Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination failure, Weight decreased
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; sweats; lost 25 lbs; Runny nose; Pneumonia; Heart beating too fast; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4285746-00 (Agency).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at 40 mg (cf[citrate free]) for rheumatoid arthritis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (caused and prolonged hospitalization, medically significant), VACCINATION FAILURE (caused and prolonged hospitalization, medically significant) all with onset 04Jan2022, outcome "recovered" (23Jan2022) and all described as "COVID-19 virus test positive"; PNEUMONIA (medically significant) with onset 23Jan2022, outcome "recovering", described as "Pneumonia"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 25 lbs"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; HEART RATE INCREASED (non-serious) with onset 07Jan2022, outcome "unknown", described as "Heart beating too fast". The patient was hospitalized and prolonged hospitalization for covid-19, vaccination failure (start date: 04Jan2022, discharge date: 23Jan2022, hospitalization duration: 19 day(s)). The patient underwent the following laboratory tests and procedures: heart rate: (07Jan2022) too fast; sars-cov-2 test: (04Jan2022) positive; weight decreased: (unspecified date) 25 lbs. The action taken for adalimumab was dosage not changed.  Causality for Humira 40mg/0.4ml (Adalimumab): The reporter's causality for the event(s) of covid-19 positive, pneumonia and heart beating too fast with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of lost 25lbs prior to being and runny nose was not provided. Agency's opinion is that there is no reasonable possibility that the events of covid-19 positive, lost 25lbs prior to being, runny nose, pneumonia and heart beating too fast are related to Humira 40mg/0.4ml (Adalimumab). Relevant laboratory & other diagnostic tests unknown date covid test: positive.  Causality:  for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for all the event(s) was possible.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events 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