Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Herpes zoster, Myalgia
Clinical narrative: Lost vision in one eye; Shngles; Right arm hurt after 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS UNILATERAL (Lost vision in one eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A0 and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised and Autoimmune disorder. Previously administered products included for an unreported indication: Shingrix. Concurrent medical conditions included Breast cancer, Heart failure, Lupus syndrome (Lupus) and Shingles.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (Right arm hurt after 2nd dose). In June 2021, the patient experienced HERPES ZOSTER (Shngles). On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost vision in one eye) (seriousness criterion medically significant). On 07-Feb-2021, MYALGIA (Right arm hurt after 2nd dose) had resolved. At the time of the report, BLINDNESS UNILATERAL (Lost vision in one eye) and HERPES ZOSTER (Shngles) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient took medications for autoimmune conditions and mild pain medication. Consumer got her 1st dose on 05Feb2021 (Lot # 010M20A) and 2nd dose on 05Mar2021 (Lot # 025A21A0. Both doses were administered at her workplace. Consumer states that after receiving both doses, her right arm hurt. The onset was the following day (06Feb2021 and 06Mar2021) and duration was about 24 hours. Consumer states that 1st dose hurt more than 2nd dose. The intensity consumer described was 1st dose hurt 2 times more than tetanus shot. Consumer states she is immunocompromised. She has past medical history of lupus, breast cancer, heart failure, and shingles. Consumer states that she completed the vaccination series for shingles about 3 years ago. Consumer came down with shingles in first part of June (exact dates unknown). She did not know she had shingles until she went for an eye examination. During examination consumer was diagnosed with shingles. Consumer is still recovering from shingles and has lost vision in one eye. Consumer does not blame shingles on the covid-19 vaccine. Consumer did not take any medications to alleviate any possible adverse events, but she did state she take medications for autoimmune conditions and mild pain medication.  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. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. .   This case was linked to MOD-2021-228299 (Patient Link).; 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. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. .