Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 48L21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 1  Batch/Lot No: EN6198) on 26-Feb-2021, Pfizer / BioNTech (Dose Number: 2  Batch/Lot No: EN6204) on 18-Mar-2021 and Pfizer / BioNTech (Dose Number: 3  Batch/Lot No: FC3183) on 25-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Asthma and Allergy NOS. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), MONTELUKAST SODIUM (SINGULAIR), ATORVASTATIN, ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 30-May-2022   Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 1 month and 2 weeks after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient completed a 6-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment, and presented with rebound COVID-19 infection 2 days later. No SARS-CoV-2-test was reported before and after Paxlovid treatment.  Patient previously received 3 doses of non-company brand COVID-19 vaccine Pfizer / BioNTech, the last dose of which was administered 6 months and 5 days prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a predisposing risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 1 month and 2 weeks after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient completed a 6-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment, and presented with rebound COVID-19 infection 2 days later. No SARS-CoV-2-test was reported before and after Paxlovid treatment.  Patient previously received 3 doses of non-company brand COVID-19 vaccine Pfizer / BioNTech, the last dose of which was administered 6 months and 5 days prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a predisposing risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.