Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Pneumonia, Respiratory tract infection
Clinical narrative: pneumonia; respiratory infection; infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4272717. A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 40 mg, (citrate free) (every 2 weeks) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious) with onset 2021, outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "respiratory infection". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "pneumonia" and "respiratory infection" with the suspect product(s) 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 reporter considered "infection" related to BNT162b2.  The reporter's causality for the event(s) of infection, pneumonia and respiratory infection with Adalimumab Solution for Injection was Not Provided. Regulatory Authority opinion was that the causality for the event(s) of infection, pneumonia and respiratory infection with Adalimumab Solution for Injection was Not Provided. Regulatory Authority opinion was that the causality for the event(s) of infection, pneumonia and respiratory infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: -Humira 40MG/0.4ML - Infection, Pneumonia, Respiratory infection, Regulatory Authority -Humira 40MG/0.4ML - Infection, Pneumonia, Respiratory infection, Non-Health Care Professional, Regulatory Authority, Not Reported. -Pfizer/BioNtech Covid-19 Vaccine - Infection, Pneumonia, Respiratory infection, Regulatory Authority -Pfizer/BioNtech Covid-19 Vaccine - Infection, Non-Health Care Professional, Regulatory Authority, Probable -Pfizer/BioNtech Covid-19 Vaccine - Pneumonia, Respiratory infection, Non-Health Care Professional, Regulatory Authority, Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Pneumonia, Infection and Respiratory infection. 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-202300069763 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300069764 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;