Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fall, Fatigue, Foot fracture, Injury
Clinical narrative: psoriatic arthritis flare up; broke two toes; vaccines caused fatigue and sore arm; vaccines caused fatigue and sore arm; injury/left arm hurts from fall/arm injury; injury/left arm hurts from fall; weird taste; injury; sore throat; cough; fever; Vaccination site pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. Other Case identifier(s): 22K-163-4513759-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Sep2017 (ongoing) (Lot number: 1160836) at cf, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; FOOT FRACTURE (medically significant), outcome "unknown", described as "broke two toes"; FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "vaccines caused fatigue and sore arm"; LIMB INJURY (non-serious), outcome "unknown", described as "injury/left arm hurts from fall/arm injury"; FALL (non-serious), outcome "unknown", described as "injury/left arm hurts from fall"; TASTE DISORDER (non-serious), outcome "unknown", described as "weird taste"; INJURY (non-serious), outcome "recovering"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was dosage not changed. Clinical course as follows: Solicited report from a consumer of an elderly female with events of non-serious vaccines caused fatigue and sore arm, injury/left arm hurts from fall, weird taste, injury, broke two toes, psoriatic arthritis flare up, sore throat, cough and fever with Humira (Adalimumab). On unknown dates, the patient experienced vaccines caused fatigue and sore arm, injury/left arm hurts from fall, weird taste, injury, broke two toes, psoriatic arthritis flare up, sore throat, cough and fever. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. 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 Vaccination site pain, vaccines caused fatigue and sore arm unknown onset, injury/left arm hurts unknown onset, vaccines caused fatigue and sore arm unknown onset and injury with Humira (Adalimumab) was no reasonable possibility (no related). The reporter's causality for the event(s) of weird taste (Taste disorder), broke two toes, fall, sore throat, cough and fever was not provided. The reporter's causality for the event(s) of psoriatic arthritis flare up with Humira(Adalimumab) was a reasonable possibility.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare up", "broke two toes", "vaccines caused fatigue and sore arm", "injury/left arm hurts from fall/arm injury", "injury/left arm hurts from fall", "weird taste", "injury", "sore throat", "cough", "fever" and "vaccination site pain" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "psoriatic arthritis flare up", "broke two toes", "vaccines caused fatigue and sore arm", "injury/left arm hurts from fall/arm injury", "injury/left arm hurts from fall", "weird taste", "injury", "sore throat", "cough", "fever" and "vaccination site pain" . 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.