Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On May 22 tested positive again with slight symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (On May 22 tested positive again with slight symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057m21a, 012f212, 007321a and 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Psoriasis, Hypercholesteraemia and Drug allergy (Anectine allergy). Concomitant products included LISINOPRIL, EZETIMIBE (ZETIA), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), VITAMIN D3 and CALCIUM ASCORBATE (VITAMIN C [CALCIUM ASCORBATE]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 (On May 22 tested positive again with slight symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from May 2022 to May 2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (On May 22 tested positive again with slight symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive again with slight symptoms (Binax home test). On 30-May-2022, SARS-CoV-2 test: positive (Positive) Positive (Binax home test). On an unknown date, SARS-CoV-2 test: negative (Negative) Negative (Binax home test), negative (Negative) Negative (Binax home test) and negative (Negative) Negative (Binax home test).         Patient had rebound Covid after taking Paxlovid.  Device date was reported as 30-May-2022. Company comment: This spontaneous case concerns a patient of unknown age and gender with medical history of Asthma and Hypercholesterolaemia, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. The fourth dose of mRNA-1273 was administered 6 months after the administration of third dose of mRNA-1273, The initial two doses of mRNA-1273 were given 7 months prior to the third dose, the interval between the two doses is 28 days. The patient underwent SARS-CoV-2 test on two separate occasions, May 22 and 30, 2022, which revealed both positive results. The patient was started on Paxlovid treatment regimen in May 2022, however it has been reported that patient had rebound symptoms after treatment. The patient's medical history of Asthma and Hypercholesterolaemia could be considered confounders to the event. Details of concomitant medications and clinical course were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with medical history of Asthma and Hypercholesterolaemia, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. The fourth dose of mRNA-1273 was administered 6 months after the administration of third dose of mRNA-1273, The initial two doses of mRNA-1273 were given 7 months prior to the third dose, the interval between the two doses is 28 days. The patient underwent SARS-CoV-2 test on two separate occasions, May 22 and 30, 2022, which revealed both positive results. The patient was started on Paxlovid treatment regimen in May 2022, however it has been reported that patient had rebound symptoms after treatment. The patient's medical history of Asthma and Hypercholesterolaemia could be considered confounders to the event. Details of concomitant medications and clinical course were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.