Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Stomatitis, Therapeutic product effect decreased
Clinical narrative: infection; sores in the mouth; Humira became ineffective; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4276941-00.  A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 2021 at citrate free for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFECTION (hospitalization) with onset Aug2021, outcome "recovered", described as "infection"; STOMATITIS (hospitalization) with onset Aug2021, outcome "recovered", described as "sores in the mouth"; THERAPEUTIC PRODUCT EFFECT DECREASED (hospitalization) with onset Aug2021, outcome "recovered", described as "Humira became ineffective". The action taken for adalimumab was dosage permanently withdrawn on 2021. Therapeutic measures were taken as a result of infection. Clinical information: The patient reported HUMIRA became ineffective was followed by sores in the mouth and a severe infection which landed her in the hospital. She was treated for infection and stopped HUMIRA and symptoms were resolved. Had Pfizer vaccine in May2021 and started noticing issues in Aug2021. Believed the vaccine might have impacted HUMIRA treatment. 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 INFECTION and HUMIRA BECAME INEFFECTIVE with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of SORES IN THE MOUTH was not provided. AbbVie's opinion is that the event of INFECTION is not assessable. Product manufacturer's opinion is that there is no reasonable possibility that the events of SORES IN THE MOUTH and HUMIRA BECAME INEFFECTIVE are related to HUMIRA(ADALIMUMAB) and reported for the suspect drug TOZINAMERAN as possible.  HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), UNKNOWN: Causality: Infection (Infection): Causality as per reporter (Drug/Vaccine): Reasonable possibility, Causality as per Mfr.(Drug/Vaccine): Not assessable. Sores mouth (Stomatitis) Causality as per reporter (Drug/Vaccine): Not Reported. Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Drug effect decreased (Therapeutic product effect decreased), Causality as per reporter (Drug/Vaccine): Reasonable possibility, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility.  PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN), UNKNOWN: Causality: Infection (Infection),Causality as per reporter (Drug/Vaccine): Possible, Sores mouth (Stomatitis) Causality as per reporter (Drug/Vaccine): Possible, Drug effect decreased (Therapeutic product effect decreased), Causality as per reporter (Drug/Vaccine): Possible.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.