Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, SARS-CoV-2 test, Suspected COVID-19, Vertigo
Clinical narrative: drug ineffective; COVID-19; Right shoulder pain; Carpal tunnel; Equilibrium off; Vertigo; Foggy; Hand pain; 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-163-4462143-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 09Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1157582), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "not recovered", described as "COVID-19"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Right shoulder pain"; CARPAL TUNNEL SYNDROME (non-serious), outcome "not recovered", described as "Carpal tunnel"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Equilibrium off"; VERTIGO (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Foggy"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Hand pain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed.  Clinical course: Solicited report by a consumer of an elderly female with events of  non-serious right shoulder pain, carpal tunnel, covid, equilibrium off, vertigo, foggy and hand pain with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced right shoulder pain, carpal tunnel, covid, equilibrium off, vertigo, foggy and hand pain. Pfizer Biontech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Other relevant history: Not Reported. Change history: On 06Sep2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of carpal tunnel, covid, equilibrium off, vertigo, foggy and hand pain were added.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of right shoulder pain, carpal tunnel, equilibrium off, vertigo, foggy and hand pain was not provided. The reporter's causality for the event(s) of covid with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer Biontech Covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of right shoulder pain, carpal tunnel, equilibrium off, vertigo, foggy and hand pain was not reported. The reporter's causality for the event(s) of COVID-19 was not related.  The reporter's assessment of the causal relationship of "drug ineffective", "covid-19", "right shoulder pain", "carpal tunnel", "equilibrium off", "vertigo", "foggy" and "hand pain" 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: Based on the information in the case report, a causal association between reported events Drug ineffective, suspected Covid-19, arthralgia, carpal tunnel syndrome, balance disorder, vertigo, feeling abnormal, pain in extremity and suspect BNT162B2 cannot b excluded.