Reporte zur Charge 041B21A7

Symptomtext

COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 041B21A7) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Codeine), Diabetes, GERD (reflux) and Hypertension. Concomitant products included METFORMIN from 12-Feb-2013 to an unknown date and GLIMEPIRIDE from 27-Dec-2012 to an unknown date for Diabetes, ATORVASTATIN from 27-Apr-2017 to an unknown date for GERD, HYDROCHLOROTHIAZIDE from 10-Feb-2022 to an unknown date and LOSARTAN from 10-Feb-2022 to an unknown date for Hypertension. On 29-Jul-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021 at 9:08 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Jan-2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 10-Feb-2022, the patient started taking oral Hydrochlorothiazide at a dose of 25 mg daily PRN and oral Losartan at a dose of 100 mg daily both for hypertension. No treatment information was provided by the reporter. CC:This spontaneous case concerns a 74-year-old, female patient with a relevant history of hypertension and diabetes, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 4 months and 8 days after the second dose of mRNA-1273 vaccine administration, and 5 months and 5 days after the first dose of mRNA-1273 vaccine administration. Additionally, Drug ineffective was also reported. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic can be the confounder for COVID 19 and diabetes can be a risk factor. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-539478 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old, female patient with a relevant history of hypertension and diabetes, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 4 months and 8 days after the second dose of mRNA-1273 vaccine administration, and 5 months and 5 days after the first dose of mRNA-1273 vaccine administration. Additionally, Drug ineffective was also reported. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic can be the confounder for COVID 19 and diabetes can be a risk factor. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.