Sex: M
Vaccine: COVID19
Symptoms: Varicella virus test, Vitamin B12
Clinical narrative: This is a literature report for the following literature source(s): "Isolated long thoracic nerve palsy following COVID-19 vaccine: a case report". A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypercholesterolemia" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "various fractures of the left wrist" (unspecified if ongoing); "bilateral inguinal hernia" (unspecified if ongoing); "bilateral inguinal hernia operation" (unspecified if ongoing); "Non smoker" (ongoing); "regularly drink alcohol" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: LONG THORACIC NERVE PALSY (medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "recovering", described as "Isolated long thoracic nerve palsy". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin M: Negative; Blood iron: normal results; Borrelia test: positive; Cytomegalovirus test: Negative; Electroneuromyography: neurologist was highly suggestive, notes: of an isolated long thoracic axonal neuropathy; Full blood count: normal; Hepatitis B antibody: negative; Hepatitis E antibody: negative; HIV antigen: Negative; Immunology test: was negative for proteins p17, p19, notes: p21, p30, p31, p39, p83 and VLsE, but positive for p25 (= OspC), which is compatible for early infection or cross-reactions with herpes viruses; Bilateral ulnar and median nerve sensory conduction: normal; of the right serratus anterior, notes: showed decreased recruitment of compound motor unit action potential and maximum volitional activity; normal; normal; normal; positive; Negative; Negative; Negative; Negative; Negative; Negative; Negative; strictly normal, notes: All reflexes were normal and symmetrical; Negative; Magnetic resonance imaging: right shoulder, which was normal; cervical plexus did show integrity of the brachial, notes: without hypersignal, contrast enhancement or compression, symmetrical muscles of the shoulder and scapula, without amyotrophy or oedema, normal and symmetrical serratus anterior, and moderate uncus and disk arthritis from C5 to C7 without spinal or foraminal narrowing or myelopathy; Physical examination: revealed a winged scapula on the right side, notes: and marked amyotrophy of the serratus anterior, with preservation of the other muscles of the shoulder; SARS-CoV-2 antibody test: positive; Varicella virus test: positive; Vitamin B12: normal results. Therapeutic measures were taken as a result of long thoracic nerve palsy. Clinical Information: A 46-year-old (ethnicity) man developed back pain, followed by pain in the right axilla and scapular region, clumsiness of the right arm and unusual position of his shoulder blade, three days after receiving a second dose of the Pfizer-BioNTech COVID-19 vaccine. When he consulted a neurologist six months later, the pain had subsided, but the other symptoms persisted despite physiotherapy. Main clinical findings were right scapular winging and marked amyotrophy of the serratus anterior, with preservation of the other muscles of the shoulder and scapula. Nerve conduction studies of the long thoracic nerve yielded a low amplitude with a slightly prolonged latency. Needle electromyography showed decreased compound motor action potentials on the right was normal with a few polyphasic waves on the left. Main diagnosis and interventions: A diagnosis of post-immunisation long thoracic neuritis was made. This patient was treated with physiotherapy and will be followed up every three months by the treating neurologist. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.