Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19; Patient received dose volume of 1 ml for first dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID-19) and ACCIDENTAL OVERDOSE (Patient received dose volume of 1 ml for first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (HTN) since 07-Jul-2016, AFib since 03-Jan-2018, Congestive cardiac failure (Chronic combined systolic and diastolic CHF) since 18-Sep-2016, Cardiomyopathy since 28-Sep-2016, Allergy to animal dander (Cat dander), Drug allergy (Dexamethasone), Adhesive tape allergy (Adhesive), Drug allergy (lisinopril), Drug allergy (Aleve), Drug allergy (Amioderone), Drug allergy (Benicar), Drug allergy (Darvon), Drug allergy (Digoxin), Allergy to antibiotic (Levaquin), Allergy to chemicals (Protective adhesive powder), Drug allergy (Omeprazole), Oil allergy (Lavender oil) and Drug allergy (Prevacid). Concomitant products included WARFARIN from 28-Sep-2016 to an unknown date for AFib, SOTALOL from 16-Nov-2016 to an unknown date for Cardiac disorder NOS, SPIRONOLACTONE from 17-Jan-2017 to an unknown date and LOSARTAN from 16-Nov-2016 to an unknown date for Hypertension.    On 27-Jan-2021 at 9:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 27-Jan-2021 at 9:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received dose volume of 1 ml for first dose). On 20-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) and ACCIDENTAL OVERDOSE (Patient received dose volume of 1 ml for first dose) outcome was unknown. Not provided.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 nucleocapsid protein IgG: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  On 17-Jan-2022 the patient started taking Torsemide 20 mg daily by oral route for CHF.  COMPANY COMMENT : This spontaneous case concerns a 73-year-old, female patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19, which occurred 205 days after first dose and 7 days after second dose of mRNA-1273. Additionally accidental overdose also reported. SARS-CoV-2 test was positive as on 20-Aug-2021. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503785, MOD-2022-503845 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19, which occurred 205 days after first dose and 7 days after second dose of mRNA-1273. Additionally accidental overdose also reported. SARS-CoV-2 test was positive as on 20-Aug-2021. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.