Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound covid infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound covid infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 048C21A, 023M20A and 029L20A) 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 Idiopathic thrombocytopenic purpura. Concurrent medical conditions included Asthma, Hashimoto's thyroiditis and Sulfonamide allergy (Allergic to sulfa). Concomitant products included CICLESONIDE (ALVESCO) from 01-May-2010 to 12-May-2022 for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound covid infection). At the time of the report, COVID-19 (Rebound covid infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The end date for Paxlovid was provided as 16-May-2022.  The indication for Paxlovid was provided as Treatment of COVID-19. Tested positive again on 5/24. Stuffy runny nose. Device Date : 24-May-2022 Company comment This spontaneous case reported by a patient, concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious of COVID-19 (Rebound covid infection) about 50 days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) for 5 days, from 12-May-2022 till 16 May 2022, for covid 19 treatment. SARS-CoV-2 test was negative on 18 and 19 May 2022. She tested positive on 24 May 2022 with Stuffy runny nose, 08 days after stopping Paxlovid. Patient had previously received the 2 primary doses with Moderna vaccines at an interval of 28 days and the 3 dose also with Moderna about 6 months prior to the 4 dose.  No details on concomitant and treatment medications was provided. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement. Sender's Comments: This spontaneous case reported by a patient, concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (Rebound covid infection) about 50 days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) for 5 days, from 12-May-2022 till 16 May 2022, for covid 19 treatment. SARS-CoV-2 test was negative on 18 and 19 May 2022. She tested positive on 24 May 2022 with Stuffy runny nose, 08 days after stopping Paxlovid. Patient had previously received the 2 primary doses with Moderna vaccines at an interval of 28 days and the 3 dose also with Moderna about 6 months prior to the 4 dose.  No details on concomitant and treatment medications was provided. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.