chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Feeling abnormal, Herpes zoster, Insomnia
Clinical narrative: shingles; pain; UTI infection; joint pain; couldn't sleep; nerve pain; her leg started hurting after the first dose; Her leg is getting worse; rash came out; miserable; This is a spontaneous report received from contactable consumer (patient). A 62-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administrated in Left arm on 29Jul2021 between 4PM - 4:30PM (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient's medical history included UTI. The patient's concomitant medications included Nitrofurantoin (Nitrofurantoin Mono/Mac), 100mg 1 capsule twice a day every 12 hours; Macrobid [Nitrofurantoin], for UTI infection; and Cefdinir 300mg from 14Aug2021. On an unspecified date Aug2021, 2 weeks and 10 days later the patient experienced shingles, pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose, her leg is getting worse, rash came out, and miserable. On 16Aug2021, the patient underwent lab tests and procedures which included Ultrasound for blood clot: Negative. Patient received treatment as a result of adverse events. Patient visited to emergency room as a result of adverse event. The doctor looked at it, and prescriber her medication, which she took called Valtrex. The reason she went to the doctor is because her stomach was killing her, she thought she was constipated or there was a blockage, she didn't feel good, the doctor checked her urine saw there was an UTI, because she had high White Blood Cell count, then they gave the Nitrofurantoin Mono/Mac but then her leg started hurting after the 3rd dose of the Nitrofurantoin Mono/Mac, caller clarifies that she took 5 doses in total of the Nitrofurantoin Mono/Mac and then it started hurting with the leg. She went to urgent care on Saturday because she was still having it and they changed her antibiotic. She started the new antibiotic, she knew it was related since the leg pain was already going on when she started it on 14Aug2021, the new one is doing good, it's called Cefdinir 300mg. Caller wants to know if shingles can be a side effect of the vaccine. Caller wants to know if there is a need to delay in getting the second dose of the Pfizer BioNTech COVID19 vaccine or as scheduled since she got diagnosed with shingles. The outcome of the events shingles was recovered on an unspecified date; pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose was not recovered; and Her leg is getting worse, rash came out, miserable was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity, Rash, Ultrasound scan
Clinical narrative: shingles; pain; UTI infection; joint pain; couldn't sleep; nerve pain; her leg started hurting after the first dose; Her leg is getting worse; rash came out; miserable; This is a spontaneous report received from contactable consumer (patient). A 62-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administrated in Left arm on 29Jul2021 between 4PM - 4:30PM (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient's medical history included UTI. The patient's concomitant medications included Nitrofurantoin (Nitrofurantoin Mono/Mac), 100mg 1 capsule twice a day every 12 hours; Macrobid [Nitrofurantoin], for UTI infection; and Cefdinir 300mg from 14Aug2021. On an unspecified date Aug2021, 2 weeks and 10 days later the patient experienced shingles, pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose, her leg is getting worse, rash came out, and miserable. On 16Aug2021, the patient underwent lab tests and procedures which included Ultrasound for blood clot: Negative. Patient received treatment as a result of adverse events. Patient visited to emergency room as a result of adverse event. The doctor looked at it, and prescriber her medication, which she took called Valtrex. The reason she went to the doctor is because her stomach was killing her, she thought she was constipated or there was a blockage, she didn't feel good, the doctor checked her urine saw there was an UTI, because she had high White Blood Cell count, then they gave the Nitrofurantoin Mono/Mac but then her leg started hurting after the 3rd dose of the Nitrofurantoin Mono/Mac, caller clarifies that she took 5 doses in total of the Nitrofurantoin Mono/Mac and then it started hurting with the leg. She went to urgent care on Saturday because she was still having it and they changed her antibiotic. She started the new antibiotic, she knew it was related since the leg pain was already going on when she started it on 14Aug2021, the new one is doing good, it's called Cefdinir 300mg. Caller wants to know if shingles can be a side effect of the vaccine. Caller wants to know if there is a need to delay in getting the second dose of the Pfizer BioNTech COVID19 vaccine or as scheduled since she got diagnosed with shingles. The outcome of the events shingles was recovered on an unspecified date; pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose was not recovered; and Her leg is getting worse, rash came out, miserable was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: shingles; pain; UTI infection; joint pain; couldn't sleep; nerve pain; her leg started hurting after the first dose; Her leg is getting worse; rash came out; miserable; This is a spontaneous report received from contactable consumer (patient). A 62-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administrated in Left arm on 29Jul2021 between 4PM - 4:30PM (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient's medical history included UTI. The patient's concomitant medications included Nitrofurantoin (Nitrofurantoin Mono/Mac), 100mg 1 capsule twice a day every 12 hours; Macrobid [Nitrofurantoin], for UTI infection; and Cefdinir 300mg from 14Aug2021. On an unspecified date Aug2021, 2 weeks and 10 days later the patient experienced shingles, pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose, her leg is getting worse, rash came out, and miserable. On 16Aug2021, the patient underwent lab tests and procedures which included Ultrasound for blood clot: Negative. Patient received treatment as a result of adverse events. Patient visited to emergency room as a result of adverse event. The doctor looked at it, and prescriber her medication, which she took called Valtrex. The reason she went to the doctor is because her stomach was killing her, she thought she was constipated or there was a blockage, she didn't feel good, the doctor checked her urine saw there was an UTI, because she had high White Blood Cell count, then they gave the Nitrofurantoin Mono/Mac but then her leg started hurting after the 3rd dose of the Nitrofurantoin Mono/Mac, caller clarifies that she took 5 doses in total of the Nitrofurantoin Mono/Mac and then it started hurting with the leg. She went to urgent care on Saturday because she was still having it and they changed her antibiotic. She started the new antibiotic, she knew it was related since the leg pain was already going on when she started it on 14Aug2021, the new one is doing good, it's called Cefdinir 300mg. Caller wants to know if shingles can be a side effect of the vaccine. Caller wants to know if there is a need to delay in getting the second dose of the Pfizer BioNTech COVID19 vaccine or as scheduled since she got diagnosed with shingles. The outcome of the events shingles was recovered on an unspecified date; pain, UTI infection, joint pain, couldn't sleep, nerve pain, her leg started hurting after the first dose was not recovered; and Her leg is getting worse, rash came out, miserable was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Eye pain, Gait inability
Clinical narrative: Hearing lost issue; sharp pain in my left eye; have since lost my ability to walk on my own/I am unable to walk; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation at age of 49 years old. Medical history included diabetic, kidney (disorder), high blood pressure. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergies, receive the first dose of bnt162b2 (Batch/lot number: ER8734) for covid-19 immunisation on 30Mar2021 at 12:00 PM in right arm at age of 49 years old. The patient experienced sharp pain in his left eye on 04May2021, hearing lost issue on 08May2021 at 22:30, have since lost his ability to walk on his own/he was unable to walk in 2021. The case was serious per hospitalization, disability, and life threatening. The patient was hospitalized for 20 days. Clinical course: On 04May2021, which was 8 days after his 2nd shot, he started experiencing sharp pain in his left eye and it continued for a couple of days. Then on day 11, he started experience hearing lost issue. On 08May2021 at around 10:30 pm his hearing loss become worst. He had total hearing loss and hearing within hours of each other. He could walk prior to this event but have since lost his ability to walk on his own. His wife took him to the ER (emergency room) and he was put on the ventilator within 4 hours of being admitted into the hospital. Since being released from the hospital, he was currently receiving physical therapy because he was unable to walk after taking the Pfizer shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Cardio-respiratory arrest, Chills, Cough, Death
Clinical narrative: Hearing lost issue; sharp pain in my left eye; have since lost my ability to walk on my own/I am unable to walk; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation at age of 49 years old. Medical history included diabetic, kidney (disorder), high blood pressure. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergies, receive the first dose of bnt162b2 (Batch/lot number: ER8734) for covid-19 immunisation on 30Mar2021 at 12:00 PM in right arm at age of 49 years old. The patient experienced sharp pain in his left eye on 04May2021, hearing lost issue on 08May2021 at 22:30, have since lost his ability to walk on his own/he was unable to walk in 2021. The case was serious per hospitalization, disability, and life threatening. The patient was hospitalized for 20 days. Clinical course: On 04May2021, which was 8 days after his 2nd shot, he started experiencing sharp pain in his left eye and it continued for a couple of days. Then on day 11, he started experience hearing lost issue. On 08May2021 at around 10:30 pm his hearing loss become worst. He had total hearing loss and hearing within hours of each other. He could walk prior to this event but have since lost his ability to walk on his own. His wife took him to the ER (emergency room) and he was put on the ventilator within 4 hours of being admitted into the hospital. Since being released from the hospital, he was currently receiving physical therapy because he was unable to walk after taking the Pfizer shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Heart rate decreased, Hypertension, Oxygen saturation decreased
Clinical narrative: Hearing lost issue; sharp pain in my left eye; have since lost my ability to walk on my own/I am unable to walk; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation at age of 49 years old. Medical history included diabetic, kidney (disorder), high blood pressure. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergies, receive the first dose of bnt162b2 (Batch/lot number: ER8734) for covid-19 immunisation on 30Mar2021 at 12:00 PM in right arm at age of 49 years old. The patient experienced sharp pain in his left eye on 04May2021, hearing lost issue on 08May2021 at 22:30, have since lost his ability to walk on his own/he was unable to walk in 2021. The case was serious per hospitalization, disability, and life threatening. The patient was hospitalized for 20 days. Clinical course: On 04May2021, which was 8 days after his 2nd shot, he started experiencing sharp pain in his left eye and it continued for a couple of days. Then on day 11, he started experience hearing lost issue. On 08May2021 at around 10:30 pm his hearing loss become worst. He had total hearing loss and hearing within hours of each other. He could walk prior to this event but have since lost his ability to walk on his own. His wife took him to the ER (emergency room) and he was put on the ventilator within 4 hours of being admitted into the hospital. Since being released from the hospital, he was currently receiving physical therapy because he was unable to walk after taking the Pfizer shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Vomiting
Clinical narrative: Hearing lost issue; sharp pain in my left eye; have since lost my ability to walk on my own/I am unable to walk; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation at age of 49 years old. Medical history included diabetic, kidney (disorder), high blood pressure. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergies, receive the first dose of bnt162b2 (Batch/lot number: ER8734) for covid-19 immunisation on 30Mar2021 at 12:00 PM in right arm at age of 49 years old. The patient experienced sharp pain in his left eye on 04May2021, hearing lost issue on 08May2021 at 22:30, have since lost his ability to walk on his own/he was unable to walk in 2021. The case was serious per hospitalization, disability, and life threatening. The patient was hospitalized for 20 days. Clinical course: On 04May2021, which was 8 days after his 2nd shot, he started experiencing sharp pain in his left eye and it continued for a couple of days. Then on day 11, he started experience hearing lost issue. On 08May2021 at around 10:30 pm his hearing loss become worst. He had total hearing loss and hearing within hours of each other. He could walk prior to this event but have since lost his ability to walk on his own. His wife took him to the ER (emergency room) and he was put on the ventilator within 4 hours of being admitted into the hospital. Since being released from the hospital, he was currently receiving physical therapy because he was unable to walk after taking the Pfizer shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Had pain from the injection; All of a sudden, it has become very severe; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for 2 patients (Twin daughters). This case is for 1st twin. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date reporter stated, her 12-year-old twins were given the vaccine, the COVID Vaccine on 16Aug2021, about five hours ago, about like four and a half hours ago. Well, the girls had pain from the injection but it was not that severe, now all of a sudden, it has become very severe. Reporter was asking was that normal or was that a cause of a concern. Reporter further stated, if she needs to take her daughter to the hospital, that what she need to know. The outcome of event was unknown.  Follow up (19Aug2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Linked Report(s) : PFIZER INC-202101065377 Same reporter/vaccine/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Had pain from the injection; All of a sudden, it has become very severe; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced had pain from the injection all of a sudden, it has become very severe. Consumer stated that the 12 year old twins were given COVID Vaccine today, about five hours ago, about like four and a half hours ago. Well the girls had pain from the injection but it was not that severe, now all of a sudden, it has become very severe. was that normal or was that a cause of a concern. Consumer further stated, "If I need to take my daughter to the hospital, that what I need to know." In response to further probing for safety report reporter stated, "No, it was not the right time and need to find out if my girls were fine." The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065367 Same reporter/vaccine/event, different patient
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number: EW0162) dose 2 via unknown route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 38-years-old) as dose 2 and received first dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number: ER2613) dose 1 via unknown route of administration, administered in Arm Left on 20Mar2021 2:15 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Family medical history included daughter tested positive on 09Aug2021. The patient did not require emergency Room and physician Office for event. The patient did not received and prior vaccination within 4 weeks and list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was tested positive for COVID 19 (vaccination failure and Covid-19) on 16Aug2021. The patient relevant tests included rapid COVID 19 test was positive on 16Aug2021. Since last night, he was very much improved. Outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: misplaced their vaccination cards which are needed for their cataract surgery; This is a spontaneous report from a non-contactable consumer (on-behalf of her parent) who reported the same event for two patients. This is one of two reports. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Previously received the first dose of the vaccine for covid-19 immunisation on an unknown date. Patient had cataract since an unknown date. The vaccination card needed for patient cataract surgery was misplaced. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065498 same reporter/AE/product, different patient
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Headache; runny nose; cough; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported that a 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 2 intramuscular, administered in Arm Left on 16Apr2021 (Age 20-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 1 intramuscular, administered in Arm Left on 26Mar2021 (Age 20-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not diagnosed with COVID-19, prior to vaccination. The patient not been tested for COVID-19 Since the vaccination. There were no known allergies. Facility included a clinic the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications were not received within 2 weeks of vaccination. The patient experienced headache, runny nose, cough, and sore throat on 16Aug2021. No treatment was received for the events headache, runny nose, cough, and sore throat. The outcome of the events was reported as recovering.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A fully vaccinated individual has been diagnosed with COVID-19; A fully vaccinated individual has been diagnosed with COVID-19/mild cold; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: was not reported, Expiration date: was not reported) as dose 1, single and then dose 2, single, both via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Aug2021, a fully vaccinated individual has been diagnosed with COVID-19. They first experienced symptoms on 11Aug2021. It was reported that the person had mild symptoms for a couple of days (like a mild cold) and has now fully recovered while they wait for the quarantine period to complete. Manufacturer of vaccine was not disclosed. Lab test included covid test post vaccination resulted positive on 11Aug2021. The outcome of both events was recovered on an unspecified date in Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: his chest hurts; This is a spontaneous report from a contactable consumer (patient's parent). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her son just got the second dose of Covid shot a day before reporting and she called because she was asking him if he had any side effects he really did not have much but he said his chest hurt. The reporter knew there were various reasons and she was at her pediatrician's office, she was told by them to call safety team to find out if the patient needs to be seen or what reporter need to worry about that.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, COVID-19, Cough, Drug ineffective, Headache
Clinical narrative: covid_test_result=Positive; 1st dose, 01Mar2021; 2nd dose, 19Mar2021; covid_test_result=Positive; Cough; runny nose; heavy eyes; muscle aches; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 intramuscular on 19Mar2021 (Batch/Lot Number: EN6207) as DOSE  2, SINGLE and dose 1 intramuscular on 01Mar2021 (Age at vaccination: 54 years), (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On an unspecified date the patient experienced covid test result=positive, on 13Aug2021 covid test result=positive (medically significant), on 12Aug2021 Cough, runny nose, muscle aches, headache, heavy eyes. 1st dose, 01mar2021; 2nd dose, 19mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Aug2021. Patient did not received treatment for the events. Outcome of the events drug ineffective and inappropriate schedule of product administration was unknown. While other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: covid_test_result=Positive; 1st dose, 01Mar2021; 2nd dose, 19Mar2021; covid_test_result=Positive; Cough; runny nose; heavy eyes; muscle aches; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 intramuscular on 19Mar2021 (Batch/Lot Number: EN6207) as DOSE  2, SINGLE and dose 1 intramuscular on 01Mar2021 (Age at vaccination: 54 years), (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On an unspecified date the patient experienced covid test result=positive, on 13Aug2021 covid test result=positive (medically significant), on 12Aug2021 Cough, runny nose, muscle aches, headache, heavy eyes. 1st dose, 01mar2021; 2nd dose, 19mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Aug2021. Patient did not received treatment for the events. Outcome of the events drug ineffective and inappropriate schedule of product administration was unknown. While other events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: patient had a seizure; This is a spontaneous report from a contactable consumer. An unspecified patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. On an unknown date, patient had a seizure. Outcome of the event was unknown.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died within 24 hours of the vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number and expiration dates unknown), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient died within 24 hours of the vaccine. The patient never had a problem in his life. The reporter stated that the patient died from the vaccine. It was unknown if an autopsy was done.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died within 24 hours of the vaccine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Fatigue, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: hospitalized with right leg DVT and bilateral massive pulmonary embolism 21Feb2021; hospitalized with right leg DVT and bilateral massive pulmonary embolism 21Feb2021; Presumed my extreme fatigue and shortness of breath following day was common side effect.; shortness of breath following day was common side effect.; This is a spontaneous report from a contactable nurse. A 40-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration in right arm on 15Feb2021 17:45 (Batch/Lot Number: EW6201) as a single dose for covid-19 immunization. Medical history included hypothyroidism, asthma and obesity. Concomitant medications included ethinylestradiol, norgestimate (TRI LO MARZIA), levo-thyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL); all taken for an unspecified indication from an unknown date (medications in two weeks). No other vaccine took in four weeks. No Known allergies. The patient was fully vaccinated with 2 doses, but the details completed with first vaccine information versus most recent due to that when event happened. First Vaccine received 15Feb2021; Presumed her extreme fatigue and shortness of breath following day was common side effect; symptoms worsened; hospitalized with right leg DVT and bilateral massive pulmonary embolism on 21Feb2021. The above adverse events started on 16Feb2021. The adverse resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event. Number of days of hospitalization was seven. The treatment was given with TPA, IV Heparin, Thrombectomy, Surgery, Xarelto. No covid prior vaccination. The patient had been covid tested post vaccination with nasal swab type rapid test on 07Aug2021 resulted in positive. The outcome of the events was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Vomiting
Clinical narrative: seizures; Fever; vomiting; This is a spontaneous report from a non-contactable healthcare professional. A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient was not pregnant. Medical history included depression, anxiety. No other vaccine in four weeks. No other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced seizures, fever, vomiting on 14Aug2021 03:00 with outcome of recovering. The patient was hospitalized for these events for 3 days. Therapeutic measures were taken as a result of events included Put on a breathing machine and given anti seizure medicine. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No Covid prior vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Seizures, Pyrexia and Vomiting cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Both parents tested positive the following day; Both parents tested positive the following day; This is a spontaneous report from a contactable other health care professional (Nurse). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248),via  intramuscular route of administration, administered in Arm Left on 22Jan2021 13:45 (at the age of 42-years-old) as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248), via intramuscular route of administration, administered in Arm Left 10Feb2021 13:45 (at the age of 42-years-old) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. 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. Since the vaccination, the patient had been tested for Covid-19. On 13Aug2021, reported both parents tested positive the following day. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Aug2021. Treatment received for the events was unknown. The outcome of the events was resolving.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Pain, Pyrexia
Clinical narrative: covid test date=17Aug2021, covid test result=Positive; covid test date=17Aug2021, covid test result=Positive,; Body aches; fever; Headache; This is a spontaneous report from a contactable Nurse.   A 62-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for Injection, Batch/Lot number: EL3248) dose 2 via an intramuscular route of administration, administered in Left arm on 16Feb2021 1:30 (at the age of 62-years) as dose 2, single dose for covid-19 immunisation. The patient medical history were not reported the patient past drug therapy included BNT162B2 (Lot number=EL3248) dose 1 via an intramuscular route of administration, administered in Left arm for covid-19 immunisation on an unspecified date in Jan2021 01:45. The concomitant medications were not reported. The patient experienced covid test date=17Aug2021, covid test result=Positive (vaccination failure and COVID-19), body aches, fever, headache on 17Aug2021. The patient underwent lab tests and procedures which included PCR/Nasal Swab was positive on 17Aug2021. The outcome of the events experienced covid test date=17Aug2021, covid test result=Positive was unknown, body aches, fever, headache was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Covid-19" and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Middle insomnia, Respiratory arrest
Clinical narrative: stopped breathing during the night; when it happened he woke himself up; constipation; This is a spontaneous report from a contactable consumer (patient) reported that, A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took magnesium citrate for constipation, miralax for constipation and experienced blocked up. On an unspecified date, the patient experienced stopped breathing during the night; when it happened he woke himself up and constipation. The event stopped breathing during the night was serious (medically significant). Patient was received treatment for event constipation. It was reported that consumer stated that since his first dose of the Pfizer COVID 19 vaccines he has experienced side effects. He states that he stopped breathing during the night. He sleeps alone but when it happened he woke himself up. He states that he called about this previously. He is now experiencing some constipation. He states that he was worried because this medication was so new. He has taken magnesium citrate or Miralax when "blocked up" in the past and those helped but they haven't helped now. He asks what impaction would mean and how it would be done. He would like to know if these are side effects of the Pfizer COVID 19 vaccine. Serious was No. The clinical outcome of event constipation was not recovered; while other event outcome was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: another person died; This is a spontaneous report from a contactable consumer. A patient of unspecified gender and age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date at unknown dose single for COVID-19 immunization. Medical history includes historical vaccine. No concomitant medications reported. Reporter reports that after receiving the second dose, another person died. The outcome of Event was Fatal.  Information about lot/batch number has been requested.  Follow-up attempts have been completed, Batch/lot number not available. No further information is expected.; Reported Cause(s) of Death: another person died
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID antigen test which came out positive; COVID antigen test which came out positive; This is a spontaneous report from a contactable consumer. This consumer reported for 36-year-old female patient. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734), dose 1 intramuscularly on 31Mar2021 (age at the time of vaccination was 36-year-old) as dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8729) dose 2 intramuscularly on 21Apr2021 (age at the time of vaccination was 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. The patient did not test COVID-19 positive prior to vaccination. The patient had been tested for COVID-19 since the vaccination. It was reported that on 17Aug2021, the patient took an at-home COVID antigen test (Abbott BinaxNow Antigen Self Test) which came out positive on 17Aug2021. Patient was experiencing COVID-19 symptoms which included fever, aches, loss of smell and taste, fatigue, congestion and cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 (Nasal Swab). Treatment medications included OTC DayQuil and NyQuil to treat symptoms. Outcome of the event COVID-19 was reported as not recovered at this time of the report.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disease progression, Leukaemia
Clinical narrative: leukemia advancing or progressing; leukemia advancing or progressing; white blood cells have quite taken a jumped up to 20,000; This is a spontaneous report from a Pfizer-sponsored program , received from a contactable Other-HCP via medical information team. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said that when she went to her doctor in May2021 after having received two doses of the vaccine, her white blood cells have quite taken a jumped up to 20,000 and heard that after getting the vaccine the white blood cells can go up. Her physician told her that it might be her leukaemia advancing or progressing, but he said some people are getting their elevated white blood cell count from the Pfizer COVID vaccine. Caller was going to see her doctor again next week and wants to know if Pfizer have seen increase in white blood cells as a side effect after receiving the vaccine. Adverse events resulted into physician's office visit. The patient underwent lab test which included White Blood Cell count: white blood cells jumped up to 20,000 on an unspecified date in 2021. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expe; Sender's Comments: Based on the limited information provided the role of the vaccine BNT162B2 in contributing/triggering the event advancement or progression of leukemia cannot be meaningfully assessed nor excluded. The case will reassessed once information regarding patients medical history and concomitant medications are 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.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted on Thursday 12Aug 5 days after receiving his second COVid shot; This is a spontaneous report from a contactable consumer (mother of the patient).  A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration on 07Aug2021 as dose 2, single for covid-19 immunization. There was no medical history (no prior medical issues). There were no concomitant medications (was on no other medicines). It was stated that, on 12Aug2021, 05 days after receiving second covid shot, the patient fainted. Event took place after use of product. The outcome of the event was unknown, at the time of report.  Information on the Lot/batch number has been requested.