Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 prior to Paxlovid treatment) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.  Concurrent medical conditions included Type 1 diabetes mellitus, Hypothyroidism and Drug allergy (unknown drug allergy). Concomitant products included INSULIN ASPART (NOVOLOG) from 18-May-2022 to 01-Jun-2022 for an unknown indication.  On 29-Apr-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 prior to Paxlovid treatment) was resolving.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative covid test result 3 days after finishing paxlovid. On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) positive test result 9 days after finishing Paxlovid.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. After 5 days of all doses of Paxlovid treatment, patient felt extreme fatigue, runny nose, slight cough, allergy-like symptoms. Patient tested COVID-19 negative 3 days after finishing Paxlovid and tested positive 9 days after finishing Paxlovid. The device date was reported as 01-Jun-2022.  Company comment: This spontaneous case of concerns a 54-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the fourth dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment 19 days after the fourth dose of mRNA-1273 vaccine, and after 5 days of treatment she experienced extreme fatigue, runny nose, slight cough, allergy-like symptoms. Three days after finishing Paxlovid she had a negative test and was tested positive 9 days after finishing Paxlovid. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of concerns a 54-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the fourth dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment 19 days after the fourth dose of mRNA-1273 vaccine, and after 5 days of treatment she experienced extreme fatigue, runny nose, slight cough, allergy-like symptoms. Three days after finishing Paxlovid she had a negative test and was tested positive 9 days after finishing Paxlovid. The benefit-risk relationship of mRNA-1273 is not affected by this report.