Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 1, Location of injection: Arm Left) on 17-Mar-2021, Pfizer / BioNTech (Dose Number: 2  Batch/Lot No: ER2613,  Location of injection: Arm Left) on 07-Apr-2021, Pfizer / BioNTech (Dose Number: 3  and Location of injection: Arm Left) on 16-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Osteoporosis and Drug allergy. Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GLUCOSAMINE, ATORVASTATIN CALCIUM (LIPITOR), AREDS 2 PLUS MULTI VITAMIN, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] and PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOPHED) for an unknown indication.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient had taken other medications/ products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 vaccine. Patient had Rebound symptoms and a positive covid test a week after treatment was finished.  Company comment: This spontaneous case concerns a patient (age and sex unspecified), with history of interchange of vaccine products who experienced the unexpected non-serious ADR Covid-19, within a few days after receiving a dose of mRNA-1273 as 4th dose. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. One week later the patient had recurrence of symptoms (unspecified) and SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Approximately seven months prior to the mRNA-1273 dose the patient had take three doses of Pfizer / BioNTech Covid-19 vaccine. The current Pandemic of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and sex unspecified), with history of interchange of vaccine products who experienced the unexpected non-serious ADR Covid-19, within a few days after receiving a dose of mRNA-1273 as 4th dose. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. One week later the patient had recurrence of symptoms (unspecified) and SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Approximately seven months prior to the mRNA-1273 dose the patient had take three doses of Pfizer / BioNTech Covid-19 vaccine. The current Pandemic of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.