chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully 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.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage
Clinical narrative: Gastrointestinal bleeding; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX US Support reported reporter's sister. A female patient of an unspecified age (reported as 77) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced gastrointestinal bleeding on 04Feb2021 with outcome of recovering.  The patient was hospitalized for gastrointestinal bleeding from 04Feb2021 to 09Feb2021. The patient received the 1st dose of the vaccine and is due for the 2nd dose on 18Feb2021. The patient was admitted in the hospital on 04Feb2021 for Gastrointestinal bleeding, was discharged on 09Feb2021 but was back in the ER on 10Feb2021. The patient was nearing recovery. The reporter denied that this was a side effect of the vaccine. The reporter was asking if it would be okay for her sister to take the 2nd dose as scheduled.   Information on the lot/ batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There is no evidence or argument to suggest a causal relationship between the suspect vaccine BNT162B2 and the event gastrointestinal bleeding. The event is likely due to an underlying medical condition.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: appendicitis; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:45 (03:45 PM) at a single dose as Covid vaccine. Medical history included gastrointestinal distress at the time of incident. The patient had no known allergies. Concomitant medications included cyanocobalamin (B12), calcium, levothyroxine sodium (LEVOXYL), lisinopril, and ergocalciferol (VIT D). The patient developed intense abdominal pain on 08Feb2021 10:00 AM. She went to the ER on 09Feb2021 and a CT scan on 09Feb2021 which revealed that she had appendicitis on 08Feb2021 10:00 AM. The patient was hospitalized for the events from 09Feb2021 to 13Feb2021 (4 days of hospitalization). Treatment for the events included intravenous antibiotics. The patient had no Covid prior to vaccination. Additional lab data included Covid test type post vaccination Nasal Swab with negative result on 09Feb2021 (Covid tested post vaccination). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Petechiae
Clinical narrative: petechiae on the skin; conjunctival hemorrhage; This is a spontaneous report from a contactable Consumer reporting for her mother in law. A 72-years-old female patient received the second dose of  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient experienced conjunctival hemorrhage on 13Feb2021 with outcome of unknown , petechiae on the skin  on 14Feb2021 described  as round, red spots on the arm, leg, and belly with no more than 6 spots, with outcome of unknown.   Conjunctival hemorrhage was considered an Important Medical Event.  Information about Lot number has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Gait inability, Muscular weakness
Clinical narrative: unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at times; This is a spontaneous report from a contactable consumer.   A 90-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 01Feb2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Feb2021 4 days after vaccine, patient was unable to stand or walk with rolling walker. Prior to vaccine, patient was able to ambulate slowly with rolling walker. Legs no longer able provide support. Also mentally increased disorientation at times. Patient visited doctor office due to the events considered as disabling. At the time of the reporting the patient had not yet recovered from the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disorientation, Fall, Pyrexia, Speech disorder
Clinical narrative: gets 102 degree fever; Could not speak much next two days; Within one hour or so after:  found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer.  An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: gets 102 degree fever; Could not speak much next two days; Within one hour or so after:  found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer.  An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer.   A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization.  Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer.   A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization.  Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; This is a spontaneous report from a contactable consumer or other non hcp.   A 88-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 09Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced kidney infection on an unspecified date. Patient started on sulfamethoxazole/trimethoprim. The outcome was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive/experienced more like a cold; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer (patient).  A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  She had my first shot last month.  Her 2nd shot on 12th Feb, daughter came with Covid tested positive, also her co-worker. 1st of Feb. She was also tested positive. She experienced more like a cold, She would like to know if she should take the 2nd shot.The patient underwent lab tests and procedures which included sars-cov-2 test: positive  in Feb2021. Outcome of events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac events/cardiac issues; This is a spontaneous report from a contactable Nurse.  A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was reported that patient was hospitalized on unknown date due to cardiac events/ cardiac issues (onset date unknown). The nurse was caring for a patient who received the first (1 st) dose of the vaccine in the beginning of Jan2021, then wound up sick and in the hospital. The patient's second (2 nd) dose was due around the 20th or 21Jan2021, but the patient missed the dose due to being in the hospital. Nurse wanted to know if patient should she be getting the 2nd dose now or restarting the series. Nurse stated that the patient did not have an adverse event to the vaccine; she had unrelated cardiac issues. Outcome of the event was unknown.  information about Lot/ Batch number requested.; Sender's Comments: The reported cardiac disorder was most likely an intercurrent/concurrent disease, and unrelated to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself).  A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Taste disorder, Tunnel vision
Clinical narrative: tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself).  A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Cough, Heart rate, Heart rate increased
Clinical narrative: injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur).  Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Prostatic specific antigen, Vaccination site pain
Clinical narrative: injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur).  Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Liver function test, Myalgia, Sleep disorder
Clinical narrative: abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable Consumer.  This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable Consumer.  This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neuralgia, Syncope, Vomiting
Clinical narrative: Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; This is a spontaneous report from a contactable consumer.  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 12Feb2021 14:00 at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus and hypertension. The patient had no known drug allergies. The patient's concomitant medication included metformin. The patient previously took first dose of BNT162B2 on 23Jan2021 in the right arm at 07:00 PM. The patient had no COVID prior to vaccination and no COVID tested post vaccination. The patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting on 14Feb2021 23:30. Patient was taken by POV to emergency department where he received fluids and anti-emetic. The outcome of the events were recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vertigo, Vomiting
Clinical narrative: Vertigo and throwing up; Vertigo and throwing up; This is a spontaneous report from a contactable consumer reported for herself.   A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number: EK9231 on 23Jan2021 (at the 90-year-old), at single dose for COVID-19 immunization via unspecified route of administration at the left arm. Medical history included vertigo seven years ago and she had taken a Meclizine for it. The patient wore hearing aids On the day of first COVID-19 Vaccine she was perfectly healthy. She was very alert for a 90-year-old. The patient had received influenza vaccine on unknown date. On 11Feb2021 the patient experienced Vertigo and throwing up. The patient was hospitalized for the events from 11Feb2021 to 13Feb2021. The patient received Meclizine, but it wasn't helping. The patient was admitted for 3 days until she felt well enough. The hospital took a blood test with unknown result. The patient did a little bit of physical therapy and she was given mostly IV fluids because she was throwing up. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 1st of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital.  The patient's medical history reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The event resulted in physician office visit. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event stroke cannot be excluded. The patient's age and detailed clinical course would be helpful for further 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163468 same reporter, product, event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 2nd of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history was reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The outcome of the event was unknown. The event resulted in physician office visit. The event was assessed as serious (hospitalization).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of stroke, cannot be fully excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163467 same reporter, product, event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Headache, Hypoacusis
Clinical narrative: hard of hearing; rash; faint; being hot; short of breath; headache; was achy; extremely tired/extremely exhausted; This is a spontaneous report from a contactable nurse (reporting for mother). An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 as COVID-19 immunization was received on an unknown date. Reporter was calling regarding side effects of the Pfizer COVID vaccine. Reporter stated that her mother (patient) is 89 years old and her mother was hard of hearing since an unknown date. Her mother got the second dose of the product 11Feb2021 and she was fine that Thursday, and by Friday (12Feb2021) her mother had a headache, was achy, and extremely tired. On Saturday, her mother felt a little bit better. On Sunday (14Feb2021), her mother had an episode of being hot and faint, and short of breath and extremely exhausted. This morning (15Feb2021), her mother was experiencing shortness of breath, and a rash and was exhausted. Reporter wa wondering if shortness of breath could be a side effect of the product. The outcome of the events headache, achy, and "extremely tired/extremely exhausted" was recovering, while for events hard of hearing, being hot, faint, short of breath and rash was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event syncope cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Syncope
Clinical narrative: hard of hearing; rash; faint; being hot; short of breath; headache; was achy; extremely tired/extremely exhausted; This is a spontaneous report from a contactable nurse (reporting for mother). An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 as COVID-19 immunization was received on an unknown date. Reporter was calling regarding side effects of the Pfizer COVID vaccine. Reporter stated that her mother (patient) is 89 years old and her mother was hard of hearing since an unknown date. Her mother got the second dose of the product 11Feb2021 and she was fine that Thursday, and by Friday (12Feb2021) her mother had a headache, was achy, and extremely tired. On Saturday, her mother felt a little bit better. On Sunday (14Feb2021), her mother had an episode of being hot and faint, and short of breath and extremely exhausted. This morning (15Feb2021), her mother was experiencing shortness of breath, and a rash and was exhausted. Reporter wa wondering if shortness of breath could be a side effect of the product. The outcome of the events headache, achy, and "extremely tired/extremely exhausted" was recovering, while for events hard of hearing, being hot, faint, short of breath and rash was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event syncope cannot be 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Erythema, Feeling hot, Mastitis, Pain
Clinical narrative: breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: went into shock after she got it; This is a spontaneous report from a contactable consumer (daughter's friend) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that "a friend of her daughter's went into shock after she got it" on an unspecified date with outcome of unknown.   Information on the lot/ batch number has been requested.