Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect incomplete
Clinical narrative: Psoriatic arthritis; Swelling of hands/fingers; Arthralgia; shooting pain from elbows to shoulders; Drug effect incomplete/Humira not completely effective/covered psoriasis all over body/sixty percent improvement since then; Tightness in chest; 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-163-4318108-00.  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Sep2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous, administration date 28Apr2020 (ongoing) (Batch/Lot number: unknown) as 40 mg (citrate free, 1 in 2 wk) for psoriasis. Relevant medical history included: "HYPOTHYROIDISM" (unspecified if ongoing); "BILATERAL BREAST REDUCTION", start date: Sep2018 (unspecified if ongoing), notes: (Started September 2018); "STRANGULATED UMBILICAL HERNIA", start date: 2016, stop date: 2016; "OVARIAN CYST REMOVED", start date: Feb1992 (unspecified if ongoing); "APPENDIX REMOVED", start date: Feb1992 (unspecified if ongoing); "SULFA ALLERGY" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 25Aug2021, for COVID-19 immunization. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Drug effect incomplete/Humira not completely effective/covered psoriasis all over body/sixty percent improvement since then"; CHEST DISCOMFORT (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Tightness in chest"; PERIPHERAL SWELLING (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Swelling of hands/fingers"; ARTHRALGIA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Arthralgia"; PAIN (non-serious) with onset 15Oct2021, outcome "unknown", described as "shooting pain from elbows to shoulders". Therapeutic measures were taken as a result of psoriatic arthropathy, therapeutic product effect incomplete, chest discomfort, peripheral swelling, arthralgia, pain. Clinical course was reported as, The patient was treated with Medrol, Meloxicam, Hydrocodone, Naproxen Sodium and Ibuprofen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for BNT162B2: The reporter considered "psoriatic arthritis", "drug effect incomplete/humira not completely effective/covered psoriasis all over body/sixty percent improvement since then", "tightness in chest", "swelling of hands/fingers" and "arthralgia" related to bnt162b2 (reported as Possible) and The reporters assessment of the causal relationship of the event "shooting pain from elbows to shoulders" with the suspect product 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.  Causality for (Adalimumab) HUMIRA: The reporter's causality for the event(s) of felt tightness in chest, swelling in hands/fingers, Humira not completely effective/covered psoriasis all over body/sixty percent improvement since then, unsured about psoriatic arthritis and shooting pain from elbows to shoulders was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. 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.