Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 virus test positive) and VACCINATION FAILURE (COVID-19 virus test positive) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 013A21A and 007J21-2A) for COVID-19 prophylaxis.     The patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Food allergy, Drug allergy (Allergy to Zoloft), Reactive confusion, Vitamin B12 deficiency, Back pain and Vitamin D3 deficiency. Concomitant products included ESZOPICLONE (LUNESTA) from 24-Aug-2020 to an unknown date for Back pain, PAROXETINE HCL from 21-Feb-2019 to an unknown date for Reactive confusion, CYANOCOBALAMIN (B12-VITAMIIN) from 15-Oct-2009 to an unknown date for Vitamin B12 deficiency, VITAMIN D3 from 05-Oct-2009 to an unknown date for Vitamin D3 deficiency, BIOTIN from 06-Oct-2011 to an unknown date for an unknown indication.   On 09-Mar-2021 at 11:59 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021 at 11:54 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Feb-2022 at 12:20 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Nov-2021, the patient experienced COVID-19 (COVID-19 virus test positive) and VACCINATION FAILURE (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) and VACCINATION FAILURE (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided by the reporter.  On 18-Nov-2022 at 13:28 PM, the patient received Moderna bivalent booster dose (Intramuscular) left deltoid, 0.5 milliliter (batch number AS7166B). Company comment: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of COVID-19, that occurred about 7 months after the second dose of mRNA 1273 vaccine with SARS-CoV-2 test was Positive. Vaccination failure was reported as additional event. The events outcome was reported as unknown. Patient received third and fourth dose at an interval of 3 months and 9 months respectively with respect to second dose of vaccination. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The causality of the event COVID-19 was assessed as not applicable, due to lack of biologic plausibility. The event might be explained by current pandemic outbreak.   This case was linked to MOD-2022-686043 (Patient Link).; Sender's Comments: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of COVID-19, that occurred about 7 months after the second dose of mRNA 1273 vaccine with SARS-CoV-2 test was Positive. Vaccination failure was reported as additional event. The events outcome was reported as unknown. Patient received third and fourth dose at an interval of 3 months and 9 months respectively with respect to second dose of vaccination. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The causality of the event COVID-19 was assessed as not applicable, due to lack of biologic plausibility. The event might be explained by current pandemic outbreak.