Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site warmth
Clinical narrative: booster; Itching; Pinched nerve; Feeling down; Sinus infection; Vaccination site pruritus; Vaccination site warmth; Vaccination site pain; arm hurt; aches; hot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at unk [citrate free] and second regimen subcutaneous from 30Sep2021 (Batch/Lot number: unknown) to 30Sep2021 at unk [citrate free] for psoriatic arthropathy. Relevant medical history included: "Back surgery", start date: 01Sep2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1) 1st Dose (1 in 1 Once), Route of Admin: , Intramuscular, Therapy Dates/Duration: , 1) 05Mar2021 - 05Mar2021), administration date: 05Mar2021, for COVID-19 immunization; Bnt162b2 (2nd Dose (1 in 1 Once), Route of Admin: Intramuscular, Therapy Dates/Duration: 26Mar2021 - 26Mar2021), administration date: 26Mar2021, for COVID-19 immunization. The following information was reported: PRURITUS (medically significant) with onset 2021, outcome "unknown", described as "Itching"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "booster"; NERVE COMPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Pinched nerve"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "Feeling down"; SINUSITIS (non-serious) with onset 2021, outcome "not recovered", described as "Sinus infection"; VACCINATION SITE PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pruritus"; VACCINATION SITE WARMTH (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site warmth"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm hurt"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "hot". The action taken for adalimumab was unknown. The reporter's causality for the event(s) of pinched nerve with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of second covid vaccine put patient down, sinus infection, due to covid booster arm hurt/aches /itching/hot onset in 2021, due to covid booster arm hurt/aches /itching/hot onset in 2021 and due to covid booster arm hurt/aches /itching/hot onset in 2021 was not provided. abbvie's opinion is that there is no reasonable possibility that the events of pinched nerve, second covid vaccine put patient down, due to covid booster arm hurt/aches /itching/hot onset in 2021, due to covid booster arm hurt/aches /itching/hot onset in 2021 and due to covid booster arm hurt/aches /itching/hot onset in 2021 are related to humira(adalimumab). RA's opinion is that there is a reasonable possibility that the event of sinus infection is related to humira(adalimumab).   The reporter's assessment of the causal relationship of the events "Feeling down, Vaccination site pruritus, Vaccination site warmth and vaccination site pain" was reported as possible and for other events with the suspect product 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 limited information in the case , a possible causal association between the reported events Immunisation ,Depressed mood, Nerve compression ,sinusitis, vaccination site pruritis, vaccination site warmth ,feeling hot ,pain, vaccination site pain, pain in extremity, and the suspect drug BNT162B2 cannot be 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.