Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 004M20A and 02520-2A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia. Previously administered products included for Product used for unknown indication: compazine and macrobid. Past adverse reactions to the above products included Drug allergy with compazine and macrobid. Concurrent medical conditions included Asthma, Type 2 diabetes mellitus, Migraine, Neuropathy and Allergy to NSAIDs. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jan-1998 to an unknown date, MONTELUKAST SODIUM (SINGULAIR) from 01-Jan-2000 to an unknown date, PREGABALIN (LYRICA) from 01-Jan-2018 to an unknown date, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 01-Aug-2020 to an unknown date, ESTRADIOL (FEMRING) from 01-Jun-2004 to an unknown date, METOPROLOL from 01-Jun-2018 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2018 to an unknown date for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, 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 Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid 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. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   COVID-19 symptoms include moderate illness 12 days after original diagnosis and 5 days after completion of Paxlovid. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This is a spontaneous case concerning a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, 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 9 months prior to third mRNA-1273 vaccination. Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, 5 days after the completion of Paxlovid, patient reported recurrence of moderate illness and rebound COVID-19 infection which was supported by a positive COVID-19 rapid antigen test. 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 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, 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 9 months prior to third mRNA-1273 vaccination. Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, 5 days after the completion of Paxlovid, patient reported recurrence of moderate illness and rebound COVID-19 infection which was supported by a positive COVID-19 rapid antigen test. 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.