Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Pain, Pain assessment, Sinusitis
Clinical narrative: COVID-19; COVID-19; Sinus infection; Ringing in ears; Two scaling spot; before take dosage felt aches/pains once taken it felt good about week until started had pain all over again; possible lack of effect (HUMIRA); Skin disorder; 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): 21K-163-3949443-00 (AbbVie).  A 51-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administration date May2021 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), first regimen subcutaneous from Feb2021 (Lot number: 1141161) to 2021 at 40 mg (40 mg,1 in 2 wk (citrate free)), second regimen subcutaneous from 2021 (Lot number: 1154440) to 2021 at citrate free and third regimen subcutaneous from 2021 (Lot number: 1154253) to 28Jun2021 at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Nov2021, outcome "unknown", COVID-19 (medically significant) with onset Nov2021, outcome "recovering" and all described as "COVID-19"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Two scaling spot"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "before take dosage felt aches/pains once taken it felt good about week until started had pain all over again"; DRUG INEFFECTIVE (non-serious) with onset 2021, outcome "recovering", described as "possible lack of effect (HUMIRA)"; SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Skin disorder"; SINUSITIS (non-serious) with onset Nov2021, outcome "recovering", described as "Sinus infection"; TINNITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Ringing in ears". The patient underwent the following laboratory tests and procedures: pain assessment: (2021) five to six out of ten. The action taken for adalimumab was unknown.  Clinical course: The patient had scaling spot come back, possible lack of effect/before take dosage felt aches/pains once taken felt good about until week until started had pain all over again, spots that recurring all over body, COVID, sinus infection and ringing in ears with HUMIRA 40MG/0.4ML (ADALIMUMAB). There was no reported medical history. In 2021, the patient experienced two scaling spots come back, possible lack of effect/before take dosage felt aches/pains once taken felt good about until week until started had pain all over again, spots that recurring all over body. In Nov2021, the patient experienced COVID, sinus infection and ringing in ears. In 2021, the two-scaling spot come back resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In May2021, he received COVID-19 Vaccine manufactured by Pfizer BioNTech. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of the event Skin scaly with the suspect product (bnt162b2) was possible, however causal relationship with other events was not reported.   Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter's causality for the event(s) of two scaling spot come back, possible lack of effect/before take dosage felt aches/pains once taken felt good about until week until started had pain all over again onset in 2021, spots that recurring all over body, COVID, sinus infection and ringing in ears was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (17Dec2021): This is a follow up solicited report based on the information received by Pfizer from AbbVie Inc. (Manufacturer control number: 21K-163-3949443-00). Updated information included: Event: Skin disorder, COVID-19, sinus infection, ringing in ears and drug ineffective (with description as reported: COVID-19), additional information, clinical course, laboratory/diagnostic procedures and narrative description and causality updated. Drug details (batch number, dose regimen) for HUMIRA updated.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event Drug ineffective , COVID-19, Skin exfoliation, Pain, Drug ineffective, Skin disorder , Sinusitis, Tinnitus 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.