chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin I
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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), for covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 12.1 pg/mL, notes: Initial; ejection fraction: 61 percent, notes: Initial CMR; 62 percent, notes: Follow-up CMR; electrocardiogram: no st abnormality, notes: Follow-up; st-segment elevations, notes: Initial; investigation: notes: mL/m2; Initial CMR; notes: mL/m2; Follow-up CMR; magnetic resonance imaging heart: late gadolinium enhancement; patchy lge a/il segments, notes: Initial CMR; near resolution, lge in mid al segments, notes: Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; n-terminal prohormone brain natriuretic peptide: 6.2 pg/mL, notes: Follow-up; troponin i (normal high range 60.4): 5.2 ng/L, notes: Follow-up; troponin: 16.6 ng/ml, notes: Initial. Clinical course: Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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,Linked Report(s) : US-PFIZER INC-202200508742 Same article/Event/Drug and different patient
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Ejection fraction, Electrocardiogram, Investigation, Myocarditis
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 68 pg/mL, notes: initial; ejection fraction: 50 %, notes: Initial at 3 days; 60 %, notes: follow up at 177 days; electrocardiogram: st-segment elevations, notes: Initial; nonspecific  st-t abn, notes: Follow up; investigation: lge basal/mid as segments, notes: initial 3 days; resolved lge, notes: Follow up 171 days; investigation: notes: Units: ms normal; investigation: notes: Units: ms; n-terminal prohormone brain natriuretic peptide: less than 10, notes: Follow up; troponin: 7000 ng/ml, notes: initial; troponin i: 6 ng/L, notes: Follow up; volume blood: notes: Initial at 3 days units: ml/m2; notes: follow up at 177 days units: ml/m2. Clinical course: The Study investigated the Patients With Myocarditis Associated With COVID-19 Vaccination and the following conclusion was achieved: there were no instances of severe impairment of ventricular function at baseline in this series, all patients had LGE, and several had mild LV dilation. Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis in all cases. There was no evidence of myocardial dysfunction or ongoing myocardial injury at intermediate-term follow-up and no subsequent adverse cardiac events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available,Linked Report(s) : US-PFIZER INC-202200508742 Same article/Event/Drug and different patient
Sex: M
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide, Troponin, Troponin I, Volume blood
Clinical narrative: Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 68 pg/mL, notes: initial; ejection fraction: 50 %, notes: Initial at 3 days; 60 %, notes: follow up at 177 days; electrocardiogram: st-segment elevations, notes: Initial; nonspecific  st-t abn, notes: Follow up; investigation: lge basal/mid as segments, notes: initial 3 days; resolved lge, notes: Follow up 171 days; investigation: notes: Units: ms normal; investigation: notes: Units: ms; n-terminal prohormone brain natriuretic peptide: less than 10, notes: Follow up; troponin: 7000 ng/ml, notes: initial; troponin i: 6 ng/L, notes: Follow up; volume blood: notes: Initial at 3 days units: ml/m2; notes: follow up at 177 days units: ml/m2. Clinical course: The Study investigated the Patients With Myocarditis Associated With COVID-19 Vaccination and the following conclusion was achieved: there were no instances of severe impairment of ventricular function at baseline in this series, all patients had LGE, and several had mild LV dilation. Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis in all cases. There was no evidence of myocardial dysfunction or ongoing myocardial injury at intermediate-term follow-up and no subsequent adverse cardiac events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available,Linked Report(s) : US-PFIZER INC-202200508742 Same article/Event/Drug and different patient
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Cardiac tamponade, Culture, Cytology
Clinical narrative: This is a literature report. A 18 year-old male patient received bnt162b2 (BNT162B2) (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: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "patient developed pericarditis 2 weeks after COVID mRNA vaccine"; CARDIAC TAMPONADE (hospitalization, medically significant), outcome "unknown", described as "tamponade". We report the first case of incessant pericarditis and tamponade associated with the Pfizer- BioNTech vaccine. Case: An 18 year-old male presented with positional chest pain 2 weeks after the first dose of the BNT162b2 mRNA vaccine. CRP was elevated and ECG showed diffuse ST segment elevations. Troponin, BNP, and transthoracic echocardiogram were normal. He was discharged with ibuprofen and colchicine. Two weeks later, he returned with chest pain and a large pericardial effusion with tamponade. Pericardiocentesis was performed with placement of a pericardial drain. Cultures and cytology were negative. 4 days after drain removal, he developed recurrent chest pain. Decision-making: Our patient developed pericarditis 2 weeks after COVID mRNA vaccine with no other etiology identified. Despite appropriate initial therapy, he developed incessant pericarditis and tamponade. Treatment success was ultimately obtained with prednisone and rilonacept. Conclusion(s): Pericarditis is a rare adverse effect associated with the mRNA COVID-19 vaccine, however this is the first description of a pericardial effusion resulting in cardiac tamponade associated with the vaccine in the literature. In patients with incessant pericarditis, the use of rilonacept has been associated with marked reduction in recurrence. Rilonacept may serve as a therapeutic strategy for severe refractory cases of pericarditis secondary to mRNA vaccines. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: normal; c-reactive protein: elevated; culture: negative; cytology: negative; echocardiogram: normal; electrocardiogram: diffuse ST segment elevations; troponin: normal. Therapeutic measures were taken as a result of pericarditis, cardiac tamponade. Sender's Comments: As there is limited information in the case provided, the causal association between the event pericarditis and Cardiac tamponade  and the suspect drug cannot be excluded. This is literature- spontaneous case. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Pericarditis, Troponin
Clinical narrative: This is a literature report. A 18 year-old male patient received bnt162b2 (BNT162B2) (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: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "patient developed pericarditis 2 weeks after COVID mRNA vaccine"; CARDIAC TAMPONADE (hospitalization, medically significant), outcome "unknown", described as "tamponade". We report the first case of incessant pericarditis and tamponade associated with the Pfizer- BioNTech vaccine. Case: An 18 year-old male presented with positional chest pain 2 weeks after the first dose of the BNT162b2 mRNA vaccine. CRP was elevated and ECG showed diffuse ST segment elevations. Troponin, BNP, and transthoracic echocardiogram were normal. He was discharged with ibuprofen and colchicine. Two weeks later, he returned with chest pain and a large pericardial effusion with tamponade. Pericardiocentesis was performed with placement of a pericardial drain. Cultures and cytology were negative. 4 days after drain removal, he developed recurrent chest pain. Decision-making: Our patient developed pericarditis 2 weeks after COVID mRNA vaccine with no other etiology identified. Despite appropriate initial therapy, he developed incessant pericarditis and tamponade. Treatment success was ultimately obtained with prednisone and rilonacept. Conclusion(s): Pericarditis is a rare adverse effect associated with the mRNA COVID-19 vaccine, however this is the first description of a pericardial effusion resulting in cardiac tamponade associated with the vaccine in the literature. In patients with incessant pericarditis, the use of rilonacept has been associated with marked reduction in recurrence. Rilonacept may serve as a therapeutic strategy for severe refractory cases of pericarditis secondary to mRNA vaccines. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: normal; c-reactive protein: elevated; culture: negative; cytology: negative; echocardiogram: normal; electrocardiogram: diffuse ST segment elevations; troponin: normal. Therapeutic measures were taken as a result of pericarditis, cardiac tamponade. Sender's Comments: As there is limited information in the case provided, the causal association between the event pericarditis and Cardiac tamponade  and the suspect drug cannot be excluded. This is literature- spontaneous case. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Meniere's disease
Clinical narrative: Meniere's ear 20 years ago. Have never had any flare up until after taking vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: L#EL9266) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Trees" (unspecified if ongoing); "Meniere's ear" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; FAMOTIDINE; LOSARTAN; POTASSIUM. Facility type vaccine was public health clinic administration facility. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The following information was reported: MENIERE'S DISEASE (hospitalization) with onset 2021, outcome "unknown", described as "Meniere's ear 20 years ago. Have never had any flare up until after taking vaccine.". The patient was hospitalized for meniere's disease (hospitalization duration: 3 day(s)). The event "meniere's ear 20 years ago. have never had any flare up until after taking vaccine." required emergency room visit. We both were diagnosed with the Meniere's ear 20 years ago. Have never had any flare up until after taking vaccine. Therapeutic measures were taken as a result of meniere's disease.Ae treatment includes physical therapy. Patient recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; manufacturer unknown), for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "developed a DVT one month after receiving the Pfizer Booster". Clinical Information: The patient developed a DVT one month after receiving the Pfizer Booster. No previous history and no identified reason. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; manufacturer unknown), for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "developed a DVT one month after receiving the Pfizer Booster". Clinical Information: The patient developed a DVT one month after receiving the Pfizer Booster. No previous history and no identified reason. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Developed a DVT one month after receiving the Phizer Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "Developed a DVT one month after receiving the Phizer Booster". Clinical Course: Patient developed a DVT one month after receiving the Pfizer Booster. No previous history and no identified reason. The patient wanted to known is it safe to receive the 2nd booster?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Developed a DVT one month after receiving the Phizer Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "Developed a DVT one month after receiving the Phizer Booster". Clinical Course: Patient developed a DVT one month after receiving the Pfizer Booster. No previous history and no identified reason. The patient wanted to known is it safe to receive the 2nd booster?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: lower extremity swelling of her leg; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: EW0179) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot Number: EL3248, Expiry Date: unknown, Route, Anatomical Location: left arm), administration date: 16Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, single, Lot Number: EN9581, Expiry Date: unknown, Route, Anatomical Location: left arm), administration date: 06Feb2021, when the patient was 76-year-old, for COVID-19 immunization; Flu vaccine (Manufacturer and lot number: unknown, Route of anatomical location: unknown, No. of Previous Doses: NA, Date: Caller states sometime in Oct2021), administration date: Oct2021. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset Nov2021, outcome "recovered" (Feb2022), described as "DVT"; PERIPHERAL SWELLING (non-serious) with onset Feb2022, outcome "not recovered", described as "lower extremity swelling of her leg". The events "dvt" and "lower extremity swelling of her leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound Doppler: (Nov2021) Positive, notes: DVT Unit: Not provided; (Feb2022) Negative, notes: Unit: Not provided. Therapeutic measures were taken as a result of deep vein thrombosis. She had received prior vaccination within 4 weeks. She had no Adverse event occurred prior to vaccination. Pt received first booster dose of the Pfizer Covid-19 vaccine back in the middle of Oct2021 and in the middle of Nov2021 was diagnosed with a DVT. Her HCP has ran tests to determine the cause of her DVT but so far no reason has been found. Patient denies a medical history of DVT. Patient asked if the second booster dose of the Pfizer Covid-19 vaccine related to DVT and if it is safe to get a second booster dose of the Pfizer Covid-19 vaccine. She was diagnosed with a DVT, and that she had never had one before.  She had not been in emergency room with respect to events however she had visited physician office with respect to events. She was still having lower extremity swelling of her leg, but her DVT resolved completely. She was not admitted to the hospital. She was on a blood thinner for 3 months, and the medication helped the clot absorb. She had a follow up venous ultrasound and it was negative for DVT.    No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler
Clinical narrative: lower extremity swelling of her leg; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: EW0179) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot Number: EL3248, Expiry Date: unknown, Route, Anatomical Location: left arm), administration date: 16Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, single, Lot Number: EN9581, Expiry Date: unknown, Route, Anatomical Location: left arm), administration date: 06Feb2021, when the patient was 76-year-old, for COVID-19 immunization; Flu vaccine (Manufacturer and lot number: unknown, Route of anatomical location: unknown, No. of Previous Doses: NA, Date: Caller states sometime in Oct2021), administration date: Oct2021. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset Nov2021, outcome "recovered" (Feb2022), described as "DVT"; PERIPHERAL SWELLING (non-serious) with onset Feb2022, outcome "not recovered", described as "lower extremity swelling of her leg". The events "dvt" and "lower extremity swelling of her leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound Doppler: (Nov2021) Positive, notes: DVT Unit: Not provided; (Feb2022) Negative, notes: Unit: Not provided. Therapeutic measures were taken as a result of deep vein thrombosis. She had received prior vaccination within 4 weeks. She had no Adverse event occurred prior to vaccination. Pt received first booster dose of the Pfizer Covid-19 vaccine back in the middle of Oct2021 and in the middle of Nov2021 was diagnosed with a DVT. Her HCP has ran tests to determine the cause of her DVT but so far no reason has been found. Patient denies a medical history of DVT. Patient asked if the second booster dose of the Pfizer Covid-19 vaccine related to DVT and if it is safe to get a second booster dose of the Pfizer Covid-19 vaccine. She was diagnosed with a DVT, and that she had never had one before.  She had not been in emergency room with respect to events however she had visited physician office with respect to events. She was still having lower extremity swelling of her leg, but her DVT resolved completely. She was not admitted to the hospital. She was on a blood thinner for 3 months, and the medication helped the clot absorb. She had a follow up venous ultrasound and it was negative for DVT.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo, Vestibular disorder, Visual impairment, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: L#EL8987), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Meniere's ear" (unspecified if ongoing), notes: We both were diagnosed with the Meniere's ear 20 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number: dose 1, single, lot number: EL9266), administration date: 2021, for Covid-19 immunization. The following information was reported: VESTIBULAR DISORDER (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "Diagnosed with Vestibular  this has occurred with my husband. Received vaccine on the same day"; VERTIGO (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae"; VISUAL IMPAIRMENT (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "effects vision"; BALANCE DISORDER (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "lose of balance"; VOMITING (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "throwing up". Vertigo, throwing up lose of balance, effects vision. Diagnosed with Vestibular this has occurred with reporters husband. Received vaccine on the same day. They both were diagnosed with the Meniere's ear 20 years ago. Have never had any flare up until after taking vaccine. The patient was hospitalized for vertigo, vomiting, balance disorder, visual impairment, vestibular disorder (hospitalization duration: 3 day(s)). The events "vertigo", "throwing up", "lose of balance", "effects vision" and "diagnosed with vestibular  this has occurred with my husband. received vaccine on the same day" required emergency room visit/department or urgent care, Hospitalization. Therapeutic measures were taken as a result of vertigo, vomiting, balance disorder, visual impairment, vestibular disorder. Adverse event treatment was physical therapy.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Caller reported that his friend informed him that he was not taking the second booster due to loosing his hair after the first booster dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (COMIRNATY) (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. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, Primary Immunization series complete.), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, Primary Immunization series complete.), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "recovered", described as "Caller reported that his friend informed him that he was not taking the second booster due to loosing his hair after the first booster dose.".  Additional information: Caller reporting that he & his wife received both doses of the Pfizer Covid 19 Vaccine along with the first booster. Caller reported that his friend informed him that he was not taking the second booster due to losing his hair after the first booster dose. Caller asking if the booster dose has the same ingredient's as the previous booster or if the ingredient's change with each variant. PQC Present was reported as no. Report was related to a study or program was reported as yes. The caller is old and can't hear very well. The caller has a friend who this last time he got the booster dose, not the current one but the previous one. The patient is around 75 and lost some of his hair. Is this booster, the current booster, does it have the same ingredients at the previous booster or do the ingredients change every time there is a new variant. The caller didn't call to give information about this event. The patient's hair has come back and the caller is sure he consulted with (name) and did what they said to do. The patient's hair is back to normal.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Hypoaesthesia, Muscle twitching, Pain in extremity, Paraesthesia
Clinical narrative: she presented reaction in eyes and skin; she presented reaction in eyes and skin; twitching in the hands; pain, numbness and tingling in arms and legs; numbness and tingling in arms and legs; numbness and tingling in arms and legs; This is a spontaneous report received from a non-contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (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: SKIN REACTION (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "she presented reaction in eyes and skin"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain, numbness and tingling in arms and legs"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in arms and legs".  Additional information: Caller reported that she had got 1st and 2nd dose of the vaccine already but that she presented reaction in eyes and skin, twitching in the hands; pain, numbness and tingling in arms and legs; and also mentioned that she is afraid that pain presents with booster and doesn't go away. Caller asked if it is safe to take the booster since she had presented this reactions before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin reaction
Clinical narrative: she presented reaction in eyes and skin; she presented reaction in eyes and skin; twitching in the hands; pain, numbness and tingling in arms and legs; numbness and tingling in arms and legs; numbness and tingling in arms and legs; This is a spontaneous report received from a non-contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (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: SKIN REACTION (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "she presented reaction in eyes and skin"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain, numbness and tingling in arms and legs"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in arms and legs".  Additional information: Caller reported that she had got 1st and 2nd dose of the vaccine already but that she presented reaction in eyes and skin, twitching in the hands; pain, numbness and tingling in arms and legs; and also mentioned that she is afraid that pain presents with booster and doesn't go away. Caller asked if it is safe to take the booster since she had presented this reactions before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Hypoaesthesia, Muscle twitching, Nervous system disorder, Neuralgia
Clinical narrative: she presented reaction in eyes and skin; she presented reaction in eyes and skin; twitching in the hands; pain, numbness and tingling in arms and legs; numbness and tingling in arms and legs; numbness and tingling in arms and legs; This is a spontaneous report received from a non-contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (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: SKIN REACTION (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "she presented reaction in eyes and skin"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain, numbness and tingling in arms and legs"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in arms and legs".  Additional information: Caller reported that she had got 1st and 2nd dose of the vaccine already but that she presented reaction in eyes and skin, twitching in the hands; pain, numbness and tingling in arms and legs; and also mentioned that she is afraid that pain presents with booster and doesn't go away. Caller asked if it is safe to take the booster since she had presented this reactions before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Sensitive skin, Teething
Clinical narrative: she presented reaction in eyes and skin; she presented reaction in eyes and skin; twitching in the hands; pain, numbness and tingling in arms and legs; numbness and tingling in arms and legs; numbness and tingling in arms and legs; This is a spontaneous report received from a non-contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (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: SKIN REACTION (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "she presented reaction in eyes and skin"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain, numbness and tingling in arms and legs"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in arms and legs".  Additional information: Caller reported that she had got 1st and 2nd dose of the vaccine already but that she presented reaction in eyes and skin, twitching in the hands; pain, numbness and tingling in arms and legs; and also mentioned that she is afraid that pain presents with booster and doesn't go away. Caller asked if it is safe to take the booster since she had presented this reactions before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Guillain-Barre syndrome, Inflammation, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FF8839) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown"; MUSCLE FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "painful"; MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "severe pain and weakness in legs"; GAIT INABILITY (non-serious), outcome "unknown", described as "unable to walk"; INFLAMMATION (non-serious), outcome "unknown", described as "MRI of right knee showed inflammation"; WALKING DISABILITY (non-serious), outcome "unknown", described as "3 days started having severe pain and weakness in legs, within 2 weeks was unable to walk. 6 months later am still weak, muscle fatigue, painful"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: knee inflammation, notes: MRI of right knee showed inflammation but not much else. Clinical source: Patient received the Pfizer booster at the same time as the flu shot and within 3 days started having severe pain and weakness in legs, within 2 weeks was unable to walk. 6 months later patient was still weak, muscle fatigue, painful. Concerned may have Guillain-Barre syndrome. Her physician assistant know 6+ months of being weak, unsteady, in pain was not normal. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event 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: Muscle fatigue, Muscular weakness, Pain, Pain in extremity, Walking disability
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FF8839) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown"; MUSCLE FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "painful"; MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "severe pain and weakness in legs"; GAIT INABILITY (non-serious), outcome "unknown", described as "unable to walk"; INFLAMMATION (non-serious), outcome "unknown", described as "MRI of right knee showed inflammation"; WALKING DISABILITY (non-serious), outcome "unknown", described as "3 days started having severe pain and weakness in legs, within 2 weeks was unable to walk. 6 months later am still weak, muscle fatigue, painful"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: knee inflammation, notes: MRI of right knee showed inflammation but not much else. Clinical source: Patient received the Pfizer booster at the same time as the flu shot and within 3 days started having severe pain and weakness in legs, within 2 weeks was unable to walk. 6 months later patient was still weak, muscle fatigue, painful. Concerned may have Guillain-Barre syndrome. Her physician assistant know 6+ months of being weak, unsteady, in pain was not normal. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event 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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Additional information: Caller is a 77 years old, male patient, positive to Covid; he reached with a question regarding Paxlovid. Caller stated that his risk factors included Age and medical conditions that makes him immunocompromised. Caller mentioned to have COVID even though he had his 3 doses of Pfizer Covid Vaccine. Caller reported to had been in contact with pharmacies and that nobody seemed to know if Paxlovid was available. Caller asked for the availability of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Investigation
Clinical narrative: My blood pressure reading is over 200; My blood pressure was stable and controlled and suddenly after taking the booster, my systolic started going up and up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year and 4-month-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, LOT# EP7534), administration date: 18Mar2021, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Lot: EP7533), administration date: 08Apr2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: HYPERTENSION (medically significant) with onset 2021, outcome "not recovered", described as "My blood pressure reading is over 200; My blood pressure was stable and controlled and suddenly after taking the booster, my systolic started going up and up". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) over 200; (01Apr2022) 208 over 118; lab test: (unspecified date) Unknown result. Therapeutic measures were taken as a result of hypertension. Consumer stated that he got the booster (clarified as COVID-19 booster vaccine) in Octo of last year. He had very high Blood Pressure, 200, he never used to have that. He wanted to know why after he had the booster blood pressure reading is over 200." Consumer stated that his blood pressure was stable and controlled and suddenly after taking the booster, his systolic started going up and up. He had two procedures, a foot operation and a dental implant surgery cancelled because his blood pressure is too high, over 200. He stated that he need to know all side effects from the booster. He never had blood pressure this high. Consumer stated, "he just wanted to know what side effects and how many other people have high systolic readings like him." He is on more medications than ever before in his life and he is on Clonidine, Imdur, several other Edarbi, and on lot of potent high blood pressure pills because of this." Consumer stated, "It is persisting without the medication regularly my systolic, like today 208 over 118, reflects with my medication."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: swollen lymph nodes; fever; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 20May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Patient received his first dose of vaccine in the left arm without any issues.), for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "swollen lymph nodes"; PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "body aches".  Additional Information: 55-year-old male reported having had swollen lymph nodes, fever, chills, and body aches after receiving his second dose of COVID vaccine. Optional Information: Patient received his first dose of vaccine in the left arm without any issues. He received his second dose in the right arm and experienced the reported AEs. Second dose was received on 20May2021. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.