Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Recurrence of symptoms /Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Recurrence of symptoms /Treatment of COVID-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy. Concomitant products included AMLODIPINE from 13-May-2022 to an unknown date and PRAVASTATIN from 13-May-2022 to an unknown date for an unknown indication.    On 21-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Recurrence of symptoms /Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recurrence of symptoms /Treatment of COVID-19) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was also on Amlodipine and Pravastatin for unknown indication, which started on 13-May-2022. It was reported that the patient had recurrence of symptoms 6 days after completing Paxlovid.  Company Comment: This spontaneous case concerns a 67-year-old, male patient, with a concurrent condition of high blood pressure, who experienced an unexpected, non-serious COVID-19 in association with a 4th dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 in relation to mRNA-1273 vaccination cannot be determined with an unknown event onset date. A 5-day paxlovid treatment regimen started 22 days after his 4th COVID-19 vaccination. Reportedly, COVID-19 symptoms recurred 6 days after completing paxlovid treatment. Event outcome of COVID-19 was reported as recovering. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. An underlying high blood pressure increases the patient's likelihood of contracting a more severe form of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 67-year-old, male patient, with a concurrent condition of high blood pressure, who experienced an unexpected, non-serious COVID-19 in association with a 4th dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 in relation to mRNA-1273 vaccination cannot be determined with an unknown event onset date. A 5-day paxlovid treatment regimen started 22 days after his 4th COVID-19 vaccination. Reportedly, COVID-19 symptoms recurred 6 days after completing paxlovid treatment. Event outcome of COVID-19 was reported as recovering. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. An underlying high blood pressure increases the patient's likelihood of contracting a more severe form of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.