Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Infection, Influenza like illness, Tooth extraction, Vaccination site pain
Clinical narrative: Fibromyalgia; Flu like symptoms; Walking difficulty; Chills; Vaccination site pain; Arthritis; Difficulty in standing; booster dose; Tooth extraction; Infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4180771-00 (RA).  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of administration: Intramuscular), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Route of administration: Intramuscular), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; TOOTH EXTRACTION (medically significant) with onset 2021, outcome "recovering", described as "Tooth extraction"; FIBROMYALGIA (non-serious), outcome "unknown", described as "Fibromyalgia"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (2021), described as "Flu like symptoms"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "Walking difficulty"; INFECTION (non-serious) with onset 2021, outcome "recovering", described as "Infection"; CHILLS (non-serious), outcome "recovered" (2021), described as "Chills"; VACCINATION SITE PAIN (non-serious), outcome "recovered" (2021), described as "Vaccination site pain"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis"; DYSSTASIA (non-serious), outcome "not recovered", described as "Difficulty in standing". The action taken for adalimumab was unknown. The events of non-serious flu like symptoms, could not walk or stand for long periods of time, tooth pulled, infection, chills, arm was sore on other vaccine, fibromyalgia and arthritis with Humira (Adalimumab). On unknown dates, the patient experienced flu like symptoms, could not walk or stand for long periods of time, chills, arm was sore on other vaccine, fibromyalgia and arthritis. In 2021, the patient experienced tooth pulled and infection. On unknown dates, flu like symptoms, chills and arm was sore on other vaccine resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of flu like symptoms, could not walk or stand for long periods of time unknown onset, tooth pulled, infection, chills, arm was sore on other vaccine and could not walk or stand for long periods of time unknown onset with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of fibromyalgia and Arthritis was not provided. The reporter's causality for the events of flu like symptoms, walking difficulty, tooth extraction, infection, chills, vaccination site pain, fibromyalgia, arthritis and difficulty in standing with PFIZER BIONTECH COVID-19 Vaccine was not related.   The reporter's assessment of the causal relationship of the events immunisation with the suspect product 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 reporter considered "tooth extraction", "fibromyalgia", "flu like symptoms", "walking difficulty", "infection", "chills", "vaccination site pain", "arthritis" and "difficulty in standing" not related to bnt162b2 and was unrelated for event immunisation. Company causality for event immunisation was unrelated and reporter causality was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: as there is limited information in the case provided, the causal association between the events immunisation, tooth extraction, fibromyalgia, influenza like illness, gait disturbance, infection, chills, vaccination site pain, arthritis and dysstasia with the suspect drug BNT162B2 cannot be excluded. the case will be reassessed once new information is available.