outcome of the events was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Headache, Insomnia
Clinical narrative: skin pain; Nausea; Unable to sleep; Stomach pain; Diarrhea; Passed out from pain; Very extreme joint, muscle, organ, skin pain in every cell of body; 40 hours later, joints are still nearly unbearably sore; Very extreme joint, muscle, organ, skin pain in every cell of body; Headache; This is a spontaneous report from a contactable consumer (patient)  A 28-years-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  via an unspecified route of administration, administered in Arm Right on 02May2021 (reported as at 15:30 ) (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunization.  The patient had no known medical history or allergies. Historical Vaccine includes 1st Dose of bnt162b2 on 11Apr2021 at 15:30 in right arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02May2021 at 02:00 the patient experienced passed out from pain,  very extreme joint, muscle, organ, skin pain in every cell of body, 40 hours later, joints are still nearly unbearably sore, headache, skin pain, nausea, unable to sleep, stomach pain, diarrhea.  Therapeutic measures were taken as a result of very extreme joint, muscle, organ, skin pain in every cell of body, headache. The clinical course was reported as follows  Very extreme joint, muscle, organ, skin pain in every cell of body. Passed out from pain, Headache,  Nausea. Pain only became slightly tolerable after taking 400 mg of both ibuprofen and acetaminophen nearly every 4 hours for the first 32 hours. Unable to sleep. Stomach pain. Diarrhea. 40 hours later, joints are still nearly unbearably sore. Continued stomach pain and diarrhea. The clinical outcome of the events was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Myalgia, Nausea, Pain, Pain of skin
Clinical narrative: skin pain; Nausea; Unable to sleep; Stomach pain; Diarrhea; Passed out from pain; Very extreme joint, muscle, organ, skin pain in every cell of body; 40 hours later, joints are still nearly unbearably sore; Very extreme joint, muscle, organ, skin pain in every cell of body; Headache; This is a spontaneous report from a contactable consumer (patient)  A 28-years-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  via an unspecified route of administration, administered in Arm Right on 02May2021 (reported as at 15:30 ) (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunization.  The patient had no known medical history or allergies. Historical Vaccine includes 1st Dose of bnt162b2 on 11Apr2021 at 15:30 in right arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02May2021 at 02:00 the patient experienced passed out from pain,  very extreme joint, muscle, organ, skin pain in every cell of body, 40 hours later, joints are still nearly unbearably sore, headache, skin pain, nausea, unable to sleep, stomach pain, diarrhea.  Therapeutic measures were taken as a result of very extreme joint, muscle, organ, skin pain in every cell of body, headache. The clinical course was reported as follows  Very extreme joint, muscle, organ, skin pain in every cell of body. Passed out from pain, Headache,  Nausea. Pain only became slightly tolerable after taking 400 mg of both ibuprofen and acetaminophen nearly every 4 hours for the first 32 hours. Unable to sleep. Stomach pain. Diarrhea. 40 hours later, joints are still nearly unbearably sore. Continued stomach pain and diarrhea. The clinical outcome of the events was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Pain in extremity, Thrombosis, Ultrasound scan abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 09Apr2021 as 1st dose, single; via an unspecified route of administration on 30Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced first signs of blood clot on 28Apr2021 and ended up in hospital from 30Apr2021 to 02May2021, getting blood thinner. The patient thought he/she should report this in case it is possibly connected to vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 09Apr2021 as 1st dose, single; via an unspecified route of administration on 30Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced first signs of blood clot on 28Apr2021 and ended up in hospital from 30Apr2021 to 02May2021, getting blood thinner. The patient thought he/she should report this in case it is possibly connected to vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 09Apr2021 as 1st dose, single; via an unspecified route of administration on 30Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced first signs of blood clot on 28Apr2021 and ended up in hospital from 30Apr2021 to 02May2021, getting blood thinner. The patient thought he/she should report this in case it is possibly connected to vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure occurred 10 days after second Pfizer covid vaccine and lasted approximately 2 minutes. Pt has never had a seizure before. Pt was taken to the emergency department immediately.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Magnetic resonance imaging head, Seizure
Clinical narrative: Seizure occurred 10 days after second Pfizer covid vaccine and lasted approximately 2 minutes. Pt has never had a seizure before. Pt was taken to the emergency department immediately.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy - Left Side of Face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Apr2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. The first dose was received on 03Apr2021 (lot number: ER8733). There were no medical history. Concomitant medications included metformin, diazepam and lisinopril. No other vaccine were received within 4 weeks. The patient experienced bell's palsy - left side of face on 03May2021 10:00. Event resulted in physician's clinic visit. Outcome of the event was not recovered. Patient was not diagnosed with covid-19 prior to vaccination and had not been tested post vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Diarrhoea, Dizziness, Vomiting
Clinical narrative: DEATH AT HOME.  REPORTED NOT FEELING WEEL SINCE 2ND DOSE.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: DEATH AT HOME.  REPORTED NOT FEELING WEEL SINCE 2ND DOSE.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cognitive disorder, Computerised tomogram, Gait inability, Loss of personal independence in daily activities
Clinical narrative: My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Neurological decompensation, Walking aid user, Wheelchair user
Clinical narrative: My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cognitive disorder, Computerised tomogram, Gait disturbance, Magnetic resonance imaging
Clinical narrative: My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nervous system disorder, Neuralgia, Skin burning sensation
Clinical narrative: My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cytomegalovirus test, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Laboratory test normal, Liver function test normal
Clinical narrative: High fever for 4 days followed by rash covering face torso arms and hips. Very low platelets and low white blood cell counts when blood was tested 4/30/21. Low counts were improved but not yet normal upon retest on 5/3/21.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphocyte percentage decreased, Mononucleosis heterophile test negative, Myalgia, Neutrophil count normal, Oropharyngeal pain
Clinical narrative: High fever for 4 days followed by rash covering face torso arms and hips. Very low platelets and low white blood cell counts when blood was tested 4/30/21. Low counts were improved but not yet normal upon retest on 5/3/21.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Rash, White blood cell count decreased
Clinical narrative: High fever for 4 days followed by rash covering face torso arms and hips. Very low platelets and low white blood cell counts when blood was tested 4/30/21. Low counts were improved but not yet normal upon retest on 5/3/21.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Audiogram, Cerebrovascular accident, Computerised tomogram, Coordination abnormal
Clinical narrative: head spinning; dizzy; irritability; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on an unspecified date for COVID-19 immunization. 18 hours after receiving the vaccine, on 25Mar2021, the patient experienced head spinning, feeling dizzy, and irritability. The patient was reported to be in the hospital due to the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysarthria, Head discomfort, Illness, Loss of personal independence in daily activities
Clinical narrative: head spinning; dizzy; irritability; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on an unspecified date for COVID-19 immunization. 18 hours after receiving the vaccine, on 25Mar2021, the patient experienced head spinning, feeling dizzy, and irritability. The patient was reported to be in the hospital due to the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Malaise, Nausea, Neck pain, Nervous system disorder
Clinical narrative: head spinning; dizzy; irritability; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on an unspecified date for COVID-19 immunization. 18 hours after receiving the vaccine, on 25Mar2021, the patient experienced head spinning, feeling dizzy, and irritability. The patient was reported to be in the hospital due to the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paralysis, Tinnitus
Clinical narrative: head spinning; dizzy; irritability; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on an unspecified date for COVID-19 immunization. 18 hours after receiving the vaccine, on 25Mar2021, the patient experienced head spinning, feeling dizzy, and irritability. The patient was reported to be in the hospital due to the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Irritability, Vertigo
Clinical narrative: head spinning; dizzy; irritability; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on an unspecified date for COVID-19 immunization. 18 hours after receiving the vaccine, on 25Mar2021, the patient experienced head spinning, feeling dizzy, and irritability. The patient was reported to be in the hospital due to the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; getting sick; This is a spontaneous report from a contactable consumer (patient) received through a Pfizer sponsored program. This consumer reported events with both vaccine doses. This case refers to the first dose of two vaccine doses. This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after her first dose she started getting sick (unspecified date in 2021) and she was tested positive with COVID-19 on 08Apr2021. the patient also mentioned that she was advised by a physician that they will administer the second dose after 90 days. The patient tested positive on a SARS-COV-2 test on 08Apr2021. The clinical outcomes of the events "started getting sick" and "tested positive with COVID-19" were not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459147 same patient, different vaccine dose/AE
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test positive
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; getting sick; This is a spontaneous report from a contactable consumer (patient) received through a Pfizer sponsored program. This consumer reported events with both vaccine doses. This case refers to the first dose of two vaccine doses. This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after her first dose she started getting sick (unspecified date in 2021) and she was tested positive with COVID-19 on 08Apr2021. the patient also mentioned that she was advised by a physician that they will administer the second dose after 90 days. The patient tested positive on a SARS-COV-2 test on 08Apr2021. The clinical outcomes of the events "started getting sick" and "tested positive with COVID-19" were not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459147 same patient, different vaccine dose/AE
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast tenderness, Dysmenorrhoea, Menstruation irregular, Premenstrual syndrome
Clinical narrative: I got my period today; moderate to severe PMS symptoms; cramps; back pain; breast tenderness; This is a spontaneous report from a contactable consumer(herself). A 50-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ew0162, Expiry date not reported), dose 2 via unspecified route of administration in left arm on 13Apr2021 09:15 (at age of 50-year) as single dose for COVID-19 immunization. Patient medical history was not reported. Patient concomitant medication included bupropion hydrochloride (welbutrin) for unspecified indication from unknown date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613, Expiry date not reported) via unspecified route of administration in left arm on 20Feb2021 13:15 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 30Apr2021, she got her period today, (after 31days of second shot). Patient stated that I am 51years old and I have an IUD. I had a period in over 2 years. I had moderate to severe PMS symptoms for the last 7 days including cramps, back pain & breast tenderness. Not an alarming side effect, just weird. The events assessed as non-serious. No treatment was received by patient. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast tenderness, Menstrual disorder, Muscle spasms, Premenstrual syndrome
Clinical narrative: I got my period today; moderate to severe PMS symptoms; cramps; back pain; breast tenderness; This is a spontaneous report from a contactable consumer(herself). A 50-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ew0162, Expiry date not reported), dose 2 via unspecified route of administration in left arm on 13Apr2021 09:15 (at age of 50-year) as single dose for COVID-19 immunization. Patient medical history was not reported. Patient concomitant medication included bupropion hydrochloride (welbutrin) for unspecified indication from unknown date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613, Expiry date not reported) via unspecified route of administration in left arm on 20Feb2021 13:15 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 30Apr2021, she got her period today, (after 31days of second shot). Patient stated that I am 51years old and I have an IUD. I had a period in over 2 years. I had moderate to severe PMS symptoms for the last 7 days including cramps, back pain & breast tenderness. Not an alarming side effect, just weird. The events assessed as non-serious. No treatment was received by patient. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: A couple of days after the injection, I felt soreness in my left arm. I knew it was to be expected, but the soreness never went away. Here we are 2 months later and the pain is worse, and over time has limited my range of motion and has created weakness in the left arm.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Ultrasound scan
Clinical narrative: A couple of days after the injection, I felt soreness in my left arm. I knew it was to be expected, but the soreness never went away. Here we are 2 months later and the pain is worse, and over time has limited my range of motion and has created weakness in the left arm.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Photopsia, Vitreous detachment, Vitreous floaters
Clinical narrative: Vitreous Detachment; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 68-years-old), administered in Arm Left on 13Apr2021 10:45 (Lot Number: ER8732) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure and allergy to bananas. The patient's concomitant medications included losartan. The patient reported that, "Within 48 hours of receiving said vaccine, I had a Vitreous Detachment in my right eye causing severe floaters and flashes. This detachment was confirmed by my ophthalmologist. My ophthalmologist did not attribute the Vitreous Detachment to the vaccine, but I am making this report on my own initiative." Adverse events start date was on 15Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. No treatment received for the adverse events. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vitreous detachment
Clinical narrative: Vitreous Detachment; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 68-years-old), administered in Arm Left on 13Apr2021 10:45 (Lot Number: ER8732) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure and allergy to bananas. The patient's concomitant medications included losartan. The patient reported that, "Within 48 hours of receiving said vaccine, I had a Vitreous Detachment in my right eye causing severe floaters and flashes. This detachment was confirmed by my ophthalmologist. My ophthalmologist did not attribute the Vitreous Detachment to the vaccine, but I am making this report on my own initiative." Adverse events start date was on 15Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. No treatment received for the adverse events. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in left arm on 28Apr2021 16:45 (Lot Number: er8731) as single dose for COVID-19 immunisation. Medical history included rosacea from an unknown date and unknown if ongoing. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (DAYSEE) taken as birth control, start and stop date were not reported. The patient previously took cefdinir and experienced allergies. The patient previously received 1st dose of bnt162b2 (brand: Pfizer, lot number: er8733) in left arm on 06Apr2021 for COVID-19 immunisation. The patient experienced anaphylaxis on 28Apr2021 16:45. The patient had itching and rash on neck and face, swelling throat, slurred and studdering speech, ear pressure, itching, facial and mouth tingling and itching. Outcome of event was recovered/resolved with sequel. Treatment received were Benadryl, epinephrine, dexamethasone, and famotidine. The AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (brand: Pfizer), dose 2 via an unspecified route of administration, administered in left arm on 28Apr2021 16:45 (Lot Number: er8731) as single dose for COVID-19 immunisation. Medical history included rosacea from an unknown date and unknown if ongoing. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (DAYSEE) taken as birth control, start and stop date were not reported. The patient previously took cefdinir and experienced allergies. The patient previously received 1st dose of bnt162b2 (brand: Pfizer, lot number: er8733) in left arm on 06Apr2021 for COVID-19 immunisation. The patient experienced anaphylaxis on 28Apr2021 16:45. The patient had itching and rash on neck and face, swelling throat, slurred and studdering speech, ear pressure, itching, facial and mouth tingling and itching. Outcome of event was recovered/resolved with sequel. Treatment received were Benadryl, epinephrine, dexamethasone, and famotidine. The AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.