chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Influenza like illness, Nausea, Vitreous floaters
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (18May2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the non-HCP letter sent that included: events outcome has been updated.   Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.  Amendment: This follow-up is being submitted to amend the previously reported information: To add the latest significant FUP 18May2021
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Influenza, Nausea, Pain
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (18May2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the non-HCP letter sent that included: events outcome has been updated.   Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.  Amendment: This follow-up is being submitted to amend the previously reported information: To add the latest significant FUP 18May2021
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (18May2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the non-HCP letter sent that included: events outcome has been updated.   Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.  Amendment: This follow-up is being submitted to amend the previously reported information: To add the latest significant FUP 18May2021
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain, Sensory disturbance
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (18May2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the non-HCP letter sent that included: events outcome has been updated.   Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.  Amendment: This follow-up is being submitted to amend the previously reported information: To add the latest significant FUP 18May2021
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vital signs measurement, Vomiting
Clinical narrative: About 10 seconds after injection he felt dizzy. They gave him a timer. He started throwing up several times. They gave him a choice of hospital or going home. He chose home. About 20 minutes later he had the chills and developed a headache. He then developed diarrhea.  He went to bed. When he woke up in the middle of the night he felt like he went into a GrandMal seizure. He had memory loss and confusion. He could not get up. His entire body was hurting. He went to the hospital. They gave him anti-nausea medicine. Put him on an IV (UNKNOWN NAME).  They prescribed him on a medicine for cluster headaches (can not remember name). Gave him 2 or different meds for his migraines. Dr. said he would call him in a week. The hospital gave him Ondansetron 8mg as needed.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blood test, Chills, Confusional state, Diarrhoea
Clinical narrative: About 10 seconds after injection he felt dizzy. They gave him a timer. He started throwing up several times. They gave him a choice of hospital or going home. He chose home. About 20 minutes later he had the chills and developed a headache. He then developed diarrhea.  He went to bed. When he woke up in the middle of the night he felt like he went into a GrandMal seizure. He had memory loss and confusion. He could not get up. His entire body was hurting. He went to the hospital. They gave him anti-nausea medicine. Put him on an IV (UNKNOWN NAME).  They prescribed him on a medicine for cluster headaches (can not remember name). Gave him 2 or different meds for his migraines. Dr. said he would call him in a week. The hospital gave him Ondansetron 8mg as needed.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Generalised tonic-clonic seizure, Headache, Immediate post-injection reaction, Mobility decreased
Clinical narrative: About 10 seconds after injection he felt dizzy. They gave him a timer. He started throwing up several times. They gave him a choice of hospital or going home. He chose home. About 20 minutes later he had the chills and developed a headache. He then developed diarrhea.  He went to bed. When he woke up in the middle of the night he felt like he went into a GrandMal seizure. He had memory loss and confusion. He could not get up. His entire body was hurting. He went to the hospital. They gave him anti-nausea medicine. Put him on an IV (UNKNOWN NAME).  They prescribed him on a medicine for cluster headaches (can not remember name). Gave him 2 or different meds for his migraines. Dr. said he would call him in a week. The hospital gave him Ondansetron 8mg as needed.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: About 10 seconds after injection he felt dizzy. They gave him a timer. He started throwing up several times. They gave him a choice of hospital or going home. He chose home. About 20 minutes later he had the chills and developed a headache. He then developed diarrhea.  He went to bed. When he woke up in the middle of the night he felt like he went into a GrandMal seizure. He had memory loss and confusion. He could not get up. His entire body was hurting. He went to the hospital. They gave him anti-nausea medicine. Put him on an IV (UNKNOWN NAME).  They prescribed him on a medicine for cluster headaches (can not remember name). Gave him 2 or different meds for his migraines. Dr. said he would call him in a week. The hospital gave him Ondansetron 8mg as needed.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Feeling abnormal, Herpes zoster, Pain in extremity, Post-traumatic neuralgia
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer.   A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included antibiotic for an unknown indication, start date and stop date not reported. On an unknown date, the patient experienced side effects but she was not sure if it was because of the Pfizer vaccine. She took antibiotic and then received first dose of Pfizer covid vaccine. After 3 to 4 days she got shingles. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administration error, X-ray
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer.   A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included antibiotic for an unknown indication, start date and stop date not reported. On an unknown date, the patient experienced side effects but she was not sure if it was because of the Pfizer vaccine. She took antibiotic and then received first dose of Pfizer covid vaccine. After 3 to 4 days she got shingles. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer.   A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included antibiotic for an unknown indication, start date and stop date not reported. On an unknown date, the patient experienced side effects but she was not sure if it was because of the Pfizer vaccine. She took antibiotic and then received first dose of Pfizer covid vaccine. After 3 to 4 days she got shingles. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Within 10 minutes I had an allergic reaction my face and irrs turn bright red/immediate, moderate allergic reaction; My throat closed up but did not have problems breathing.; My skin whole body God flushed.; a month of burning and tingling in the upper body; a month of burning and tingling in the upper body; really swollen knee and joints (bilateral; left and right); really swollen knee and joints (bilateral; left and right); my face and irrs turn bright red; I started itching all over.; This is a spontaneous report from a contactable other HCP (patient). A 65-year-old non-pregnant female patient recceived first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: En6200), via an unspecified route of administration in right arm on 25Feb2021 at 16:45(at the age of 65-years-old) as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Medical history of the patient included autoimmune issues. The allergic history of the patient includes drug hypersensitivity to penicillin. The patient concomitant medications were not reported. 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 not been tested with covid-19. It was reported that the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, a month of burning and tingling in the upper body, really swollen knee and joints, i started itching all over on 25Feb2021 at 17:00. She reports concern and wants to know if there have been reports similar to what she is having and also wants to know if Pfizer Medical Information can see if there are reported issues on the lot number: EN6200. Patient underwent lab tests and procedures that included: two mri w dye within several months of of unknown results. The outcome of the events the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, my face and irrs turn bright red, i started itching all over are reported as not resolved and the outcome of the events a month of burning and tingling in the upper body, really swollen knee and joints are reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Within 10 minutes I had an allergic reaction my face and irrs turn bright red/immediate, moderate allergic reaction; My throat closed up but did not have problems breathing.; My skin whole body God flushed.; a month of burning and tingling in the upper body; a month of burning and tingling in the upper body; really swollen knee and joints (bilateral; left and right); really swollen knee and joints (bilateral; left and right); my face and irrs turn bright red; I started itching all over.; This is a spontaneous report from a contactable other HCP (patient). A 65-year-old non-pregnant female patient recceived first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: En6200), via an unspecified route of administration in right arm on 25Feb2021 at 16:45(at the age of 65-years-old) as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Medical history of the patient included autoimmune issues. The allergic history of the patient includes drug hypersensitivity to penicillin. The patient concomitant medications were not reported. 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 not been tested with covid-19. It was reported that the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, a month of burning and tingling in the upper body, really swollen knee and joints, i started itching all over on 25Feb2021 at 17:00. She reports concern and wants to know if there have been reports similar to what she is having and also wants to know if Pfizer Medical Information can see if there are reported issues on the lot number: EN6200. Patient underwent lab tests and procedures that included: two mri w dye within several months of of unknown results. The outcome of the events the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, my face and irrs turn bright red, i started itching all over are reported as not resolved and the outcome of the events a month of burning and tingling in the upper body, really swollen knee and joints are reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Flushing, Hypersensitivity, Joint swelling
Clinical narrative: Within 10 minutes I had an allergic reaction my face and irrs turn bright red/immediate, moderate allergic reaction; My throat closed up but did not have problems breathing.; My skin whole body God flushed.; a month of burning and tingling in the upper body; a month of burning and tingling in the upper body; really swollen knee and joints (bilateral; left and right); really swollen knee and joints (bilateral; left and right); my face and irrs turn bright red; I started itching all over.; This is a spontaneous report from a contactable other HCP (patient). A 65-year-old non-pregnant female patient recceived first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: En6200), via an unspecified route of administration in right arm on 25Feb2021 at 16:45(at the age of 65-years-old) as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Medical history of the patient included autoimmune issues. The allergic history of the patient includes drug hypersensitivity to penicillin. The patient concomitant medications were not reported. 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 not been tested with covid-19. It was reported that the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, a month of burning and tingling in the upper body, really swollen knee and joints, i started itching all over on 25Feb2021 at 17:00. She reports concern and wants to know if there have been reports similar to what she is having and also wants to know if Pfizer Medical Information can see if there are reported issues on the lot number: EN6200. Patient underwent lab tests and procedures that included: two mri w dye within several months of of unknown results. The outcome of the events the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, my face and irrs turn bright red, i started itching all over are reported as not resolved and the outcome of the events a month of burning and tingling in the upper body, really swollen knee and joints are reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Within 10 minutes I had an allergic reaction my face and irrs turn bright red/immediate, moderate allergic reaction; My throat closed up but did not have problems breathing.; My skin whole body God flushed.; a month of burning and tingling in the upper body; a month of burning and tingling in the upper body; really swollen knee and joints (bilateral; left and right); really swollen knee and joints (bilateral; left and right); my face and irrs turn bright red; I started itching all over.; This is a spontaneous report from a contactable other HCP (patient). A 65-year-old non-pregnant female patient recceived first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: En6200), via an unspecified route of administration in right arm on 25Feb2021 at 16:45(at the age of 65-years-old) as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Medical history of the patient included autoimmune issues. The allergic history of the patient includes drug hypersensitivity to penicillin. The patient concomitant medications were not reported. 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 not been tested with covid-19. It was reported that the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, a month of burning and tingling in the upper body, really swollen knee and joints, i started itching all over on 25Feb2021 at 17:00. She reports concern and wants to know if there have been reports similar to what she is having and also wants to know if Pfizer Medical Information can see if there are reported issues on the lot number: EN6200. Patient underwent lab tests and procedures that included: two mri w dye within several months of of unknown results. The outcome of the events the patient experienced within 10 minutes i had an allergic reaction my face and irrs turn bright red/immediate moderate allergic reaction, my throat closed up but did not have problems breathing, my skin whole body god flushed, my face and irrs turn bright red, i started itching all over are reported as not resolved and the outcome of the events a month of burning and tingling in the upper body, really swollen knee and joints are reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Borrelia test, Chills, Fatigue, Full blood count
Clinical narrative: no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; headache; This is a spontaneous report from a contactable Nurse (patient, self-reporting). A 57-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3246 and expiration dates were not reported), via an unspecified route of administration in arm right on 26Jan2021 at 08:45 PM as 2nd dose, single for COVID-19 immunisation. Medical history included gastroesophageal reflux disease, allergies: latex from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported in two weeks. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL1284 and expiration dates were not reported), via an unspecified route of administration in right arm on 05Jan2021 at 09:45 AM as first dose, single for COVID-19 immunisation. No other vaccine in four weeks. There was no initial reaction. On 13Feb2021, 03:00 PM two and a half weeks after 2nd shot patient experienced chills, extreme fatigue, body aches, headache intermittently and ongoing for three weeks. No treatment received for adverse event, no COVID prior vaccination and did not COVID tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab) resulted as negative on 02Mar2021. Facility type vaccine : Hospital. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Metabolic function test, Pain, SARS-CoV-2 test negative, Vitamin D
Clinical narrative: no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; headache; This is a spontaneous report from a contactable Nurse (patient, self-reporting). A 57-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3246 and expiration dates were not reported), via an unspecified route of administration in arm right on 26Jan2021 at 08:45 PM as 2nd dose, single for COVID-19 immunisation. Medical history included gastroesophageal reflux disease, allergies: latex from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported in two weeks. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL1284 and expiration dates were not reported), via an unspecified route of administration in right arm on 05Jan2021 at 09:45 AM as first dose, single for COVID-19 immunisation. No other vaccine in four weeks. There was no initial reaction. On 13Feb2021, 03:00 PM two and a half weeks after 2nd shot patient experienced chills, extreme fatigue, body aches, headache intermittently and ongoing for three weeks. No treatment received for adverse event, no COVID prior vaccination and did not COVID tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab) resulted as negative on 02Mar2021. Facility type vaccine : Hospital. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, SARS-CoV-2 antibody test
Clinical narrative: no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; no initial reaction.  Two and a half weeks after 2nd shot: chills, extreme fatigue, body aches, headache intermittently  and ongoing for three weeks; headache; This is a spontaneous report from a contactable Nurse (patient, self-reporting). A 57-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3246 and expiration dates were not reported), via an unspecified route of administration in arm right on 26Jan2021 at 08:45 PM as 2nd dose, single for COVID-19 immunisation. Medical history included gastroesophageal reflux disease, allergies: latex from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported in two weeks. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL1284 and expiration dates were not reported), via an unspecified route of administration in right arm on 05Jan2021 at 09:45 AM as first dose, single for COVID-19 immunisation. No other vaccine in four weeks. There was no initial reaction. On 13Feb2021, 03:00 PM two and a half weeks after 2nd shot patient experienced chills, extreme fatigue, body aches, headache intermittently and ongoing for three weeks. No treatment received for adverse event, no COVID prior vaccination and did not COVID tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab) resulted as negative on 02Mar2021. Facility type vaccine : Hospital. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: itchy skin on upper back and chest area; This is a spontaneous report received from a contactable nurse. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6198), via intramuscular route of administration in right arm on 06Mar2021 at 04:15 PM as single for covid-19 immunisation. Medical history included asthma, allergic event to influenza vaccine in 2018. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 at 04:45 PM, patient experienced itchy skin on upper back and chest area. Treatment received: 50 mg Benadryl IM. The outcome of event was recovered with lasting effects on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pruritus and the suspect drug.  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: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: had notice mild to medium tinnitus in both ears. I have been experiencing consistent ringing in my ears since then; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 01Mar2021 (Batch/Lot Number: Em9809) at 15:00 as a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not administer any other vaccine in four weeks. The patient did not administer any other medications in two weeks. On 02Mar2021 at 01:00 AM, the patient had notice mild to medium tinnitus in both ears. I have been experiencing consistent ringing in my ears since then. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID. The patient has no known allergies. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain
Clinical narrative: Painful lymphnode in left armpit; This is a spontaneous report from a contactable other hcp. A 40-years-old male patient received BNT162B2, (COMIRNATY, solution for injection; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 AM as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. Patient has COVID prior vaccination. Patient has not COVID tested post vaccination. No Known allergies. Concomitant medication included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced painful lymphnode in left armpit on 05Mar2021. Outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained .
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain
Clinical narrative: Painful lymphnode in left armpit; This is a spontaneous report from a contactable other hcp. A 40-years-old male patient received BNT162B2, (COMIRNATY, solution for injection; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 AM as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. Patient has COVID prior vaccination. Patient has not COVID tested post vaccination. No Known allergies. Concomitant medication included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced painful lymphnode in left armpit on 05Mar2021. Outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained .
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Chest pain, Dysgeusia, Fatigue
Clinical narrative: I had lingering fatigue; metallic taste in mouth; nausea; burning heat on my back; sweating; This is a spontaneous report from a contactable patient. A non-pregnant 63 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: En6207) solution for injections via an unspecified route of administration administered in arm Left on 16Mar2021 at 13:00 (at the age of vaccination of 63years old) as a single dose for COVID-19 immunisation. Medical history included Maple Syrup Urine Disease (MSUD), Hashimoto's Thyroiditis from an unknown date. Patient was allergic to Penicillin, CT contrast dye, MRI contrast dye (gadolinium), Sulpha drugs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Tirosint (MANUFACTURER: UNKNOWN), Fluoxetine (MANUFACTURER: UNKNOWN), MSUD Complex Amino Acid Blen (MANUFACTURER: UNKNOWN) within two weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient experienced metallic taste in mouth, nausea, burning heat on her back and sweating from 16Mar2021 and lingering fatigue on the next day (17Mar2021). No treatment was received for treating the reported adverse events. The outcome of the metallic taste in mouth, nausea, burning heat on her back and sweating were recovering and the reaction outcome for the event and lingering fatigue was Unknown. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: I had lingering fatigue; metallic taste in mouth; nausea; burning heat on my back; sweating; This is a spontaneous report from a contactable patient. A non-pregnant 63 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: En6207) solution for injections via an unspecified route of administration administered in arm Left on 16Mar2021 at 13:00 (at the age of vaccination of 63years old) as a single dose for COVID-19 immunisation. Medical history included Maple Syrup Urine Disease (MSUD), Hashimoto's Thyroiditis from an unknown date. Patient was allergic to Penicillin, CT contrast dye, MRI contrast dye (gadolinium), Sulpha drugs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Tirosint (MANUFACTURER: UNKNOWN), Fluoxetine (MANUFACTURER: UNKNOWN), MSUD Complex Amino Acid Blen (MANUFACTURER: UNKNOWN) within two weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient experienced metallic taste in mouth, nausea, burning heat on her back and sweating from 16Mar2021 and lingering fatigue on the next day (17Mar2021). No treatment was received for treating the reported adverse events. The outcome of the metallic taste in mouth, nausea, burning heat on her back and sweating were recovering and the reaction outcome for the event and lingering fatigue was Unknown. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: I had lingering fatigue; metallic taste in mouth; nausea; burning heat on my back; sweating; This is a spontaneous report from a contactable patient. A non-pregnant 63 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: En6207) solution for injections via an unspecified route of administration administered in arm Left on 16Mar2021 at 13:00 (at the age of vaccination of 63years old) as a single dose for COVID-19 immunisation. Medical history included Maple Syrup Urine Disease (MSUD), Hashimoto's Thyroiditis from an unknown date. Patient was allergic to Penicillin, CT contrast dye, MRI contrast dye (gadolinium), Sulpha drugs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Tirosint (MANUFACTURER: UNKNOWN), Fluoxetine (MANUFACTURER: UNKNOWN), MSUD Complex Amino Acid Blen (MANUFACTURER: UNKNOWN) within two weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient experienced metallic taste in mouth, nausea, burning heat on her back and sweating from 16Mar2021 and lingering fatigue on the next day (17Mar2021). No treatment was received for treating the reported adverse events. The outcome of the metallic taste in mouth, nausea, burning heat on her back and sweating were recovering and the reaction outcome for the event and lingering fatigue was Unknown. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Hyperhidrosis, Nausea, Skin burning sensation
Clinical narrative: I had lingering fatigue; metallic taste in mouth; nausea; burning heat on my back; sweating; This is a spontaneous report from a contactable patient. A non-pregnant 63 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: En6207) solution for injections via an unspecified route of administration administered in arm Left on 16Mar2021 at 13:00 (at the age of vaccination of 63years old) as a single dose for COVID-19 immunisation. Medical history included Maple Syrup Urine Disease (MSUD), Hashimoto's Thyroiditis from an unknown date. Patient was allergic to Penicillin, CT contrast dye, MRI contrast dye (gadolinium), Sulpha drugs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Tirosint (MANUFACTURER: UNKNOWN), Fluoxetine (MANUFACTURER: UNKNOWN), MSUD Complex Amino Acid Blen (MANUFACTURER: UNKNOWN) within two weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient experienced metallic taste in mouth, nausea, burning heat on her back and sweating from 16Mar2021 and lingering fatigue on the next day (17Mar2021). No treatment was received for treating the reported adverse events. The outcome of the metallic taste in mouth, nausea, burning heat on her back and sweating were recovering and the reaction outcome for the event and lingering fatigue was Unknown. No follow-up attempts are needed. No further information is expected.