Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | B0005 | IM / RA |
Eating disorder; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; This spontaneous case was reported by a nurse and describes the occurrence of EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) in an 18-year-old patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis. Concurrent medical conditions included Dermatitis since 17-Nov-2021, Scoliosis (Mild scoliosis) since 22-Oct-2018 and ADHD, combined type since 09-Jan-2018. Concomitant products included Ethinylestradiol, Ferrous fumarate, Norethisterone acetate (Loestrin 24 fe) from 05-Jul-2022 to an unknown date for Contraception, Influenza vaccine inact split 3v (Flulaval) and Meningococcal vaccine B (MenB) for an unknown indication. On 17-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Dec-2024, the patient experienced EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). At the time of the report, EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered EATING DISORDER (Eating disorder) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). HCP reported multiple excursions in their refrigerator over a period ranging from 03-Dec-2024 to 11-Jun-2025. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes. On 13-Dec-2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range were reported as 16. No Moderna pediatric vaccine was stored in their refrigerator after 04-Feb-2025. No adverse reactions noted by patient with respect to vaccinations of 17-Dec-2024. No treatment medication was reported. This case contains information for the 5th patient out of 9 patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-787640 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2025: Follow up contains significant information. Reporter's details, patient details (initials, age, height, weight, race, medical history), suspect product details were added, co suspects were added, event was added and narrative was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787640:Patient 1 (Master case)
ADHD, combined type; Dermatitis; Scoliosis (Mild scoliosis)
Flulaval; MenB; Loestrin 24 fe