Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Infection, Pneumonia, Respiratory tract infection
Clinical narrative: pneumonia; respiratory infection; Dose 1 on 15Jun2021 and dose 2 on 18Aug2021; 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 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg citrate free, every 2 weeks), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 15Jun2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "Pneumonia", "Respiratory infection"; BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 15Jun2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Infection". The following information was reported: INFECTION (non-serious) with onset 2021, outcome "unknown"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "Dose 1 on 15Jun2021 and dose 2 on 18Aug2021"; PNEUMONIA (medically significant), outcome "unknown"; RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "respiratory infection". The action taken for adalimumab was unknown. The formulation of humira was reported as Solution for Injection, Single Dose Pen.  Causalities: The reporters causality for the event(s) of infection, pneumonia and respiratory infection with Adalimumab Solution for Injection was Not Provided. The reporters causality for the event(s) of pneumonia and respiratory infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporters causality for the event(s) of infection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. RA opinion was that the causality for the event(s) of infection, pneumonia and respiratory infection with Adalimumab Solution for Injection was Not Provided RA 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 and Pfizer/BioNtech Covid-19 Vaccine- Pneumonia, Respiratory infection, Not Reported. Humira 40MG/0.4ML - Infection - Humira 40MG/0.4ML - Infection, Non-Health Care Professional, Not Reported. Pfizer/BioNtech Covid-19 Vaccine - Infection- Pfizer/BioNtech Covid-19 Vaccine - Infection, Non-Health Care Professional, Probable.  The reporter's assessment of the causal relationship of "pneumonia", "respiratory infection" and "dose 1 on 15jun2021 and dose 2 on 18aug2021" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events pneumonia, infection, respiratory tract infection, Inappropriate schedule of vaccine administration 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.  ,Linked Report(s) : US-PFIZER INC-PV202300029663 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300069764 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;