Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod bite, Chills, Hepatic steatosis, Lymphadenopathy, Pain
Clinical narrative: Psoriatic arthritis flare up; Fatty liver; Pain on right side; Allergic to spider bites; Sore arm on right side; Slight fever; Chills; Swollen lymph nodes in left under arms; 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-163-4423021-00 (AbbVie).  A 34-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 13Apr2022 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer biontech coviD-19 vaccine (Dose 1, Route of administration : Intramuscular), administration date: 20Mar2021, when the patient was 34-year-old, for covid-19 immunization, reaction(s): "swollen lymph nodes in left under arms". The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021); PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Slight fever"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Sore arm on right side"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen lymph nodes in left under arms"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis flare up"; HEPATIC STEATOSIS (non-serious), outcome "not recovered", described as "Fatty liver"; PAIN (non-serious), outcome "unknown", described as "Pain on right side"; ALLERGY TO ARTHROPOD BITE (non-serious), outcome "not recovered", described as "Allergic to spider bites". The action taken for adalimumab was unknown.  The reporter considered "psoriatic arthritis flare up", "pain on right side" and "allergic to spider bites" not related to BNT162b2. The reporter's assessment of the causal relationship of "sore arm on right side", "slight fever", "chills", "fatty liver" and "swollen lymph nodes in left under arms" 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.  Clinical course: Events of non-serious first booster caused swollen lymph nodes in left under arms, second booster caused sore arm on right side, allergic to spider bites, prizer vaccinations caused slight fever and chills for six to eight hours, fatty liver, psoriatic arthritis flare up and pain on right side with Humira (Adalimumab). It was unknown if the patient was enrolled in a Covid vaccine trial. Humira (Daily dose: Citrate free). Other relevant history was not reported. Dose 1st was taken on 20Mar2021, dose 2nd on 20Apr2021 and dose 3rd on 20Aug2021. Causality was reported as not related for suspect BNT162b2 and Humira as per reporter.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.