Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional 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.     Concurrent medical conditions included Food allergy (Sucrose), Food allergy (Aspartame), Food allergy (Stevia), Food allergy (Equal), Allergy to antibiotic (Zithromax) and Drug allergy (Chloraprep). Concomitant products included AMLODIPINE from 19-May-2022 to an unknown date, THYROID (ARMOUR THYROID), ATORVASTATIN from 19-May-2022 to an unknown date, CALCIUM, CELECOXIB (CELEBREX), GABAPENTIN, GLUCOSAMINE, LIOTHYRONINE SODIUM, MAGNESIUM, METOPROLOL SUCCINATE, PROBIOTICS NOS, SELENIUM, SUPER B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;LECITHIN;MEDICAGO SATIVA HERB;NASTURTIUM OFFICINALE LEAF;NICOTINAMIDE;ORYZA SATIVA;PETROSELINUM CRISPUM LEAF;PYRIDOXINE HYDROCHLORIDE, VITAMIN D3, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), ZINC and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second 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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 31 May 2022, patient was started with rebound symptoms and repeat COVID test was positive.  Device Date : 06 Jun 2022 Company comment- This spontaneous case concerns a patient of unknown gender and age with no relevant medical history reported, who experienced the unexpected non serious AESI COVID-19. Two doses of mRNA-1273 vaccine, at an adequate Interval, were administered. Temporal association cannot be assessed due to lack of information on onset date of the event.  It was reported that the patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for 4 days for COVID-19 treatment. Details on the onset date, lab results and symptoms of this initial COVID-19 infection and its outcome were not reported.  Patient tested negative after treatment completion; 8 days later he started with rebound symptoms. 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 concerns a patient of unknown gender and age with no relevant medical history reported, who experienced the unexpected non serious AESI COVID-19. Two doses of mRNA-1273 vaccine, at an adequate Interval, were administered. Temporal association cannot be assessed due to lack of information on onset date of the event.  It was reported that the patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for 4 days for COVID-19 treatment. Details on the onset date, lab results and symptoms of this initial COVID-19 infection and its outcome were not reported.  Patient tested negative after treatment completion; 8 days later he started with rebound symptoms. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.