Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Paxlovid rebound- completed 5 day course, started day of diagnosis (positive rapid and PCR) 5/12/2022, two negative rapid tests 5/17/2022 and 5/19/2022. Cold symptoms 5/21/22 and strongly positive rap/ Cold symptoms; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Paxlovid rebound- completed 5 day course, started day of diagnosis (positive rapid and PCR) 5/12/2022, two negative rapid tests 5/17/2022 and 5/19/2022. Cold symptoms 5/21/22 and strongly positive rap/ Cold symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced COVID-19 (Paxlovid rebound- completed 5 day course, started day of diagnosis (positive rapid and PCR) 5/12/2022, two negative rapid tests 5/17/2022 and 5/19/2022. Cold symptoms 5/21/22 and strongly positive rap/ Cold symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Paxlovid rebound- completed 5 day course, started day of diagnosis (positive rapid and PCR) 5/12/2022, two negative rapid tests 5/17/2022 and 5/19/2022. Cold symptoms 5/21/22 and strongly positive rap/ Cold symptoms) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) positive rapid and PCR. On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative rapid test. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative rapid test. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Strongly positive rapid test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had allergic reaction to unspecified drug. Concomitant medication was not reported. The patient was taking other medications within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Device Date : 22May2022  Company comment: This spontaneous case concerns a 55-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive rapid and PCR test), which occurred 7 months and 7 days after receiving a dose of mRNA-1273 vaccine. Patient  tested positive for COVID-19 both in Rapid and PCR test and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) on the day of diagnosis to complete a 5 day course. Patient tested negative on two separate occasions after completing treatment, on the 5th day and 7th day of the disease. Two days later she complained of cold symptoms and tested strongly positive again. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive rapid and PCR test), which occurred 7 months and 7 days after receiving a dose of mRNA-1273 vaccine. Patient  tested positive for COVID-19 both in Rapid and PCR test and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) on the day of diagnosis to complete a 5 day course. Patient tested negative on two separate occasions after completing treatment, on the 5th day and 7th day of the disease. Two days later she complained of cold symptoms and tested strongly positive again. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.