Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Device issue, Drug ineffective, Incorrect dose administered, Pain in extremity
Clinical narrative: COVID; COVID; Humira Pen Misfire/Pen Injected And Not All Went In Skin; Humira Pen Misfire/Pen Injected And Not All Went In Skin; Did not squeeze skin at injection site prior and during injection/just waited for five to eight seconds prior to removing pen from site/when lifted pen up; Rheumatoid arthritis flare up; Hand pain; 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-163-4217936-00 (Agency).  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single and intramuscular, administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 30Dec2021 (ongoing) (Lot number: 1155267) at 40 mg ((40 mg,1 in 2 wk)) and second regimen subcutaneous from 2011 (Lot number: 1155267) to 2020 at 40 mg ((40 mg,1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "ALCOHOL USE", start date: 2012 (unspecified if ongoing), notes: ALCOHOL USE/WINE OR BEER OR HARD LIQUOR (Started 2012); "NON SMOKER" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Methotrexate for Drug used for unknown indication, notes: METHOTREXATE for UNKNOWN INDICATION; Aleve for Drug used for unknown indication, notes: ALEVE for UNKNOWN INDICATION; Prednisone for Drug used for unknown indication, notes: PREDNISONE for UNKNOWN INDICATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID"; RHEUMATOID ARTHRITIS (medically significant) with onset Oct2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 30Dec2021, outcome "unknown" and all described as "Did not squeeze skin at injection site prior and during injection/just waited for five to eight seconds prior to removing pen from site/when lifted pen up"; DEVICE ISSUE (non-serious), outcome "recovering", described as "Humira Pen Misfire/Pen Injected And Not All Went In Skin"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "not recovered", described as "Hand pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  The reporter's causality assessment for the events Rheumatoid arthritis flare up and Hand pain with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was Possible and for other events, it was not reported. The reporter's causality for the event(s) of Covid, rheumatoid arthritis flare up and hand pain with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of Humira pen misfire/pen injected and not all went in skin unknown onset and Humira pen misfire/pen injected and not all went in skin unknown onset with Humira 40mg/0.4ml (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of did not squeeze skin at injection site prior and during injection/just waited for five to eight seconds prior to removing pen from site/when lifted pen up, a stream of liquid ran down leg was not provided.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events COVID-19, drug ineffective, rheumatoid arthritis, incorrect dose administered, wrong technique in product usage process, device issue, pain in extremity  and the suspect drug BNT162B2.