Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive SARS-CoV-2 test (antibody nasopharyngeal swab)/Covid-19 pneumonia; Positive SARS-CoV-2 test (antibody nasopharyngeal swab)/Covid-19 pneumonia; This is a spontaneous report received from contactable reporter (Other HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) and on 19Oct2021 as dose 3 (booster), 0.3 ml single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "not recovered" and all described as "Positive SARS-CoV-2 test (antibody nasopharyngeal swab)/Covid-19 pneumonia". The patient was hospitalized for vaccination failure, covid-19 pneumonia (start date: 19May2022, discharge date: 24May2022, hospitalization duration: 5 days). 19May2022 16:34 Pt arrived to clinic this morning for # activities and assessments. Lab work within treatment parameters. Patient with tachypnea upon arrival and reported increased shortness of breath over the past few days accompanied by mild fevers and night sweats. T-max reported by family to be 100.5 F. Patient also reported that her typically dry cough had become more wet and productive. It was then decided by PI to hold treatment and admit the patient to hospital for infectious work-up and monitoring. Covid-19 nasopharyngeal swab resulted positive and Covid-19 pneumonia was diagnosed. Additional tests and plans for treatment remain pending at this time. It was reported Covid-19 pneumonia related to this SAE and hospitalization was treated with the following medications: methylprednisolone sodium succinate, 30mg, once, IV, 19May2022 methylprednisolone sodium succinate, 40mg, once, IV, 20May2022 methylprednisolone sodium succinate, 80mg, once, IV, 21May2022 methylprednisolone sodium succinate, 60mg, daily, IV, start: 22May2022, stop: 23May2022 remdesivir, 200mg, once, IV, 19May2022 remdesivir, 100mg, daily, IV, start: 20May2022, stop: 23May2022. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 100.5 Fahrenheit, notes: max; Lab work: (19May2022) Unknown results, notes: Lab work within treatment parameters; SARS-CoV-2 test: (19May2022) Positive, notes: antibody nasopharyngeal swab.    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 the available information and known product profile , the causal relationship between the reported  drug ineffectiveness and the use of BNT162b2 cannot be fully excluded.  However, the limited information on medical history and underlying illness precludes a more meaningful assessment. The case will be assessed further upon receipt of additional 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 RAs, Ethics Committees, and Investigators, as appropriate.