Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. The patient's past medical history included CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetes). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The patient received the Moderna COVID-19 vaccine in 2021. On 28-Apr-2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. On 15-Jan-2023, the patient was administered the Moderna COVID-19 Bivalent Vaccine. Subsequently, on 19-Oct-2023, patient received the Spikevax 2023-2024 PFS and on 24-Sep-2024 patient received the SPIKEVAX 2024-2025 PFS. It was reported that patient received all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that post COVID-19 vaccination each time almost 10 hours after the vaccine the patient used to start vomit for every 20 to 30 minutes and that vomit used to last for 6-8 hours for the patient. It was reported that patient used to receive Moderna vaccines except for once she got Pfizer but experienced the same symptom. In addition, there were for other 4 other Moderna -Covid-19 vaccine patient had no information. No treatment medications provided by the reporter. This case was linked to MOD-2025-789725 (Patient Link).
CAPD (CAPD (dialysis)); Type 1 diabetes mellitus (Type 1 diabetes)