Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Ear pruritus, Metastatic cutaneous Crohn's disease, Paranasal sinus inflammation, Productive cough
Clinical narrative: Paranasal sinus inflammation; sinus phlegm; itchy skin behind ears; rash on underarm with Humira; gained weight; metastatic crohn's disease; 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-163-4511651-00.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 2, single (Lot number: EW0191) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 02May2022 as 80 mg (citrate free) (Batch/Lot number: unknown) and in 2022 (ongoing) as 40 mg (citrate free) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis, crohn's disease. The patient's relevant medical history included: "Alcohol use" (unspecified if ongoing), notes: Alcohol use/one glass of wine every night. Concomitant medication(s) included: MESALAMINE. Past drug history included: Penicillin, reaction(s): "Penicillin allergy manifested by rash and discoloration at injection site", notes: Penicillin allergy manifested by rash and discoloration at injection site; Sulfa, reaction(s): "Sulfa allergy manifested by rash", notes: Sulfa allergy manifested by rash; Codeine, reaction(s): "Codeine allergy manifested by rash", notes: Codeine allergy manifested by rash; Penicillin, reaction(s): "Penicillin allergy manifested by rash and discoloration at injection site", notes: Penicillin allergy manifested by rash and discoloration at injection site. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EW0168 via intramuscular), administration date: 14May2021, when the patient was 55-year-old, for Covid-19 immunisation. The following information was reported: WEIGHT INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "gained weight"; METASTATIC CUTANEOUS CROHN'S DISEASE (medically significant) with onset 2022, outcome "unknown", described as "metastatic crohn's disease"; PARANASAL SINUS INFLAMMATION (non-serious) with onset 02Jul2022, outcome "recovering"; EAR PRURITUS (non-serious) with onset 02Jul2022, outcome "recovering", described as "itchy skin behind ears"; PRODUCTIVE COUGH (non-serious) with onset 02Jul2022, outcome "recovering", described as "sinus phlegm"; RASH (non-serious) with onset Jul2022, outcome "not recovered", described as "rash on underarm with Humira". The patient underwent the following laboratory tests and procedures: Biopsy skin: (2022) Metastatic Crohn's disease, notes: Metastatic Crohn's disease; Weight: (2022) Weight gain, notes: Weight gain. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of ear pruritus, rash.  The reporter's assessment of the causal relationship of "metastatic crohn's disease", "paranasal sinus inflammation" and "gained weight" 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 "sinus phlegm" and "itchy skin behind ears" related to BNT162b2. The reporter considered "rash on underarm with humira" not related to BNT162b2.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded for both regimens. The patient was treated with hydrocortisone. Causality for humira (adalimumab): the reporter's causality for the event(s) of sinus inflammation, gained weight, sinus phlegm, itchy skin behind ears and metastatic crohn's disease was not provided. The reporter's causality for the event(s) of rash on underarm with humira(adalimumab) was a reasonable possibility. For Humira for event paranasal sinus inflammation causality as per reporter (drug/vaccine) was not reported. For events weight gain, phlegm (productive cough), localised itching (pruritus ) and causality as per reporter (drug/vaccine) was not accessable . For event crohn's disease (crohn's disease) causality as per reporter (drug/vaccine) was not reported. For localised rash (rash) causality as per reporter (drug/vaccine) was probable. For BNT162B2 for event paranasal sinus inflammation (paranasal sinus inflammation), weight gain (weight increased) and crohns disease (crohns disease) causality as per reporter (drug/vaccine) was not reported. For event phlegm (productive cough), localised itching (pruritus) causality as per reporter (drug/vaccine) was probable. For localised rash (rash) causality as per reporter (drug/vaccine) was not related.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the onset of "paranasal sinus inflammation" ,productive cough,pruritus and "gained weight cannot be excluded. however the reported event of rash was assessed unrelated to vaccine and related the concomitant medication Humira . The reported event of Metastatic Crohn's disease is assessed as not related to vaccine but more likely due to progression of disease and lack of efficacy of on going treatment of the medical condition. 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.