Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Suspected COVID-19 infection; Interchange of vaccine products; This spontaneous case was reported by a consumer 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) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Type 1 diabetes mellitus, Hypothyroidism, Allergy to antibiotic (dicloxacillin), Drug allergy (Pfenergan), Drug allergy (Inapsine) and Drug allergy (Reglan). Concomitant products included INSULIN, METOPROLOL, GABAPENTIN and LEVOTHYROXINE for an unknown indication.   On 03-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19 infection) (seriousness criterion medically significant) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-Jun-2022 to 22-Jun-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (Suspected COVID-19 infection) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            It was unknown whether patient had any adverse events following second dose of Moderna vaccine.  On an unspecified date, the patient had suspected clinical vaccination failure. On 18-Jun-2022, the patient experienced extremely bitter taste in the mouth which lasted for greater than 12 hours. It came and went and brushing teeth or mouthwash did nothing. It subsided if the patient ate something, the bitter taste started again and tasted like chewing on a mouthful of vitamins or bitter medications.  Company comment-This spontaneous case concerns a patient of unknown gender and age with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI of Suspected COVID-19 that occurred on an unknown date after a dose (3rd dose) of mRNA-1273 vaccine in covid-19  vaccination series. Additionally Interchange of vaccine products was noted as patient had received initial first dose of vaccination with JANSSEN COVID-19 VACCINE approximately one year prior to current vaccination. Patient had received 2nd dose of mRNA-1273 vaccine 181 days prior to 3rd dose of mRNA-1273 vaccine. On 18th June 2022 patient had extremely bitter taste in the mouth lasting for 12 hours, suspecting Covid -19 infection treated with Paxlovid for 5 days from 18th to 22nd June 2022. No further details on clinical course, lab test and other treatment received were reported. Outcome of the event Suspected COVID-19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as 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 serious (medically significant) AESI of Suspected COVID-19 that occurred on an unknown date after a dose (3rd dose) of mRNA-1273 vaccine in covid-19  vaccination series. Additionally Interchange of vaccine products was noted as patient had received initial first dose of vaccination with JANSSEN COVID-19 VACCINE approximately one year prior to current vaccination. Patient had received 2nd dose of mRNA-1273 vaccine 181 days prior to 3rd dose of mRNA-1273 vaccine. On 18th June 2022 patient had extremely bitter taste in the mouth lasting for 12 hours, suspecting Covid -19 infection treated with Paxlovid for 5 days from 18th to 22nd June 2022. No further details on clinical course, lab test and other treatment received were reported. Outcome of the event Suspected COVID-19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.