Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: She was hospitalized on 14Oct2024 where she received treatment for nausea and vomiting; Vomiting; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (She was hospitalized on 14Oct2024 where she received treatment for nausea and vomiting), VOMITING (Vomiting) and DIARRHOEA (Diarrhea) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   In October 2024, the patient received third dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 08-Oct-2024, the patient experienced NAUSEA (She was hospitalized on 14Oct2024 where she received treatment for nausea and vomiting) (seriousness criterion hospitalization). 08-Oct-2024, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhea) (seriousness criterion hospitalization). The patient was hospitalized on 14-Oct-2024 due to DIARRHOEA, NAUSEA and VOMITING. At the time of the report, NAUSEA (She was hospitalized on 14Oct2024 where she received treatment for nausea and vomiting), VOMITING (Vomiting) and DIARRHOEA (Diarrhea) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. It was reported that the patient took Moderna and Flu shot at the same time 1 week ago. She was hospitalized on 14-oct-2024 and she received treatment for nausea and vomiting. The patient had relieved all shots ever since the vaccine has come out and she even had side effects with first and second shot.   This case was linked to US-MODERNATX, INC.-MOD-2021-386053, US-MODERNATX, INC.-MOD-2021-045956 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2024: Live non-significant follow-up received and added Reference number. On 14-Oct-2024: Live non-significant follow-up received and added Reference number. On 15-Oct-2024: Live Follow-up received and added no new information. On 15-Oct-2024: Live Significant follow-up received and added new reporter, DOB of patient added, events no appetite, Fatigue, vaccination site pain were added. Updated onset date of events diarrhea, vomiting and abdominal pain, Dosage regimen of suspect added. On 15-Oct-2024: Live significant follow up received and updated outcome of event diarrhea to recovering, added seriousness criteria hospitalization to event diarrhea and vomiting, added co-suspect influenza vaccine, suspect is updated to SPIKEVAX 2024-2025 PFS. and updated narrative. On 15-Oct-2024: Live non-significant follow-up received and added reference number.; Reporter's Comments: Co-suspect Influenza vaccine is a confounder for the events. The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-386053:Husband case US-MODERNATX, INC.-MOD-2021-045956:Case for Monovalent dose