Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Recurrence of covid-19 symptoms on 10 days after starting Paxlovid treatment; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Recurrence of covid-19 symptoms on 10 days after starting Paxlovid treatment) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic bronchitis and Drug allergy (Codeine). Concomitant products included IODINE and COLECALCIFEROL, MENAQUINONE-7 (VITAMIN D3 K2) from January 2021 to an unknown date for an unknown indication.   On 31-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 01-Sep-2021, received third 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 (Recurrence of covid-19 symptoms on 10 days after starting Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recurrence of covid-19 symptoms on 10 days after starting Paxlovid treatment) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient race was reported. Proprietary medicinal product name for concomitant was reported.  Patient reported recurrence of COVID-19 symptoms (extreme fatigue, body aches) on 10 days after starting  Paxlovid treatment.  Company Comment:  This spontaneous case concerns a 57-year-old female with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with recurrence of COVID-19 symptoms of extreme fatigue and body aches 6 days later (8.5 months after current mRNA-1273 vaccination and 10 days after starting day1 of Paxlovid)). Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the last dose administered approximately 7 months prior to current mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 57-year-old female with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with recurrence of COVID-19 symptoms of extreme fatigue and body aches 6 days later (8.5 months after current mRNA-1273 vaccination and 10 days after starting day1 of Paxlovid)). Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the last dose administered approximately 7 months prior to current mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.