Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, GERD, Osteoporosis and Drug allergy (Unknown historical drug.). Concomitant products included ROMOSOZUMAB (EVENITY [ROMOSOZUMAB]), FAMOTIDINE, LISINOPRIL, SERTRALINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL]) and MULTIVITAMIN [VITAMINS NOS] 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 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, 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 (Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative after initial 5 day treatment. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was reported.  It was reported that symptoms recurred and patient was tested positive again on 31-May-2022. Company comment This spontaneous case reported by a physician, concerns a 71-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms) unknown days after receiving the 4 dose of mRNA-1273 vaccine on 18 April 2022, in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) From 19 May to 24 May 2022 for 5 days for covid 19 treatment. SARS-CoV-2 test became negative on an unknown date in May after stopping Paxlovid treatment and was positive again on 31 May 2022 5 days after stopping paxlovid treatment.. Patient received primary 2 doses, about an year ago with Moderna and the 3 dose also with Moderna vaccine about 6 months prior to 4 dose, with no adverse events reported for previous Moderna vaccines. Advanced Age of this Hypertensive subject and the ongoing Covid 19 pandemia are confounders. The event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement   This case was linked to MOD-2022-581876 (Patient Link).; Sender's Comments: This spontaneous case reported by a physician, concerns a 71-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (Patient had rebound infection after Paxlovid, tested negative after initial 5 day treatment, symptoms) unknown days after receiving the 4 dose of mRNA-1273 vaccine on 18 April 2022, in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) From 19 May to 24 May 2022 for 5 days for covid 19 treatment. SARS-CoV-2 test became negative on an unknown date in May after stopping Paxlovid treatment and was positive again on 31 May 2022 5 days after stopping paxlovid treatment.. Patient received primary 2 doses, about an year ago with Moderna and the 3 dose also with Moderna vaccine about 6 months prior to 4 dose, with no adverse events reported for previous Moderna vaccines. Advanced Age of this Hypertensive subject and the ongoing Covid 19 pandemia are confounders. The event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement