Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Crazy cough/annoying cough; She missed work for almost the entire month of September because annoying cough; First:- Date: 29Mart21/Second: Received - Date: 26Apr2021/Third- Date:24Nov21/tested positive for Covid the last week in August 2022; tested positive for Covid the last week in August 2022; Fever of 100-101 for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid the last week in August 2022), PYREXIA (Fever of 100-101 for 3 days), COUGH (Crazy cough/annoying cough), VACCINATION FAILURE (First:- Date: 29Mart21/Second: Received - Date: 26Apr2021/Third- Date:24Nov21/tested positive for Covid the last week in August 2022) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She missed work for almost the entire month of September because annoying cough) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 036B21A and 018B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE] and TOPROL. Past adverse reactions to the above products included No adverse event with ANTIVERT [DIHYDROERGOCRISTINE; andLOMIFYLLINE] and TOPROL.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. In August 2022, the patient experienced COVID-19 (tested positive for Covid the last week in August 2022) and VACCINATION FAILURE (First:- Date: 29Mart21/Second: Received - Date: 26Apr2021/Third- Date:24Nov21/tested positive for Covid the last week in August 2022). On an unknown date, the patient experienced PYREXIA (Fever of 100-101 for 3 days), COUGH (Crazy cough/annoying cough) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She missed work for almost the entire month of September because annoying cough). In September 2022, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She missed work for almost the entire month of September because annoying cough) had resolved. At the time of the report, COVID-19 (tested positive for Covid the last week in August 2022), PYREXIA (Fever of 100-101 for 3 days) and COUGH (Crazy cough/annoying cough) had resolved and VACCINATION FAILURE (First:- Date: 29Mart21/Second: Received - Date: 26Apr2021/Third- Date:24Nov21/tested positive for Covid the last week in August 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test positive: Positive. On an unknown date, Body temperature: Fever of 100-101 for 3 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient tested positive for COVID the last week in August 2022. Symptoms were Fever of 100-101 for 3 days and Crazy cough.  No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a 71-year-old female patient with no relevant medical history reported, who experienced unexpected non-serious event of COVID-19 which occurred approximately 9 months after receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Vaccination failure and Loss of personal independence in daily activities were reported in this case. Primary series of COVID-19 vaccination with 1 dose and 2 dose administered 28 days apart were performed with mRNA-1273, with 2 dose administered 6 months before the current vaccination. Details regarding clinical course, diagnostic work-up and treatment, alternative causalities and investigations performed are not available in the report. COVID-19 outcome was resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient with no relevant medical history reported, who experienced unexpected non-serious event of COVID-19 which occurred approximately 9 months after receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Vaccination failure and Loss of personal independence in daily activities were reported in this case. Primary series of COVID-19 vaccination with 1 dose and 2 dose administered 28 days apart were performed with mRNA-1273, with 2 dose administered 6 months before the current vaccination. Details regarding clinical course, diagnostic work-up and treatment, alternative causalities and investigations performed are not available in the report. COVID-19 outcome was resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.