Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: potts; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: N9581, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: FK9894, Location of injection: Arm Right), administration date: 12Apr2022, when the patient was 77-year-old, for COVID-19 immunization; Bnt162b2 (Dose Number: 3, Batch/Lot No: FK49894F, Location of injection: Arm Right), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Dec2022, outcome "not recovered" and all described as "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; BONE TUBERCULOSIS (medically significant) with onset 11Dec2022, outcome "not recovered", described as "potts". The events "potts" and "1st-5th doses mild flulike: ha, slcough,fatigue sore arm 48hrs" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive. It was unknown if therapeutic measures were taken as a result of bone tuberculosis, influenza like illness, headache, cough, fatigue, pain in extremity.  Additional information: Device timestamp: 17Dec2022 Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Pott's disease and BNT162B2.  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-202201381626 same patient and different drug dose/events.;US-PFIZER INC-202201381627 same patient and different drug dose/events.;US-PFIZER INC-202201381628 same patient and different drug dose/events.;US-PFIZER INC-202201381629 same patient and different drug dose/events.;