Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna COVID-19 vaccine was received on 04-May-2021 and second dose was received on 22-Jun-2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022c21a) for COVID-19 vaccination. The patient had no allergies to medications, food and other products. The patient had no acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concomitant products included LISINOPRIL for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna COVID-19 vaccine was received on 04-May-2021 and second dose was received on 22-Jun-2021). On 26-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna COVID-19 vaccine was received on 04-May-2021 and second dose was received on 22-Jun-2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience similar events in the past. No treatment information was provided by the reporter. Company comment: This spontaneous case concerns a 36-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI event of Covid 19 with a positive SARS-CoV-2 test, about 11 months 4 days after receiving the second dose of mRNA1273 vaccine in the Covid 19 vaccination series and outcome was unknown. Inappropriate schedule of product administration reported as an event as patient received second dose after 49 days in the case (interval between dose 1 and dose 2 longer than 35 days). Ongoing Covid 19 pandemia is a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed based on medical judgement. This case was linked to MOD-2022-606384 (Patient Link). Sender's Comments: This spontaneous case concerns a 36-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI event of Covid 19 with a positive SARS-CoV-2 test, about 11 months 4 days after receiving the second dose of mRNA1273 vaccine in the Covid 19 vaccination series and outcome was unknown. Inappropriate schedule of product administration reported as an event as patient received second dose after 49 days in the case (interval between dose 1 and dose 2 longer than 35 days). Ongoing Covid 19 pandemia is a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed based on medical judgement.