Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Irritable bowel syndrome, Palpitations, Sleep disorder, Small fibre neuropathy
Clinical narrative: Unrestful sleep; Brain fog; headaches; vertigo; fatigue; tinnitus; Irritable bowel syndrome and change in bowel habits/change in bowel habits; visual disturbances; hair loss; joint pain; Heart palpitations; Extremity paresthesias, numbness, and tingling that progressed centrally and cephalad to include the trunk, chest, face, scalp, and oropharynx/ Skin biopsy confirmed new small fiber neuropathy; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (vertigo), FATIGUE (fatigue), TINNITUS (tinnitus), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome and change in bowel habits/change in bowel habits), VISUAL IMPAIRMENT (visual disturbances), ALOPECIA (hair loss), ARTHRALGIA (joint pain) and PALPITATIONS (Heart palpitations) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), TINNITUS (tinnitus) (seriousness criterion medically significant), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome and change in bowel habits/change in bowel habits) (seriousness criterion medically significant), VISUAL IMPAIRMENT (visual disturbances) (seriousness criterion medically significant), ALOPECIA (hair loss) (seriousness criterion medically significant), ARTHRALGIA (joint pain) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), SMALL FIBRE NEUROPATHY (Extremity paresthesias, numbness, and tingling that progressed centrally and cephalad to include the trunk, chest, face, scalp, and oropharynx/ Skin biopsy confirmed new small fiber neuropathy) and HEADACHE (headaches). On an unknown date, the patient experienced SLEEP DISORDER (Unrestful sleep) and FEELING ABNORMAL (Brain fog). At the time of the report, VERTIGO (vertigo), FATIGUE (fatigue), TINNITUS (tinnitus), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome and change in bowel habits/change in bowel habits), VISUAL IMPAIRMENT (visual disturbances), ALOPECIA (hair loss), ARTHRALGIA (joint pain), PALPITATIONS (Heart palpitations), SMALL FIBRE NEUROPATHY (Extremity paresthesias, numbness, and tingling that progressed centrally and cephalad to include the trunk, chest, face, scalp, and oropharynx/ Skin biopsy confirmed new small fiber neuropathy) and HEADACHE (headaches) had not resolved and SLEEP DISORDER (Unrestful sleep) and FEELING ABNORMAL (Brain fog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: Skin biopsy confirmed new small fiber neuropathy.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. t was reported that patient had extremity paresthesias, numbness, and tingling that progressed centrally and cephalad to include the trunk, chest, face, scalp, and oropharynx. Skin biopsy confirmed new small fiber neuropathy, Brain fog, severe headaches, vertigo, fatigue, tinnitus, unrestful sleep, Irritable bowel syndrome and change in bowel habits. Patient also experienced visual disturbances, hair loss, joint pain and heart palpitations  t was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.  Company comment:This Spontaneous case concerns a 38-years-old, male patient with no medical history, who experienced unexpected serious (medically significant) events of vertigo, fatigue, tinnitus, irritable bowel syndrome, visual impairment, alopecia, arthralgia, palpitations, which occurred 18 days after the second dose of mRNA-1273 vaccination. Patient experienced Extremity paresthesia, numbness, and tingling, which progressed centrally and cephalad included the trunk, chest, face, scalp, and oropharynx. Skin biopsy confirmed small new fiber neuropathy. At the time of reporting events are not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.