Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 046A21A | IM |
she suffers an unspecified bone defect from which it is not known if it is based in the patient´s genetics or if it was provoked partially from the Spikevax vaccinations; her health has become worse; after having been vaccinated her health has become worse, especially her lever has been affected two months after the second dose of Spikevax; First dose was given on 24-Mar-2021 and second dose was given on 6-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of BONE DISORDER (she suffers an unspecified bone defect from which it is not known if it is based in the patient´s genetics or if it was provoked partially from the Spikevax vaccinations), GENERAL PHYSICAL HEALTH DETERIORATION (her health has become worse), LIVER DISORDER (after having been vaccinated her health has become worse, especially her lever has been affected two months after the second dose of Spikevax) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 24-Mar-2021 and second dose was given on 6-May-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 24-Mar-2021 and second dose was given on 6-May-2021). In July 2021, the patient experienced LIVER DISORDER (after having been vaccinated her health has become worse, especially her lever has been affected two months after the second dose of Spikevax). On an unknown date, the patient experienced BONE DISORDER (she suffers an unspecified bone defect from which it is not known if it is based in the patient´s genetics or if it was provoked partially from the Spikevax vaccinations) and GENERAL PHYSICAL HEALTH DETERIORATION (her health has become worse). At the time of the report, BONE DISORDER (she suffers an unspecified bone defect from which it is not known if it is based in the patient´s genetics or if it was provoked partially from the Spikevax vaccinations) had not resolved, GENERAL PHYSICAL HEALTH DETERIORATION (her health has become worse) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 24-Mar-2021 and second dose was given on 6-May-2021) outcome was unknown and LIVER DISORDER (after having been vaccinated her health has become worse, especially her lever has been affected two months after the second dose of Spikevax) had resolved. Relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Before having been vaccinated patient had received a comprehensive workup for her liver (in Mar-2021). After having been vaccinated her health had become worse, especially her liver had been affected two months after the second dose of Spikevax (she had recovered on the day of reporting). Currently, she suffered an unspecified bone defect from which it was not known if it was based in the patient´s genetics or if it was provoked partially from the Spikevax vaccinations. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.