chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Break through infection; Break through infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL3247) at the age of 22 years as dose 2, single and administered in arm left, administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient No allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Dec2021, outcome "recovering" and all described as "Break through infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed.; was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A 80 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed."; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was concerned that, caller Dr. (name withheld) has an 80-year-old patient that was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed. Stated that, the caller was trying to find out whether the PAXLOVID was recommended for people tested positive or at high risk and asymptomatic. Any medical questions addressed by this program forwarded/referred to Medical Information was reported as yes: Customer and/or medical inquiry forwarded or referred.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a causal association between reported events drug ineffective, covid-19, and the suspect BNt162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy.  Tested positive for Covid on 21Dec2021; Lack of efficacy.  Tested positive for Covid on 21Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid tested post vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: RP6953, Location of injection: Arm Right), administration date: 30Mar2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "recovering" and all described as "Lack of efficacy. Tested positive for Covid on 21Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received any other vaccine within 4 weeks. No List of any other medications the patient received within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Psychotic disorder
Clinical narrative: passed out; psychosis and on 3 different occasions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (COMIRNATY, Solution for injection) (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome unknown, described as passed out; PSYCHOTIC DISORDER (non-serious), outcome unknown, described as psychosis and on 3 different occasions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: 3 doses; Showing signs of having COVID-19; Showing signs of having COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "severely immunocompromised" (unspecified if ongoing); "very immunosuppressed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "3 doses"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "Showing signs of having COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (unspecified date) did not develop antibodies; sars-cov-2 test: (2021) unknown results. The patient showed signs of having COVID-19 after being exposed by her husband who was positive for COVID-19. The reporter stated that the patient received all 3 doses of bnt162b2 and developed no antibodies as determined by a SARS-CoV-2 semi-qauntitative antibody test. The patient and reporter were waiting on the COVID-19 test results to come back at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: 6 x 4 red, swollen welt at injection site.; 6 x 4 red, swollen welt at injection site.; 6 x 4 red, swollen welt at injection site.; Temp at injection site is 101.8 degrees; Swollen lymph node in left armpit, size of softball; Dose received:3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 09:00 (Lot number: 3313OBA) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical location: left arm, Route of administration: Unspecified), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW015, Anatomical location: left arm, Route of administration: Unspecified), administration date: 14Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 09:00, outcome "unknown", described as "Dose received:3"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE URTICARIA (non-serious), VACCINATION SITE WARMTH (non-serious), LYMPHADENOPATHY (non-serious) all with onset 23Dec2021 at 03:00, outcome "not recovered", and all described as "6 x 4 red, swollen welt at injection site". The events "6 x 4 red, swollen welt at injection site.", "Temp at injection site is 101.8 degrees" and "Swollen lymph node in left armpit, size of softball" were evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Temperature at injection site was 101.8 degrees and swollen lymph node in left armpit which was in the size of softball. Since the vaccination, the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: 6 x 4 red, swollen welt at injection site.; 6 x 4 red, swollen welt at injection site.; 6 x 4 red, swollen welt at injection site.; Temp at injection site is 101.8 degrees; Swollen lymph node in left armpit, size of softball; Dose received:3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 09:00 (Lot number: 3313OBA) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical location: left arm, Route of administration: Unspecified), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW015, Anatomical location: left arm, Route of administration: Unspecified), administration date: 14Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 09:00, outcome "unknown", described as "Dose received:3"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE URTICARIA (non-serious), VACCINATION SITE WARMTH (non-serious), LYMPHADENOPATHY (non-serious) all with onset 23Dec2021 at 03:00, outcome "not recovered", and all described as "6 x 4 red, swollen welt at injection site". The events "6 x 4 red, swollen welt at injection site.", "Temp at injection site is 101.8 degrees" and "Swollen lymph node in left armpit, size of softball" were evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Temperature at injection site was 101.8 degrees and swollen lymph node in left armpit which was in the size of softball. Since the vaccination, the patient had not been tested for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for the COVID virus; Tested positive for the COVID virus; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 14:30 (Lot number: EW0196) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included in two weeks: ATORVASTATIN; ASPIRINE; TAMSULOSIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 18Dec2021, outcome "recovering" and all described as "Tested positive for the COVID virus"; IMMUNISATION (medically significant) with onset 16Nov2021 14:30, outcome "unknown", described as "booster". The events "tested positive for the covid virus", "tested positive for the covid virus" and "booster" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: Nasal Swab PCR. Therapeutic measures were not taken as a result of drug ineffective, covid-19, immunisation.  Clinical course: No other vaccine taken in four weeks. No covid prior vaccination. Covid tested positive post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test result to COVID-19 and developed symptoms; Positive test result to COVID-19 yesterday morning and developed symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 64-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Positive test result to COVID-19 and developed symptoms"; COVID-19 (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Positive test result to COVID-19 yesterday morning and developed symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: In the morning. The reporter reported that the patient was vaccinated and got a positive test result to COVID-19 in the morning of 22Dec2021 and developed symptoms.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: QuickVue at home OTC COVID-19 Test: Positive; QuickVue at home OTC COVID-19 Test: Positive; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single, administration date 17Mar2021 (Lot number: EL3248) as dose 2, single and administration date 24Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 23Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "QuickVue at home OTC COVID-19 Test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Nasal Swab.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 was reported as Yes.The patient was not received any other medications within 2 weeks of vaccination.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19; received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 10 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 27Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Additional information:  Reporter stated that 10yo received his second Covid vaccine dose 27Nov2021, but just tested positive for Covid-19. Reporter queried for are boosters being studied in 5-11yo yet. What age range was the antiviral pill tested on.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Tremor
Clinical narrative: Dose received 3; Chills/shaking; Chills/shaking; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is company representative.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 23Dec2021 (Lot number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as unknown. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN), and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious), TREMOR (non-serious) all with onset 23Dec2021, outcome "recovered" (23Dec2021), and all described as "Chills/shaking". Therapeutic measures were not taken as a result of chills and tremor. Additional Information: It was unknown whether the patient had any known allergies. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Head discomfort, Illness, Investigation
Clinical narrative: temperature is up again to 100.4, the first time I took it, it was at 101.9 it hasn''t gone underneath 99.4; Nauseous; I have not been feeling good at all; I have been sick ever since Friday which is the 24th and as of today I am still sick; I felt like my head, my brain was frying that''s how sick I was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101878330 (pfizer).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Verbatim: Diabetic; "Hypertension" (ongoing), notes: Verbatim: Hypertensive. Concomitant medication(s) included: AMLODIPINE; METFORMIN; BENAZEPRIL. The following information was reported: ILLNESS (non-serious) with onset 24Dec2021, outcome "not recovered", described as "I have been sick ever since Friday which is the 24th and as of today I am still sick"; BODY TEMPERATURE INCREASED (non-serious) with onset 26Dec2021, outcome "not recovered", described as "temperature is up again to 100.4, the first time I took it, it was at 101.9 it hasn''t gone underneath 99.4"; NAUSEA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Nauseous"; MALAISE (non-serious) with onset 26Dec2021, outcome "unknown", described as "I have not been feeling good at all"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I felt like my head, my brain was frying that''s how sick I was". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, body temperature increased, nausea, malaise, head discomfort.  Additional information:Reason for no lot number of Covid-19 vaccine was reported as "It is 33B0B or it's probably BO because then there is BA (not sure).Patient was took Tylenol and Ibuprofen for the treatment of event.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: temperature is up again to 100.4, the first time I took it, it was at 101.9 it hasn''t gone underneath 99.4; Nauseous; I have not been feeling good at all; I have been sick ever since Friday which is the 24th and as of today I am still sick; I felt like my head, my brain was frying that''s how sick I was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101878330 (pfizer).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Verbatim: Diabetic; "Hypertension" (ongoing), notes: Verbatim: Hypertensive. Concomitant medication(s) included: AMLODIPINE; METFORMIN; BENAZEPRIL. The following information was reported: ILLNESS (non-serious) with onset 24Dec2021, outcome "not recovered", described as "I have been sick ever since Friday which is the 24th and as of today I am still sick"; BODY TEMPERATURE INCREASED (non-serious) with onset 26Dec2021, outcome "not recovered", described as "temperature is up again to 100.4, the first time I took it, it was at 101.9 it hasn''t gone underneath 99.4"; NAUSEA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Nauseous"; MALAISE (non-serious) with onset 26Dec2021, outcome "unknown", described as "I have not been feeling good at all"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I felt like my head, my brain was frying that''s how sick I was". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, body temperature increased, nausea, malaise, head discomfort.  Additional information:Reason for no lot number of Covid-19 vaccine was reported as "It is 33B0B or it's probably BO because then there is BA (not sure).Patient was took Tylenol and Ibuprofen for the treatment of event.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Didn't feel well; This is a spontaneous report from a contactable reporter (consumer or other non-hcp).  A child male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date an unknown date in 2021 (Lot number: unknown) as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Didn't feel well".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Dysphonia, Fatigue, Headache
Clinical narrative: Severely terrible sore throat when swallowing; Severely terrible sore throat when swallowing; Raspy voice like losing it; Bad joint pain; Body aches; Headache; Runny nose; hot flashed; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101863713.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious), DYSPHAGIA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Severely terrible sore throat when swallowing"; DYSPHONIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Raspy voice like losing it"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Bad joint pain"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "Runny nose"; HOT FLUSH (non-serious) with onset Dec2021, outcome "not recovered", described as "hot flashed"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "Fatigue".  Additional information: The patient reported that is it typical if she just got her first Pfizer covid vaccine dose it's been 6 days now I have a severely terrible sore throat when swallowing and raspy voice like losing it. The first few days I have bad joint pain and body aches, headache, runny nose, child's, hot flashed, fatigue and still have some of them still. But now it's this throat.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Severely terrible sore throat when swallowing; Severely terrible sore throat when swallowing; Raspy voice like losing it; Bad joint pain; Body aches; Headache; Runny nose; hot flashed; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101863713.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious), DYSPHAGIA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Severely terrible sore throat when swallowing"; DYSPHONIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Raspy voice like losing it"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Bad joint pain"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "Runny nose"; HOT FLUSH (non-serious) with onset Dec2021, outcome "not recovered", described as "hot flashed"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "Fatigue".  Additional information: The patient reported that is it typical if she just got her first Pfizer covid vaccine dose it's been 6 days now I have a severely terrible sore throat when swallowing and raspy voice like losing it. The first few days I have bad joint pain and body aches, headache, runny nose, child's, hot flashed, fatigue and still have some of them still. But now it's this throat.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cough, Headache, Sneezing
Clinical narrative: a blood clot in my brain; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101871718.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 (Lot number: FH8028) at the age of 39 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; ARIMIDEX; LEXAPRO; BLUDEC; PROLIA. The following information was reported: CEREBRAL THROMBOSIS (medically significant) with onset 18Dec2021, outcome "unknown", described as "a blood clot in my brain"; HEADACHE (non-serious), SNEEZING (non-serious), COUGH (non-serious) all with onset 18Dec2021, outcome "unknown" and all described as "I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds". Therapeutic measures were taken as a result of headache, sneezing, cough. Treatment taken with Ibuprofen 800 mg.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Did not feel her best; Started running a fever yesterday (or potentially day before); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 14-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 24Dec2021, outcome "unknown", described as "Started running a fever yesterday (or potentially day before)"; MALAISE (non-serious), outcome "unknown", described as "Did not feel her best". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Lot unknown reason: Not available/provided to reporter at the time of report completion. Adverse event: Started running a fever yesterday (or potentially day before). Had at home covid test and it came back negative, and a doctor gave them Tamiflu. (Note that based on recent experience, the at-home tests can give false negatives) Unsure vaccinate status, which one, dosage received. Adverse event treatment included Tamiflu. Follow up to previous report regarding running fever and negative at-home covid test. We do believe patient was vaccinated, but not sure which and how many doses and when. Previously, we were not totally sure of vaccine status. Believe does have a vaccine card. Covid test post vaccination: covid test date was Dec2021, covid test result was negative. Was made aware yesterday that individual was vaccinated. Recounted a story where name went to a camp after Thanksgiving and did not feel her best. This was after covid exposure over the Thanksgiving weekend. Never heard if they were tested for covid. Do not know vaccine, dosage, when dosed, but is at least partially vaccinated. Have submitted other recent AEs for name. 14YO female.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: She still had a fever at 03:50 AM, it was 40; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "She still had a fever at 03:50 AM, it was 40". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was given the bnt162b2 vaccine last Tuesday (as reported) and she still had a fever like last time her fever at 03:50 AM, it was 40 which was more than 72 hours after the vaccine. The reporter was informed to reach out to the nearest emergency in case of medical emergency.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: did not feel 100% on 12/25 but had tested negative for covid; This is a spontaneous report from a contactable reporter (consumer or other non hcp).  A 24-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date an unknown date in 2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing), notes: some chronic pain from injuries and some being still diagnosed for reason,; "Abdominal pain" (unspecified if ongoing), notes: some abnormal pain associated with reproductive tract as well (not sure if that diagnosed); "Multiple injuries" (unspecified if ongoing), notes: some chronic pain from injuries and some being still diagnosed for reason and "Reproductive tract disorder NOS" (unspecified if ongoing), notes: some abnormal pain associated with reproductive tract as well (not sure if that diagnosed). It was unsure whether the patient received any medications in two weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, Lot number: Unknown Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: MALAISE (non-serious) with onset 25Dec2021, outcome "unknown", described as "did not feel 100% on 12/25 but had tested negative for covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was unsure whether the patient had any known allergies. It was unknown whether, the patient receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that the patient was vaccinated (probably fully by at least Jul2021 as the patient had to work in person so she probably was able to receive it earlier than some others) as of this summer, but the reporter was not sure the amount of doses had currently received or which vaccine or exact dates. Since the vaccination, the patient had been tested for COVID-19 and the result was negative.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles.; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 at 04:45 (Lot number: EP6955) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: Meniere's Disease with Vestibular Migraines and "Vestibular migraine" (unspecified if ongoing), notes: Meniere's Disease with Vestibular Migraines. Concomitant medications included: MONTELUKAST 10MG and TRIAMTERENE 37.5 MG/HYDROCHLOROTHIAZIDE 25 MG. Past drug history included: Codeine, reactions: "Drug allergy", notes: known allergies: Codine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6204; Administration Time: 05:45; Vaccine Location: Left Arm, Route of administration: Unspecified), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Apr2021, outcome "not recovered", described as "Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles"; BACK PAIN (non-serious), MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Apr2021, outcome "not recovered", and all described as "Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles". Therapeutic measures were taken as a result of pain in extremity, back pain, myalgia and arthralgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with steroids for the reported events. The patient received COVID-19 vaccine mRNA (mRNA 123)(MODERNA VACCINE COVID19) administered in arm left, administration date 20Dec2021 at 14:15 (Lot Number: 012H21B), as dose 3, single for COVID-19 immunisation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular
Clinical narrative: From June through August 2021 I had on and off all three months bleeding during my menstrual cycle. The cycle went back to normal in September.; I also had rather strong headaches on and off.; Fatigue.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 07May2021 at 13:00 (Lot number: EW0172) at the age of 52 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction: "Drug allergy", notes: Known allergies: Codeine and Zithromax, reaction: "Drug allergy", notes: Known allergies: Zithromax. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE, Lot Number: EW0169, Anatomical Location: Right arm, Administration time: 13:00), administration date: 16Apr2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in Sep2021), described as "From June through August 2021 I had on and off all three months bleeding during my menstrual cycle. The cycle went back to normal in September"; HEADACHE (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in 2021), described as "I also had rather strong headaches on and off"; FATIGUE (non-serious) with onset 01Jun2021, outcome "recovered" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of menstruation irregular, headache and fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient also received Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm, Lot Number: FD0809, Administration time: 13:00), administration date: 27Dec2021, when the patient was 53 years old, for COVID-19 immunisation.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 positive; COVID-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; negative. Reporter would like to know the time he can get a booster. He received his first and second dose of COVID-19 Vaccine. Tested positive for COVID-19 three weeks ago. Needs a booster shot. Has already tested negative for COVID-19 seven days ago. Reporter wants to know the timing for the booster, if he can get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Immunisation, Nasal congestion
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 03Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "tested positive for COVID"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "Stuffy and running nose"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "bad head cold"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (26Dec2021) negative; sars-cov-2 test: (27Dec2021) positive.  Additional information: It was reported that reporter husband tested positive for COVID today. His booster was on 03Oct2021. He was 53 and felt like he had a bad head cold. Stuffy and running nose and really bad headache. He did a Rapid yesterday and was negative, but woke up today feeling bad so tested and was now positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 03Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "tested positive for COVID"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "Stuffy and running nose"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "bad head cold"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (26Dec2021) negative; sars-cov-2 test: (27Dec2021) positive.  Additional information: It was reported that reporter husband tested positive for COVID today. His booster was on 03Oct2021. He was 53 and felt like he had a bad head cold. Stuffy and running nose and really bad headache. He did a Rapid yesterday and was negative, but woke up today feeling bad so tested and was now positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.