Age: 61.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Ligament disorder, Nerve injury, Pain
Clinical narrative: Ligament disorder; Nerve damage; Pain; FACILITATED COLLECT  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-163-4160871-00 (Agency).  A 61-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1153557) at citrate free for psoriatic arthropathy; apremilast (OTEZLA), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Route of Admin : 1) Intra-muscular), administration date: 15Mar2021, when the patient was 61 years old, for COVID-19 vaccination, reaction(s): "body swelled up", "tumor in back of head got bigger". The following information was reported: LIGAMENT DISORDER (medically significant), outcome "unknown", described as "Ligament disorder"; NERVE INJURY (non-serious), outcome "unknown", described as "Nerve damage"; PAIN (non-serious), outcome "not recovered", described as "Pain". The action taken for adalimumab and apremilast was unknown.  The patient had Knee surgery on ligaments in the knee and bad reaction to first pfizer covid shot which was body swelled up and tumor in back of head got bigger and non-serious nerve damage, bad reaction to first pfizer covid shot which was body swelled up and tumor in back of head got bigger and pain with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) and Otezla (apremilast) were also considered suspect. Her physician advised her not to take second shot. In Aug2021, she had knee surgery on ligaments in the knee. She was not recovered from knee surgery. 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 knee surgery on ligaments in the knee, bad reaction to first Pfizer covid shot which was body swelled up and tumor in back of head got bigger unknown onset, nerve damage, bad reaction to first pfizer covid shot which was body swelled up and tumor in back of head got bigger onset in mar2021 and pain was not provided. Agency's opinion is that there is no reasonable possibility that the events of knee surgery on ligaments in the knee, nerve damage, bad reaction to first Pfizer covid shot which was body swelled up and tumor in back of head got bigger onset in mar2021 and pain are related to humira(adalimumab). Agency's opinion is that the event of bad reaction to first Pfizer covid shot which was body swelled up and tumor in back of head got bigger unknown onset is not assessable. On 14Dec2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of " nerve damage " and "pain" were added. The reporter causality of event Ligament disorder was not reported with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) and causality of other events Brain tumor, Nerve damage, Swelling and pain was possible with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN). The causality of Ligament disorder, brain tumor, nerve damage, swelling and pain was not reported with OTEZLA(APREMILAST)(APREMILAST), UNKNOWN.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of ligament disorder, nerve injury, pain,is assessed as possibly related to the suspect drug "BNT162B2" based on temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.