Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Bronchitis, Chest discomfort, Chills, Cough
Clinical narrative: Headache; Heavy chest feeling; Chest congestion; Flu-like symptoms; Throat pain; Pain / Aching; Pneumonia; Nasal sinus discharge; Weakness; Tiredness; Runny nose; Chills; Smoker's cough; Bronchitis; Sinusitis; This is a solicited report received from non-contactable reporter(s) (Consumer) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4190209-00 (MFR. CONTROL NO), 21K-163-4198756-00.  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for moderate to severe rheumatoid arthritis. Relevant medical history included: "Tobacco user" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "not recovered", described as "Pneumonia"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "Throat pain"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain / Aching"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "Heavy chest feeling"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered", described as "Chest congestion"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "Flu-like symptoms"; PARANASAL SINUS HYPERSECRETION (non-serious) with onset 2021, outcome "not recovered", described as "Nasal sinus discharge"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tiredness"; RHINORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Runny nose"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "Chills"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "Smoker's cough"; BRONCHITIS (non-serious) with onset 2021, outcome "not recovered", described as "Bronchitis"; SINUSITIS (non-serious) with onset 2021, outcome "not recovered", described as "Sinusitis". The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced throat pain, soreness/pain, heavy chest feeling, chest congestion, flu-like symptoms, sinus draining and headache due to smoking and living in a cold. In 2021, the patient experienced weakness, tiredness, runny nose, chill, coughing due to smoking, pneumonia with sinus drainage, bronchitis, sinusitis and aching. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of throat pain, soreness/pain, heavy chest feeling, congestion, flu-like symptoms, sinus draining and headache due to smoking and living in a cold with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of weakness, tiredness, runny nose, chill, coughing due to smoking, pneumonia with sinus drainage onset in 2021, bronchitis, sinusitis, pneumonia with sinus drainage onset in 2021 and aching was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pneumonia and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.