Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Drug ineffective, Immunisation reaction, Insomnia
Clinical narrative: 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): 22K-163-4313941-00 (RA). A 22 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. Relevant medical history included: "joint pain" (ongoing), notes: felt a lot more joint pain with Humira. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "not recovered" and all described as "had Covid"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "recovered", described as "Vaccination adverse reaction"; LUNG DISORDER (non-serious), outcome "not recovered", described as "Lung had a bad reaction"; INSOMNIA (non-serious), outcome "not recovered", described as "less sleep"; ARTHRALGIA (non-serious), outcome "not recovered", described as "felt a lot more joint pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Sore Shoulder"; LIGAMENT SPRAIN (non-serious), outcome "not recovered", described as "wrist was sprained". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) had Covid, notes: the patient experienced had Covid. The action taken for adalimumab was unknown. The reporter considered "vaccination adverse reaction" related to bnt162b2. Clinical course: Solicited report by a consumer of a 22-year-old female with events of non-serious vaccine caused sore shoulder, had Covid and lungs had a bad reaction, wrist was sprained, less sleep and felt a lot more joint pain with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced had Covid and lungs had a bad reaction, wrist was sprained, less sleep and felt a lot more joint pain. In 2021, the patient experienced vaccine caused sore shoulder. In Jan2022, the patient experienced had Covid and lungs had a bad reaction. On an unknown date, vaccine caused sore shoulder resolved. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira(Adalimumab): The reporter's causality for the event(s) of Vaccine caused "vaccination adverse reaction" related to bnt162b2 and events Lung disorder, Wrist sprain, Sleep decreased, Arthralgia aggravated, COVID-19 was Not reported. The reporter causality for the events "vaccination adverse reaction" Possible to bnt162b2 and events Lung disorder, Wrist sprain, Sleep decreased, Arthralgia aggravated, COVID-19 was not reported to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up. Since no determination has been received for other events, the case is managed based on the company causality assessment. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.