Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound symptoms and positive rapid test; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Rebound symptoms and positive rapid test) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (received at 12 PM in right arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Drug allergy.   On 22-Oct-2021 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022 at 12:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022 at 6:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound symptoms and positive rapid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 10-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound symptoms and positive rapid test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-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.   No concomitant medication information was provided. Patient was not taking other medications or products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine. No treatment for the event was reported.  Company comment: This spontaneous case concerns a 52-year-old female patient, with no reported medical history, who experienced unexpected, non-serious, AESI of COVID-19, approximately 1 month, after receiving a dose of mRNA-1273 vaccine as a second dose.  Dose 1 and Dose 2 were administered with a 6-month interval.  Interchange of vaccine products is noted in this case since the patient reported receiving a dose of Janssen COVID-19 vaccine approximately 7 months before receiving mRNA-1273 vaccine.  The patient started taking Nirmatrelvir-Ritonavir (Paxlovid) at unspecified dose and frequency.  11 days after onset, the patient reported rebound symptoms. The patient underwent SARS-CoV-2 test which showed positive result.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with no reported medical history, who experienced unexpected, non-serious, AESI of COVID-19, approximately 1 month, after receiving a dose of mRNA-1273 vaccine as a second dose.  Dose 1 and Dose 2 were administered with a 6-month interval.  Interchange of vaccine products is noted in this case since the patient reported receiving a dose of Janssen COVID-19 vaccine approximately 7 months before receiving mRNA-1273 vaccine.  The patient started taking Nirmatrelvir-Ritonavir (Paxlovid) at unspecified dose and frequency.  11 days after onset, the patient reported rebound symptoms. The patient underwent SARS-CoV-2 test which showed positive result.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report