Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mycobacterium tuberculosis complex test, SARS-CoV-2 test
Clinical narrative: Vaccination reaction; She got sick for nine days after receiving the second booster with Pfizer on 18Apr2022.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426107-00.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 2022 (Batch/Lot number: unknown) to Jul2022 at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Sinus infection" (unspecified if ongoing); "Ear ache" (unspecified if ongoing); "Swollen face" (unspecified if ongoing); "Allergic reaction" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Bnt162b2 (Primary booster dose, Intramuscular), for COVID-19 immunization; Moderna covid-19 vaccine (1st dose: Mar2021 , 2nd dose: Apr2021, route of administration: intramuscular), for COVID-19 immunization, reaction(s): "Tuberculosis exposure", "Fear of disease", "Shingles", "Tuberculosis test positive", "Nausea", "Nerve block", "Knee osteoarthritis", "Lung nodule", "Tuberculosis", "Chickenpox"; Moderna covid-19 vaccin (1st dose: Mar2021 , 2nd dose: Apr2021, route of administration: intramuscular), for COVID-19 immunization, reaction(s): "Pain". The following information was reported: ILLNESS (medically significant) with onset 2022, outcome "unknown", described as "She got sick for nine days after receiving the second booster with Pfizer on 18Apr2022."; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "Vaccination reaction". The patient underwent the following laboratory tests and procedures: Blood test: (2022) Negative; Chest X-ray: (07Jun2022) Negative Tuberculosis; Mycobacterium tuberculosis complex test: (unspecified date) Unknown result; SARS-CoV-2 test: (12Apr2022) Negative; (Jun2022) Unknown result; unidentified laboratory test: (2022) positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "she got sick for nine days after receiving the second booster with pfizer on 18apr2022." and "vaccination reaction" 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 assessment.  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 and a plausible temporal relationship, a possible causal association between the 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.