Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | 011A21A | — |
flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 007B21A and 076C21A) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to US-MODERNATX, INC.-MOD-2025-788167 (E2B Linked Report). This case was linked to MOD-2025-788134, MOD-2025-788137, MOD-2025-788138, MOD-2025-788141 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788167:Husband's case
Hemochromatosis; Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more)