Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blister, Body temperature, Ear pain, Fatigue
Clinical narrative: Vision loss; Nose blisters; Ear pain; Rash on right face above eye,scalp,chest; Extreme fatigue; Diagnosed shingles; Fever 103.8; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision loss) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088DZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Episodes shingles in 2009) in 2009 and Shingles (Episodes shingles in 2014) in 2014. Previously administered products included for Product used for unknown indication: Shingles vaccine (Shingles vaccine) in 2010. Past adverse reactions to the above products included Adverse event with Shingles vaccine.    On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PYREXIA (Fever 103.8). On 24-Aug-2021, the patient experienced HERPES ZOSTER (Diagnosed shingles). On 25-Aug-2021, the patient experienced BLISTER (Nose blisters), EAR PAIN (Ear pain) and RASH (Rash on right face above eye,scalp,chest). 25-Aug-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced BLINDNESS (Vision loss) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Vision loss) had not resolved, HERPES ZOSTER (Diagnosed shingles) and PYREXIA (Fever 103.8) had resolved and BLISTER (Nose blisters), EAR PAIN (Ear pain), RASH (Rash on right face above eye,scalp,chest) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Body temperature: 103.8 (High) fever 103.8. On 24-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 25-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 26-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 27-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 28-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 29-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 30-Aug-2021, Body temperature: 100.5 (High) fever 100.5. On 31-Aug-2021, Body temperature: 100.5 (High) fever 100.5.         The concomitant medications were not reported. The treatment information was not 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. Some individuals have been known to develop autoimmune diseases following vaccines such as Herpes.  Fever and fatigue are consistent with the product known safety profile   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: The follow up document was received and had no new information. On 10-Sep-2021: Follow-up document received contain patient new event (Vision loss) added and case upgraded to serious.; 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. Some individuals have been known to develop autoimmune diseases following vaccines such as Herpes.  Fever and fatigue are consistent with the product known safety profile