Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested Positive for COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested Positive for COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19, at a dose of 3 pills in the morning and 3 at night. At the time of the report, COVID-19 (Tested Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was provided by the reporter  Patient stated that he took Paxlovid from 03 May 2022 afternoon until 08 May 2022. Patient stated that his symptoms reoccurred a week later on 14 May 2022.  Company Comment: This spontaneous case concerns a 65-year-old, male patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 months after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient first tested positive for SARS-CoV-2 on 03May2022. No symptoms were reported. The patient sought consultation and was prescribed with Paxlovid (nirmatrelvir, ritonavir), 3 tablets twice daily. He took and completed a 6-day course of Paxlovid from 03May2022 to 08May2022. It was reported that the patient developed reoccurrence of symptoms 6 days after treatment with Paxlovid. The patient experienced terrible body aches especially in his upper arms, he felt like he was extremely congested and his head was 'in a vice'. He was also coughing and spitting up mucus. The patient was given fluids, and was treated with Advil (ibuprofen) of unspecified dose, frequency and duration. The reporter stated that the patient's symptoms had mainly subsided within the last 5 days, however, the patient still 'doesn't feel his self'. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 months after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient first tested positive for SARS-CoV-2 on 03May2022. No symptoms were reported. The patient sought consultation and was prescribed with Paxlovid (nirmatrelvir, ritonavir), 3 tablets twice daily. He took and completed a 6-day course of Paxlovid from 03May2022 to 08May2022. It was reported that the patient developed reoccurrence of symptoms 6 days after treatment with Paxlovid. The patient experienced terrible body aches especially in his upper arms, he felt like he was extremely congested and his head was 'in a vice'. He was also coughing and spitting up mucus. The patient was given fluids, and was treated with Advil (ibuprofen) of unspecified dose, frequency and duration. The reporter stated that the patient's symptoms had mainly subsided within the last 5 days, however, the patient still 'doesn't feel his self'. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.