chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Caller reports she has a friend who experienced myocarditis after vaccination with Comirnaty.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101883041.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: MYOCARDITIS (medically significant), outcome "unknown", described as "Caller reports she has a friend who experienced myocarditis after vaccination with Comirnaty.".  Clinical information: Caller reports she has a friend who experienced myocarditis after vaccination with Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: The information provided is too limited to make a meaningful medical evaluation of the case. However, based on the available information in the case provided, the causal association between the events Myocarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; body aches; 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 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 (Lot number: EL00196) at the age of 48 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 26Jan2021 (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. The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 07:00, outcome "recovering" and all described as "tested positive for Covid 19"; PAIN (non-serious) with onset 27Dec2021 07:00, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pain.  Additional Information: if other vaccine in four weeks: No .If covid prior vaccination: no
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Dyspnoea, Migraine, Pain
Clinical narrative: Female Breast Cancer; Migraines; Pain on right side in rib area; Hard to catch breath at times; FACILITATED COLLECT NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not provided). The reporter is the patient. Other Case identifier(s): 21K-163-4209745-00 (AbbVie).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single and intramuscular, administration date 28Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: BREAST CANCER FEMALE (medically significant) with onset 2021, outcome "not recovered", described as "Female Breast Cancer"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraines"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain on right side in rib area"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Hard to catch breath at times". The action taken for adalimumab was unknown. Clinical course was reported as the patient had places on scalp, migraines, breast cancer, had a lot of pain on the right side in rib area, hard to catch her breath at times. Patient agrees to have MD contacted. No concomitant drugs taken. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Female breast cancer, Migraines, Pain on right side in rib area and hard to catch breath at times was not provided. AbbVie's opinion (causality as per Mfr.) is that the event of Female Breast Cancer is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of Migraines, Pain on right side in rib area and hard to catch breath at times are related to Humira (Adalimumab).  The reporter's causality for the event(s) of Female breast cancer, Migraines, Pain on right side in rib area and hard to catch breath at times to BNT162B2 was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events reported and the suspect drug BNT162B2 is assessed possibly unrelated The case will be reassessed once new information is available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Lymph node pain
Clinical narrative: Fever; Nausea; Slight headache; Chills; Sore arm; Extremely painful lymph node under left arm; Muscle ache/muscle pain; Joint ache/joint pain; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 15:00 (Batch/Lot number: 33130BA) at the age of 64 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Drug intolerance" (unspecified if ongoing), notes: known allergies: Intolerant of opioids. The patient did not receive concomitant medications. Past drug history included: Aspirin, reaction(s): "Drug intolerance", notes: known allergies: Intolerant of aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Administration time: 10:00 Administration Location: Left Arm), administration date: 18Mar2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event" and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Administration time: 10:00 Administration Location: Left Arm), administration date: 08Apr2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 at 15:00, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Fever"; NAUSEA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Nausea"; HEADACHE (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Slight headache"; CHILLS (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Sore arm"; LYMPH NODE PAIN (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Extremely painful lymph node under left arm"; MYALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Muscle ache/muscle pain"; ARTHRALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Joint ache/joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, headache, chills, pain in extremity, lymph node 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 the prior to the COVID-19 vaccine. 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Nausea; Slight headache; Chills; Sore arm; Extremely painful lymph node under left arm; Muscle ache/muscle pain; Joint ache/joint pain; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 15:00 (Batch/Lot number: 33130BA) at the age of 64 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Drug intolerance" (unspecified if ongoing), notes: known allergies: Intolerant of opioids. The patient did not receive concomitant medications. Past drug history included: Aspirin, reaction(s): "Drug intolerance", notes: known allergies: Intolerant of aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Administration time: 10:00 Administration Location: Left Arm), administration date: 18Mar2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event" and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Administration time: 10:00 Administration Location: Left Arm), administration date: 08Apr2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 at 15:00, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Fever"; NAUSEA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Nausea"; HEADACHE (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Slight headache"; CHILLS (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Sore arm"; LYMPH NODE PAIN (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Extremely painful lymph node under left arm"; MYALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Muscle ache/muscle pain"; ARTHRALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Joint ache/joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, headache, chills, pain in extremity, lymph node 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 the prior to the COVID-19 vaccine. 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully vaccinated with booster, but still tested positive for COVID; Fully vaccinated with booster, but still tested positive for COVID; Fully vaccinated with booster, but still tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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) with onset Nov2021, outcome "unknown", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "Fully vaccinated with booster, but still tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19. The events did not result in causing hospitalization; prolongation of existing hospitalization; life threatening; disability or incapacitating; death; congenital anomaly or birth defect. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had  been tested for COVID-19. The patient had no known allergies. The facility type vaccine was temp vaccination site set up by local Health System.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant mild to severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 17:00 (Lot number: FK5127) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Dec2021 22:00, outcome "recovered" (Dec2021), described as "Constant mild to severe headache". The event "constant mild to severe headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: List of any other medications the patient received within 2 weeks of vaccination: Multivitamin- Fluoride 1mg Tab Chewable. Constant mild to severe headache lasting nearly three weeks, starting the night of the injection. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was on 30Dec2021. Treatment medication included Tylenol or motrin every six hours.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear infection, Immunisation, Pain
Clinical narrative: booster shot; Chills; Ache; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: ER8727 or ER8121, Anatomical location: first dose injected in her arm, no EXP was provided), administration date: 01Apr2021, when the patient was 61 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, LOT: EW0162, no EXP provided), administration date: 22Apr2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster shot"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "Ache"; EAR INFECTION (non-serious) with onset Dec2021, outcome "recovering", described as "Ear infection". Therapeutic measures were taken as a result of chills, pain, ear infection.  Additional information: She says her booster dose was given 17Dec2021, and that the LOT number was cut off so it is either E or F then J8762. Caller clarifies that her potential side effects were: chills, aches, and ear infection. She said the chills started within a few hours of booster shot, and for treatment she took Tylenol, dose unknown, and they eventually got better. She says the aches started within a few hours of the booster shot, and she took Tylenol also for this. She said the chills eventually got better. She said the ear infection started within a week of the booster shot, during December, and for treatment she took an antibiotic, which was Amoxicillin. Amoxicillin dose unknown, caller said she took it for 7 days, twice daily. She says the ear infection has gotten better.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis infective
Clinical narrative: had to get another shoulder surgery today because the shoulder got infected post-first surgery; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shoulder surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS INFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "had to get another shoulder surgery today because the shoulder got infected post-first surgery". Not positive on vaccine status of individual (believe Adult age), but reporting anyway. Patient had shoulder surgery and had to get another shoulder surgery today (29Dec2021) because the shoulder got infected post-first surgery. Need for surgery identified believe on 29Dec2021. Had to have a tube put in so that antibiotics could be administered post-surgery via syringe at home. Will stay overnight post-surgery. Therapeutic measures were taken as a result of arthritis infective included antibiotics. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event infective arthritis  and the suspect drug BNT162B2 cannot be 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; 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 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0171) at the age of 33 years as dose 2, single and intramuscular, administered in arm left, administration date 21Apr2021 15:30 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. The following information was reported: COVID-19 (medically significant) with onset 27Dec2021 02:30, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 27Dec2021 02:30, outcome "unknown" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Headache, Immunisation
Clinical narrative: Positive Bianax Now COVID test; Positive Bianax Now COVID test on 30Dec2021.; Congestion; sinus pain; headache; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FH 8028) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose number unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test"; COVID-19 with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test on 30Dec2021."; IMMUNISATION with onset 27Nov2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Congestion"; SINUS PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "sinus pain"; HEADACHE (non-serious) with onset 27Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 27Dec2021, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Bianax. Clinical courses: Consumer was around unvaccinated individual that became sick.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, Sinus pain
Clinical narrative: Positive Bianax Now COVID test; Positive Bianax Now COVID test on 30Dec2021.; Congestion; sinus pain; headache; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Lot number: FH 8028) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose number unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test"; COVID-19 with onset 30Dec2021, outcome "unknown", described as "Positive Bianax Now COVID test on 30Dec2021."; IMMUNISATION with onset 27Nov2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Congestion"; SINUS PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "sinus pain"; HEADACHE (non-serious) with onset 27Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 27Dec2021, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Bianax. Clinical courses: Consumer was around unvaccinated individual that became sick.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter from a sales representative. The reporter is the patient.  A 23 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Feb2021 (Lot number: EL3247) at the age of 22 years as dose 2, single and administration date 01Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. The following information was reported: COVID-19, VACCINATION FAILURE all with onset 29Dec2021, outcome recovering. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  Follow-up attempts are completed. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested postive; tested postive; Booster; This is a spontaneous report received from a non-contactable reporter from product quality group.  An adult female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), administration date 16Dec2021 (Lot number: unknown) as dose 3 (booster), single, administration date 16Apr2021 (Lot number: EP6955) as dose 2, single, and administration date 26Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19 (unspecified if ongoing), prior vaccination. The patient's concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 16Dec2021, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome recovering. The event tested positive and tested positive was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (30Dec2021) positive, post vaccination. Therapeutic measures were taken as a result of vaccination failure, covid-19, and included treatment with OTC meds. Booster 16Dec2021 then exposed 25Dec2021 at family gathering and tested positive 30Dec2021 rapid Ag and sx started 29Dec2021 and 14 family members had been positive.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 12 year-old 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: PARALYSIS (medically significant), outcome "unknown", described as "paralized". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Immunisation, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: 29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; 29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; sunny nose; cough; sneezing; dose 3; This is a spontaneous report received from a non-contactable reporter (Nurse) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient receive other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021"; RHINORRHOEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "sunny nose"; COUGH (medically significant) with onset 29Dec2021, outcome "recovering", described as "cough"; SNEEZING (medically significant) with onset 29Dec2021, outcome "recovering", described as "sneezing". The events "29dec2021 covid sx ha sunny nose cough sneezing and tested + - found out 30dec2021", "sunny nose", "cough" and "sneezing" were evaluated at the physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, cough, sneezing.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events immunization, Vaccination Failure, Covid-19, Sneezing, rhinorrheoa, cough and suspect drug BNT162B2 cannot be 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
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination failure
Clinical narrative: 29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; 29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021; sunny nose; cough; sneezing; dose 3; This is a spontaneous report received from a non-contactable reporter (Nurse) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient receive other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "29Dec2021 covid sx HA sunny nose cough sneezing and tested + - found out 30Dec2021"; RHINORRHOEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "sunny nose"; COUGH (medically significant) with onset 29Dec2021, outcome "recovering", described as "cough"; SNEEZING (medically significant) with onset 29Dec2021, outcome "recovering", described as "sneezing". The events "29dec2021 covid sx ha sunny nose cough sneezing and tested + - found out 30dec2021", "sunny nose", "cough" and "sneezing" were evaluated at the physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, cough, sneezing.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events immunization, Vaccination Failure, Covid-19, Sneezing, rhinorrheoa, cough and suspect drug BNT162B2 cannot be 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; chills; fever; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL3247) at the age of 40 years as dose 2, single and administration date 04Feb2021 (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 26Dec2021, outcome "recovering" and all described as "Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive; (30Dec2021) positive. Clinical course: The events did not Result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. It did not know if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; chills; fever; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL3247) at the age of 40 years as dose 2, single and administration date 04Feb2021 (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 26Dec2021, outcome "recovering" and all described as "Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive; (30Dec2021) positive. Clinical course: The events did not Result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. It did not know if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (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 26Dec2021, outcome "recovering" and all described as "Patient colleague got sx 26Dec after exposure 25Dec and tested + covid PCR 28Dec2021". The event "patient colleague got sx 26dec after exposure 25dec and tested + covid pcr 28dec2021" and "patient colleague got sx 26dec after exposure 25dec and tested + covid pcr 28dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (28Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Since the vaccination, the patient has been tested for COVID-19. Case reported as non-serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Vaccination failure, COVID -19 and the suspect drug BNT162B2 cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gynaecological examination, Inappropriate schedule of product administration, Menstrual disorder, Postmenopausal haemorrhage
Clinical narrative: Date for first shot: Consumer stated, "First shot was done on 06Apr2021."; I am having periods which I shouldn't have because I am very post menopausal; I started bleeding;  menopausal female; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Dec2021 14:00 (Lot number: 83030BD) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 06Apr2021, for Covid-19 Immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "I started bleeding;  menopausal female"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Date for first shot: Consumer stated, "First shot was done on 06Apr2021.""; MENSTRUAL DISORDER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "I am having periods which I shouldn't have because I am very post menopausal". The events "i started bleeding;  menopausal female" and "i am having periods which i shouldn't have because i am very post menopausal" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: all good; gynaecological examination: unknown results; smear cervix: unknown results. Therapeutic measures were not taken as a result of postmenopausal haemorrhage, menstrual disorder. Clinical course: The consumer reported that she was very healthy forever and she still believing, it's been 8 days now and pretty convinced that it's because of the shot, there is no other reason to this, she had been post menopausal for probably about 8 years. She was having a uterine ultrasound next week and she have to go to the hospital for that. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Smear cervix
Clinical narrative: Date for first shot: Consumer stated, "First shot was done on 06Apr2021."; I am having periods which I shouldn't have because I am very post menopausal; I started bleeding;  menopausal female; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Dec2021 14:00 (Lot number: 83030BD) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 06Apr2021, for Covid-19 Immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "I started bleeding;  menopausal female"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Date for first shot: Consumer stated, "First shot was done on 06Apr2021.""; MENSTRUAL DISORDER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "I am having periods which I shouldn't have because I am very post menopausal". The events "i started bleeding;  menopausal female" and "i am having periods which i shouldn't have because i am very post menopausal" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: all good; gynaecological examination: unknown results; smear cervix: unknown results. Therapeutic measures were not taken as a result of postmenopausal haemorrhage, menstrual disorder. Clinical course: The consumer reported that she was very healthy forever and she still believing, it's been 8 days now and pretty convinced that it's because of the shot, there is no other reason to this, she had been post menopausal for probably about 8 years. She was having a uterine ultrasound next week and she have to go to the hospital for that. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, CSF protein, CSF white blood cell count, Investigation, Lumbar puncture
Clinical narrative: Miller Fisher Syndrome; This is a literature report for the following literature source(s): (privacy)  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic painless vertical diplopia" (unspecified if ongoing); "inflammatory pseudotumor" (unspecified if ongoing); "painless paresthesiae of hands" (unspecified if ongoing); "severe gait ataxia" (unspecified if ongoing); "COVID-19 infection", start date: Feb2021 (unspecified if ongoing); "painless paresthesiae of feet" (unspecified if ongoing); "2 falls" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 15Jan2021, reaction(s): "COVID-19 infection". The following information was reported: MILLER FISHER SYNDROME (life threatening), outcome "recovering", described as "Miller Fisher Syndrome". The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) equivocal, 31 iv, (arup); csf protein: (unspecified date) 218 mg; csf white blood cell count: (unspecified date) 6, notes: cells/hpf; investigation: (unspecified date) was notable for limited movement of the right, notes: lateral rectus, right medial rectus, right inferior oblique, and left superior rectus with mixed diplopia in all directions of gaze; lumbar puncture: (unspecified date) showed albuminocytological dissociation with a csf, notes: protein of 218 mg and a CSF nucleated cell count of 6 cells/hpf; magnetic resonance imaging head: (unspecified date) unremarkable; magnetic resonance imaging neck: (unspecified date) unremarkable; sars-cov-2 test: (Feb2021) positive; (unspecified date) negative; vital capacity: (unspecified date) 1.1 L; (Feb2021) 1.8 L, notes: increase. Therapeutic measures were taken as a result of miller fisher syndrome.; Sender's Comments: As there is limited information in the case provided, the causal association between the event miller fisher syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.