chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dry mouth, Erectile dysfunction, Loss of consciousness, Urinary incontinence
Clinical narrative: mini-stroke; passing out; erectile dysfunction; dry mouth; urinary problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 41 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: CEREBROVASCULAR ACCIDENT (medically significant) with onset Apr2021, outcome "recovering", described as "mini-stroke"; LOSS OF CONSCIOUSNESS (medically significant) with onset Apr2021, outcome "recovering", described as "passing out"; ERECTILE DYSFUNCTION (medically significant) with onset Apr2021, outcome "recovering", described as "erectile dysfunction"; DRY MOUTH (non-serious) with onset Apr2021, outcome "recovering", described as "dry mouth"; URINARY INCONTINENCE (non-serious) with onset Apr2021, outcome "recovering", described as "urinary problems". The events "mini-stroke", "passing out", "erectile dysfunction", "dry mouth" and "urinary problems" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, loss of consciousness, erectile dysfunction, dry mouth, urinary incontinence. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he tested positive for covid on 30Dec2021; he tested positive for covid on 30Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200036789 (Pfizer).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Lot number: EN6202) at the age of 78 years as dose 2, single and administration date 07Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovered" (08Jan2022) and all described as "he tested positive for covid on 30Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive; (08Jan2022) negative. Therapeutic measures were taken as a result of covid-19. The patient is scheduled to receive Pfizer Covid 19 Booster on 12Jan2021. The patient was treated with over the counter medication to make him comfortable. He and his wife received the first Pfizer Covid 19 Vaccine on 07Feb2021. The second Pfizer Covid 19 Vaccine was recieved on 28Feb2021. Per caller he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior. Caller reports they both tested negative on 08Jan2022. They are scheduled to receive the Pfizer Covid 19 Booster on 12Jan2021. Caller states the hospitals are all full of Covid patients, so they rode it out at home.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037079 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 result; Positive COVID-19 result; 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 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: APRI. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive COVID-19 result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Dose 1 administration time: 10:45 AM. No other vaccine was administered in four weeks. No covid prior vaccination and post vaccination. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: tested positive yesterday afternoon for Covid; tested positive yesterday afternoon for Covid; receiving the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "receiving the booster shot"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "tested positive yesterday afternoon for Covid". The patient reported they received the booster shot back in "late 2021." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: booster dose; get COVID after booster dose; get COVID after booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "get COVID after booster dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her COVID 19 Diagnosis on 01Jan2022; her COVID 19 Diagnosis on 01Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 01Jun2021 (Lot number: EW0187) at the age of 17 years as dose 2, single and administered in arm right, administration date 11May2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she has a history of pseudo seizures" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "her COVID 19 Diagnosis on 01Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive; (09Jan2022) negative; (01Jan2022) positive; (09Jan2022) negative.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Immunisation, SARS-CoV-2 test, Throat irritation
Clinical narrative: PCR test 06Jan and it was positive; PCR test 06Jan and it was positive; occasional cough; Itchy throat; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 22Mar2021 (Lot number: EL3247) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR test 06Jan and it was positive"; IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "occasional cough"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "recovering", described as "Itchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. It was unknown if therapeutic measures were taken as a result of cough, throat irritation.  Clinical information: son sick with COVID first and then sx started 5Jan2022 occasional cough itchy throat describes as mild symptoms  she did a PCR test 06Jan2022 and it was positive she just got the result. Since the vaccination, patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event vaccination failure, COVID-19, immunization, cough, throat irritation and the suspect drug BNT162B2.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: PCR test 06Jan and it was positive; PCR test 06Jan and it was positive; occasional cough; Itchy throat; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 22Mar2021 (Lot number: EL3247) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR test 06Jan and it was positive"; IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "occasional cough"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "recovering", described as "Itchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. It was unknown if therapeutic measures were taken as a result of cough, throat irritation.  Clinical information: son sick with COVID first and then sx started 5Jan2022 occasional cough itchy throat describes as mild symptoms  she did a PCR test 06Jan2022 and it was positive she just got the result. Since the vaccination, patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event vaccination failure, COVID-19, immunization, cough, throat irritation and the suspect drug BNT162B2.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Tinnitus
Clinical narrative: Significant tinnitus in both ears; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 18:00 (Lot number: 33025bd) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0150, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 03May2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0164, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 12Apr2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset 29Dec2021 15:00, outcome "not recovered", described as "Significant tinnitus in both ears"; IMMUNISATION (non-serious) with onset 23Dec2021 18:00, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of tinnitus.  No follow-up attempts are possible. No further information is expected.       Dose received: 3 Most recent dose details:  Product=COVID 19 Brand= Pfizer  Brand unknown=False Lot number= 33025bd Lot unknown=False Administration date= 23Dec2021 Administration time=06:00 PM Dose number=3 Vaccine location= Left arm  Previous dose details: Prev dose product=COVID 19 Prev dose brand=Pfizer Prev dose brand unknown=False Prev dose lot number= Ew0150 Prev dose lot unknown= False Prev dose administration date= 03May2021 Prev dose administration time=03:00 PM Prev dose dose number=2 Prev dose vaccine location=Left arm Prev dose product=COVID 19 Prev dose brand=Pfizer Prev dose brand unknown=False Prev dose lot number= Ew0164 Prev dose lot unknown= False Prev dose administration date= 12Apr2021 Prev dose administration time= 03:00 PM Prev dose dose number=1 Prev dose vaccine location=Left arm  Facility type Vaccine: Hospital If other vaccine in four weeks : No Other medications in two weeks: No  Adverse event: Significant tinnitus in both ears Adverse event start date: 29Dec2021 Adverse event start time: 03:00 PM Adverse event country:  AE resulted in: Disability or permanent damage If patient recovered: Not recovered If treatment ae: No  If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination  Covid test type post vaccination=Nasal Swab Covid test result=Negative  Known allergies: Sulfa drug  Follow-Up (12Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for Covid using RT-PCR test with symptoms runny nose and cough; Positive for Covid using RT-PCR test with symptoms runny nose and cough; booster; 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 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 14:00 (Lot number: FF2589) at the age of 58 years as dose 3, (booster) single, administration date 15Mar2021 15:30 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 15:45 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 14Dec2021 14:00, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovering" and all described as "Positive for Covid using RT-PCR test with symptoms runny nose and cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive for Covid using RT-PCR test. Patient experienced symptoms such as runny nose and cough. Patient received no other vaccine in four weeks and did not have Covid-19 prior vaccination. Patient had no COVID prior vaccination. Patient was tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; Home Ag positive; Home Ag positive; dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: EL3247) at the age of 33 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 Number: 2, Batch/Lot No: EL3247), administration date: 18Feb2021; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Jan2022, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Home Ag positive"; COUGH (non-serious) with onset 09Jan2022, outcome "recovering", described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of immunisation, drug ineffective, covid-19, cough.  Clinical Course: Adverse Event: covid sx dry cough 09Jan2022 and home Ag same day - twin lives with her and she has same and same Ag. If covid prior vaccination: Unknown, If covid tested post vaccination: Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037718 same reporter/ product, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: transverse mellitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female 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: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse mellitus".  Medical Information: Yes: Customer and/or medical inquiry forwarded or referred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Immunisation
Clinical narrative: booster; cold symptoms; cough; stuffy nose; headache; scratchy throat; Breakthrough case of Covid; Breakthrough case of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: EW0217) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 55 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "not recovered" and all described as "Breakthrough case of Covid"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NASOPHARYNGITIS (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cold symptoms"; COUGH (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "stuffy nose"; HEADACHE (non-serious) with onset 05Jan2022, outcome "not recovered", described as "headache"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis, cough, nasal congestion, headache, throat irritation. No any other vaccine in four weeks. No covid prior vaccination and no Known allergies. The patient had covid tested post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, SARS-CoV-2 test, Throat irritation
Clinical narrative: booster; cold symptoms; cough; stuffy nose; headache; scratchy throat; Breakthrough case of Covid; Breakthrough case of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: EW0217) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 55 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "not recovered" and all described as "Breakthrough case of Covid"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NASOPHARYNGITIS (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cold symptoms"; COUGH (non-serious) with onset 05Jan2022, outcome "not recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "stuffy nose"; HEADACHE (non-serious) with onset 05Jan2022, outcome "not recovered", described as "headache"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "not recovered", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis, cough, nasal congestion, headache, throat irritation. No any other vaccine in four weeks. No covid prior vaccination and no Known allergies. The patient had covid tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) 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: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms; After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Jun2021 (Lot number: EW0191) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 15May2021 (Lot number: EW0183) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No COVID prior vaccination. Tested positive post vaccination. No other vaccine in four weeks. Facility type vaccine reported as Hospital.  Follow up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure, Vaccination site pain
Clinical narrative: Covid-19 positive with symptoms; Covid-19 positive with symptoms; sore at injection site; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: 3303680) at the age of 39 years as dose 3 (booster) single, administered in arm left, administration date 17Feb2021 09:30 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 27Jan2021 09:30 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022 17:00, outcome "recovering" and all described as "Covid-19 positive with symptoms"; VACCINATION SITE PAIN (non-serious) with onset 04Jan2022 17:00, outcome "recovering", described as "sore at injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, vaccination site pain.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Got vaccinated with 3 doses of the vaccine and tested positive; Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Got vaccinated with 3 doses of the vaccine and tested positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was reported that, Reporter had a person visiting her house who got vaccinated with 3 doses of the vaccine and tested positive. Patient's information was not provided. Reporter Dr. (withheld) asking if she can give prescription to her patient for the product Paxlovid, also asking if which Pharmacy it was supplied. Able to provide the answer on her first query then tried to transfer her with her additional question but she said will call another department then said goodbye.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization, drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it; had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), 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 "had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037142 Same reporter, drug & event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Fall, Immunisation, Weight
Clinical narrative: didn't have hearing; lost his balance, didn't have equilibrium; Caller had a Pfizer booster; would have been falling many times; Lost 20 lbs; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06Dec2021 (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 (Dose Unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "Caller had a Pfizer booster"; DEAFNESS (medically significant), outcome "unknown", described as "didn't have hearing"; BALANCE DISORDER (non-serious), outcome "unknown", described as "lost his balance, didn't have equilibrium"; FALL (non-serious) with onset 2021, outcome "unknown", described as "would have been falling many times"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost 20 lbs". The patient underwent the following laboratory tests and procedures: weight: 20 lbs, notes: Lost.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: didn't have hearing; lost his balance, didn't have equilibrium; Caller had a Pfizer booster; would have been falling many times; Lost 20 lbs; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06Dec2021 (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 (Dose Unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "Caller had a Pfizer booster"; DEAFNESS (medically significant), outcome "unknown", described as "didn't have hearing"; BALANCE DISORDER (non-serious), outcome "unknown", described as "lost his balance, didn't have equilibrium"; FALL (non-serious) with onset 2021, outcome "unknown", described as "would have been falling many times"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Lost 20 lbs". The patient underwent the following laboratory tests and procedures: weight: 20 lbs, notes: Lost.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Home antigen positive; Home antigen positive; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: EL3247) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunization at a workplace clinic. The patient's relevant medical history and concomitant medications were not reported. Clinical course: On 09Jan2022, the patient experienced dry cough symptom with a positive home antigen  test on the same day.  The following information was reported: IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "recovering" and all described as "Home antigen positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. It was unknown if therapeutic measures were taken as a result of immunisation, vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for events vaccination failure/booster and COVID-19. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202200037242 same reporter/ product, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR 03Jan2022; Result: Positive; PCR 03Jan2022; Result: Positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered" and all described as "PCR 03Jan2022; Result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: PCR. It was unknown if therapeutic measures were taken as a result of covid-19. Additional information:  It is unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced slight cough and congestion 29Dec2021 after exposure to infected cousin. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Booster, Vaccination failure, and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Pharyngeal swelling, Swollen tongue
Clinical narrative: Angio Edema; swelling of the tongue and throat; swelling of the tongue and throat; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Jan2021 17:00 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient took concomitant medications (other medications in two weeks). The patient did not receive any other vaccine in four weeks. The following information was reported: ANGIOEDEMA (medically significant) with onset 07Jan2021 07:00, outcome "recovered", described as "Angio Edema"; SWOLLEN TONGUE (non-serious), PHARYNGEAL SWELLING (non-serious) all with onset 07Jan2021 07:00, outcome "recovered" and all described as "swelling of the tongue and throat". The events "angio edema", "swelling of the tongue and throat" and "swelling of the tongue and throat" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of angioedema, swollen tongue, pharyngeal swelling and included benadryl/antihistamine. The patient had not been tested for COVID-19 post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Angioedema , swollen tongue and pharyngeal swelling  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Mobility decreased
Clinical narrative: Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 16:15 (Lot number: Fl3209) at the age of 46 years as dose 1, single for covid-19 immunisation.  Relevant medical history included: "known allergies: Sulfa medicine" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The following information was reported: ARTHRITIS (non-serious), MOBILITY DECREASED (non-serious), ARTHRALGIA (non-serious) all with onset 08Jan2022 16:15, outcome "not recovered" and all described as "Severe flare up of arthritis in hip and knee causing extreme pain and mobility". Therapeutic measures were not taken as a result of Severe flare up of arthritis in hip and knee causing extreme pain and mobility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pulmonary embolism, Thrombosis
Clinical narrative: booster; blood clot behind his left knee; pulmonary emboli; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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), outcome "unknown", described as "booster"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clot behind his left knee"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary emboli". The clinical course was reported as follows: The reporter had a gentleman friend who was a friend of their family that experienced a blood clot behind his left knee just like the reporter did after he had his booster and pulmonary emboli.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202200038366 same reporter/RA, different patient
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: B-cell lymphoma, Breast cancer female, Lung neoplasm malignant
Clinical narrative: Lung cancer; B-cell non-Hodgkin's lymphoma; Breast cancer female; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4148979-00 (AbbVie).  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 76 years as dose 2, single and intramuscular, administration date 26Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 05May2021 for ankylosing spondylitis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BREAST CANCER FEMALE (medically significant) with onset May2021, outcome "unknown", described as "Breast cancer female"; LUNG NEOPLASM MALIGNANT (medically significant) with onset 05May2021, outcome "unknown", described as "Lung cancer"; B-CELL LYMPHOMA (medically significant) with onset 05May2021, outcome "not recovered", described as "B-cell non-Hodgkin's lymphoma". The action taken for adalimumab was unknown.  Additional Information: The reporter's causality for the event(s) of breast cancer female and lung cancer with Pfizer BioNTech Covid-19 Vaccine was a reasonable possibility. The reporter's causality for the event(s) of basal cell non hodgkin's lymphoma was  not provided. AbbVie's opinion is that the events of breast cancer female, lung cancer and basal CELL NON hodgkin's lymphoma  are not assessable. The reporter's causality for the event(s) of breast cancer female and lung cancer with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of basal cell non-hodgkin's lymphoma was not provided. AbbVie's opinion is that the events of breast cancer female, lung cancer and basal CELL non-hodgkin's lymphoma are not assessable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: B-cell lymphoma, Immunisation
Clinical narrative: B-cell non-Hodgkin's lymphoma; booster; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4148979-00 (AbbVie).  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Aug2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3(booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 26Jan2021, when the patient was 77 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2), administration date: 23Feb2021, for Covid-19 immunization, reaction(s): "Breast Cancer"; Bnt162b2 (Dose: 2), administration date: 23Feb2021, for COVID-19 immunization, reaction(s): "Lung Cancer". The following information was reported: B-CELL LYMPHOMA (medically significant) with onset 03Nov2021, outcome "not recovered", described as "B-cell non-Hodgkin's lymphoma"; IMMUNISATION (medically significant) with onset 17Aug2021, outcome "unknown", described as "booster".  Additional Information:Causality for Humira (adalimumab) The reporter's causality for the event of BASAL CELL NON HODGKIN'S LYMPHOMA was not provided. AbbVie's opinion is that the events of BASAL CELL NON HODGKIN'S LYMPHOMA are not assessable.Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) The reporter's causality for the event of BASAL CELL NON HODGKIN'S LYMPHOMA was not reported. Action taken was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the reported event B cell lymphoma not related to suspect product BNT162B2 due to long temporal association.