Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 032B21A and 026A21A) for COVID-19 vaccination.  Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol, Seasonal allergy and Allergy to antibiotic (Sulfa antibiotics). Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER) from 31-Jan-2018 to an unknown date, LISINOPRIL from 12-Mar-2018 to an unknown date and ATORVASTATIN from 11-Oct-2021 to 11-May-2022 for an unknown indication.  On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. On 21-May-2022, the symptoms returned; runny nose, then dizziness and tiredness, some headache and sneezing. The device date was 25-May-2022.  Company comment: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 31 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. Patient was given a five-day-course of Paxlovid treatment for the initial COVID-19 infection. However, five days after the treatment with Paxlovid, patient noted runny nose, dizziness, tiredness, some headache and sneezing, then tested positive again for COVID-19 after 2 days. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 31 days which falls within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination. Patient was given a five-day-course of Paxlovid treatment for the initial COVID-19 infection. However, five days after the treatment with Paxlovid, patient noted runny nose, dizziness, tiredness, some headache and sneezing, then tested positive again for COVID-19 after 2 days. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.