Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Drug allergy (Codeine), Anxiety, Hypertension and Diabetic polyneuropathy. Concomitant products included ALPRAZOLAM (XANAX) from 24-Jul-2015 to an unknown date for Anxiety, PIOGLITAZONE HYDROCHLORIDE (ACTOS) from 25-Aug-2020 to an unknown date for Diabetic polyneuropathy, ACETYLSALICYLIC ACID (ASPIRIN 81) from 26-Aug-2012 to an unknown date and IRBESARTAN (AVAPRO) from 09-Aug-2018 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 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (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.   No treatment information was reported.  Frequency for concomitant Xenax as reported as PRN(As necessary).  Company comment-This Spontaneous case concerns a 78-year-old, male patient with relevant medical history of Diabetes reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 130 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 28 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. The current pandemic situation of COVID 19 may remain a confounder and underlying diabetes and elderly age of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-539483 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 78-year-old, male patient with relevant medical history of Diabetes reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 130 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 28 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. The current pandemic situation of COVID 19 may remain a confounder and underlying diabetes and elderly age of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.