Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for covid on 03-Jan-2022 5 days later after he received his booster vaccine; Lack of drug effect; This spontaneous case was reported by a medical assistant and describes the occurrence of COVID-19 (Patient tested positive for covid on 03-Jan-2022 5 days later after he received his booster vaccine) and VACCINATION FAILURE (Lack of drug effect) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since 11-Jun-2021 and Hyperlipidemia since 24-Mar-2021. Concomitant products included METFORMIN from 24-Mar-2021 to an unknown date, ROSUVASTATIN from 24-Mar-2021 to an unknown date and FENOFIBRATE from 07-Jun-2021 to an unknown date for an unknown indication.   On 21-May-2021 at 4:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Jun-2021 at 1:52 PM, 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 (Patient tested positive for covid on 03-Jan-2022 5 days later after he received his booster vaccine) and VACCINATION FAILURE (Lack of drug effect). The patient was treated with AZITROMYCIN in January 2022 at a dose of 250 milligram; ASCORBIC ACID in January 2022 at a dose of 1000 milligram; VITAMIN D3 in January 2022 at a dose of 50 mcg (2,000 unit) and ZINC in January 2022 at a dose of 50 milligram. At the time of the report, COVID-19 (Patient tested positive for covid on 03-Jan-2022 5 days later after he received his booster vaccine) 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) Rapid test Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Patient tested positive for covid on 03-Jan-2022 5 days later after he received his booster vaccine) and VACCINATION FAILURE (Lack of drug effect) to be not related.    Company comment-This Spontaneous case concerns a 34-year-old, male patient with relevant medical history of diabetes mellitus reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 17 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 27 days apart. Hence vaccination failure is considered in the case. Patient reported mild symptoms, treated with Azithromycin250 mg, Vit C- 1000mg, Vit D3 -50 mcg and Zinc 50 mg. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor and underlying diabetes could be risk factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503313 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 34-year-old, male patient with relevant medical history of diabetes mellitus reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 17 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 27 days apart. Hence vaccination failure is considered in the case. Patient reported mild symptoms, treated with Azithromycin250 mg, Vit C- 1000mg, Vit D3 -50 mcg and Zinc 50 mg. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor and underlying diabetes could be risk factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.