Sex: F
Vaccine: COVID19
Symptoms: Spinal cord compression
Clinical narrative: Spinal cord compression; 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-131-4429044-00.  An elderly female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 10Apr2015 (Batch/Lot number: unknown) at 40mg/ 0.8ml, second regimen (Batch/Lot number: unknown) at 40mg/ 0.4ml (1 in 2 wk) and third regimen (ongoing) (Batch/Lot number: unknown) at 40mg/ 0.4ml (1 in 2 wk), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing); "Spinal operation", start date: Jan2018 (unspecified if ongoing); "cervical spine surgery", start date: Jan2018 (unspecified if ongoing), notes: In Jan2018, the patient experienced cervical spine surgery. The patient's concomitant medications were not reported. The following information was reported: SPINAL CORD COMPRESSION (medically significant), outcome "recovered". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "spinal cord compression" 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.  Causality for Humira 40mg/0.4ml (Adalimumab):  The reporter's causality for the event(s) of pinched spinal cord and herniated disc from lumbar 3 to sacral area with humira 40mg/ 0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event (s) of cervical spine surgery was not provided.  Agency opinion is that there is no reasonable possibility that the events of pinched spinal cord, herniated disc from lumbar 3 to sacral area and cervical spine surgery are related to humira 40mg/0.4ml (Adalimumab).  Causality:  1) Spinal cord compression (Spinal cord compression) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfg. (Drug/Vaccine): No reasonable possibility Dechallenge: N/A 2) Herniated disc (Intervertebral disc protrusion) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfg. (Drug/Vaccine): No reasonable possibility Dechallenge: N/A 3) Spinal operation (Spinal operation)  Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfg. (Drug/Vaccine): No reasonable possibility Dechallenge: N/A  Causality for Bnt162b2 (Tozinameran):  1) Spinal cord compression (Spinal cord compression) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A 2) Herniated disc (Intervertebral disc protrusion) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  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 known safety profile and Limited information in the case report, a casual association between reported event Spinal cord compression and the suspect drug 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