Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Illness
Clinical narrative: Brain fog; COVID-19; COVID-19; Sick; 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-163-4391849-00.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Intramuscular), as dose 2, single (Lot number: Intramuscular), as dose 3 (booster), single (Lot number: Intramuscular) and in 2022 as dose 4 (booster), single (Lot number: Intramuscular) at the age of 30 years for covid-19 immunisation; adalimumab (HUMIRA), since 02Jan2009 (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19"; ILLNESS (non-serious), outcome "recovered", described as "Sick"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Brain fog". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "covid-19" and "brain fog" 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 "sick" related to BNT162b2. Additional information: Solicited report by a consumer of a 30-year-old female with events of non-serious sick, brain fog and COVID-19 with Humira (Adalimumab). 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 sick and brain fog with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event (s) of COVID-19 was not provided. HUMIRA (Solution for injection in pre-filled pen) (Adalimumab) Causality: 1) Sickness (Illness): Causality as per reporter (Drug/Vaccine):  Not Related 2) Foggy feeling in head  (Feeling abnormal): Causality as per reporter (Drug/Vaccine):  Not Related 3)COVID-19  (COVID-19): Causality as per reporter (Drug/Vaccine):  Not Reported. Pfizer BioNTech COVID-19 vaccine (Tozinameran). Causality: 1) Sickness (Illness): Causality as per reporter (Drug/Vaccine):  Possible 2)Foggy feeling in head  (Feeling abnormal) Causality as per reporter (Drug/Vaccine):  Not Reported. 3)COVID-19  (COVID-19) Causality as per reporter (Drug/Vaccine):  Not Reported  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.