Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; Relapse of symptoms and testing positive for COVID 1 week after completing treatment and testing negative; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Relapse of symptoms and testing positive for COVID 1 week after completing treatment and testing negative) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 066F21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unknown drug).   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Relapse of symptoms and testing positive for COVID 1 week after completing treatment and testing negative). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Relapse of symptoms and testing positive for COVID 1 week after completing treatment and testing negative) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative (after testing positive on 21-May-2022). On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously did not receive a COVID-19 Vaccine. No concomitant medications were reported.  Company Comment: This is a spontaneous case concerning a 41-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately less than a month after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms resolved and tested negative after completing the treatment. 1 week after the treatment, symptoms relapsed and tested positive for COVID. The event had not resolved at the time of the report. Inappropriate schedule of vaccine administered was also reported as the first two doses of mRNA-1273 vaccine was given on approximately 6-month interval. The second dose was given approximately 5 months prior to the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately less than a month after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms resolved and tested negative after completing the treatment. 1 week after the treatment, symptoms relapsed and tested positive for COVID. The event had not resolved at the time of the report. Inappropriate schedule of vaccine administered was also reported as the first two doses of mRNA-1273 vaccine was given on approximately 6-month interval. The second dose was given approximately 5 months prior to the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.