Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration, Ophthalmic migraine, Optic nerve injury, Pruritus, Rash
Clinical narrative: The itchiness got worse; After second dose symptoms got worse,  itchiness got worse, rash got worse; Started having ocular migraines; Could not sleep because of the steroids; Dermal hypersensitivity reaction to a drug- your COVID vaccine!; The rash got worse; Optic nerve damage; Macular degeneration; Diagnosed acute eczema; This spontaneous case was reported by a consumer and describes the occurrence of OPTIC NERVE INJURY (Optic nerve damage) and MACULAR DEGENERATION (Macular degeneration) in a 71-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.     Concurrent medical conditions included Sjogren's syndrome and Eczema acute. Concomitant products included VITAMINS NOS, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MONTELUKAST SODIUM (SINGULAIR), NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), CELECOXIB (CELEBREX), PARACETAMOL (TYLENOL) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ECZEMA (Diagnosed acute eczema). On an unknown date, the patient experienced OPTIC NERVE INJURY (Optic nerve damage) (seriousness criterion medically significant), MACULAR DEGENERATION (Macular degeneration) (seriousness criterion medically significant), CONDITION AGGRAVATED (After second dose symptoms got worse,  itchiness got worse, rash got worse) and SENSITIVE SKIN (Dermal hypersensitivity reaction to a drug- your COVID vaccine!). an unknown date, the patient experienced PRURITUS (The itchiness got worse), OPHTHALMIC MIGRAINE (Started having ocular migraines) and INSOMNIA (Could not sleep because of the steroids). an unknown date, the patient experienced RASH (The rash got worse). At the time of the report, OPTIC NERVE INJURY (Optic nerve damage), MACULAR DEGENERATION (Macular degeneration), CONDITION AGGRAVATED (After second dose symptoms got worse,  itchiness got worse, rash got worse), OPHTHALMIC MIGRAINE (Started having ocular migraines) and SENSITIVE SKIN (Dermal hypersensitivity reaction to a drug- your COVID vaccine!) outcome was unknown, ECZEMA (Diagnosed acute eczema), PRURITUS (The itchiness got worse) and RASH (The rash got worse) had not resolved and INSOMNIA (Could not sleep because of the steroids) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: abnormal (abnormal) The patient underwent a biopsy wand and result was-dermal hypersensitivity reaction by interaction by a drug-COVID-19 vaccine. In 2021, Blood test: normal (normal) normal.         A patient with Sjogren's syndrome stated that she went to a physician's assistant, to her dermatologist, on 31 March 2021 and was diagnosed with acute eczema.  The patient stated that her Health care professional suggested her that she take the second dose. The patient received second dose of Moderna on 31 March 2021.   The patient stated that her symptoms developed after first dose got worse after second dose. She stated that her rash got worse, her itchiness got worse, could not sleep because of the steroids.   The patient stated that she also developed ocular migraines and visited the ophthalmologist. The ophthalmologist said that the migraines might be due to trouble she was having sleeping.  The patient stated that she visited another physician and she was prescribed with something to sleep and it got better. She was also prescribed with antihistamines and the itchiness got better but she cannot get rid of it.  The patient stated that she was afraid that some medicine that she was taking had caused optic nerve damage and macular degeneration.  The patient stated that she was prescribed with a steroid shot and also a steroid cream for acute eczema. The patient stated that she used the cream but the itch did not resolved.  The patient stated that she visited a dermatologist that did blood work and result was normal. The patient also stated that she had a biopsy wand and received the result on 24 August 2021. The result was dermal hypersensitivity reaction by interaction by a drug. Her dermatologist told her that it could be due to the vaccine, based on timeline of events.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of Sjogren's syndrome and Eczema acute could probably be contributory factors to the events.   This case was linked to MOD-2021-295451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Significant follow-up. Reporter's information updated. Patient's date of birth or age updated. New events- Condition aggravated, optic nerve injury, macular degeneration added. Events outcome updated. Concomitant and treatment medications included.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of Sjogren's syndrome and Eczema acute could probably be contributory factors to the events.