Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eczema, Pain in extremity, Psoriasis, White blood cell count, White blood cell count increased
Clinical narrative: White blood cell count increased; Eczema; Pain in thigh; Psoriasis; 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): 21K-163-4066290-00 (Abbvie).  A 61-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21May2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriasis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose (1 in 1 once), Route of Admin: Intra-muscular), administration date: 30Apr2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (hospitalization) with onset 2021, outcome "unknown", described as "White blood cell count increased"; ECZEMA (hospitalization) with onset 2021, outcome "unknown", described as "Eczema"; PAIN IN EXTREMITY (hospitalization) with onset 2021, outcome "unknown", described as "Pain in thigh"; PSORIASIS (hospitalization) with onset 2021, outcome "unknown", described as "Psoriasis". The patient was hospitalized for white blood cell count increased, eczema, pain in extremity, psoriasis (start date: 27Sep2021). The patient underwent the following laboratory tests and procedures: white blood cell count: elevated white blood count, notes: Patient was hospitalized on 27Sep2021, due to elevated white blood count. The action taken for adalimumab was unknown. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. Clinical course was reported as, the patient had events of elevated white blood count and non-serious eczema, thigh pain following covid vaccine and psoriasis with humira (Adalimumab). On unknown dates, the patient experienced elevated white blood count, eczema, thigh pain following covid vaccine and psoriasis. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect.  Patient was hospitalized on 27Sep2021, due to elevated white blood count. She had thigh pain following covid vaccines. She had eczema and psoriasis on her feet. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for humira (adalimumab) was reported as, the reporter's causality for the event(s) of elevated white blood count, eczema, thigh pain following covid vaccine and psoriasis was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of elevated white blood count, eczema, thigh pain following covid vaccine and psoriasis are related to humira(adalimumab). Change history: On 06Dec2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. the events of "elevated white blood count", "thigh pain following covid vaccine" and "psoriasis" were added. Check all appropriate to adverse reaction: involved or prolonged inpatient hospitalization.  Causality for humira (adalimumab): As per reporter causality for events white blood cell count increased, eczema, pain in thigh and psoriasis was not reported. Causality as per Manufacturer causality for events white blood cell count increased, eczema, pain in thigh and psoriasis was reported as no reasonable possibility. Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran):  As per reporter causality for events white blood cell count increased, eczema and psoriasis were not reported and pain in thigh was probably related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided a possible causal association between the reported events psoriasis, eczema, white blood cell count increased and BNT162b2 is unlikely.  Event pain in extremity association with BNT162B2 cannot be totally excluded. 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