Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, SARS-CoV-2 test, Skin disorder, X-ray
Clinical narrative: skin disorder/area on elbow; Pain in arm; Shoulder pain//pain in shoulder; Back pain/pain in back; Neck pain/pain was coming from neck; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4240828-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from Nov2021 (Batch/Lot number: unknown) to Jan2022 at 40 mg (40 mg (citrate free), 1 in 2 weeks) and second regimen since Jan2022 (ongoing) (Batch/Lot number: unknown) at 40 mg, all subcutaneous for psoriasis. The patient's relevant medical history included: "Plantar Fasciitis", start date: 2020 (unspecified if ongoing), notes: Started 2020; "Non Smoker" (unspecified if ongoing); "Dermatitis" (unspecified if ongoing); "Alcohol/one beer or one glass wine, Occasionally" (unspecified if ongoing). Concomitant medication(s) included: MINOCYCLINE taken for dermatitis. Vaccination history included: Covid-19 vaccine (Intramuscular), administration date: Jan2021, for Covid-19 immunisation; Covid-19 vaccine (Intramuscular), administration date: Mar2021, for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "COVID-19"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin disorder/area on elbow"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; ARTHRALGIA (non-serious), outcome "unknown", described as "Shoulder pain//pain in shoulder"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain/pain in back"; NECK PAIN (non-serious), outcome "unknown", described as "Neck pain/pain was coming from neck". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; X-ray: (13Apr2022) Unknown results, notes: Pain was coming from neck; (13Apr2022) Unknown results, notes: Pain was coming from neck. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "covid-19", "skin disorder/area on elbow", "pain in arm", "shoulder pain//pain in shoulder", "back pain/pain in back" and "neck pain/pain was coming from neck" 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug Ineffective, Covid 19, skin disorder, pain in arm, arthralgia, back pain, neck pain to product and the suspect drug cannot be ruled out, hence the causality was kept as related. The case will be reassessed once new information is available.