Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Drug ineffective, Pain, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Soreness; Bronchitis; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from AbbVie. A contactable consumer (patient) reported that a 58-year-old male patient of an unspecified age received bnt162b2, intramuscularly on 20Apr2021 (Batch/Lot number was not reported) at the age of 57-year-old as dose 1, single, intramuscularly on 20May2021 (Batch/Lot number was not reported) at the age of 57-year-old as dose 2, single for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) and ongoing, at unknown dose (CF) for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 on 20Aug2021 with outcome of unknown, soreness in 2021 with outcome of unknown, bronchitis in 2021 with outcome of not recovered. Solicited report by a consumer of a 58 years old male with events of non-serious covid-19 Pfizer Booster caused soreness, bronchitis and-COVID-19 with adalimumab (HUMIRA). There was no reported medical history. On an unknown date, the patient experienced bronchitis. In 2021, the patient experienced COVID-19 Pfizer booster caused soreness. On 20Aug2021, the patient experienced COVID-19. Pfizer Biontech covid-19 vaccine (TOZINAM-ERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Apr2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20May2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was dose not change.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of covid-19 Pfizer booster caused soreness, bronchitis and covid-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality for Pfizer Biontech covid-19 vaccine (TOZINAMERAN): The reporter's causality for the events of soreness with bnt162b2 was Probable, for bronchitis and covid-19 was not reported.  The reporter's assessment of the causal relationship of the events (bronchitis and covid-19) with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the reported events Drug ineffective, suspected COVID-19,pain, Bronchitis and  the suspect drug "BNT162B2" cannot be completely 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.