Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Suspected Covid-19 Infection; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (Suspected Covid-19 Infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Jannsen covid-19 vaccine (Batch number 043A21A, dose number in series 1 and left arm) on 11-Apr-2021. Past adverse reactions to the above products included Vaccination failure with Jannsen covid-19 vaccine. Concurrent medical conditions included Exercise induced asthma. Concomitant products included FAMOTIDINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN B COMPLEX, ALBUTEROL [SALBUTAMOL], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MAGNESIUM for an unknown indication.    On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced SUSPECTED COVID-19 (Suspected Covid-19 Infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19, at an unspecified dose and frequency. On 09-Jun-2022, SUSPECTED COVID-19 (Suspected Covid-19 Infection) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: (Negative) Negative. On 30-May-2022, SARS-CoV-2 test: (Positive) Positive. On 09-Jun-2022, SARS-CoV-2 test: (Negative) Negative.   Patient had no known allergy. 12 hours after taking 1st dose of paxlovid patient experienced very bitter ashy taste in mouth.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, serious (due to medically significant) AESI of COVID-19, after the dose of mRNA-1273 vaccine, considered as the second dose of the vaccine schedule. Previously the patient received a dose of Jannsen covid-19 vaccine (interchange of vaccine products). As per source document, Paxlovid was prescribed as treatment. After a full course of Paxlovid the patient had recurrence of symptoms and tested positive on a rapid test. Twenty days after treatment the patient finally tested negative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, serious (due to medically significant) AESI of COVID-19, after the dose of mRNA-1273 vaccine, considered as the second dose of the vaccine schedule. Previously the patient received a dose of Jannsen covid-19 vaccine (interchange of vaccine products). As per source document, Paxlovid was prescribed as treatment. After a full course of Paxlovid the patient had recurrence of symptoms and tested positive on a rapid test. Twenty days after treatment the patient finally tested negative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.