chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Start of a headache noticeable at 1530 on date 02/11/21.  Headache did not go away until 02/13/21 with aid of headache medicine.; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 11Feb2021 at 14:30 (at the age of 31-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included asthma and seasonal allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks. No other medications in two weeks. The patient did not have COVID prior to vaccination. The patient previously took the first dose of BNT162B2 administered in the left arm on 21Jan2021 at 02:30 for COVID-19 immunisation. On 11Feb2021 at 15:30, the patient experienced start of a headache. Headache did not go away until 13Feb2021 with aid of headache medicine. Headache medicine was received for the treatment of event. The patient had not been tested for COVID post-vaccination. The outcome of the event was recovering/resolving.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Lung disorder, Vomiting, Wheezing
Clinical narrative: I heard gurgling in my lungs followed by wheezing almost like an asthma attach; I heard gurgling in my lungs followed by wheezing almost like an asthma attach; I heard gurgling in my lungs followed by wheezing almost like an asthma attach; Vomited heavy mucus; This is a spontaneous report from a contactable other healthcare professional (patient). A female non-pregnant patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3302), via an unspecified route of administration in arm left on 01Feb2021 at 15:30 as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. 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. It was reported that, the patient received her first vaccine on 01Feb2021. On 10Feb2021 at 12:00 AM, the patient vomited heavy mucus. The next morning on 11Feb2021, the patient heard gurgling in her lungs followed by wheezing almost like an asthma attach, that lasted for 1 day. On 12Feb2021, she was perfectly fine. Stated that, was it possible to get a reaction 10 days after the vaccine. Should she get the second vaccine. Treatment was not received for the events. The outcome of the events was recovered on 12Feb2021.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Feeling abnormal, Feeling drunk, Headache
Clinical narrative: Within 5 hours I felt as if I was in a fog.; I was driving home and felt as if I had been drinking alcohol (I didn't); Fever; Chills; Very bad headache; I still feel very sick today; I was very fatigued after the first dose but this is much worse; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 12Feb2021 at 13:00 (at the age of 48 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 22Jan2021 (at the age of 48 years old) for covid-19 immunization and patient experienced very fatigued after the first dose. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 12Feb2021 at 18:00, within 5 hours patient experienced felt as if she was in a fog. She was driving home and felt as if she had been drinking alcohol (she didn't). 12 hours after, she woke in the middle of night with fever, chills and a very bad headache. She still feels very sick today. She was very fatigued after the first dose but this was much worse. The patient did not received treatment due to the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Within 5 hours I felt as if I was in a fog.; I was driving home and felt as if I had been drinking alcohol (I didn't); Fever; Chills; Very bad headache; I still feel very sick today; I was very fatigued after the first dose but this is much worse; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 12Feb2021 at 13:00 (at the age of 48 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 22Jan2021 (at the age of 48 years old) for covid-19 immunization and patient experienced very fatigued after the first dose. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 12Feb2021 at 18:00, within 5 hours patient experienced felt as if she was in a fog. She was driving home and felt as if she had been drinking alcohol (she didn't). 12 hours after, she woke in the middle of night with fever, chills and a very bad headache. She still feels very sick today. She was very fatigued after the first dose but this was much worse. The patient did not received treatment due to the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Severe chills; Aches; This is a spontaneous report from a non-contactable consumer (patient).   A non-pregnant 25-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in arm right on 12Feb2021 10:30 (at the age of 25 years old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included prazosin, and sertraline. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262) administered on arm right on 23Jan2021 (at the age of 25 years old) as dose 1, single for COVID-19 immunisation. On 12Feb2021 23:30, the patient experienced severe chills and aches. The facility type vaccine was reported as hospital. The patient received no other vaccine in four weeks. No COVID prior vaccination and not COVID tested post vaccination. There was no treatment for adverse events. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: Episodic chills; muscle aches and pains; Fever; Pain; Inability to sleep; This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Feb2021 at 18:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma (mild) from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Feb2021 at 12:00 pm, the patient experienced episodic chills, muscle aches and pains, fever and inability to sleep. No treatment was received for the adverse events. The outcome of the events was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Excessive soreness of injection site; Chills; Sore joints and muscles all over body; Sore joints and muscles all over body; Fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 22-years-old female non pregnant patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 07:30 am (age at the vaccination 22-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Birth control pills. Patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. 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 experienced excessive soreness of injection site, chills, sore joints and muscles all over body, fever, and headache on 13Feb2021 19:00. The patient did not receive any other treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Excessive soreness of injection site; Chills; Sore joints and muscles all over body; Sore joints and muscles all over body; Fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 22-years-old female non pregnant patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 07:30 am (age at the vaccination 22-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Birth control pills. Patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. 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 experienced excessive soreness of injection site, chills, sore joints and muscles all over body, fever, and headache on 13Feb2021 19:00. The patient did not receive any other treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: light red rash on left arm/Also a bright red rash on ring finger on left hand/wrapped around the finger and in centre of finger with knuckle in middle; This is a spontaneous report from a contactable other HCP. This 55-year-old female other HCP (Patient) reported that: A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EH4176), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 15:45 (at the age of 55-year-old) as single dose for COVID-19 immunisation at Hospital. Patient was not pregnant at the time of vaccination. Medical history included Known allergies: Penicillin (rash as a child). Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included probiotics (PROBIOTICS); vitamin d NOS (VITAMIN D NOS); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); calcium (CALCIUM); magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EH4176), via an unspecified route of administration, administered in Arm Left on 07Jan2021at 15:45 (at the age of 55-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. Patient reported adverse event 3"x2" light red rash on left arm about an inch under where vaccine was administered on 27Jan2021. Rash was not raised also a bright red rash on ring finger on left hand rash not raised but wrapped around the finger completely and in centre of finger with knuckle in middle. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on hands; This is a spontaneous report received from a contactable nurse. A 38-year-old non pregnant female patient 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, administered in Arm Right on 27Dec2020 06:30 (at the age of 38-year-old) as single dose for covid-19 immunisation. Medical history included asthma and sulfa meds allergy. The patient's concomitant medications were not reported. Patient did not receive other vaccine within four weeks of suspect vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID since vaccination. On 28Dec2020, the patient experienced rash on hands. Patient received steroid cream as a therapeutic measure to treat rash. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was recovered/resolved.   Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pyrexia, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: injection site had a blue spot and it was sore to touch but today it is not sore; injection site had a blue spot and it was sore to touch but today it is not sore; Fever; Lethargic; injection site is real red; Injection site itching; Injection site swelling; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiration date was not reported), dose 2 intramuscular on 05Feb2021 09:40 (age at vaccination 80 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing moderate stage 3 kidney disease (Verbatim: moderate stage 3 kidney disease) diagnosed a year ago, blood pressure (Why was the patient taking Concomitant Products Lisinopril (Verbatim): stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys). Concomitant medications included lisinopril (LISINOPRIL) taken for stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys.The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) on 15Jan2021 09:45am (age at vaccination 80 years) Intramuscular injection in left shoulder for covid19 immunization. On Feb2021 the patient experienced injection site is real red, injection site itching, injection site swelling, fever (duration of reaction -4day), lethargic, on an unspecified date the injection site had a blue spot, and it was sore to touch but today it is not sore. Patient reported, the only thing beside a vitamin that she takes is lisinopril. She has not been to the doctor for this. Advised to contact hcp. The first dose didn't bother her. Patient not visited Emergency Room nor Physician Office. The patient underwent lab tests and procedures which included body temperature was 100 point something on 06Feb2021. Patient received treatment for injection site is real red, injection site itching, injection site swelling. last night she put cortisone cream on it thinking it would help. The outcome of event fever, Vaccination site pain recovered, and lethargy was recovering. Vaccination site discoloration was unknown, Rest of all event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site had a blue spot and it was sore to touch but today it is not sore; injection site had a blue spot and it was sore to touch but today it is not sore; Fever; Lethargic; injection site is real red; Injection site itching; Injection site swelling; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiration date was not reported), dose 2 intramuscular on 05Feb2021 09:40 (age at vaccination 80 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing moderate stage 3 kidney disease (Verbatim: moderate stage 3 kidney disease) diagnosed a year ago, blood pressure (Why was the patient taking Concomitant Products Lisinopril (Verbatim): stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys). Concomitant medications included lisinopril (LISINOPRIL) taken for stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys.The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) on 15Jan2021 09:45am (age at vaccination 80 years) Intramuscular injection in left shoulder for covid19 immunization. On Feb2021 the patient experienced injection site is real red, injection site itching, injection site swelling, fever (duration of reaction -4day), lethargic, on an unspecified date the injection site had a blue spot, and it was sore to touch but today it is not sore. Patient reported, the only thing beside a vitamin that she takes is lisinopril. She has not been to the doctor for this. Advised to contact hcp. The first dose didn't bother her. Patient not visited Emergency Room nor Physician Office. The patient underwent lab tests and procedures which included body temperature was 100 point something on 06Feb2021. Patient received treatment for injection site is real red, injection site itching, injection site swelling. last night she put cortisone cream on it thinking it would help. The outcome of event fever, Vaccination site pain recovered, and lethargy was recovering. Vaccination site discoloration was unknown, Rest of all event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches; Low grade fever (100.3); Sore arm; Headache; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), intramuscular, administered in arm right on 12Feb2021 13:30 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. Medical history was reported as none. Known allergies were reported as no. The patient concomitant medications were not reported. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Prior to vaccination, the patient did not have Covid. Post vaccination, the patient did not test for Covid. Facility type vaccine was Public Health Clinic. The patient experienced body aches, low grade fever (100.3), sore arm, headache on 13Feb2021 04:00. Patient did not receive any treatment for adverse events. The patient underwent laboratory data and procedures which included body temperature was 100.3 on 13Feb2021 04:00. The outcome of all events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever up to 37.8 degree C; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 12Feb2021 (at age of 34-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to sulfonamides. Concomitant medication(s) included acetaminophen (ACETAMINOPHEN) 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 bnt162b2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 21Jan2021 (at age of 34-years-old) as dose 1, single dose for covid-19 immunisation. On 13Feb2021 at 12:00, the patient experienced fever up to 37.8 degree c. The patient underwent lab tests and procedures which included body temperature: up to 37.8 centigrade degree on an unspecified date. No therapeutic measures were taken. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: severe chills; severe aches; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 12Feb2021, at 10:30 (Lot Number: EL9267, at the age of 56 years old) as dose 2, single for COVID-19 immunisation. The vaccine was received in a hospital facility. The patient's medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination and she did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, administered in the left arm on 23Jan2021, at 16:45 (Lot Number: EL9267, at the age of 56 years old) for COVID-19 immunisation. On 12Feb2021, at 20:00, the patient experienced severe chills and severe aches. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Muscle pain; injection site pain; headache; Very tired; Possible fever; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 13Feb2021 11:30 (at the age of 23-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Feb2021 12:15 the patient experienced muscle pain, injection site pain, headache, very tired, possible fever. No therapeutic measure was taken. The patient underwent lab tests and procedures which included body temperature: unknown results. The outcome of events was unknown.   Information about lot/batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle pain; injection site pain; headache; Very tired; Possible fever; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 13Feb2021 11:30 (at the age of 23-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Feb2021 12:15 the patient experienced muscle pain, injection site pain, headache, very tired, possible fever. No therapeutic measure was taken. The patient underwent lab tests and procedures which included body temperature: unknown results. The outcome of events was unknown.   Information about lot/batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Fever of up to 102; severe body aches; severe headache; injection site pain; tiredness; general fluish feeling; This is a spontaneous report from a contactable consumer.  A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 12:45 PM (Batch/Lot number was not reported) (age at the vaccination 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included obesity on an unspecified date. The patient's historical vaccine included BNT162B2 as dose 1, Arm Left single for covid-19 immunization on 23Jan2021 at 12:30 PM (age at vaccination 51 years). Concomitant medications included omeprazole (OMEPRAZOLE), 5000 IU of vitamin D and multi vitamin taken for an unspecified indication, on an unspecified date. On 13Feb2021 05:00 am, the patient had experienced fever of up to 102, severe body aches, severe headache, injection site pain, tiredness and general fluish feeling. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included body temperature: up to 102 on 13Feb2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no Known allergies. The outcome of events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.  Follow-up (21May2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever of up to 102; severe body aches; severe headache; injection site pain; tiredness; general fluish feeling; This is a spontaneous report from a contactable consumer.  A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 12:45 PM (Batch/Lot number was not reported) (age at the vaccination 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included obesity on an unspecified date. The patient's historical vaccine included BNT162B2 as dose 1, Arm Left single for covid-19 immunization on 23Jan2021 at 12:30 PM (age at vaccination 51 years). Concomitant medications included omeprazole (OMEPRAZOLE), 5000 IU of vitamin D and multi vitamin taken for an unspecified indication, on an unspecified date. On 13Feb2021 05:00 am, the patient had experienced fever of up to 102, severe body aches, severe headache, injection site pain, tiredness and general fluish feeling. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included body temperature: up to 102 on 13Feb2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no Known allergies. The outcome of events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.  Follow-up (21May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: I started feeling sharp pain in my knee; it still hurting and swollen; I could hardly walk/ limping; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266, Expiry date: not reported), via an unspecified route of administration in left arm on 10Feb2021 (at age of 68-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension and diabetes mellitus. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiration Date: Not reported), via an unspecified route of administration on 20Jan2021 as dose 1, single for covid-19 immunisation. On 11Feb2021, the patient started feeling sharp pain in my knee, it still hurting and swollen, the patient could hardly walk and was limping. When the patient came the next day 11th which was day before the reporting, before the patient went to work, started feeling sharp pain in the knee. Left knee was hurting and so as the patient got to the work then when the patient got off the work, she could hardly walk. The patient was limping to get to the car and so then she get off the car came home and elevated it and the patient called last night and it was around 8. The patient thought the recording said that all were busy but to leave a message so she left a message. So now up to the morning of reporting day and it still hurting and swollen so the patient was going to the urgent care but what the patient wanted to know was, was that one of the allergic reaction from the medicine. That's why the patient was calling. The patient also took bone health dietary supplement. Consumer stated she had lab work in last August. Consumer stated were they going to call her back or she need to call on the number which was given to her. Consumer was requested to dial the number that was provided. The outcome of the events I started feeling sharp pain in my knee; it still hurting and swollen was not recovered and the outcome of the events I could hardly walk and limping was unknown.  Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Diarrhoea, Headache, Influenza like illness
Clinical narrative: I became very ill; just like the flu; Chest pain; Body aches; low grade fever I mean like 100, 101.; Nausea; Diarrhea; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK9261), via an unspecified route of administration on 11Feb2021 17:30 as DOSE 2, SINGLE for COVID-19 Immunization at hospital. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced low grade fever, nausea, diarrhea, chest pain, body aches, patient became very ill, just like the flu and terrible headache. The patient also underwent the lab test and procedures included body temperature and resulted into 100, 101. The outcome of events were unknown.  Follow-up attempts were completed. No further information was expected. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I became very ill; just like the flu; Chest pain; Body aches; low grade fever I mean like 100, 101.; Nausea; Diarrhea; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK9261), via an unspecified route of administration on 11Feb2021 17:30 as DOSE 2, SINGLE for COVID-19 Immunization at hospital. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced low grade fever, nausea, diarrhea, chest pain, body aches, patient became very ill, just like the flu and terrible headache. The patient also underwent the lab test and procedures included body temperature and resulted into 100, 101. The outcome of events were unknown.  Follow-up attempts were completed. No further information was expected. Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash, Vaccination site erythema, Vaccination site warmth
Clinical narrative: I felt like typical achy; this morning I noticed that I have red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was; this morning I noticed that I have red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was; The injection where it was is also red and it is warm to the touch; I had some, might be a localized reaction; The injection where it was is also red and it is warm to the touch; I had some, might be a localized reaction; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 11Feb2021 (at the age of 57-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cholesterol. The concomitant medication included fluoxetine. On 13Feb2021, the patient felt like typical achy and this morning noticed red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was and the injection where it was also red and it was warm to the touch. The patient reported that she took Tylenol yesterday and Benadryl last night, but she normally take that anyway with her allergies. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; muscular pain; severe headache; This is a spontaneous report from Contactable Physician (patient) via Pfizer Sales Representative.   A 63-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration as Dose 2, Single on an unspecified date for Covid-19 immunisation. The patient' medical history which include Lipoprotein a little high, on a statin to lower effect on plaque buildup. Concomitant medication was not reported. Historical vaccination included the patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration as Dose 1, Single on an unspecified date for Covid-19 immunisation.Within eight hours of receiving second dose, the patient experienced fever chills, body aches muscular pain and severe headache, on an unspecified date for almost 24 hours. Outcome of all event was unknown.  No follow-up attempts are possible. Information about batch/Lot number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Illness
Clinical narrative: She woke up in the middle of the night, and she was so sick; fever of 102; Headache; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) on an unspecified date for COVID-19 immunisation. The patient woke up in the middle of the night and she was so sick; she had fever of 102 (unit not reported); headache; chills; sweats; on 09Feb2021. The patient took Tylenol for the fever. The outcome of even fever was not recovered; while outcome for events she was so sick, headache, chills, and sweats was unknown. The patient was asking if she was contagious. She lived with her son who was immunosuppressed.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She woke up in the middle of the night, and she was so sick; fever of 102; Headache; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) on an unspecified date for COVID-19 immunisation. The patient woke up in the middle of the night and she was so sick; she had fever of 102 (unit not reported); headache; chills; sweats; on 09Feb2021. The patient took Tylenol for the fever. The outcome of even fever was not recovered; while outcome for events she was so sick, headache, chills, and sweats was unknown. The patient was asking if she was contagious. She lived with her son who was immunosuppressed.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very fatigued after the first dose; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on 22Jan2021 (at the age of 48-years-old), as dose 1, single for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very fatigued after the first dose on an unspecified date. The outcome of event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Nausea, Pain in extremity
Clinical narrative: nausea; fatigue; chills; hot; left arm sore; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES portal. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04Feb2021 (Batch/Lot Number: EL3247) (at the age of 47-years-old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies for latex. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3248) (at the age of 47-years-old) administered in left arm on 15Jan2021 for COVID-19 immunisation and experienced left arm soreness and fatigue. The patient experienced nausea, fatigue, chills, hot, left arm sore on 05Feb2021. The patient received treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Slight fever; I have been checking my temperature and it is like 99.5; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 61-years), on 09Feb2021 as dose 1, single for COVID-19 immunization. Medical history included high blood pressure and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. On 10Feb2021, the patient experienced slight fever; i have been checking my temperature and it is like 99.5. The patient stated, I was calling because I had the Covid vaccine, the Pfizer shot, the first shot on Monday and today I have a slight fever so, I am trying to figure out, should I just take Tylenol or what should I do. She stated that I am a social worker. She stated for the lot number that E and then it looks like a M9309. She stated about expiration date that I do not know, it does not say. She stated about date of vaccination, 09Feb. She stated about start date that this evening and was not clarified further. She further stated that I have been checking my temperature and it is like 99.5. She stated about treatment that I took the Tylenol and I am eating ice chips. The treatment was received for the adverse event with drug Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.5 on an unspecified date noted as slight fever. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever; chills; Body aches; headache; This is a spontaneous report from a non-contactable consumer. This 28-year-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 Vaccine, Solution for injection, lot number: EL3248), via an unspecified route of administration on 12Feb2021 07:00 AM (at the age of 28-year-old) at dose 2, single at left arm for COVID-19 immunisation. The medical history included Migraines and Bacterium allergy. Concomitant medications were not reported. The patient had not received any other vaccine in four weeks of vaccination. The patient did not have covid prior vaccination. The patient was not tested positive for covid post vaccination. The historic vaccine included bnt162b2 (PFIZER COVID-19 Vaccine, Lot number: EL3248) on 22Jan2021 at 03:00 PM on right arm as dose 1, single for COVID-19 immunisation. On 13Feb2021, the patient experienced low grade fever, chills, body aches, headache. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.