chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tinnitus
Clinical narrative: Skipping beats; heart rate went to 100 or over at rest; Headache; loud ringing ING ears; Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-  EW0172) via an unspecified route of administration in left arm on 18May2021 12:30 as 1st dose, single dose for COVID-19 immunization. Patient was 52-years-old and was not pregnant at the time of vaccination. Patient medical history included Raynaurds, active TB, Allergic to sulfa, penicillin, tetracycline, erythromycin, experienced drug reaction due to prednisone, alleve (muscle relaxants), allergies to antibiotics, latex and wasp, had shoulder surgery after which used cold medicines, was not getting another, COVID-19 in Nov2020. The concomitant medications included birth control, pseudoephedrine hydrochloride (SUDAFED 12-HOUR). Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 19May2021 at 10:00, patient experienced headache, loud ringing in ears, heart rate went to 100 or over at rest and was skipping beats and was out of rhythm, dizzy. She read studies from country that shows 1 shot for those who had covid is same as having 2 shot. She still was testing that she had antibodies. All she could do was drink water and wait till she metabolized whatever set her system off. She did not want go through that again. Device date was reported as 21May2021. Adverse events did not result in hospitalization. The outcome of the events was resolving.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: it was determined I have Bell's Palsy; This is a spontaneous report received from a contactable consumer (patient).  A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02May2021 13:00 (Lot number: EW0172) as single dose for (at the age of 44-years-old) COVID-19 immunization. Medical history included diabetes, sleep apnea, high blood pressure, neuropathy. The patient was not pregnant at the time of vaccination. No allergies. Unspecified concomitant medications were taken ("Yes my prescribed medications"). The patient reported that, "My face started getting droopy, my speech slurred and started having extreme facial pain. I went to my Primary Care Physician she did blood work and it was determined I have Bell's Palsy." Date of start of reaction was on 18May2021 07:15. The adverse event resulted in any Doctor or other healthcare professional office/clinic visit. Hospitalization not Prolonged. The outcome of event was not recovered. The event is serious (medically significant). Another dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered via an unspecified route of administration on 23May2021 03:00 PM, administered in Arm Left (Lot number: EW0172) as single dose for COVID-19 immunization (pending clarification).  Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Nausea, Pyrexia
Clinical narrative: fever of 102 degrees Fahrenheit; nausea; tiredness; Blood pressure was up; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 12May2021 11:20 (lot number: EW0173) at the age of 73 years old as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 virus on Jan2021 (completed his isolation and recovery; came out of quarantine on 10Jan2021), ongoing atrial fibrillation (Diagnosed 20 years ago in 2001), ongoing parkinson's disease (Diagnosed 12 years ago in 2009). There were no concomitant medications. The patient had no history of previous vaccination with the Pfizer vaccine considered as suspect. No vaccines administered on the same date with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. No relevant tests reported. When the patient had the COVID-19 virus in Jan2021, the patient completed his isolation and recovery and then waited the suggested 90 days until he received his first dose of the Pfizer COVID-19 vaccine. After he received his first dose of the vaccine (symptoms began about 12 hours after the shot, at the same time on the evening of 12May2021), he had a "bad reaction" which included fever of 102 degrees Fahrenheit, nausea, tiredness and his blood pressure was up so he went to the hospital. The patient was admitted to the hospital for 3 days (from 14May2021 to 17May2021) and then released. He was scheduled to receive the second dose of the vaccine on 04Jun2021 (23rd day after the first dose) and he would like to know if it was advisable to proceed with the second dose or not. The patient wanted to know how effective was receiving only the first dose of the Pfizer COVID-19 vaccine if he chose to forgo his second dose. The patient stated that he listened to all these people on the news one day, they said to get it, then one day, they said don't get it. The patient mentioned that they said wait 60 days then they said 90 days, so he had to make a decision and then waited 90 days after he was clear of the virus. The events required a visit to the emergency room but not to the physician's office. The patient received unspecified treatments as a result of all the events. The patient recovered completely from all the symptoms reported on 16May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Fatigue, Headache
Clinical narrative: weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
Sex: M
Vaccine: COVID19
Symptoms: Increased appetite, Peripheral swelling
Clinical narrative: eating out a lot; Swelling in legs and feet; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A 74-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 05May2021 (at an unspecified age) at 1st dose, single dose for COVID-19 immunization. Medical history included diabetes, blood pressure high, kidney transplant patient, allergic reactions, hay fever, sinusitis, and beginning stage of leukoma. Concomitant medications included empagliflozin (JARDIANCE) for diabetes, and unspecified 18 to 27 medications. The patient previously took diphenhydramine HCl (BENADRYL) for allergic reactions. The patient received his first dose on 05May2021 and was scheduled to receive the second dose on 26May2021, however, he reported that he received his second dose a day earlier than he was scheduled. The patient got confused since he thought that today was Wednesday, 26May2021, so he panicked and received his second dose today, 25May2021. The patient walked in panic at the vaccination site because he thought that it was closed down. The patient did not realize that he was a day early until after the injection was already given. The patient reported that on 16May2021, he had swelling in legs and feet but thinks that it was from one of his medical conditions. The patient stated that the swelling in his feet has been going on for about a week and he does not think that it has anything to do with the vaccine, and that maybe he ate too much salt. The patient further clarified that he probably ate too much salt as he was eating out a lot, and the salt from that might have added to the swelling. The patient was thinking if he could get some diuretic medication for this. The patient did not receive treatment for the event swelling in legs and feet. The patient did not go to the doctor for the swelling in legs and feet. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The event peripheral swelling is considered not related to BNT162B2, but intercurrent medical condition.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Migraine, Nausea, Pain
Clinical narrative: rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; dizziness; nausea; migraine; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21May2021 10:00 (at the age of 46-year-old) (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Septra, Cipro, Erthamycin, Lexipro, protonix, strawberries and house dust. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) and multivitamin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0123) on 30Apr2021 at 10:00 AM (at the age of 46-year-old) for COVID-19 immunisation. On 21May2021, the patient experienced fever, chills, and body aches 8 hours after 2nd shot. On 23May2021 at 10:00 AM, the patient experienced rash formed under injection site with burning/itching, dizziness, nausea, and migraine began 48 hours after the injection. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which included Benadryl, Tylenol, and ice. The patient was recovering from all events.  Follow-up attempts are needed. Further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; dizziness; nausea; migraine; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21May2021 10:00 (at the age of 46-year-old) (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Septra, Cipro, Erthamycin, Lexipro, protonix, strawberries and house dust. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) and multivitamin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0123) on 30Apr2021 at 10:00 AM (at the age of 46-year-old) for COVID-19 immunisation. On 21May2021, the patient experienced fever, chills, and body aches 8 hours after 2nd shot. On 23May2021 at 10:00 AM, the patient experienced rash formed under injection site with burning/itching, dizziness, nausea, and migraine began 48 hours after the injection. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which included Benadryl, Tylenol, and ice. The patient was recovering from all events.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable nurse via the sponsored program. 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 on Jan2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer Covid vaccine in Jan2021, tested positive for Covid 19 on an unspecified date, and subsequently received convalescent therapy. It was mentioned that the patient received the first dose of the Covid-19 Vaccine in Jan2021 and shortly after tested positive for Covid and also had a antibody test done as well. It has been over 90 days since the first dose and they are wondering if the patient can get the second dose now. The reporting nurse clarified that she wanted to know if the patient can either get the second dose or if they need to restart the vaccine series. The patient was only 3 weeks past the 90 days and was really anxious to get the vaccine. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies; he received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies; This is a spontaneous report from a contactable pharmacist via a sponsored program. A male patient of an unspecified age (reported as older than 60) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies/antibody therapy. The patient was wanting to get the second dose. The pharmacist was calling for recommendations on what to do. The pharmacist did not know when he got his first dose, or when he tested positive for COVID. The outcome of the event was unknown.   Information on lot batch/lot number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on available clinical data, a causal relation between reported events and vaccination with BNT162B2 cannot be excluded. This case will be re-evaluated upon receipt of additional relevant information.  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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Bradycardia, Cardiac monitoring, Contusion
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Dizziness, Heart rate, Heart rate irregular, Hyperhidrosis
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoxia, Malaise, Nodal rhythm, Oxygen saturation
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Polymerase chain reaction, Presyncope, Vaccination site swelling, Ventricular extrasystoles
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Bradycardia, Dizziness, Echocardiogram abnormal, Electrocardiogram
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Feeling hot, Heart rate irregular, Hyperhidrosis, Hypoxia
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Mitral valve prolapse, Nodal rhythm, Presyncope
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Running a fever since the 2nd vaccine on 14May2021.  My entire body is itching all over.  I want to the doctor and emergency room.  Nothing helps including oral steroids,  Tylenol and Benadryl.; Running a fever since the 2nd vaccine on 14May2021.  My entire body is itching all over.  I want to the doctor and emergency room.  Nothing helps including oral steroids,  Tylenol and Benadryl.; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14May2021 12:15 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Asthma, hay fever, ulcers,  lactose intolerant. Concomitant medications included montelukast sodium (SINGULAIR); cisapride (MOBID); buspirone (BUSPIRONE); taken for unspecified indications, start and stop dates were not reported. The patient previously took aspirin for hypersensitivity, visceral for hypersensitivity, cafergot comp for hypersensitivity. Prior the vaccination the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 on 25Feb2021 at 10:30 AM in right arm for COVID-19 immunization. Running a fever since the 2nd vaccine on 14May2021. My entire body is itching all over.  I went to the doctor and emergency room. Nothing helps including oral steroids, Tylenol and Benadryl. The patient received treatment for the events: Benadryl, Tylenol, oral steroids, cortisone cream. The outcome of the events was not recovered.   Follow-up attempts needed. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Dry mouth, Fatigue
Clinical narrative: Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint pain; Muscle pain; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:30 at 35-years-old (Batch/Lot Number: ER8729) as 1st dose, single for COVID-19 immunization. There was no medical history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL). The patient had dry mouth, sore throat, chills, nausea, fatigue, cramped legs, sore arm, joint pain, muscle pain, extreme anxiety, chronic chest pain lasted for 5 days constantly and ER visit Dr. says it was due to the vaccine: heart inflammation. Happened to 50% of chest pain ER visitors due to vaccine 3-4 days after vaccine dose. And should only last 6 days. Heart inflammation should be added to info packet and more studies should be done asap. All events started on 22Apr2021 03:30. No treatment given. Outcome of events was recovered in 2021.