chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter mentioned that his "significant other" received the Pfizer-BioNTech COVID-19 Vaccine first dose but s/he is currently experiencing some side effects (loss of taste) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen Lympnodes left arm; aches; chills; fatigue; bruising soreness swollen at injection site; bruising soreness swollen at injection site; bruising soreness swollen at injection site; fever; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 07:45 (at the age of 53 year) as dose 2, single for COVID-19 immunisation at Workplace clinic. Medical history included High Blood Pressure, Hypothyroidism and High Cholesterol. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included amlodipine besilate (NORVASC); simvastatine (SIMVASTATINE); levothyroxine sodium (SYNTHROID); furosemide (FUROSEMIDE). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), dose 1 via an unspecified route of administration in Left arm on 19Jan2021 at 08:00 AM for COVID-19 immunisation. On 10Feb2021 at 12:00 PM, patient experienced swollen lympnodes left arm, aches, chills, fatigue, bruising soreness swollen at injection site, fever all of the above lasted for 3 days, patient swollen lympnodes under left arm have just started to go down on Tuesday and patient have started being able to use my arm more with each day. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unknown date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen Lympnodes left arm; aches; chills; fatigue; bruising soreness swollen at injection site; bruising soreness swollen at injection site; bruising soreness swollen at injection site; fever; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 07:45 (at the age of 53 year) as dose 2, single for COVID-19 immunisation at Workplace clinic. Medical history included High Blood Pressure, Hypothyroidism and High Cholesterol. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included amlodipine besilate (NORVASC); simvastatine (SIMVASTATINE); levothyroxine sodium (SYNTHROID); furosemide (FUROSEMIDE). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), dose 1 via an unspecified route of administration in Left arm on 19Jan2021 at 08:00 AM for COVID-19 immunisation. On 10Feb2021 at 12:00 PM, patient experienced swollen lympnodes left arm, aches, chills, fatigue, bruising soreness swollen at injection site, fever all of the above lasted for 3 days, patient swollen lympnodes under left arm have just started to go down on Tuesday and patient have started being able to use my arm more with each day. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unknown date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother) via Sponsored Program Support. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Mother wanted to know if it was okay for her not to have any side effects since everyone she knows including her daughter experienced arm pain. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pyrexia, Rash, Swelling
Clinical narrative: an allergic reaction; rashes; fever; swelling; This is a spontaneous report from a non-contactable consumer via Medical Information team. A male patient (reporter's brother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter stated that her brother had symptoms of an allergic reaction after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. She said he had rashes, fever, and swelling on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Pain in extremity
Clinical narrative: sore arm; due to pain was unable to sleep; migraine for 24 hours; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and was fine after the first injection. On an unspecified date, the patient experienced migraine for 24 hours, sore arm and due to pain was unable to sleep. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Malaise, Nausea
Clinical narrative: injection site pain; Fatigue; nausea; Dizziness; fever; chills; shaky hands; general feeling of being unwell; This is a spontaneous report from a contactable other health care professional (reported for herself). A 33-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 08Feb2021 at 13:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunisation at Public Health Clinic/ Administration facility. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing and pneumonia from an unknown date and unknown if ongoing. Concomitant medication(s) included vyvanse (LISDEXAMFETAMINE MESILATE) taken for an unspecified indication, start and stop date were not reported, trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported and Daily multivitamin. 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. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL2348/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 at 15:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation and experienced vaccination site pain at Public Health Clinic/Veterans Administration facility. The patient experienced injection site pain on 08Feb2021, fatigue, nausea, dizziness, fever, chills, shaky hands and general feeling of being unwell on an unspecified date in Feb2021. Therapeutic measures were taken as a result of events fatigue, fever and chills included treatment with OTC acetaminophen. No treatment was given for the other 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: Pyrexia, Tremor, Vaccination site pain
Clinical narrative: injection site pain; Fatigue; nausea; Dizziness; fever; chills; shaky hands; general feeling of being unwell; This is a spontaneous report from a contactable other health care professional (reported for herself). A 33-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 08Feb2021 at 13:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunisation at Public Health Clinic/ Administration facility. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing and pneumonia from an unknown date and unknown if ongoing. Concomitant medication(s) included vyvanse (LISDEXAMFETAMINE MESILATE) taken for an unspecified indication, start and stop date were not reported, trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported and Daily multivitamin. 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. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL2348/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 at 15:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation and experienced vaccination site pain at Public Health Clinic/Veterans Administration facility. The patient experienced injection site pain on 08Feb2021, fatigue, nausea, dizziness, fever, chills, shaky hands and general feeling of being unwell on an unspecified date in Feb2021. Therapeutic measures were taken as a result of events fatigue, fever and chills included treatment with OTC acetaminophen. No treatment was given for the other events. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Body temperature increased, Chills
Clinical narrative: Difficulty with ADLs; Temps: ranging from 99.2-101.8; Lymph nodes swollen; Achy joints and muscles; Achy joints and muscles; Exhaustion; Abdominal Pain; Headache; Chills; blurred vision; This is a spontaneous report from a contactable nurse (Patient).   A 60-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. Medical history included HTN (Hypertension). The patient had sulfa allergies. Concomitant medications included coreg (CARVEDILOL), advil (IBUPROFEN), tylenol (PARACETAMOL) and ASA. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was E189982) via intramuscular route of administration in left arm on 19Jan2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Feb2021, at 21:30, the patient experienced Temps: ranging from 99.2-101.8, Lymph nodes swollen, Achy joints and muscles, Exhaustion, Abdominal Pain, Headache, chills, blurred vision and Difficulty with ADLs. The patient did not receive any treatment for adverse events. Patient underwent lab test and procedure which included Body temperature ranging from 99.2-101.8 on 09Feb2021. Outcome of all the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up (12May2021): Follow-up attempts completed. No further information expected
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Lymphadenopathy, Myalgia
Clinical narrative: Difficulty with ADLs; Temps: ranging from 99.2-101.8; Lymph nodes swollen; Achy joints and muscles; Achy joints and muscles; Exhaustion; Abdominal Pain; Headache; Chills; blurred vision; This is a spontaneous report from a contactable nurse (Patient).   A 60-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. Medical history included HTN (Hypertension). The patient had sulfa allergies. Concomitant medications included coreg (CARVEDILOL), advil (IBUPROFEN), tylenol (PARACETAMOL) and ASA. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was E189982) via intramuscular route of administration in left arm on 19Jan2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Feb2021, at 21:30, the patient experienced Temps: ranging from 99.2-101.8, Lymph nodes swollen, Achy joints and muscles, Exhaustion, Abdominal Pain, Headache, chills, blurred vision and Difficulty with ADLs. The patient did not receive any treatment for adverse events. Patient underwent lab test and procedure which included Body temperature ranging from 99.2-101.8 on 09Feb2021. Outcome of all the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up (12May2021): Follow-up attempts completed. No further information expected
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Difficulty with ADLs; Temps: ranging from 99.2-101.8; Lymph nodes swollen; Achy joints and muscles; Achy joints and muscles; Exhaustion; Abdominal Pain; Headache; Chills; blurred vision; This is a spontaneous report from a contactable nurse (Patient).   A 60-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. Medical history included HTN (Hypertension). The patient had sulfa allergies. Concomitant medications included coreg (CARVEDILOL), advil (IBUPROFEN), tylenol (PARACETAMOL) and ASA. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was E189982) via intramuscular route of administration in left arm on 19Jan2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Feb2021, at 21:30, the patient experienced Temps: ranging from 99.2-101.8, Lymph nodes swollen, Achy joints and muscles, Exhaustion, Abdominal Pain, Headache, chills, blurred vision and Difficulty with ADLs. The patient did not receive any treatment for adverse events. Patient underwent lab test and procedure which included Body temperature ranging from 99.2-101.8 on 09Feb2021. Outcome of all the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up (12May2021): Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: having been taking an antibiotic for a week now because of her UTI; This is a spontaneous report from a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient experienced having been taking an antibiotic for a week now because of her uti (urinary tract infection) (non-serious) on an unspecified date. Caller was asking about her mom that is scheduled today for her 2nd dose, having been taking an antibiotic for a week now because of her UTI. Therapeutic measures were taken as a result of event includes antibiotic. The outcome for event was unknown.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has missed the window for the second dose of covid-19 vaccine due to being sick. Caller is asking when it would be safe for the patient to get it. Outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain at injection site; This is a spontaneous report received from a contactable pharmacist. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), Solution for injection, intramuscular, administered in Arm Right on 21Dec2020 (at the age of 43-year-old) as single dose for covid-19 immunisation. The patient medical history including any illness at time of vaccination was reported as none. Concomitant medications included ergocalciferol (VIT D [ERGOCALCIFEROL]) at 1000 units PO (oral) daily taken for supplementation therapy, docusate sodium (COLACE) at 100 mg PO (oral) daily taken as stool softener, loratadine (CLARITIN [LORATADINE]) at 10 mg PO (oral) daily PRN (as needed) taken for seasonal allergy, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) at 50 mcg/ spray + spray daily PRN (as needed) each nostril taken for seasonal allergy. On 21Dec2021, the patient experienced arm pain at injection site. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231), Solution for injection, intramuscular, administered in Arm Right on 11Jan2021 at 13:00 as 0.3 ml, single dose for covid-19 immunisation. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: left sided facial numbness in cheek, lip and tongue; left sided facial numbness in cheek, lip and tongue; This is a spontaneous report from a contactable other health care professional (Patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date not reported) via intramuscular route of administration in left arm on 17Feb2021 at 10:00 (at the age of 45-year-old) as single dose for COVID-19 immunization at School or Student Health Clinic. The patient medical history was reported as none. The concomitant medications were not reported. The patient previously took erythromycin and experienced allergies on an unspecified date. The patient has not received any other vaccine in four weeks. No other medications in two weeks were reported. No COVID prior vaccination was reported. The patient has not been tested for COVID, post vaccination. On 17Feb2021 at 10:45, the patient experienced left sided facial numbness in cheek, lip and tongue; started 45 minutes after vaccine. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The clinical outcome of both events was not resolved.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Lymphadenopathy, Migraine, Pain of skin
Clinical narrative: fever of 103 for 2.5 days; migraine; worst bone pain I have ever had; My skin hurt to go though; lymph nodes in armpit are still very swollen; This is a spontaneous report from a non-contactable other hcp (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in right arm on 28Jan2021 at 14:30 (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included Hashimoto's, covid prior vaccination. Patient had known allergies to antihistamine and narcotics. The concomitant medications were not reported. The patient previously received first dose of (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration, administered in left arm on 05Jan2021 at 12:30 for covid-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No covid tested post vaccination. On 28Jan2021 at 19:00, the patient experienced fever of 103 for 2.5 days and reported a migraine (never had one before), and the worst bone pain she ever had. The patient reported my skin hurt to go though, and 2 weeks later lymph nodes in armpit were still very swollen. The patient underwent lab tests included fever 103 on 28Jan2021 (for 2.5 days). Patient did not receive any treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 103 for 2.5 days; migraine; worst bone pain I have ever had; My skin hurt to go though; lymph nodes in armpit are still very swollen; This is a spontaneous report from a non-contactable other hcp (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in right arm on 28Jan2021 at 14:30 (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included Hashimoto's, covid prior vaccination. Patient had known allergies to antihistamine and narcotics. The concomitant medications were not reported. The patient previously received first dose of (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration, administered in left arm on 05Jan2021 at 12:30 for covid-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No covid tested post vaccination. On 28Jan2021 at 19:00, the patient experienced fever of 103 for 2.5 days and reported a migraine (never had one before), and the worst bone pain she ever had. The patient reported my skin hurt to go though, and 2 weeks later lymph nodes in armpit were still very swollen. The patient underwent lab tests included fever 103 on 28Jan2021 (for 2.5 days). Patient did not receive any treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: With second covid vaccination, temperature rose to 100.2; This is a spontaneous report from a contactable physician. A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 04Feb2021 12:05 (at the age of 74-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3248, expiration date: Exp Apr2021) via intramuscular route of administration, administered in arm right on 14Jan2021 12:05 (at the age of 74-year-old) at dose 1, single for covid-19 immunisation for which patient experienced temp increase 102.0 on 14Jan2021 17:00. Causal relationship: Yes. On an unspecified date the patient experienced with second covid vaccination, temperature rose to 100.2. On an unspecified date the patient underwent lab tests and procedures which included body temperature: 100.2 Temperature rose to 100.2. Patient did not require treatment. Adverse event did not require a visit to emergency room, physician office. Outcome of the event was resolved on an unspecified date.  Information regarding lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Gastrointestinal pain, Malaise
Clinical narrative: Diarrhea (gone to bathroom roughly 8 times today. Intense cramping along with it); Diarrhea (gone to bathroom roughly 8 times today. Intense cramping along with it); light headed; overall feeling unwell; This is a spontaneous report from a contactable other health care professional (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201, patient was 31-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 07:30 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. Concomitant medication(s) included amlodipine (AMLODIPINE); methylphenidate (METHYLPHENIDATE); omeprazole (OMEPRAZOLE) all taken within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3246, patient was 31-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No Covid prior vaccination, not tested covid post vaccination. No Known allergies reported. On 17Feb2021, the patient experienced diarrhea (gone to bathroom roughly 8 times today. intense cramping along with it), lightheaded, overall feeling unwell. No treatments were received for events. The outcomes of events were not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Hip flexor pain; This is a spontaneous report from a contactable physician. This Physician reported similar events for three patients. This report is for 2nd of three patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility of the most recent COVID-19 vaccine was administered was reported Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The reporter was EM physician and mentioned that, approximately 5 days after vaccination reporter got hip flexor pain. The reporter stated that, the reporter knew 2 others with similar experience and reporter advised them to contact Pfizer also. The reporter stated that keep up the good work! Thanked Pfizer for all that you did. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip flexor pain; This is a spontaneous report from a contactable physician. This physician reported similar events for three patients. This report is for 3rd of three patients. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, approximately 5 days after vaccine, the patient started to get hip flexor pain on an unspecified date. Stated that, the reporter was an EM physician and the reporter know 2 others with similar experiences and advised them to contact Pfizer also. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: the arm on the intake side felt heavy and dull pain; the arm on the intake side felt heavy and dull pain; swelling in my arms; This is a spontaneous report from a contactable physician (patient), mail trail received in response to the query sent regarding the translation of language. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The 1st dose of COVID-19 vaccine (COMIRNATY) was inoculated at noon on 10Feb2021, immediately felt swelling in arms and after 4 hours later, the patient felt mild heavy sensation and dull pain in the vaccinated arm. Now, the patient had recovered and had no problem. A doctor who was personal in "PRIVACY" went to the United States to study abroad at "PRIVACY" the other day. At the university, the patient received the community as a preliminary intake for medical staff. The patient received a comment in a chat online with the intention of giving an impression after ingestion. The patient was reconfirmed the date of occurrence of the event with the reporter's doctor. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Night sweats
Clinical narrative: radiating myalgia; right arm muscle soreness; pain; minor headache; fatigue; chills; night sweats; mild fever; This is a spontaneous report received from a contactable consumer or other non hcp.A 31-years-old female patient received 2nd dose of bnt162b2 (Pfizer-covid19 vaccine,Batch/Lot Number: EL3247; Expiration Date: May2021),via an unspecified route of administration, administered in Arm Left on 17Feb2021 21:15,at the age of 31 years old, as Dose 2,single for covid-19 immunization.The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.The patient experienced radiating myalgia, right arm muscle soreness, pain, minor headache , fatigue, chills, night sweats, mild fever on 18Feb2021 12:00 with outcome of recovering.The patient underwent lab tests and procedures which included pyrexia: 99.5 degrees on 18Feb2021.The patient previously received her 1st dose of Pfizer covid19 vaccine on 26 jan2021,02:00 am.The patient had not been diagnosed with covid19 vaccine prior to vaccination and not tested for covid19 post vaccination.The patient had not received any treatment for the event.The outcome of the event was recovering.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: radiating myalgia; right arm muscle soreness; pain; minor headache; fatigue; chills; night sweats; mild fever; This is a spontaneous report received from a contactable consumer or other non hcp.A 31-years-old female patient received 2nd dose of bnt162b2 (Pfizer-covid19 vaccine,Batch/Lot Number: EL3247; Expiration Date: May2021),via an unspecified route of administration, administered in Arm Left on 17Feb2021 21:15,at the age of 31 years old, as Dose 2,single for covid-19 immunization.The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.The patient experienced radiating myalgia, right arm muscle soreness, pain, minor headache , fatigue, chills, night sweats, mild fever on 18Feb2021 12:00 with outcome of recovering.The patient underwent lab tests and procedures which included pyrexia: 99.5 degrees on 18Feb2021.The patient previously received her 1st dose of Pfizer covid19 vaccine on 26 jan2021,02:00 am.The patient had not been diagnosed with covid19 vaccine prior to vaccination and not tested for covid19 post vaccination.The patient had not received any treatment for the event.The outcome of the event was recovering.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Feeling abnormal, Headache
Clinical narrative: Body aches and pains; tightness of chest; a slight mental fog; headache; slight fever; chills; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 17Feb2021 at 13:15 (at the age of 24-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications in two weeks included ethinylestradiol, levonorgestrel (LEVONORGESTREL AND ETHINYL ESTRADIOL), taken for birth control. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 27Jan2021 at 13:15 (at the age of 24-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No COVID prior vaccination and no COVID tested post vaccination. On 17Feb2021 at 21:00, around 8 hours after injection, the patient experienced body aches and pains developed along with chills, tightness of chest, a slight mental fog, headache and a slight fever. The reporter considered the events as non-serious. Treatment was not received for the events. On 17Feb2021, the patient underwent lab tests and procedures which included slight fever (body temperature), resulted as unknown results. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches and pains; tightness of chest; a slight mental fog; headache; slight fever; chills; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 17Feb2021 at 13:15 (at the age of 24-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications in two weeks included ethinylestradiol, levonorgestrel (LEVONORGESTREL AND ETHINYL ESTRADIOL), taken for birth control. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 27Jan2021 at 13:15 (at the age of 24-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No COVID prior vaccination and no COVID tested post vaccination. On 17Feb2021 at 21:00, around 8 hours after injection, the patient experienced body aches and pains developed along with chills, tightness of chest, a slight mental fog, headache and a slight fever. The reporter considered the events as non-serious. Treatment was not received for the events. On 17Feb2021, the patient underwent lab tests and procedures which included slight fever (body temperature), resulted as unknown results. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: got colds after the first dose; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age 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 dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced colds after the first dose on an unspecified date. The patient took Tylenol and Acalka Ferrer for his colds. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Very slight chills lasting 2 hours evening after first dose.; Slightly sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 28Jan2021 at 01:00 pm (71-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure), high cholesterol, hypothyroid from an unknown date and unknown if ongoing. The patient have allergies to bees and sulfa. Concomitant medications included Levothyroxine (LEVOTHYROXINE SODIUM), Sanctura (TROSPIUM CHLORIDE), Pravastatin (PRAVASTATIN), Buspar (BUSPIRONE HYDROCHLORIDE), Ateno (ATENOLOL); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took tramadol (TRAMADOL), celebrex (CELEBREX) and theophylline (THEOPHYLLINE) and experienced allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 28Jan2021, at 08:00 pm, the patient experienced very slight chills in the evening after first dose and slightly sore arm at. No treatment was received for the events. The outcome of the events were recovered.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes face, back, and chest.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 11Feb2021 at 12:00 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Feb2021 at 12:00 PM the patient experienced rashes face, back, and chest. The clinical outcome of the event was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little soreness in our arms.; This is a spontaneous report from a contactable Consumer, the patient. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little soreness in our arms on an unspecified date. Caller stated that she and husband had Pfizer vaccine two weeks ago. Stated that their arm was a little sore at first with no other symptoms. Wanted to know if one can get side effects after two weeks. Clarified that it was the right arm. Clarified that it is for Pfizer Covid vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Insomnia, Pain in extremity
Clinical narrative: Started having chills at night; could not sleep; Then had a high fever; Back ache; pain in the arm; This is a spontaneous report from a contactable consumer.  A 36-year old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 17Feb2021 (age at the time of vaccination was 36-year-old) at 8:00, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot number was EL9264) via unspecified route in left arm on 27Jan2021 (age at the time of vaccination was 36-year-old) at 17:00 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 17Feb2021, at 22:00, the patient experienced, Started having chills at night and could not sleep, Then had a high fever, back ache and pain in the arm by vaccine site. Outcome of all the events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started having chills at night; could not sleep; Then had a high fever; Back ache; pain in the arm; This is a spontaneous report from a contactable consumer.  A 36-year old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 17Feb2021 (age at the time of vaccination was 36-year-old) at 8:00, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot number was EL9264) via unspecified route in left arm on 27Jan2021 (age at the time of vaccination was 36-year-old) at 17:00 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 17Feb2021, at 22:00, the patient experienced, Started having chills at night and could not sleep, Then had a high fever, back ache and pain in the arm by vaccine site. Outcome of all the events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program COVAX Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced headache. Verbatim and Event Description: Patient received the first dose of Covid-19 vaccine today, 5-6 hours ago and she is experiencing headache. Asking if she can take Tylenol for the headache. Outcome of the event was unknown.  Follow-Up (PRD/SRD 02Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever. The outcome of event was unknown.    Follow-up attempts completed. No further information expected.