Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Sinusitis
Clinical narrative: More pain; Bad sinus infection; very tired; Drug ineffective; COVID-19; Pulmonary embolism; 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-163-4465128-00 (Agency).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 34 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till 2022 at unk (citrate free) and second regimen since 2022 (ongoing) (Batch/Lot number: unknown) at unk (citrate free), all subcutaneous for ankylosing spondylitis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The following information was reported: SINUSITIS (non-serious) with onset Aug2021, outcome "recovered", described as "Bad sinus infection"; COVID-19 (medically significant) with onset Aug2021, outcome "recovered"; DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome "recovered"; PULMONARY EMBOLISM (medically significant) with onset Aug2021, outcome "recovered"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered", described as "very tired"; PAIN (non-serious) with onset 2022, outcome "not recovered", described as "More pain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. The action taken for adalimumab was dosage not changed.  Clinical information: In Aug2021, patient developed pulmonary embolism might have been covid-19 vaccine related. Also in Aug2021, she had covid-19, really bad sinus infection and very tired. She had more pain as of 11Jul2022 due to having to stop taking every ten days due to insurance switch.  The reporter's assessment of the causal relationship of "drug ineffective", "covid-19", "more pain", "bad sinus infection" and "very tired" 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 "pulmonary embolism" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of pulmonary embolism, covid-19 and bad sinus infection with Humira (Adalimumab) was no reasonable possibility/ Not Related. The reporter's causality for the event(s) of more pain with Humira (Adalimumab) was a reasonable possibility/ Probable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective", "covid-19", "more pain", "bad sinus infection,Pulmonary embolism. 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