chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan brain, Vomiting
Clinical narrative: chills; fever; nausea; rapid heart rate; body aches; headaches; lose my mental capacity; I was incoherent; threw up; This is a spontaneous report from a contactable consumer (patient). A 29-Year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number=ER8729) on 11Apr2021 11:45 AM on Left arm for covid-19 immunization. Medical history was hospitalizations for heat exhaustion in 2014 and 2017, Herpes Type 2, covid prior vaccination. No other vaccine in four weeks. Concomitant drugs included Vitamin D, One-A-Day Vitamin. Symptoms started at 12:00 am midnight on 12Apr2021 with chills and fever. The morning of 12Apr2021, symptoms progressed into nausea, rapid heart rate, body aches, headaches, and I started to lose my mental capacity. I didn't know my address when I called an ambulance. When at the hospital, I didn't recognize my wife and forgot my mother's name. I was incoherent. I threw up. I don't remember 7 hours of time from my first day at the hospital. I got a spinal tap to test for meningitis which came back negative. I had an MRV brain scan which came back clear (no blood clots). Hospitalized for 5 days (12Apr2021-16Apr2021). AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Outcome of the event was recovering. AE treatment was IV fluids, sodium, spinal tap, MRV brain scan. No covid tested post vaccination.  No follow-up attempts needed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pain in left side of chest, light headed, cold sweats and fainted. Taken to Hospital and released in about 3 hours. Two days later started getting back pains on my left side. Pain got worse and after another couple of days I started coughing up some blood. On March 17th 2021 I was admitted to the hospital with a pulmonary embolism.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test normal, Chest X-ray, Chest pain, Cold sweat
Clinical narrative: Pain in left side of chest, light headed, cold sweats and fainted. Taken to Hospital and released in about 3 hours. Two days later started getting back pains on my left side. Pain got worse and after another couple of days I started coughing up some blood. On March 17th 2021 I was admitted to the hospital with a pulmonary embolism.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Haemoptysis, Pulmonary embolism
Clinical narrative: Pain in left side of chest, light headed, cold sweats and fainted. Taken to Hospital and released in about 3 hours. Two days later started getting back pains on my left side. Pain got worse and after another couple of days I started coughing up some blood. On March 17th 2021 I was admitted to the hospital with a pulmonary embolism.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Ultrasound scan normal
Clinical narrative: Pain in left side of chest, light headed, cold sweats and fainted. Taken to Hospital and released in about 3 hours. Two days later started getting back pains on my left side. Pain got worse and after another couple of days I started coughing up some blood. On March 17th 2021 I was admitted to the hospital with a pulmonary embolism.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Facial paralysis, Hemiparesis, Hypoaesthesia, Lumbar puncture
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Muscle twitching, Paraesthesia, Tremor
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiotensin converting enzyme, Antinuclear antibody negative, Blood test normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF cell count normal, CSF immunoglobulin G index, CSF myelin basic protein normal, CSF protein normal, CSF test normal
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF white blood cell differential, Computerised tomogram normal, Differential white blood cell count normal, Erythema, Facial paralysis
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lumbar puncture, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Metabolic function test normal
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Paraesthesia, Peripheral swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Speech disorder, Tremor, Treponema test negative, Tri-iodothyronine free normal
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin D, West Nile virus test negative
Clinical narrative: One day after the shot I experienced redness and swelling of the arm where it was administered. Day two I started experiencing tingling and twitching of the face. Day three I had to go to the ER because of facial droop. The doctor said possible bell palsy and sent me home to follow up with normal doctor. Day four I went to normal doctor and by end of the day ended up in the ER with facial droop and body tremors. I was admitted into the hospital for day 5 through day 7 where I had CT scan, MRI and spinal tap. We are still awaiting the test results but I am still experiencing side effects. My speech is now being effected along with the body tremors. I am waiting to get set up with PT, OT and speech therapy to start that process but we are unsure of the test results at this time.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal sepsis, Asthenia, Death, Defaecation urgency
Clinical narrative: Bowel Ischemia with perforation; Bowel Ischemia with perforation; She had a severely stomach ache; its really painful; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney transplant from an unknown date and unknown if ongoing. First shot, in 22Apr morning, She is completely fine, that morning she had a severely stomach ache and its really painful then unless she said she need to go to the bathroom but couldn't go out and then after she got admitted to the hospital then kept her till morning ,she went to the hospital. It was reported that the patient passed away after COVID-19 vaccine. The reason of death was reported as Bowel Ischemia with perforation. The patient underwent lab tests and procedures which included investigation: no problem, no blood pressure, no blood sugar on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The events were assessed as serious (hospitalization), fatal for the events Bowel Ischemia with perforation.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Bowel Ischemia with perforation; Bowel Ischemia with perforation
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal necrosis, Intestinal ischaemia, Metabolic acidosis, Septic shock, Thrombosis
Clinical narrative: Bowel Ischemia with perforation; Bowel Ischemia with perforation; She had a severely stomach ache; its really painful; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney transplant from an unknown date and unknown if ongoing. First shot, in 22Apr morning, She is completely fine, that morning she had a severely stomach ache and its really painful then unless she said she need to go to the bathroom but couldn't go out and then after she got admitted to the hospital then kept her till morning ,she went to the hospital. It was reported that the patient passed away after COVID-19 vaccine. The reason of death was reported as Bowel Ischemia with perforation. The patient underwent lab tests and procedures which included investigation: no problem, no blood pressure, no blood sugar on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The events were assessed as serious (hospitalization), fatal for the events Bowel Ischemia with perforation.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Bowel Ischemia with perforation; Bowel Ischemia with perforation
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Bowel Ischemia with perforation; Bowel Ischemia with perforation; She had a severely stomach ache; its really painful; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney transplant from an unknown date and unknown if ongoing. First shot, in 22Apr morning, She is completely fine, that morning she had a severely stomach ache and its really painful then unless she said she need to go to the bathroom but couldn't go out and then after she got admitted to the hospital then kept her till morning ,she went to the hospital. It was reported that the patient passed away after COVID-19 vaccine. The reason of death was reported as Bowel Ischemia with perforation. The patient underwent lab tests and procedures which included investigation: no problem, no blood pressure, no blood sugar on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The events were assessed as serious (hospitalization), fatal for the events Bowel Ischemia with perforation.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Bowel Ischemia with perforation; Bowel Ischemia with perforation
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Intestinal ischaemia, Investigation, Perforation
Clinical narrative: Bowel Ischemia with perforation; Bowel Ischemia with perforation; She had a severely stomach ache; its really painful; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney transplant from an unknown date and unknown if ongoing. First shot, in 22Apr morning, She is completely fine, that morning she had a severely stomach ache and its really painful then unless she said she need to go to the bathroom but couldn't go out and then after she got admitted to the hospital then kept her till morning ,she went to the hospital. It was reported that the patient passed away after COVID-19 vaccine. The reason of death was reported as Bowel Ischemia with perforation. The patient underwent lab tests and procedures which included investigation: no problem, no blood pressure, no blood sugar on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The events were assessed as serious (hospitalization), fatal for the events Bowel Ischemia with perforation.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Bowel Ischemia with perforation; Bowel Ischemia with perforation
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Platelet count normal, Sinus pain
Clinical narrative: Cavernous sinus thrombosis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Chills, Computerised tomogram head abnormal, Headache, Intensive care
Clinical narrative: Cavernous sinus thrombosis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Cavernous sinus thrombosis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cavernous sinus thrombosis, Computerised tomogram head, Computerised tomogram head abnormal, Heparin-induced thrombocytopenia test, Prothrombin time
Clinical narrative: Cavernous sinus thrombosis
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Patient received vaccination on 04/29/2021 and came into the pharmacy the following day (04/30/2021) at approximately 1030am with an uncontrollable arm tremor in the right arm which is where she received the injection. The patient said that the tremors began the night after receiving the vaccination around 0700pm and had continued throughout the night. She did not have any pain or noticeable swelling. The patient was advised to check in with a physician, she went to urgent care and was prescribed a muscle relaxant. Upon checking in on the patient the night of 04/30/2021 (approx.: 830pm) the arm tremor was still present but the patient did not mention any other symptoms upon asking. The pharmacy attempted to call the patient on 05/01/2021 but the patient has not responded to our message at the time that this report was filed.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Hyperhidrosis, Swollen tongue
Clinical narrative: Dizziness with shaking and elevated heart rate began at 12:18p Tongue, lips, mouth swelling began at 12:21p Epi injection given at 12:22 in left thigh Transported to ER and given Benadryl, Solu-Medrol and Pepcid via IV Discharged with an epi pen and a 12 day course of steroids
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Lip swelling, Mouth swelling, Swollen tongue
Clinical narrative: Dizziness with shaking and elevated heart rate began at 12:18p Tongue, lips, mouth swelling began at 12:21p Epi injection given at 12:22 in left thigh Transported to ER and given Benadryl, Solu-Medrol and Pepcid via IV Discharged with an epi pen and a 12 day course of steroids
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Dizziness with shaking and elevated heart rate began at 12:18p Tongue, lips, mouth swelling began at 12:21p Epi injection given at 12:22 in left thigh Transported to ER and given Benadryl, Solu-Medrol and Pepcid via IV Discharged with an epi pen and a 12 day course of steroids
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: First time caller received first covax and then 2 days later she tested positive; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose and then 2 days later she tested positive for the virus, the event outcome was unknown. No treatment information reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node after receiving the first dose of pfizer covid vaccine; This is a spontaneous report from contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 at age of 63-year-old at single dose for SARS-COV-2 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling to report a swollen lymph node (Apr2021) after receiving the first dose of the Pfizer covid vaccine. The patient asked "Is this side effect something to worry about, or is it going to go away?", the response was "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 2 days later after her first dose, she was diagnosed as COVID19 positive; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first shot of the PFIZER-BIONTECH COVID-19 VACCINE on 01April2021. Two days later after her first dose she was diagnosed as COVID19 positive. She was scheduled for her 2nd dose supposedly, April 22 2021 however she was getting conflicting information as to when should she get her 2nd dose. Some says to wait out 90 days and some would tell her to just proceed in getting the 2nd dose. She also had completed her isolation period and had shown no symptoms for over a week. She wanted to confirm as to how long would she have to wait to have the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He experienced an extremely high fever (103.9 °F); This is a spontaneous report from a contactable consumer (patient's wife). A 65-years-male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 65-years-old) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced an extremely high fever (103.9 °F). Treatment received on same day at night (21:00) acetaminophen (TYLENOL) and the fever has not dropped so much. Today he had a fever of 101.7 °F and now it's at 101 °F. Reporter would like to know if she could be able to give patient ADVIL instead of acetaminophen or alternate between both. The outcome of event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: she had a really bad migraine; This is a spontaneous report received from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0170) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) on an unspecified date for COVID-19 immunisation. Caller stated after the second dose of Pfizer's COVID vaccine, she had a really bad migraine and wanted to know if that is associated with the vaccine. Caller asked if there was any reason to avoid taking Aspirin. The outcome of the event was unknown. The report was non-serious.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date not reported) via unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. The patient medical history, concomitant medications were not reported. On 14Apr2021 patient  tested positive for Covid  but believes he could have potentially had it a day before the official results. he would like to know if the vaccine can give you positivity (referring to covid test). He wanted to know when he could get his 2nd dose and whether he needs to. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus.; This is spontaneous report from a contactable physician (the patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 12Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Approximately 9-10 days after the vaccine caller experienced tinnitus (Apr2021). The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke 3 weeks after receiving first dose; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 09Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced stroke 3 weeks after receiving first dose(on 01Apr2021). The patient was hospitalized for 15 days. The patient underwent lab tests and procedures on 03Apr2021 which included nasal swab (for sars-cov-2) test with negative results. The outcome of event was reported as not recovered. The patient did not receive any treatment for the event. The event was considered as serious, resulting to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and disability or permanent damage.   Information on about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: miscarriage of the 16-17 week fetus; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number : ER8730), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 16:30 as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications included unspecified prenatal vitamins. The patient did not have other vaccines in four weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient had a miscarriage of the 16-17 week fetus. The patient had surgery to remove the fetus and tissue. The mother was due to deliver on 09Sep2021. The outcome of the event was recovering. The patient had a nasal swab COVID-19 test on 22Apr2021 with a result of negative. The event was reported as life-threatening.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: feeling unwell; cough; This is a spontaneous report from a contactable consumer (herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration as a single dose on 03Apr2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Apr2021 (3 days prior to her second dose appointment), the patient experienced feeling unwell and cough. The patient was scheduled for second dose for 24Apr2021 at 14:00, but she called to cancel and make another appointment because of her symptoms. The outcome of the events of feeling unwell and cough was unknown.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sensitive skin
Clinical narrative: skin sensitive to the touch; Body achiness; This is a spontaneous report from a contactable consumer. The consumer reported for a 19-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP6955) via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number:unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the reporters niece informed her that she was experiencing mild body achiness and mild skin sensitive to touch after receiving the second injection of the vaccine. Outcome was unknown for both the events.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Illness
Clinical narrative: i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; achy; i am extremely tired; This is a spontaneous report from a contactable consumer (reported for himself).  This 47-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 17Apr2021 09:00, as a single dose for covid-19 immunization. The patient did not have any medical history or allergy to medications, food or other products. Concomitant medications were not reported. He received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 27Mar2021 09:00, as a single dose for covid-19 immunization. On 18Apr2021 07:00, he was sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He did not receive any treatment events. He did not visit doctor or other healthcare professional office/clinic or emergency room/department or urgent care. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was recovering from the events of sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; achy; i am extremely tired; This is a spontaneous report from a contactable consumer (reported for himself).  This 47-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 17Apr2021 09:00, as a single dose for covid-19 immunization. The patient did not have any medical history or allergy to medications, food or other products. Concomitant medications were not reported. He received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 27Mar2021 09:00, as a single dose for covid-19 immunization. On 18Apr2021 07:00, he was sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He did not receive any treatment events. He did not visit doctor or other healthcare professional office/clinic or emergency room/department or urgent care. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was recovering from the events of sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Had the semi quantitative AB test. Showed positive response.; Had the semi quantitative AB test. Showed positive response.; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A 69-year-old (will be 70 on 05Apr2021) patient of unspecified gender received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot# unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, patient had CLL and semi quantitative AB test that showed positive response. Patient would like to be in front of line for third shot. Patient was involved in CLL vaccine study with then CLL, getting the third shots that would provide useful information. The patient underwent lab test which included semi quantitative AB test with Positive result on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19/Taste and smell are slowly starting to return; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included exposure to sars-cov-2 from 10Apr2021 to an unknown date. The patient's concomitant medications were not reported. The patient tested positive for covid-19 on 16Apr2021 and has recovered completely except for his taste and smell are slowly starting to return. Outcome of covid-19 was recovering. He has completed the required isolation and quarantine. He was scheduled to receive his second dose of the Pfizer COVID-19 vaccine on 03May2021 and he would like to know if he should proceed with getting the second dose as scheduled. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Hello i gave the pfizer vaccine to a patient and they said their face hand and back felt numb; This is a spontaneous report from a contactable pharmacist. This contactable pharmacist reported for an unknown patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, pharmacist reported that after giving a Pfizer vaccination to a patient, patient complained their face hand and back felt numb for an hour until they left the clinic. Reporter urged them to go to urgent care, but they refused. Pharmacist wanted to know the protocol for numbness. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: body aches; chills; slight fever overnight; This is a spontaneous report from a contactable consumer (patient) received via a sales representative. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient experienced body aches, chills and slight fever overnight on 16Apr2021 and the symptoms resolved by the afternoon of 17Apr2021. Outcome of the events was resolved on 17Apr2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: shivering on and off; soreness on the shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 16Apr2021 on Friday at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness on the shoulder in Apr2021 where the vaccine was administered and it lasted for about two days, shivering on and off in the upper part of his arm, where the soreness was, occurred on 21Apr2021 at around 07:00 in the morning. Patient would like to talk to someone about these symptoms whether he should go to the hospital or not. The outcome of the event soreness on the shoulder was recovered while outcome of the event shivering on and off was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Exposed to COVID-19; caller tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, in left arm on 30Mar2021 at 19:00 as single dose for covid-19 immunisation. The patient's medical and family history and concomitant medications were not reported. On an unknown date within a couple of days, the patient and his wife went for a trip and maybe during the trip were exposed to COVID-19. On 05Apr2021, he went for a test and he tested positive for COVID-19. He had some kind of tiredness and a headache, something like that. He was feeling like he had had some cough so he went to the ER and he was given Zithromycin and some cough tablet and cough syrup. He took some Advil and Tylenol while on his trip because he was tired and that kind of thing. Initially, he thought it was side effects from the vaccine so that was why he was taking medication. Some other friends of his had side effects, so he thought what he was experiencing was side effects so he was taking over the counter products for the side effects. He was not sure if the tiredness, headache were a side effect of the vaccine or if he was exposed, he is not sure. But the real COVID-19 symptoms started on 05Apr2021. When probed for when the tiredness/headache began, the caller states he drove a lot of distance and was doing a lot of things during the trip, so they were not like COVID-19 symptoms. No further details were provided regarding this statement. The patient was treated with Tylenol. The outcome of the events was reported as unknown for covid-19, tiredness, headache and recovering for cough. The patient underwent lab tests which included SARS-CoV-2 test and was tested positive on 05Apr2021. A culture was performed and it was positive and the culture source was nose. After testing positive, its been already like 2 weeks, he is asking when should he go for the second dose. He only saw a doctor once in the last 40 years. He really needs to pick one. He did make an appointment last week, but due to the COVID it got canceled.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Exposed to COVID-19; caller tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, in left arm on 30Mar2021 at 19:00 as single dose for covid-19 immunisation. The patient's medical and family history and concomitant medications were not reported. On an unknown date within a couple of days, the patient and his wife went for a trip and maybe during the trip were exposed to COVID-19. On 05Apr2021, he went for a test and he tested positive for COVID-19. He had some kind of tiredness and a headache, something like that. He was feeling like he had had some cough so he went to the ER and he was given Zithromycin and some cough tablet and cough syrup. He took some Advil and Tylenol while on his trip because he was tired and that kind of thing. Initially, he thought it was side effects from the vaccine so that was why he was taking medication. Some other friends of his had side effects, so he thought what he was experiencing was side effects so he was taking over the counter products for the side effects. He was not sure if the tiredness, headache were a side effect of the vaccine or if he was exposed, he is not sure. But the real COVID-19 symptoms started on 05Apr2021. When probed for when the tiredness/headache began, the caller states he drove a lot of distance and was doing a lot of things during the trip, so they were not like COVID-19 symptoms. No further details were provided regarding this statement. The patient was treated with Tylenol. The outcome of the events was reported as unknown for covid-19, tiredness, headache and recovering for cough. The patient underwent lab tests which included SARS-CoV-2 test and was tested positive on 05Apr2021. A culture was performed and it was positive and the culture source was nose. After testing positive, its been already like 2 weeks, he is asking when should he go for the second dose. He only saw a doctor once in the last 40 years. He really needs to pick one. He did make an appointment last week, but due to the COVID it got canceled.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Viral test
Clinical narrative: He was tested positive on the covid-19 virus this week on April 21, 2021; This is a spontaneous report from the Pfizer sponsored program Covax US support. A contactable consumer (Patient) reported a unspecified age of male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 13Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19 with swab test and resulted positive on 21Apr2021. It was reported that the patient called to advise that he and his family had their first dose of the vaccine last 13Apr2021. He was tested positive on the covid-19 virus this week on 21Apr2021. Caller also stated that he himself tested negative on the Rapid test but since his Doctor advised for further test since he was in the proximity of others who tested positive to get a deeper swab test which then turned his result as positive again. Caller wants to know if they still need to go through the second dose of the vaccine scheduled on 6May2021. The outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Covid 19, sinus, chest pain, breathing, 1 week after dose 1.; sinus; chest pain; breathing; This is a spontaneous report received from a contactable consumer. The 55-year-old non pregnant female consumer (patient) received BNT162B2 (COMIRNATY, Solution for injection, (lot number: unknown; Expiration date: not reported) on 11Apr2021 via unspecified route of administration in right arm at single dose for COVID-19 immunization. The medical history included prediabetes, high cholesterol. Patient received other medication within 2 weeks of vaccination reported as Metformin and Atorvastatin. On 17Apr2021 (one week after dose 1) patient experienced sinus, chest pain, breathing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 post vaccination patient was tested positive for COVID-19 (Nasal Swab). Patient received treatment of Antibiotics, inhaler, steroids. It was unknown if patient visited Doctor or other healthcare professional office/clinic. The outcome of the events was reported as recovered with lasting effects.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.