Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Herpes ophthalmic, Menopausal symptoms, Migraine, Optic neuropathy
Clinical narrative: Increased migraines attributed to possible menopause; Nerve issues in eye/cornea related to shingles infection; Optic neuropathy; Increased migraines attributed to possible menopause; This spontaneous case was reported by a consumer and describes the occurrence of HERPES OPHTHALMIC (Nerve issues in eye/cornea related to shingles infection) and OPTIC NEUROPATHY (Optic neuropathy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Migraine (had migraines that were before taking Humira which had increased over the past year of 2021), Abstains from alcohol, Non-tobacco user and Psoriatic arthritis. Concomitant products included MELOXICAM for Inflammation, SUMATRIPTAN for Migraine, CYCLOBENZAPRINE for Muscle spasms, MELOXICAM (MOBIC) and CYCLOBENZAPRINE HCL for an unknown indication.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 01-May-2021, the patient experienced HERPES OPHTHALMIC (Nerve issues in eye/cornea related to shingles infection) (seriousness criterion medically significant). In May 2021, the patient experienced OPTIC NEUROPATHY (Optic neuropathy) (seriousness criterion medically significant). In 2021, the patient experienced MIGRAINE (Increased migraines attributed to possible menopause). On an unknown date, the patient experienced MENOPAUSAL SYMPTOMS (Increased migraines attributed to possible menopause). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HERPES OPHTHALMIC (Nerve issues in eye/cornea related to shingles infection) and OPTIC NEUROPATHY (Optic neuropathy) was resolving and MENOPAUSAL SYMPTOMS (Increased migraines attributed to possible menopause) and MIGRAINE (Increased migraines attributed to possible menopause) had not resolved. Not applicable    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Blood test: Normal.         The patient has other concomitant therapy of Immune Support Complex, Multivitamin Capsule. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 45 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Herpes ophthalmic (reported as Nerve issues in eye/cornea related to shingles infection) and Optic neuropathy , during the following month of receiving the second dose of mRNA-1273 vaccine. She received her first dose of the same vaccine about 32 days ago. Her blood test was reported as normal.  No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the events was available in the report. The events were resolving. Co-suspect adalimumab could be a risk factor for the event Herpes ophthalmic. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623439 (Patient Link).; Sender's Comments: This spontaneous case concerns a 45 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Herpes ophthalmic (reported as Nerve issues in eye/cornea related to shingles infection) and Optic neuropathy , during the following month of receiving the second dose of mRNA-1273 vaccine. She received her first dose of the same vaccine about 32 days ago. Her blood test was reported as normal.  No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the events was available in the report. The events were resolving. Co-suspect adalimumab could be a risk factor for the event Herpes ophthalmic. The benefit-risk relationship of mRNA-1273 is not affected by this report.