Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Patient received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days; Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Glucose abnormal. Concurrent medical conditions included Coronary artery disease (history CABG and stents), Hypertension, Hyperlipidemia, GERD and Allergy. Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CLONAZEPAM, CLOPIDOGREL, EPLERENONE, DOCUSATE, FINASTERIDE, FLUTICASONE, MONTELUKAST, HYDROCHLOROTHIAZIDE, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), LORAZEPAM, PANTOPRAZOLE, ROSUVASTATIN, SERTRALINE, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) and MULTIVITAMIN [VITAMINS NOS] (MULTIVITAMIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth 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). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 14-May-2022 to 19-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) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient had a rebound infection after Pxlovid. The device date 26-May-2022. No treatment drug details was reported.  Company Comment:  This is a spontaneous case concerning a patient of an unknown age and gender 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 1 month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 24 days which did not fall within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination and 14 months prior to fourth mRNA-1273 vaccination (Inappropriate schedule of vaccine administered). Patient was treated with a six-day-course of Paxlovid for the initial COVID-19 infection. However, after the treatment with Paxlovid, patient reported rebound infection of COVID-19. 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. This case was linked to MOD-2022-579008 (Patient Link). Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender 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 1 month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 24 days which did not fall within the recommended vaccine dosing schedule, approximately 7 months prior to third mRNA-1273 vaccination and 14 months prior to fourth mRNA-1273 vaccination (Inappropriate schedule of vaccine administered). Patient was treated with a six-day-course of Paxlovid for the initial COVID-19 infection. However, after the treatment with Paxlovid, patient reported rebound infection of COVID-19. 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.