Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, General physical health deterioration, Psoriasis, Pyrexia
Clinical narrative: low grade fevers; Diarrhea; Psoriasis; down after booster covid dose for one week; FACILITATED COLLECT  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-163-4268772-00 (Agency).  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy, ankylosing spondylitis. The patient's relevant medical history included In 2018, the patient experienced shoulder injuries and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Admin: Intramuscular), for COVID-19 immunization; Bnt162b2 (Dose: 2, Route of Admin: Intramuscular), for COVID-19 vaccination, reaction(s): "down after second covid dose for one week", "lethargic after second covid dose", "Shoulder injuries". The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (medically significant) with onset 2021, outcome "recovered" (2021), described as "down after booster covid dose for one week"; PSORIASIS (medically significant) with onset 14Dec2021, outcome "recovered", described as "Psoriasis"; PYREXIA (medically significant), outcome "not recovered", described as "low grade fevers"; DIARRHOEA (medically significant), outcome "recovered", described as "Diarrhea". The action taken for adalimumab was unknown.  In 2018, the patient experienced shoulder injuries and her bone density was good. On 03Dec2021, she had) shoulder surgery and she was recovering from it. She had a better range of motion. On 14Dec2021, she was) diagnosed with psoriasis. Humira helped her with the psoriasis patches and stopped her diarrhea. After her 1st) Covid dose she was fine but after her 2nd covid dose she was down for a week. After the booster dose also she) was down for a week but not as lethargic as her 2nd dose. She experienced low grade fevers but did not know the) reason. Psoriasis patches was unified under Psoriasis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SHOULDER INJURIES, PATIENT WAS DOWN AFTER SECOND COVID DOSE FOR) ONE WEEK, PATIENT WAS LETHARGIC AFTER SECOND COVID DOSE, PATIENT WAS DOWN AFTER BOOSTER COVID DOSE FOR ONE) WEEK LOW GRADE FEVERS, PSORIASIS and DIARRHEA was not provided.) Causality of PFIZER BIONTECH COVID-19) VACCINE(TOZINAMERAN): The reporter's causality for the event(s) Shoulder injury (Limb injury) was Not Reported, Reduced general condition (General physical health deterioration): Possible, lethargic: Possible, Reduced general condition: Possible, Fever (Pyrexia): Not Reported, Psoriasis (Psoriasis): Not Reported, Diarrhea (Diarrhea): Not Reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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.