chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Feeling hot, Headache, Pain in extremity
Clinical narrative: Both arms and legs were in a lot of pain/Still head and arm hurt; Felt like someone was constantly pulling hair; Throat was dry; Kept urinating all night; Stayed mostly in bed the night of the shot then for the next two days; First night have shivers; Hot; Cold; Chest pains that night; Still head and arm hurt; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262), Solution for injection, Dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 15:00 and dose 1 via an unspecified route of administration, administered in Arm Right on 18Jan2021 15:00 (Batch/Lot Number: EL8982) both as single dose (at the age of 84-year-old) for covid-19 immunisation. Medical history included (Long-term Previous) Neuropathy, Epstein-Bar Virus. Concomitant medications included meloxicam (MELOXICAM) and amlodipine (AMLODIPINE). The patient previously took statin [atorvastatin calcium] and experienced statin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 08Feb2021 20:00, the patient experienced both arms and legs were in a lot of pain/still head and arm hurt, felt like someone was constantly pulling hair, throat was dry, kept urinating all night, stayed mostly in bed the night of the shot then for the next two days, first night have shivers, hot, cold, chest pains that night, still head and arm hurt. It was reported that, Monday night after shot Both arms and legs were in a lot of pain, felt like someone was constantly pulling hair, throat was dry, kept urinating all night. Stayed mostly in bed the night of the shot then for the next two days. First night have shivers, hot and cold (and had to take an acetaminophen to help relieve). Felt well by Wednesday afternoon, then chest pains that night. Still head and arm hurt on Thursday. Friday feeling better.Therapeutic measures were taken as a result of first night have shivers, hot and cold. No treatment was received for other events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain of skin
Clinical narrative: Chill; Fever (100F); skin pain; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 11Feb2021 14:30 as dose 2, single (at the age of 36-years-old) for covid-19 immunization. Medical history reported as none. Concomitant medication included colecalciferol (VITAMIN D). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 22Jan2021 15:30 as dose 1, single (at the age of 36-years-old) for covid-19 immunization. On 12Feb2021 05:00, the patient experienced chill, fever (100F), skin pain, headache and fatigue. Therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination and post vaccination the patient did not tested for covid. Patient did not have known allergies. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chill; Fever (100F); skin pain; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 11Feb2021 14:30 as dose 2, single (at the age of 36-years-old) for covid-19 immunization. Medical history reported as none. Concomitant medication included colecalciferol (VITAMIN D). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 22Jan2021 15:30 as dose 1, single (at the age of 36-years-old) for covid-19 immunization. On 12Feb2021 05:00, the patient experienced chill, fever (100F), skin pain, headache and fatigue. Therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination and post vaccination the patient did not tested for covid. Patient did not have known allergies. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Electrocardiogram, Heart rate irregular
Clinical narrative: retinal occlusions due to high blood pressure; Sore and achy left arm at injection site; Fever; Chills; Irregular heart rhythm; High Blood Pressure; Dizziness; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in left arm on 01Feb2021 at (14:30- 15:00) (at the age of 75-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included high blood pressure (HBP 10 years ago and was under control with medications), SVT's (diagnosed 17 years ago), and COPD (diagnosed 6 years ago). The patient's concomitant medication(s) included diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDRO-CHLORIDE]) taken for supraventricular tachycardia started taking10 years ago, atorvastatin for blood pressure high started taking 10 years ago, and ezetimibe (ZETIA). Family history of heart problems. On 01Feb2021 at 14:30, the patient experienced dizziness and blurred vision. On 01Feb2021 at 14:50, they called EMS and took blood pressure 20 minutes later, and the patient experienced high blood pressure, at 15:10 irregular heart rhythm and at 21:00, the patient had fever and chills. It was suggested that she go to the Emergency room after they did the blood pressure and EKG. On 02Feb2021 at 09:00, the patient reported sore and achy left arm at injection site, and on 11Feb2021, she found out about retinal occlusion due to high blood pressure at her eye check-up and she will see a specialist on Monday. Her eye doctor said it was due to high blood pressure. It caused the blood vessels to bursts in her left eyeball. The patient under-went lab tests and procedures which included blood pressure: 171/107 on 01Feb2021 at 14:50, EKG: right bundle block on 01Feb2021 (She showed it to cardiologist and he said this might be regular for you, but it is irregular). The patient consulted cardiologist and he said this might be regular for you, but it was irregular and patient has a right bundle block and nothing that needs to be done about it and it was present prior to vaccine. No ER or physician's office required. The outcome of event dizziness, blurred vision, fever, chills and ore and achy left arm at injection site as recovering and irregular heart rhythm, hypertension, and retinal occlusions due to high blood pressure as not recovered.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia, Retinal disorder, Vaccination site pain, Vision blurred
Clinical narrative: retinal occlusions due to high blood pressure; Sore and achy left arm at injection site; Fever; Chills; Irregular heart rhythm; High Blood Pressure; Dizziness; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in left arm on 01Feb2021 at (14:30- 15:00) (at the age of 75-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included high blood pressure (HBP 10 years ago and was under control with medications), SVT's (diagnosed 17 years ago), and COPD (diagnosed 6 years ago). The patient's concomitant medication(s) included diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDRO-CHLORIDE]) taken for supraventricular tachycardia started taking10 years ago, atorvastatin for blood pressure high started taking 10 years ago, and ezetimibe (ZETIA). Family history of heart problems. On 01Feb2021 at 14:30, the patient experienced dizziness and blurred vision. On 01Feb2021 at 14:50, they called EMS and took blood pressure 20 minutes later, and the patient experienced high blood pressure, at 15:10 irregular heart rhythm and at 21:00, the patient had fever and chills. It was suggested that she go to the Emergency room after they did the blood pressure and EKG. On 02Feb2021 at 09:00, the patient reported sore and achy left arm at injection site, and on 11Feb2021, she found out about retinal occlusion due to high blood pressure at her eye check-up and she will see a specialist on Monday. Her eye doctor said it was due to high blood pressure. It caused the blood vessels to bursts in her left eyeball. The patient under-went lab tests and procedures which included blood pressure: 171/107 on 01Feb2021 at 14:50, EKG: right bundle block on 01Feb2021 (She showed it to cardiologist and he said this might be regular for you, but it is irregular). The patient consulted cardiologist and he said this might be regular for you, but it was irregular and patient has a right bundle block and nothing that needs to be done about it and it was present prior to vaccine. No ER or physician's office required. The outcome of event dizziness, blurred vision, fever, chills and ore and achy left arm at injection site as recovering and irregular heart rhythm, hypertension, and retinal occlusions due to high blood pressure as not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Product dose omission issue
Clinical narrative: She didn't get her 2nd dose; Migraine; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) a female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced she didn't get her 2nd dose, migraine. Caller lives in an assisted living center and she got her 1st dose 3 weeks ago. Last week she went to her HCP and they put her on quarantine and yesterday came back to give 2nd doses. She spoke to who then informed her they would not be back until next month and she didn't get her 2nd dose. She wanted to know if she would have to start all over again. She also stated she had a migraine. Declined PMI number and cold transferred to PSCC for AE due to wait times, since caller won't be getting her 2nd dose until next month now and she has a migraine.  CEP 2191. The outcome of both events was unknown.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: mild fever/ has low grade fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer (Patient himself). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL1283), via an unspecified route of administration on 27Jan2021 11:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature of 100.8-degree F. Patient stated that he had first dose of Pfizer COVID-19 Vaccine two weeks ago from yesterday on 27Jan2021. He was scheduled to get second dose next Wednesday. Last night on 11Feb2021 he developed very mild fever/ has low grade fever and no other symptoms besides that. Fever peaked around 100.8-degree F. Took Tylenol and his fever broke overnight. The outcome of event was recovered on an unspecified date in 2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: The following day she developed red splotches on her face that have not resolved.; This is a spontaneous report from a contactable consumer This 79-year-old female consumer (patient) reported that: A 79-year-old female patient received first dos of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 06Feb2021 at 08:54 (at the age of 79-year-old) as single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. History of all previous immunizations with the Pfizer vaccine considered as suspect reported as none. No additional vaccines administered on the same date as the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. Patient stated she had her first Pfizer Covid vaccine on 06Feb2021, and the next day on 07Feb2021 she developed red splotches on her face that have not resolved. She wants to know if this was a reported side effect of the vaccine. Commented she had to look up the phone number for the doctor's office because she does not trust her memory. Patient did not have full HCP contact details to provide. The red splotches she believes she saw it that Sunday Morning, but it was not as prominent. As the day went on it became more prominent. Her husband did not remember seeing it that day. Her daughter had called her on video call, and she saw it. The patient then mentioned she ran her hands over her face, and she could feel it when she ran her hands over her face. She could see it in the mirror. Patient not visited to Emergency Room or Physician's Office for the event. The outcome of the event was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever; chills; headache; muscle pain; vomiting; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 46-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 11Feb2021 at 13:15 (01:15 PM) (at the age of 46-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient has not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 21Jan2021 at 01:15 PM (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. On 12Feb2021 at 02:30 AM, the patient experienced fever, chills, headache, muscle pain, vomiting. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 11May2021): Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Body Aches/Soreness; Feverish; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 09Feb2021 18:45 (age at vaccination 45years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing other medical history: anxiety/MDD (past), major depression from an unknown date and unknown if ongoing other medical history, food allergy from an unknown date and unknown if ongoing known allergies: valium, high intolerance to shellfish, covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously took valium and experienced drug hypersensitivity. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Feb2021 18:45 the patient experienced fatigue, body aches/soreness, feverish. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Cough, Diarrhoea, Ear pain
Clinical narrative: she had a temperature of 103.8; splitting headache; muscle ache; cough; diarrhea; her throat, ears, and nose hurt; her throat, ears, and nose hurt; her throat, ears, and nose hurt; tested for Covid, but it came back negative; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a temperature of 103.8, splitting headache, muscle ache, cough, diarrhoea, her throat, ears, and nose hurt leading to oropharyngeal pain and tested for covid, but it came back negative, sars-cov-2 test negative on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature 103.8 and sars-cov-2 test: negative.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal discomfort, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: she had a temperature of 103.8; splitting headache; muscle ache; cough; diarrhea; her throat, ears, and nose hurt; her throat, ears, and nose hurt; her throat, ears, and nose hurt; tested for Covid, but it came back negative; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a temperature of 103.8, splitting headache, muscle ache, cough, diarrhoea, her throat, ears, and nose hurt leading to oropharyngeal pain and tested for covid, but it came back negative, sars-cov-2 test negative on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature 103.8 and sars-cov-2 test: negative.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: she had a temperature of 103.8; splitting headache; muscle ache; cough; diarrhea; her throat, ears, and nose hurt; her throat, ears, and nose hurt; her throat, ears, and nose hurt; tested for Covid, but it came back negative; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a temperature of 103.8, splitting headache, muscle ache, cough, diarrhoea, her throat, ears, and nose hurt leading to oropharyngeal pain and tested for covid, but it came back negative, sars-cov-2 test negative on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature 103.8 and sars-cov-2 test: negative.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Extreme fatigue; cough; sore throat; headache; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jan2021 10:00 (Batch/Lot Number: 1284) as DOSE 2, SINGLE (at the age of 50-years-old) for covid-19 immunization. The patient medical history was not reported. The patient has flagly (metronidazole) allergy. Concomitant medications included Olmesartan, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks of covid vaccine. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Dec2020 10:00 (Batch/Lot Number: eh9899) for covid-19 immunization. On 15Jan2021, the patient experienced extreme fatigue, cough, sore throat and headache. The patient did not receive treatment for the reported events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: By 6:30 pm the same rash was on both outer sides of my legs again splotchy raised and itchy; Bumpy itchy rash on my knees at noontime on Friday the 12th; This is a spontaneous report from a contactable other hcp (patient herself). A 42-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) via an unspecified route of administration, administered in arm left on 10Feb2021 09:45 (age at the vaccination 42-year-old) as dose number unknown, single for COVID-19 immunization (Doctor's office/urgent care). Medical history included systemic lupus, celiac disease from an unknown date and unknown if ongoing and known allergies all sulphate drugs and penicillin an unknown date and unknown if ongoing. Concomitant medications included atomoxetine hydrochloride (STRATTERA), citalopram hydrobromide (CELEXA [CITALOPRAM HYDROBROMIDE]) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. On 12Feb2021 12:00, the patient had experienced bumpy itchy rash on my knees at noon time on Friday the 12th, by 6:30 pm the same rash was on both outer sides of my legs again splotchy raised and itchy. The patient did not receive treatment for the adverse events. The patient had not received any other vaccine within four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since post vaccination. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Ligament sprain
Clinical narrative: he experienced sprain after his first dose; This is a spontaneous report received from a contactable consumer (patient himself) via Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sprain after his first dose on an unspecified date. Patient asked if he could take Tylenol since he experienced sprain after his first dose. Outcome of event was unknown.  Information on about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: as if his tongue and lips had "this 4 hour taste of something, close to bicarb soda harshness"; Had a slight headache (2 frontal sides); This is a spontaneous report received via COVAES. A contactable consumer (patient) reported a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 12Feb2021 16:00 (at the age of 67 years old) as dose 1, single for COVID-19 immunisation. The patient was diabetic and had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 12Feb2021, the patient had a slight headache (2 frontal sides). There were no swelling and rashes. On 12Feb2021 16:35, about 35 minutes after the injection, the patient reported as if his tongue and lips had "this 4 hour taste of something, close to bicarb soda harshness". The patient did not receive any treatment. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection sites; This is a spontaneous report from a contactable other hcp. A 55-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL3248, dose 1 intramuscular, administered in Arm Left on 09Jan2021 09:00 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to Pine Nuts, Sunflower seeds from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), fish oil (OMEGA 3 [FISH OIL]), zinc (ZINC), (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date of on Jan2021 patient experienced with the 1st and 2nd vaccine there was pain at the injection sites. The patient received treatment with Advil. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: fatigue/Just extremely tired; I feel horrible; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Feb2021 as single dose for covid-19 immunisation. On an unspecified date, the patient previously received first dose of bnt162b2 via unknown route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. On unknown date, the patient feels horrible, fatigue, her appetite was okay. Just extremely tired and the patient wants to know if this was okay. The outcome of the events was unknown.  Information on about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in the ankle joint; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3246 and expiry date was not reported), via an unspecified route of administration, on 13Jan2021 at 12:45 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had known allergies. It was unknown if patient had vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. It was unknown if the patient was tested for COVID post vaccination. The patient reported that he had pain in the ankle joint 1 week after taking dose 1 on an unspecified date in Jan2021. He had to go to the ER. The patient was wondering if this was a reaction to the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a Pfizer-sponsored. A contactable pharmacist reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient who got her 1st dose of the Covid vaccine and to get her 2nd dose today. With her 1st dose, she developed a huge rash, and they want to know if she should get the 2nd dose. Provided PMI number and cold transferred for AE due to wait times, since caller developed a rash after the 1st dose. Fax for AE. CEP 2191. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable physician (Patient). A 28-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 18:06 (Age at vaccination: 28-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included Anxiety, Birth control both from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN) taken for contraception from Jan2015 to an unspecified stop date, sertraline (SERTRALINE) taken for anxiety from 01Oct2020 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:53 (Age at vaccination: 28-years-old) single dose for covid-19 immunization. It was reported that patient experienced sore arm after administration of second dose. The outcome for the events was reported as unknown at the time of this report.   Information on the lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I did received 2nd vaccination - No change in pain; This is a spontaneous report from a contactable Nurse (reported herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELQ14Q), intramuscular, administered in deltoid right on 21Jan2021 14:00 (age at vaccination was 36-year-old) as dose 2, single for covid-19 immunisation in hospital. The vaccine was not administered at military facility. Medical history included covid-19 (Pertinent Details: Very minor symptoms well resolved prior to vaccine) from 12Oct2020 to 22Dec2020. The patient's concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ELQ14Q), intramuscular, administered in arm right on 30Dec2020 14:00 (age at vaccination was 36-year-old) as dose 1, single for covid-19 immunisation and experienced severe back pain. The patient stated that "i did received 2nd vaccination - no change in pain" on an unspecified date. The outcome of the event was not resolved. The reporter consider the Pfizer product had a causal effect to the adverse event.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspepsia, Headache, Myalgia
Clinical narrative: Headache; sore right arm; little fever; nausea; heartburn; chills; muscle aches; mild dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown, at the age of 62 years), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 14:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 (The day he received the dose he was cleared 28 days on 10Feb2021 form previously having Covid 19). The concomitant medications were not reported. The patient experienced headache, sore right arm, little fever, nausea, heartburn, chills, muscle aches, and mild dizziness on 11Feb2021 02:00. He took Benadryl and Advil 25 hours after receiving the first dose. Since he took meds for headache and symptoms, will this effect the efficacy of the vaccine? He wished he had been told about not taking NSAIDs or medication after the vaccination, he would have pushed through the discomfort. He was now asking since he took this medication is the vaccine that he got is still effective or if he messed up and needs to get another vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache; sore right arm; little fever; nausea; heartburn; chills; muscle aches; mild dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown, at the age of 62 years), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 14:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 (The day he received the dose he was cleared 28 days on 10Feb2021 form previously having Covid 19). The concomitant medications were not reported. The patient experienced headache, sore right arm, little fever, nausea, heartburn, chills, muscle aches, and mild dizziness on 11Feb2021 02:00. He took Benadryl and Advil 25 hours after receiving the first dose. Since he took meds for headache and symptoms, will this effect the efficacy of the vaccine? He wished he had been told about not taking NSAIDs or medication after the vaccination, he would have pushed through the discomfort. He was now asking since he took this medication is the vaccine that he got is still effective or if he messed up and needs to get another vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rhinorrhoea
Clinical narrative: runny nose; Chills; This is a spontaneous report from a contactable male consumer via Pfizer-sponsored program Pfizer First Connect. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 07Feb2021 (on Sunday) as dose 1, single for COVID-19 immunisation. Patients medical history and concomitant medications were not reported. On 09Feb2021, (this morning) patient experienced runny nose and chills. The outcome of the events was unknown.   Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: resulted in hematoma.; This is a Spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a Patient that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The pharmacist stated that they have an issue with the administration of the second dose. He said that their nurse hit the blood vessel of the patient and resulted in hematoma on an unspecified date. The pharmacist is asking if it may have an effect with the efficacy of the vaccine due to the blood coming from the injection sight. Asked if they can get another dose if it won't be able to work. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist (patient). A 28-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 12Feb2021 at 09:30 (at the age of 28-years-old) in left arm as a single dose for covid-19 immunization. The patient medical history was reported as none. There were no concomitant medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient had no known allergies. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient experienced fatigue, weakness and chills on 12Feb2021 at 20:00, low grade fever on 12Feb2021 at 21:00 and she woke up at 12 am to another low-grade fever, mild nausea on 13Feb2021. The patient was treated with Tylenol 500mg and ODT Zofran. The outcome of all the events was resolving.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature decreased, Fatigue, Pain
Clinical narrative: Low grade temp; body aches; fatigue; joint pain; This is a spontaneous report from a contactable consumer (reported for herself). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 13Feb2021 at 10:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunisation at Health Clinic. The patient medical history included hypersensitivity from an unknown date and unknown if ongoing and other medications was received. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Feb2021 at 16:00, the patient experienced low grade temp, body aches, fatigue and joint pain. The patient underwent lab tests and procedures which included body temperature: low grade temp on 13Feb2021. No treatment was given for the events. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oral disorder, Paraesthesia, SARS-CoV-2 antibody test, Swollen tongue
Clinical narrative: I have white patches in my mouth, inside my lips, cheeks, back of throat, and on my tongue.; My tongue has swollen and inflamed taste buds all over it; This is a burning/tingling sensation and is worse when eating.; This is a burning/tingling sensation and is worse when eating.; This is a spontaneous report from a contactable nurse. This 33-year-old non-pregnant female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 18Jan2021 on right arm (at 33-year-old), as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Feb2021 on right arm (at 33-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included allergies to gabapentin and methocarbamol. The other medical history included psoriasis, hidradenitis suppurativa and migraines. The patient did not receive any other vaccine in four weeks. Concomitant medications included vitamin c (Ascorbic acid) 1000mg, zinc 30 mg, curcuma longa (Turmeric) 450 mg, cranberry, calcium 600 mg, colecalciferol (Vit D3) 2000 iU, biotin 10000 mg, fish oil 2000 mg, ashwagandha 500 mg, macrogol 3350 (Miralax) 17 g, plantago ovata (Metamucil Citron); docusate sodium (Colace) 400 mg, omeprazole 20 mg, guaifenesin (Mucinex) (1200 mg), pseudoephedrine (120 mg), pregabalin 100 mg, topiramate (100 mg), trazodone (150 mg); hydroxyzine (50 mg), sertraline hydrochloride (Zoloft) 100 mg, celecoxib (Celebrex) 200 mg; adalimumab (Humira); erenumab aooe (Aimovig) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took gabapentin and experienced drug hypersensitivity, methocarbamol and experienced drug hypersensitivity. On 08Feb2021 patient used Abbott antigen test card and underwent nasal Swab test for covid post vaccination and tested negative. On 11Feb2021 the patient had white patches in her mouth, inside her lips, cheeks, back of throat, and on her tongue. The white patches were able to be sloughed off. She had no pain with the white patches or sore throat. Her tongue had swollen and had inflamed taste buds all over it. This was a burning/tingling sensation and was worse when eating. These symptoms occurred approximately 3 days after she received her second vaccine. The event resulted to visit to emergency room/department or urgent care. The patient received treatment with prednisone and valacyclovir. The patient had not recovered.  Information of lot/batch number had been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: he missed his second shot schedule last month; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he missed his second shot schedule last month on an unspecified date. The outcome of the event product dose omission issue was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling on a lymph node; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program Pfizer First Connect. A  female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 30Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling on a lymph node on an unspecified date on Friday night. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received unknown dose of bnt161b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Unknown), via an unspecified route in the left arm on 11Feb2021 at 11:15 (age at vaccination: 54-year-old), as a single dose for covid-19 immunization. Medical history included covid scare: racing heart rate, aches, fatigue, shortness of breath and known allergies with amoxycillin and cashews. Concomitant medications included ergocalciferol (VITAMIN D), progesterone, cannabidiol (CBD) oil and melatonin. It was unknown if patient had covid prior to the vaccination. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021, patient experienced shortness of breath and racing heart rate after 2 covid scares. After vaccine: productive cough and much clearer lungs, no backache that made her think kidneys were involved. Patient stated that maybe vaccine fought against what was already in her body? Great!!! Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Caller reports diarrhea 4 days after the 1st dose; This is a spontaneous report from contactable consumer(patient) via a Pfizer-sponsored program Pfizer First Connect.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller reports diarrhoea 4 days after the 1st dose on an unspecified date. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.