Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Covid-19; Moderna Dose Number:1 on 09-MAR-2021 and Dose Number 2 on 30-MAR-2022.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose Number:1 on 09-MAR-2021 and Dose Number 2 on 30-MAR-2022.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LAMOTRIGINE, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose Number:1 on 09-MAR-2021 and Dose Number 2 on 30-MAR-2022.). On 24-May-2022, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose Number:1 on 09-MAR-2021 and Dose Number 2 on 30-MAR-2022.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Rebound illness and positive test Device Date : 24May2022  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with no relevant medial history, who experienced the unexpected non-serious AESI of Covid-19, 55 days after receiving the second dose of mRNA-1273 vaccine (3rd dose overall). SARS-CoV-2 test was positive. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of the event was reported as resolving. Details of symptoms, clinical course, additional investigation reports were not provided. The interval between the first and second doses of mRNA-1273 vaccine is approximately 8 months and between 2nd and 3rd doses is five months (Inappropriate schedule of vaccination). The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577961 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with no relevant medial history, who experienced the unexpected non-serious AESI of Covid-19, 55 days after receiving the second dose of mRNA-1273 vaccine (3rd dose overall). SARS-CoV-2 test was positive. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of the event was reported as resolving. Details of symptoms, clinical course, additional investigation reports were not provided. The interval between the first and second doses of mRNA-1273 vaccine is approximately 8 months and between 2nd and 3rd doses is five months (Inappropriate schedule of vaccination). The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.