Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Inflammation, Macular degeneration
Clinical narrative: Macular degeneration; Inflammatory reaction; Sinus infection; Vision changed and decreased; Sore throat; Fatigue; Tested positive for COVID; Tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID) and DRUG INEFFECTIVE (Tested positive for COVID). On an unknown date, the patient experienced MACULAR DEGENERATION (Macular degeneration) (seriousness criterion medically significant), INFLAMMATION (Inflammatory reaction), SINUSITIS (Sinus infection), VISUAL IMPAIRMENT (Vision changed and decreased), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue). The patient was treated with SOTROVIMAB for COVID-19, at an unspecified dose and frequency. At the time of the report, MACULAR DEGENERATION (Macular degeneration), INFLAMMATION (Inflammatory reaction), SINUSITIS (Sinus infection), VISUAL IMPAIRMENT (Vision changed and decreased), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Tested positive for COVID), FATIGUE (Fatigue) and DRUG INEFFECTIVE (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included ACE inhibitor.  On an unknown date, the patient experienced an inflammatory reaction, reports experienced macular degeneration, vision changed and decreased.  The patient was tested positive for COVID on 26-Dec-2021. The patient had mild symptoms of COVID.   Treatment information included, the patient received monoclonal antibody treatment for COVID, called sotrovimab.  This is a spontaneous case concerning  a  80-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Macular degeneration and unexpected non-serious events of Inflammation, Sinusitis, Visual impairment, Oropharyngeal pain, Covid-19, Drug ineffective and expected non-serious event of fatigue. The event covid-19 and drug ineffective occurred 9 months after the second dose of mRNA-1273 COVID 19 Vaccine. While the events Macular degeneration, Inflammation , Sinusitis, Visual impairment, Oropharyngeal pain, Fatigue occurred on an unknown day afte the second dose.  The rechallenge was not applicable, as patient was treated with monoclonal antibody treatment. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-463254 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  80-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Macular degeneration and unexpected non-serious events of Inflammation, Sinusitis, Visual impairment, Oropharyngeal pain, Covid-19, Drug ineffective and expected non-serious event of fatigue. The event covid-19 and drug ineffective occurred 9 months after the second dose of mRNA-1273 COVID 19 Vaccine. While the events Macular degeneration, Inflammation , Sinusitis, Visual impairment, Oropharyngeal pain, Fatigue occurred on an unknown day afte the second dose.  The rechallenge was not applicable, as patient was treated with monoclonal antibody treatment. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.