Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: localized peripheral neuropathy; pain at the injection site in the contralateral shoulder; Circular, raised, painless hive with a red border appeared in the center of the anterior thigh; This literature-non-study case was reported in a literature article and describes the occurrence of NEUROPATHY PERIPHERAL (localized peripheral neuropathy) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.       The patient's past medical history included Malaria, Typhoid, Brucellosis, Klebsiella pneumonia and Tick bite. Concurrent medical conditions included Chronic fatigue.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NEUROPATHY PERIPHERAL (localized peripheral neuropathy) (seriousness criterion medically significant), VACCINATION SITE PAIN (pain at the injection site in the contralateral shoulder) and URTICARIA (Circular, raised, painless hive with a red border appeared in the center of the anterior thigh). In 2021, NEUROPATHY PERIPHERAL (localized peripheral neuropathy), VACCINATION SITE PAIN (pain at the injection site in the contralateral shoulder) and URTICARIA (Circular, raised, painless hive with a red border appeared in the center of the anterior thigh) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammatory marker test: Unremarkable. On an unknown date, Lasegue's test: (Negative) Negative. On an unknown date, Metabolic function test: Unremarkable. On an unknown date, Nerve conduction studies: Normal. On an unknown date, Neurological examination: Unremarkable. On an unknown date, Physical examination: Preserved proximal and distal motor strength. On an unknown date, Reflex test: Normal. On an unknown date, SARS-CoV-2 antibody test: (Positive) Recently tested positive for COVID IgM. On an unknown date, Skin test: Decreased pinprick sensation in the anterior right thigh numbness in a lateral femoral cutaneous nerve distribution.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROPATHY PERIPHERAL (localized peripheral neuropathy), VACCINATION SITE PAIN (pain at the injection site in the contralateral shoulder) and URTICARIA (Circular, raised, painless hive with a red border appeared in the center of the anterior thigh) to be related.    No concomitant and treatment medications were reported.  Sixteen hours after the vaccine administration, the patient awoke with constant, unilateral right anterior thigh numbness. The numbness persisted even though the sleep routine returned to normal and within 1 week a circular, raised, painless hive with a red border appeared in the center of the anterior thigh which got resolved spontaneously 2 weeks later.  Patient visited to an outpatient neurology clinic.  Patient had no weakness, paresthesia or pain and there was no involvement of the face or any other extremity. Patient had no history of shingles, CMV, B12 defciency, stroke, multiple sclerosis, syphilis, DM2, HIV, Lyme, ETOH abuse and uremia.  Patient denied dry eyes or mouth, prior chemotherapy, vitamin B6 supplementation, weight loss, night sweats, double vision, speech problems, facial asymmetry, back pain or manipulation.  Patient also denied ever having TB, falls, head strike, or issues with joint space perception. The patient was continuing to ambulate without an issue and denied excessive supine or lateral decubitus positioning.  The medical team confirmed there was no history of diabetes, tight prolonged use of belts, or large objects in the pocket and patient had not been carrying heavy objects using support from the thigh or groin. Patient had recent negative Lyme test and had unremarkable lateral femoral cutaneous sensory nerve action potentials (SNAP).  Six months after onset, a 2-inch area on the affected thigh remained numb with no pain or paresthesia and no motor symptoms or mobility issues.  The area and intensity of numbness remained stable after the patient received a Moderna booster with no additional reaction. Although there was one night of ipsilateral decubitus positioning with sleep.  Company comment: This is a literature non-study case concerning a 56-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral. 16 hours after the receiving the second dose of mRNA-1273 vaccine in the left deltoid, the patient experienced constant, unilateral right anterior thigh numbness. The numbness persisted and within 1 week a circular, raised, painless hive with a red border appeared in the center of the anterior thigh which resolved spontaneously 2 weeks later. Examination revealed decreased pinprick sensation in the anterior right thigh, negative straight leg raise, preserved proximal and distal motor strength and normal reflexes. Nerve conduction studies, lateral femoral cutaneous sensory nerve action potentials, basic metabolic and inflammatory laboratory tests were unremarkable. A 2 inch area on the affected thigh remained numb 6 months after onset. The area and intensity of numbness remained stable after receiving a booster/third dose of mRNA-1273 with no additional reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow up received by safety on 04-Aug-2022 has Email and contains significant information: Reporter information, literature information, medical history, lab data, suspect vaccine details and event details were updated.; Sender's Comments: This is a literature non-study case concerning a 56-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral. 16 hours after the receiving the second dose of mRNA-1273 vaccine in the left deltoid, the patient experienced constant, unilateral right anterior thigh numbness. The numbness persisted and within 1 week a circular, raised, painless hive with a red border appeared in the center of the anterior thigh which resolved spontaneously 2 weeks later. Examination revealed decreased pinprick sensation in the anterior right thigh, negative straight leg raise, preserved proximal and distal motor strength and normal reflexes. Nerve conduction studies, lateral femoral cutaneous sensory nerve action potentials, basic metabolic and inflammatory laboratory tests were unremarkable. A 2 inch area on the affected thigh remained numb 6 months after onset. The area and intensity of numbness remained stable after receiving a booster/third dose of mRNA-1273 with no additional reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report.