Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon pain
Clinical narrative: Could Not Walk; Pain; Tendon Pain; Inflammation; Walking Causing Si Joint Painful; Bulging Disc Rupturned After Vaccination; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 27May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "Bulging Disc" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (prolonged hospitalization), outcome "unknown", described as "Could Not Walk"; PAIN (prolonged hospitalization), outcome "unknown"; TENDON PAIN (prolonged hospitalization), outcome "unknown"; INFLAMMATION (prolonged hospitalization), outcome "unknown"; ARTHRALGIA (prolonged hospitalization), outcome "unknown", described as "Walking Causing Si Joint Painful"; INTERVERTEBRAL DISC PROTRUSION (prolonged hospitalization), outcome "unknown", described as "Bulging Disc Rupturned After Vaccination". The action taken for adalimumab was unknown.  Solicited report from a consumer Of an adult female With events Of COULD NOT WALK AFTER VACCINATION and non-serious PAIN, TENDON PAIN, INFLAMMATION, WALKING CAUSING Sl JOINT PAINFUL and BULGING DISC RUPTURNED AFTER VACCINATION with HUMIRA (ADALIMUMAB). The patient had a relevant medical history Of BULGING DISC.   On unknown dates, the patient experienced COULD NOT WALK AFTER VACCINATION, PAIN, TENDON PAIN, INFLAMMATION, WALKING CAUSING SI JOINT PAINFUL and BULGING DISC RUPTURNED AFTER VACCINATION. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had a bulging disc before taking HUMIRA that ruptured after the vaccination. The physician said they did see incidences where the COVID vaccination seemed to exacerbated whatever issues she had before the vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting.  The reporter's causality for the event (S) of COULD NOT WALK AFTER VACCINATION and BULGING DISC RUPTCRNED AFTER VACCINATION With HCMIRA (ADALIMITMAB) was no reasonable possibility. The reporter's causality far the event (s) of PAIN, TENDON PAIN, INFLAMMATION and WALKING CAUSING JOINT PAINFUL was not provided. Company's opinion is that there is no reasonable possibility that the events Of COULD NOT WALK AFTER VACCINATION, PAIN, TENDON PAIN, INFLAMMATION, WALKING CAUSING Sl JOINT PAINFUL and BULGING DISC RUPTURNED AFTER VACCINATION are related to HUMIRA (ADALIMUMAB).  The reporter's assessment of the causal relationship of "could not walk", "pain", "tendon pain", "inflammation", "walking causing si joint painful" and "bulging disc rupturned after vaccination" 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 reporter's assessment of the causal relationship of the event with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.