Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (feeling bad / husband was headed for pneumonia yesterday/ Fever about 101 degrees) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909 and 029A21A) for COVID-19 prophylaxis. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19. The patient's past medical history included weight loss. Concurrent medical conditions included Type 2 diabetes mellitus (condition for 5-10 years, diabetes stable for a year.) and Arthritis (had a little arthritis but is healthy and exercises.). On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (feeling bad / husband was headed for pneumonia yesterday/ Fever about 101 degrees). At the time of the report, COVID-19 (feeling bad / husband was headed for pneumonia yesterday/ Fever about 101 degrees) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2022, SARS-CoV-2 test: (Positive) Result Positive Unit not provided. In July 2022, Body temperature: 101 degree Celsius. On an unknown date, Oxygen saturation: 98 %.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that Lot Number for second booster dose was either: 060A22A or 060A2ZA. It was reported that patient had his first dose of Paxlovid, hi fever broke during the night, he is breathing better, his oxygen saturations are up to 98%, some appetite, and had been afebrile today. It was reported that covid 19 positive after 4 doses of Moderna Covid Vaccine. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 77-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred approximately one month after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. A prior booster dose of mRNA-1273 was taken 6 months before the second booster dose. There was no information regarding the primary series of vaccination. Patient developed fever and tested positive with home COVID-19 test. He was treated with Paxlovid which afforded improvement of symptoms. Oxygen saturation was reported at 98%. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred approximately one month after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. A prior booster dose of mRNA-1273 was taken 6 months before the second booster dose. There was no information regarding the primary series of vaccination. Patient developed fever and tested positive with home COVID-19 test. He was treated with Paxlovid which afforded improvement of symptoms. Oxygen saturation was reported at 98%. The benefit-risk relationship of mRNA-1273 is not affected by this report.