Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Headache, Memory impairment
Clinical narrative: Tension in body; Brain fogg; Memory issues; Headache; COVID-19; COVID-19; This is a solicited report from a Non-Interventional Study based on information received by Pfizer.  Solicited report by a non-contactable 31-year-old male patient with events of non-serious COVID, tension in body, brain fogg, memory issues and headache with HUMIRA (adalimumab). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Medical history and concomitant medications were not reported. On unspecified date, patient started to receive adalimumab (HUMIRA) subcutaneous, at unspecified dose, for moderate to severe adult Crohn's disease and ankylosing spondylitis. On 09Jul2021, patient received COVID-19 Vaccine (manufactured by Pfizer/biontech, lot number and expiration date were unknown) at the age of 31-years-old as dose 1, single, for COVID-19 immunization. On an unknown date in 2021, the patient experienced COVID. Patient showed a positive SARS-CoV-2 test on unspecified date in 2021.  In Jul2021, the patient experienced tension in body, brain fogg, memory issues and headache. In 2021, the tension in body, brain fogg, memory issues and headache were resolved. On an unknown date in 2021, COVID was resolved. Action taken with adalimumab was unknown.  Causality for Humira (ADALIMUMAB): The reporter's causality for the event COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of tension in body, brain fogg, memory issues and headache were not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): The reporter's causality for the event COVID-19 was not reported, while for events muscle tension, foggy feeling in head, memory impaired, and headache was possible.  Change History: On 09Sep2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The events of "tension in body", "brain fogg", "memory issues" and "headache" were added.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed upon receipt of follow-up information.   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.