Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Impaired healing, Mouth haemorrhage, Stomatitis
Clinical narrative: suspected auto immune reaction exacerbated with covid vaccination; sores developed in the mouth; mouth bleeding; sores developed in the mouth/were not healing; 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): 21K-163-4163210-00.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)), second regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)) and third regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)) for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "suspected auto immune reaction exacerbated with covid vaccination"; STOMATITIS (non-serious), outcome "recovering", described as "sores developed in the mouth"; MOUTH HAEMORRHAGE (non-serious), outcome "recovering", described as "mouth bleeding"; IMPAIRED HEALING (non-serious), outcome "unknown", described as "sores developed in the mouth/were not healing". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of sores developed in the mouth/were not healing unknown onset and mouth bleeding with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of suspected auto immune reaction exacerbated with covid vaccination with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of sores developed in the mouth/were not healing unknown onset with HUMIRA(ADALIMUMAB) was not provided.   Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event(s) of sores developed in the mouth/were not healing unknown onset and mouth bleeding, suspected auto immune reaction exacerbated with covid vaccination and sores developed in the mouth/were not healing unknown onset with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was 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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Autoimmune disorder 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