Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Osteoarthritis, Pain, Pruritus, Pyrexia
Clinical narrative: Osteoarthritis knees; general body ache; fever; Itchy legs; This is a solicited report from a Pfizer sponsored  based on information received by Pfizer, manufacture control number: 21K-163-3977066-00.  A contactable consumer (patient) reported a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 13Apr2021 (Batch/Lot number was not reported), at the age of 60-years-old,  as DOSE 2, SINGLE for Covid-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2018 (Batch/Lot number was not reported) to 2018, at unspecified dose for psoriatic arthritis.  Medical history included tobacco user and alcoholic, all from an unknown date and unknown if ongoing. Concomitant medication included meloxicam taken for inflammation, start and stop date were not reported. The patient received dose 1 of bnt162b2 on 15Mar2021 (batch/lot number not reported), intramuscular for Covid-19 immunisation and experienced legs itchy. In 2021, the patient experienced osteoarthritis in knees, fever, body ache, and running a temp. In Jun2021, the patient underwent knee surgery and was doing her physical therapy. She agreed to have physician contacted. In 2021, patient had second knee surgery, she was doing great but knees were tight. She was using cane. She had knee surgery and there might some arthritis left in her knees, because they were stiff, her healthcare professional was monitoring this. With the first COVID vaccine her legs itchy, and 2nd COVID vaccine she had fever and body ache, running a temp, she took paracetamol (TYLENOL). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown.   The reporter's causality of the events osteoarthritis knees, itchy legs, fever and body pain with Pfizer/Biontech Covid vaccine was not related. AbbVie's causality for the events was not provided for Pfizer/Biontech Covid vaccine.   The reporter's causality for the events of osteoarthritis in knees and itchy legs with HUMIRA 40MG/0.4ML(ADALIMUMAB) was not related. The reporter's causality for the events fever and body pain was not provided for HUMIRA 40MG/0.4ML(ADALIMUMAB). AbbVie's opinion is that there is no reasonable possibility that the events of osteoarthritis in knees, PFIZER/BIONTECH FIRST COVID VACCINE caused legs itchy, PFIZER/BIONTECH SECOND VACCINE caused fever and body ache, running a temp unknown onset and PFIZER/BIONTECH SECOND VACCINE caused ever and body ache, running a temp unknown onset are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Osteoarthritis knee, pyrexia, pain, pruritis and the suspect drug BNT162B2 cannot be excluded.    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.