Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Paxlovid used for treatment of COVID-19/Rebounding of COVID symptoms.Today,5/27/22 still congested and rapid tested positive again this morning; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Paxlovid used for treatment of COVID-19/Rebounding of COVID symptoms.Today,5/27/22 still congested and rapid tested positive again this morning) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: ER8733 Location of injection: Arm Left) on 26-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0167 Location of injection: Arm Right) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Sulfonamide allergy (Sulfa antibiotics allergy).    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Paxlovid used for treatment of COVID-19/Rebounding of COVID symptoms.Today,5/27/22 still congested and rapid tested positive again this morning). 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 (Paxlovid used for treatment of COVID-19/Rebounding of COVID symptoms.Today,5/27/22 still congested and rapid tested positive again this morning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Rapid test: Positive. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Rapid test: Positive.         No concomitant medications were reported.  The patient had rebounding of COVID symptoms. On Tuesday 17-May-2022 was last day of Paxlovid. On 24-May-2022 she started feeling congested. On 25-May-2022 rapid tested positive. Today, on 27-May-2022 she was still congested and rapid tested positive again this morning. The patient was taking (unknown) medications/products within 2 weeks of starting COVID-19 treatment. On 12-May-2022 patient had received NightTime Multi-Symptom Relief for Cold/Flu (Batch no:Y89695). Company comment: This is a spontaneous case concerning a 41-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Pfizer vaccines with the 2 dose given about 7 months prior to the 3 dose. Interchange of vaccine products was noted. It was reported that the patient received treatment with Paxlovid for 5 days from 13 May to 17 may 2022, for covid 19. The outcome of this event was unknown. The ongoing Covid 19 pandemia is a confounder. It was reported that on 24-May-2022, 07 days after stopping Paxlovid treatment, there was rebounding of COVID symptoms. Patient started feeling congested and on the next day, rapid test was positive and again she tested positive2 days later. She was still congested and this event was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Pfizer vaccines with the 2 dose given about 7 months prior to the 3 dose. Interchange of vaccine products was noted. It was reported that the patient received treatment with Paxlovid for 5 days from 13 May to 17 may 2022, for covid 19. The outcome of this event was unknown. The ongoing Covid 19 pandemia is a confounder. It was reported that on 24-May-2022, 07 days after stopping Paxlovid treatment, there was rebounding of COVID symptoms. Patient started feeling congested and on the next day, rapid test was positive and again she tested positive2 days later. She was still congested and this event was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.