Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: One week after stopping paxlovid, I got running nose and watery eyes and lost sense of taste and smell. I started testing positive again after testing negative on day 7; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (One week after stopping paxlovid, I got running nose and watery eyes and lost sense of taste and smell. I started testing positive again after testing negative on day 7) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient has no allergy.  Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose number: 1. Drug administered in Left arm and time of vaccination was 12 pm.) on 03-Apr-2021 and Pfizer / BioNTech (Dose number: 2. Drug administered in Left arm and time of vaccination was 12 pm.) on 24-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech.    On 13-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022 at 5:00 PM, the patient experienced COVID-19 (One week after stopping paxlovid, I got running nose and watery eyes and lost sense of taste and smell. I started testing positive again after testing negative on day 7). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 10-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (One week after stopping paxlovid, I got running nose and watery eyes and lost sense of taste and smell. I started testing positive again after testing negative on day 7) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Started testing positive again after testing negative on day 7. On an unknown date, SARS-CoV-2 test: negative (Negative) Started testing positive again after testing negative on day 7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. One week after stopping Paxlovid, the patient got running nose and watery eyes and lost sense of taste and smell. Patient started testing positive again after testing negative on day 7. No treatment medication reported by reporter.  Company comment: This spontaneous case concerns a 59-year-old male patient, with no reported medical history, who experienced unexpected, non-serious, AESI of COVID-19, approximately 6 months after receiving mRNA-1273 vaccine as a third dose. Interchange of vaccine products is noted in this case since the patient reported receiving two doses of Pfizer vaccine with the second dose given approximately 7 months before receiving mRNA-1273 vaccine. The patient was started with Nirmatrevlir-Ritonavir (Paxlovid) at an unspecified dose and frequency. One week after completing Paxlovid, the patient reported runny nose, watery eyes, lost sense of taste and smell. The patient previously tested negative for SARS-CoV-2, however, tested positive again. The event is resolving. The ongoing pandemic could be considered as possible confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old male patient, with no reported medical history, who experienced unexpected, non-serious, AESI of COVID-19, approximately 6 months after receiving mRNA-1273 vaccine as a third dose. Interchange of vaccine products is noted in this case since the patient reported receiving two doses of Pfizer vaccine with the second dose given approximately 7 months before receiving mRNA-1273 vaccine. The patient was started with Nirmatrevlir-Ritonavir (Paxlovid) at an unspecified dose and frequency. One week after completing Paxlovid, the patient reported runny nose, watery eyes, lost sense of taste and smell. The patient previously tested negative for SARS-CoV-2, however, tested positive again. The event is resolving. The ongoing pandemic could be considered as possible confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.