Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of drug was unknown). Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) from 01-May-2021 to 17-May-2022 for an unknown indication.    On 02-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) by the 4th day the rapid test was just mildly positive. On 17-May-2022, SARS-CoV-2 test: positive (Positive) on rapid home testing. On 27-May-2022, SARS-CoV-2 test: positive (Positive) again strongly positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had rebound COVID symptoms on 26-May-2022 which was 4 days after the last Paxlovid dose. The patient was initially strongly positive on 17-May-2022 on rapid home testing. 3 days after starting Paxlovid patient was much improved and by the 4th day rapid test was just mildly positive. With recurrent symptoms of marked rhinorrhea, head congestion and achiness patient was once again strongly positive when patient was tested on 27-May-2022. It was reported that the patient had mild symptoms 5/14 but tested negative until 5/17 at which time  had marked rhinorrhea, achiness and sinus congestion. The criteria for taking Paxlovid were too rigid by demanding a positive Covid test.  Rest and Phenylephrine were reported for sinus congestion.  Company Comment: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19 approximately 15 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing and started with Paxlovid for treatment of covid-19 from 17th May to 21 st May 2022. 3 days after starting Paxlovid patient was much improved and by the 4th day rapid test was mildly positive. With recurrent symptoms of rhinorrhea, sinus congestion and achiness patient was tested positive again on 27-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19 approximately 15 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported patient had mild symptoms on 14-May-2022 and was positive on 17-May-2022 on rapid home testing and started with Paxlovid for treatment of covid-19 from 17th May to 21 st May 2022. 3 days after starting Paxlovid patient was much improved and by the 4th day rapid test was mildly positive. With recurrent symptoms of rhinorrhea, sinus congestion and achiness patient was tested positive again on 27-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.