chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness.  ER visit for chest pains, labs and testing done, heart attack ruled out.  Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed.  Patient reports feeling better.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Nausea, Orthostatic hypotension, Oxygen saturation decreased
Clinical narrative: Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath, increased Heartrate, pulse ox fell to 88-93-Normal 95%, orthostatic hypotension
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath, increased Heartrate, pulse ox fell to 88-93-Normal 95%, orthostatic hypotension
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Skin laceration, Skin swelling
Clinical narrative: mild right sided tear through swelling where dermal filler has been used; mild right sided tear through swelling where dermal filler has been used; received BNT162B2; first dose on 18Dec2020 15:00 and second dose on 06Jan2021 20:45; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899 and expiry date unknown) via unspecified route of administration on 06Jan2021 20:45 at left arm for Covid-19 immunization in a workplace clinic. Medical history included covid prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (lot number EJ1685) on 18Dec2020 15:00 at right arm for Covid-19 immunization. On 08Jan2021 18:30, the patient experienced mild right sided tear through swelling where dermal filler has been used. The patient was not covid tested post vaccination. The outcome of the events mild right sided tear through swelling where dermal filler has been used was recovering. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Swollen tongue
Clinical narrative: Facial Flushing, face tingling, tongue swelling, appx 5' after injection.  transferred to ED & tx with  Benadryl, Pepcid. solumedrol IV. : with sx resolution  - observed for 4 hrs in ED & d/cd
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I had a swollen lymph node approximately the size of a baseball that developed under my left armpit; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EJ1685), intramuscular in the left arm on 18Dec2020 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included that the patient was diagnosed with COVID-19 prior to the vaccination. The patient did not have any allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medication in the two weeks prior to the vaccination. On 19Dec2020 14:00 PM, the patient experienced a swollen lymph node approximately the size of a baseball that developed under her left armpit. It took about 5 days to completely resolve. The patient did not receive any treatment for the event. The patient had not tested for COVID-19 post vaccination. The outcome of the event, swollen lymph node, was recovered, in Dec2020.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate pain in left arm around injection site; This is a spontaneous report from a contactable physician, the patient. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK9231), via an unspecified route of administration in the left arm on 07Jan2021 17:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 07Jan2021 23:00, the patient experienced moderate pain in left arm around injection site. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event, moderate pain in left arm around injection site, was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: swollen, warm itchy knot at injection site lasting 3 days
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a contactable physician reporting for himself. A male patient of an unspecified age (reported as "aged 64") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided),  via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included hypertension and borderline diabetes. The patient's concomitant medications were not reported. The patient called on 08Jan2021 after receiving second dose on 07Jan2021. He is concerned he has not had a single side effect from the second vaccine. Patient reported that a doctor said "if you get side effects its good because you're body is building antibodies". Patient's toddler daughter had a cold that he caught between the two immunizations. Patient stated that he felt well yesterday during immunization and could honestly answer the questionnaire that he was not ill. Patient asked if he should have antibody testing done two weeks after his second dose to check his immunity. Outcome of the event was recovered on an unspecified date.  Information on lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; a low grade fever of 100; Body aches; chills; runny nose; sneezing; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 06Jan2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with COVID-19 on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. On 07Jan2021, the patient experienced sore arm, had a low grade fever of 100, body aches, chills, runny nose, and sneezing. The outcome of the events sore arm, had a low grade fever of 100, body aches, chills, runny nose, and sneezing was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sore arm; a low grade fever of 100; Body aches; chills; runny nose; sneezing; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 06Jan2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with COVID-19 on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. On 07Jan2021, the patient experienced sore arm, had a low grade fever of 100, body aches, chills, runny nose, and sneezing. The outcome of the events sore arm, had a low grade fever of 100, body aches, chills, runny nose, and sneezing was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness, headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Neck pain
Clinical narrative: swollen lymph nodes to left arm pit; headache; fatigue; severe neck pain; This is a spontaneous report from a contactable health care professional (nurse), the patient.   A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: eha899), in the left arm on 06-JAN-2021 12:00 as a single dose, for COVID-19 vaccination.  The most recent COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included duloxetine hydrochloride (CYMBALTA), omeprazole (PROTONIX [OMEPRAZOLE]). On 07-JAN-2021 05:00, The patient experienced swollen lymph nodes to left arm pit, headache, fatigue, severe neck pain..  No treatment was  given for the event. . No other vaccines were given within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of swollen lymph nodes to left arm pit,  headache, fatigue and severe neck pain.was not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Myocardial infarction, SARS-CoV-2 test negative
Clinical narrative: Myocardial Infarction; This is a spontaneous report from a contactable Other healthcare professional (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 20201216-1), via an unspecified route of administration on 16Dec2020 08:15 at single dose for COVID-19 immunization, vaccine location provided as Left arm.  Medical history included arthritis and sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced myocardial infarction on 19Dec2020 23:00. The patient was hospitalized for myocardial infarction for 3 days. The patient underwent lab test which included Covid test via Nasal Swab post vaccination on 20Dec2020 with test result Negative. Therapeutic measure Cardiac cath procedure was taken as a result of myocardial infarction. The outcome of the event was recovering. This case was reported as Serious with seriousness criteria hospitalization.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myocardial infarction and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.  However, more information is required, such as the complete medical history, clinical course, for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site bruising, Injection site pain
Clinical narrative: About 4inches down from the injection site. There was bruising all the way down to my elbow. Very sore to the touch Purplish Red. I spoke to my MD CNA and she stated that it should be OK by the time I get my next shot. Eveyday The bruise is getting better but it is not 100% gone
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Headache, Pain
Clinical narrative: Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EKS730 and expiration date not provided), via an unspecified route of administration in the right arm on 05Jan2021 09:30 at a single dose for COVID-19 immunization. The patient has no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 02:00, the patient experienced fever of 102, body aches, chills, confusion, and headache. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EKS730 and expiration date not provided), via an unspecified route of administration in the right arm on 05Jan2021 09:30 at a single dose for COVID-19 immunization. The patient has no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 02:00, the patient experienced fever of 102, body aches, chills, confusion, and headache. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Polydipsia, Pyrexia, Tunnel vision
Clinical narrative: Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilling and could not get warm. Fever reached 101 degrees.  I took 2 Tylenol every 4 hours.  While I had a fever, I could not seem to drink enough water. I consumed about 90 ounces of water from 2pm til 9pm. The fever and chills became less prevalent by 9pm. Continued the Tylenol through 7AM the morning of 1/12/21. My chills were gone and I had no fever by then.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: took a rapid test and it came up positive; took a rapid test and it came up positive; fever 100.8; coughing; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, reported as Pfizer covid19 el1284), via an unspecified route of administration on 30Dec2020 14:30 in left arm at single dose for covid-19 immunisation. Medical history included asthma and arthritis. Concomitant medication included ibuprofen and paracetamol (TYLENOL). The most recent COVID-19 vaccine was administered in public health clinic/ administration facility. 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 had been tested for COVID-19. Patient got the vaccine on Wednesday 30Dec2020, and by Saturday (02Jan2021 22:30) she started with a little coughing that increase on Monday (04Jan2021), Monday afternoon she had fever 100.8. She thought she was experiencing side effects and reported to her supervisor and didn't work the 2 next days. She when back to work on Thursday (07Jan2021), she was sent to a covid clinic and took a rapid test and it came up positive.  The patient underwent lab tests and procedures which included nasal swab (rapid antigen testing - SARS-CoV-2): positive on 07Jan2021. The events were reported as non-serious. No treatment was received for the events. Outcome of events were recovering.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Fever, chills, tiredness, headache, face feels swollen/punched in face
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Fever, chills, tiredness, headache, face feels swollen/punched in face
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amblyopia, Eye pain, Fatigue, Headache, Muscle spasms
Clinical narrative: wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Somnolence
Clinical narrative: wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Nausea, Vomiting
Clinical narrative: Systemic: Anaphylaxis-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium; symptoms lasted 1 day
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID on 08Jan2021; Received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID on 08Jan2021; This is a spontaneous report from a non-contactable consumer.  A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID (Nasal Swab) on 08Jan2021. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: Woke up at 11/132021 4:30AM with fever (101.4), injection site pain and chills. Took Tylenol. Later in morning experience nausea and vomiting for "a couple hours".  Fatigued throughout day. Reports feeling better 1/14/2021.  Spoke to Dr (PCP) he has recommended getting 2nd dose when she is able
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Woke up at 11/132021 4:30AM with fever (101.4), injection site pain and chills. Took Tylenol. Later in morning experience nausea and vomiting for "a couple hours".  Fatigued throughout day. Reports feeling better 1/14/2021.  Spoke to Dr (PCP) he has recommended getting 2nd dose when she is able
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Headache, Injection site pain, Movement disorder
Clinical narrative: Patient reported symptoms of headahce, weakness and nausea starting at 1600 on the day of recieving the vaccine. Patient reported symptoms got worse over the course of 48 hours. Same symptoms with added body aches. Patient repoted right arm where injection was given was so sore she could hardly move arm. She also had low grade temp of 99.8
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Patient reported symptoms of headahce, weakness and nausea starting at 1600 on the day of recieving the vaccine. Patient reported symptoms got worse over the course of 48 hours. Same symptoms with added body aches. Patient repoted right arm where injection was given was so sore she could hardly move arm. She also had low grade temp of 99.8
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Eyelid function disorder, Facial paralysis
Clinical narrative: Bell's palsy; Loss of taste; Can not close one eye, no muscle movement on one side of the face.; This is a spontaneous report from a contactable nurse.  An adult female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization.  There were no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced Half face paralysis, Bell's palsy. Loss of taste. Can not close one eye, no muscle movement on one side of the face. All on 08Jan2021 14:30 with outcome of unknown. No treatment was received.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Half face paralysis/Bell's palsy cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Culture negative, Fatigue, Hemiparesis, Impaired work ability
Clinical narrative: He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered.   Unknown if 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 was not tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension.  Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Intracranial mass, Muscular weakness, Myalgia, Platelet count decreased, Pyrexia
Clinical narrative: He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered.   Unknown if 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 was not tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension.  Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered.   Unknown if 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 was not tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension.  Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use.  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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm pain and swelling initially then subsided over the next 7 days/  day 7 arm became swollen / red and itchy arm pain and swelling came back after 7 days
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 1/13 Histamine reaction: sore, itchy, red, warm, swollen. distal injection site. 3 inches wide and 4 long. including a small ring around the injection site. Also a histamine reaction on my R cheek ~ 1cm. 1/14 1000 new spot medial to original site  1inx1in red, swollen, warm. Marginal reduction in 1st reaction site and face reaction. 25mg Benadryl 1/13 2300.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Skin warm, Swelling face
Clinical narrative: 1/13 Histamine reaction: sore, itchy, red, warm, swollen. distal injection site. 3 inches wide and 4 long. including a small ring around the injection site. Also a histamine reaction on my R cheek ~ 1cm. 1/14 1000 new spot medial to original site  1inx1in red, swollen, warm. Marginal reduction in 1st reaction site and face reaction. 25mg Benadryl 1/13 2300.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen, warm at injection site
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; Chest pain; feeling like I was going to vomit and faint; feeling like I was going to vomit and faint; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. There was no medical history. Concomitant medication included valaciclovir hydrochloride (VALTREX), topiramate (TOPAMAX), lamotrigine (LAMICTAL), duloxetine hydrochloride (CYMBALTA), ziprasidone hydrochloride (GEODON). On 06Jan2021 at 12:30, The patient experienced heart rate shot up to 170 with numbness of feet, started to feel chest pain, and feeling like she was going to vomit and faint. The events required emergency room visit and were reported as serious per hospitalization. Heart rate at the hospital was 135-140 where two EKG were done and fluids were given. An x-ray of the heart was done and blood work was completed. The patient didn't receive treatment for the events. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on batch/lot number has been requested.; Sender's Comments: There is a reasonable possibility that the event "feeling like she was going to vomit" was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT 162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Nausea
Clinical narrative: Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; Chest pain; feeling like I was going to vomit and faint; feeling like I was going to vomit and faint; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. There was no medical history. Concomitant medication included valaciclovir hydrochloride (VALTREX), topiramate (TOPAMAX), lamotrigine (LAMICTAL), duloxetine hydrochloride (CYMBALTA), ziprasidone hydrochloride (GEODON). On 06Jan2021 at 12:30, The patient experienced heart rate shot up to 170 with numbness of feet, started to feel chest pain, and feeling like she was going to vomit and faint. The events required emergency room visit and were reported as serious per hospitalization. Heart rate at the hospital was 135-140 where two EKG were done and fluids were given. An x-ray of the heart was done and blood work was completed. The patient didn't receive treatment for the events. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on batch/lot number has been requested.; Sender's Comments: There is a reasonable possibility that the event "feeling like she was going to vomit" was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT 162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: half dollar sized area of itching, erythema, and swelling at the injection site
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death.  More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case.  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; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired