Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dysphagia, Gingival pain, Magnetic resonance imaging, Pharyngitis, Spinal cord compression
Clinical narrative: compression in lower back; hard time swallowing; Throat infection; Sore gums; 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): 22K-163-4302425-00.  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 29Oct2021 (Lot number: 1155993) to Feb2022 at 40 mg (cf (40 mg 1 in 2 wk)) and second regimen subcutaneous since 2022 (ongoing) (Lot number: 1155993) at 40 mg (cf (40 mg 1 in 2 wk)) for ankylosing spondylitis. Relevant medical history included: "SPINAL FUSION" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Intramuscular), administration date: 30Mar2021, for covid-19 immunization; Bnt162b2 (DOSE 2, Intramuscular), administration date: 20Apr2021, for covid-19 immunization. The following information was reported: SPINAL CORD COMPRESSION (medically significant), outcome "unknown", described as "compression in lower back"; PHARYNGITIS (medically significant) with onset Feb2022, outcome "unknown", described as "Throat infection"; DYSPHAGIA (medically significant), outcome "unknown", described as "hard time swallowing"; GINGIVAL PAIN (medically significant) with onset Jan2022, outcome "unknown", described as "Sore gums". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: compression in lower back. The action taken for adalimumab was unknown.  Clinical course: The patient was experienced of compression in lower back and non-serious throat infection, injection site hole/injection site ring mark. On 26Feb2022, the patient had an issue with humira pen. He checked the pen window and the solution was clear, colorless and normal. He cleaned the injection site with alcohol, then removed cap 1 first straight off followed by cap 2 in order. Patient squeezed his skin at injection site prior And during the injection. Patient placed the pen at 90 degree angle against the injection site(thigh). Patient pressed the plum activator button and heard a click. Patient waited for 10 seconds prior to removing the pen From the site. When patient lifted the pen up, about half of the solution squirted out. Yellow indicator was Observed. He was on Antibiotics for a couple of days which he took Cefalexin 500mg capsule. He thought it might had been Streptococcus, but he was told it was viral. He also had hole on injection site from the needle puncture with the ring mark from white needle sleeve with humira 40mg/0.4ml (adalimumab). He also had hole on injection site from the needle puncture with the ring mark from white needle sleeve with humira 40mg/0.4ml (adalimumab). The patient was treated with cefalexin. It was also reported that, he had a hard time swallowing. He had been gum sore for two Months. He was gargling with sage water, which would help. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for BNT162B2 (Pfizer Biontech covid-19): The reporter assessed the causality for spinal cord compression, throat infection (pharyngitis) as possible while did not report the causality for Swallowing (dysphagia), Sore gums (gingival pain and reporter's assessment of the causal relationship of the events 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  Agency's opinion is that there is no reasonable possibility that the events of compression in lower back, e, hard time swallowing and sore gums are related to Humira 40mg/0.4ml(adalimumab). Agency's opinion is that there is a reasonable possibility that the events of Throat infection   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 information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  compression in lower back, hard time swallowing and sore gums and Throat infection is assessed as unrelated and mo0relikl;ry due to concomitant medication . 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.