Age: 59.0
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 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022j21a, 033f4a, 036b21a and 037a21b) for COVID-19 vaccination.     The patient's past medical history included Spinal cord injury. Concurrent medical conditions included Diabetes, Hypertension and Seafood allergy. Concomitant products included METFORMIN, GLIMEPIRIDE, RAMIPRIL, METOPROLOL, ATORVASTATIN, OXYCODONE, NAPROXEN SODIUM (ALEVE), PARACETAMOL (TYLENOL) and DULAGLUTIDE (TRULICITY) for an unknown indication.   On 16-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 and tested negative at day 7 after completing Paxlovid. However, she had mild symptoms 3 days later with positive covid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI  of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 and tested negative at day 7 after completing Paxlovid. However, she had mild symptoms 3 days later with positive covid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.