Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid; Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid) and DRUG INEFFECTIVE (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007M20A and 025L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Dehiscence (Tracheal). Concurrent medical conditions included Tracheal stenosis, Extrinsic asthma, Penicillin allergy, Drug allergy (Morphine) and Drug allergy (Demoral). Concomitant products included SALBUTAMOL SULFATE (VENTOLIN HFA) from 01-Mar-2005 to an unknown date, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 01-Mar-2005 to an unknown date, BUDESONIDE (NASOCORT) from 01-Mar-2005 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Mar-2005 to an unknown date for an unknown indication.   On 10-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid) and DRUG INEFFECTIVE (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid). At the time of the report, COVID-19 (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid) was resolving and DRUG INEFFECTIVE (Rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was rebound which started in the morning of 10-May-2022 before taking 8th dose of 10 of Paxlovid. The patient had headache, sore or scratchy throat, runny nose, cough, clear, yellow tinted, thick sputum, slightly foggy or dusted mentation and fatigue on 10-May-2022 at 06:30 hours.  Bebtelovimab was also reported as the treatment medication. company comment This spontaneous case reported by a nurse, concerns a 58 year old female patient, with concurrent medical conditions included Tracheal stenosis and Extrinsic asthma, who experienced the unexpected, non-serious AESI of covid 19 Infection unknown days, after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 11 months ago. Patient was treated with PAXLOVID from for 6 days from 06-May-2022 to 11-May-2022, for COVID-19 Infection. It was reported that rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid. The patient had headache, sore or scratchy throat, runny nose, cough, clear, yellow tinted, thick sputum, slightly foggy or dusted mentation and fatigue. Bebtelovimab was also reported as the treatment. Event outcome was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a nurse, concerns a 58 year old female patient, with concurrent medical conditions included Tracheal stenosis and Extrinsic asthma, who experienced the unexpected, non-serious AESI of covid 19 Infection unknown days, after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 11 months ago. Patient was treated with PAXLOVID from for 6 days from 06-May-2022 to 11-May-2022, for COVID-19 Infection. It was reported that rebound started morning of May 10, 2022 before taking 8th dose of 10 of Paxlovid. The patient had headache, sore or scratchy throat, runny nose, cough, clear, yellow tinted, thick sputum, slightly foggy or dusted mentation and fatigue. Bebtelovimab was also reported as the treatment. Event outcome was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.