Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Hepatic steatosis, Lymphadenopathy, Pain, Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE UP; FATTY LIVER; PAIN ON RIGHT SIDE; SWOLLEN LYMPH NODES IN LEFT UNDER ARMS; SLIGHT FEVER; CHILLS; 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 35-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: unknown) at the age of 34 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 13Apr2021 (ongoing) (Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "SLIGHT FEVER"; 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".  solicited report from a consumer of a 35-year-old female with events of non-serious first booster caused swollen lymph nodes in left under arms, 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). there was no reported medical history.   in 2021, the patient experienced first booster caused swollen lymph nodes in left under arms and pfizer vaccinations caused slight fever and chills for six to eight hours. in 2021, the pfizer vaccinations caused slight fever and chills for six to eight hours resolved. pfizer biotech covid-19 vaccine (tozinameran) was also considered suspect. it was unknown if the patient was enrolled in a covid vaccine trial.  The reporter considered "swollen lymph nodes in left under arms", "slight fever" and "chills" related to BNT162b2. The reporter's assessment of the causal relationship of "fatty liver", "psoriatic arthritis flare up" and "pain on right side" 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 causality for the event (a) of FIRST BOOSTER CAUSED SWOLLEN LYMPH NODES IN LEFT UNDER ARMS, PFIZER VACCINATIONS CAUSED SLIGHT FEVER AND CHILLS FOR SIX TO EIGHT HOURS onset in 2021, FATTY LIVER, PFIZER VACCINATIONS CAUSED SLIGHT FEVER AND CHILLS FOR SIX TO RIGHT HOURS onset in 2021 and PAIN ON RIGHT SIDE with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.