Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052784 | — |
No adverse effect; discoloration of the cap for the Spikevax syringes; Poor quality vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE COLOUR ISSUE (discoloration of the cap for the Spikevax syringes), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch nos. 3052784 and 8146545) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052784) for COVID-19 prophylaxis. No Medical History information was reported. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. In 2025, received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced DEVICE COLOUR ISSUE (discoloration of the cap for the Spikevax syringes) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE COLOUR ISSUE (discoloration of the cap for the Spikevax syringes), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. The case was considered as invalid since multiple number of patients were involved without mention of particular patient identifier. No concomitant medication was reported. The reporter had concern receiving many Spikevax PFS with yellow tip cap discoloration. The quantity of the product affected was 250 boxes. This had been distributed to multiple clinics and the main hospital and had been given to patients. It was hard to track how many patients were administered the vaccines because the reporter had so many lot numbers and the vaccines went to multiple clinics so the reporter cannot say for sure the exact lot number and how many patients received it. The reporter stated that he would have to look at his order history but so far, there were at least 4 or 5 other lot numbers that he had checked multiple boxes for, that had that same discoloration. The Device Problem Information included FDA code: 1170, IMDRF Code: A0407, Device problem: Material Discolored. For lot 3052784, NDC number was 80777-0112-96 (10-syringe box), expiry date was 17-May-2026, and serial number was 834CHBFRP2BX. For lot 8146545, NDC number was 80777-112-01, expiry date was 12-May-2026. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2025: Live follow-up received contains non-significant information (narrative was updated and reference numbers were added).