Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | — | IM |
little injection site reaction limited to a localized area in the arm; Covid infection in 14-Feb-2024 and has experienced very mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis. On 02-Dec-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 27-Apr-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2024, the patient experienced COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms). On an unknown date, the patient experienced 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, INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (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. Patient had a Covid infection in 14-Feb-2024 and had experienced very mild symptoms. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects. This case was linked to MOD-2025-788129 (Patient Link).
Hemochromatosis; Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more)