Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Took drug, tested negative after 5 days. 4 days later tested positive again and new symptoms; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Took drug, tested negative after 5 days. 4 days later tested positive again and new symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Depression and Drug allergy (Sulfa allergy).    On 04-Apr-2022 at 12:00 PM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced COVID-19 (Took drug, tested negative after 5 days. 4 days later tested positive again and new symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Took drug, tested negative after 5 days. 4 days later tested positive again and new symptoms) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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.  No concomitant medications were provided by the reporter.  It was reported that patient was tested negative after 5 days. 4 days later tested positive again and on 25-May-2022 and symptoms were new .   Device Date was reported as 28-May-2022.  Company comment: This is a spontaneous case concerning a 52-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. Inappropriate schedule of product administration was also reported. The event exact occurrence was unknown with respect to the fifth dose of mRNA-1273 vaccine administration. However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) approximately 43 days after the fifth dose of mRNA-1273 vaccine administration for treatment of Covid-19. It was also reported that the patient was tested negative after 5 days of treatment. However, 4 days later the patient was tested positive again with new symptoms. No other information surrounding the event was reported. The outcome of the event was reported as resolving from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. Inappropriate schedule of product administration was also reported. The event exact occurrence was unknown with respect to the fifth dose of mRNA-1273 vaccine administration. However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) approximately 43 days after the fifth dose of mRNA-1273 vaccine administration for treatment of Covid-19. It was also reported that the patient was tested negative after 5 days of treatment. However, 4 days later the patient was tested positive again with new symptoms. No other information surrounding the event was reported. The outcome of the event was reported as resolving from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.