Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046732 | SC |
created an indent on the injection site; Patient is claiming that the vaccine was given sub-Q rather than intramuscularly; Patient believes that the vaccine was ineffective; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use) .5 milliliter. On an unknown date, the patient experienced INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective). At the time of the report, INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. No other vaccines within the past 4 weeks and no relevant medical history were reported as per HCP. According to the HCP, after the vaccination, the patient reported that the vaccine was given subcutaneously instead of intramuscularly and noted an indent at the injection site. The patient believed that the vaccine was ineffective and subsequently requested a second dose of Spikevax. HCP inquired whether administering another dose would be appropriate. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results available. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.