Sex: F
Vaccine: COVID19
Symptoms: Aspiration bone marrow, Biopsy bone marrow, Blood culture, COVID-19, COVID-19 pneumonia
Clinical narrative: Covid 19 Pneumonia; Covid 19 Pneumonia; Covid 19 - again Post Covid; Covid 19 Pneumonia; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 17May2021 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 (hospitalization, medically significant) with onset Jan2022, outcome "recovered" (05Apr2022), COVID-19 PNEUMONIA (medically significant) with onset Jan2022, outcome "unknown", DISEASE RECURRENCE (hospitalization, medically significant) with onset 31Mar2022, outcome "recovered" (05Apr2022) and all described as "Covid 19 Pneumonia"; COVID-19 (medically significant) with onset 20Oct2022, outcome "unknown", described as "Covid 19 - again Post Covid". The patient was hospitalized for drug ineffective, disease recurrence (start date: 31Mar2022, discharge date: 05Apr2022, hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: Aspiration bone marrow: (04Apr2022) results pending; Biopsy bone marrow: (24Oct2022) awaiting pathology results; Blood culture: (unspecified date) negative; (31Mar2022) Normal; (12Apr2022) Normal; BCMA mRNA: (unspecified date) Extremely low; SARS-CoV-2 test: (Jan2022) Positive, notes: COVID in Jan2022; (31Mar2022) Positive, notes: Date of start of reaction/event: 31Mar2022; (20Oct2022) Positive, notes: Covid 19 - again Post Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia, disease recurrence, covid-19. Clinical courses: The patient had Covid 19 Pneumonia from 31Mar2022, and recovered on 05Apr2022. And was hospitalized from 31Mar2022 to 05Apr2022. It was also reported that 64-Year-old woman with COVID in Jan2022, organizing pneumonia requiring supplemental oxygen at home and on clinical trial with BITE admitted with fevers. BCx negative. Bone marrow aspirate/biopsy 04Apr2022 - results pending. Afebrile. Steroids being tapered. Will arrange outpatient PET/CT. OK for discharge from oncologic perspective. Afebrile overnight. On room air. Denies dyspnea; cough improving. S/P BMBx yesterday - awaiting pathology results. Continues on steroid dosing per pulmonology. Cleared for discharge from oncology perspective with follow-up next week at (Withheld) as an outpatient. PET/CT scan can be scheduled as an outpatient. Blood cultures drawn on 31Mar and 12Apr. Normal results. There is no evidence of mutations or abnormal expression in any of the tested genes. Extremely low BCMA mRNA -The lack of abnormalities suggests lack of evidence of neoplastic clone or multiple myeloma. NS bolus 1,893 mL Ordered, Dose: 30 mL/kg 63.1 kg, Intravenous ONCE at 1,893 mL/hr over 1 Hours. Acetaminophen (Tylenol) tablet 650 mg orally once. Piperacillin-tazobactam (Zosyn) 4.5 g in 100 mL D5W IVPB, intravenously, once at 200 mL/hr over 30 Minutes Volume: 100 mL; Vancomycin 1.5g in D5W 300 mL IVPB (Premix), intravenously once at 200 mL/hr over 90 Minutes. Acetaminophen (Ofirmev) injection 1,000mg, intravenously once at mL/hr over 15 minutes. The patient had fever- unclear etiology, Covid 19 - again Post Covid, antibiotics, ID recommended no further treatment. The following medications were given as treatment for this SAE: Immune globulin 20 g intravenously, potassium chloride (10%) solution 40 mEq, oral 05Apr2022, and hydrocortisone (Cortef) 20 mg, from 01Apr2022 to 05Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional 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.