Received Jul 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | B0005 | IM / RA |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 45546 | IM / LA |
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | B4J4B | IM / RA |
Pectus excavatum; 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 PECTUS EXCAVATUM (Pectus excavatum) in a 17-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Influenza vaccine inact split 3v (Flulaval) for an unknown indication and Meningococcal vaccine B (MenB) for an unknown indication. Concurrent medical conditions included Pseudostrabismus since 17-May-2014, Congenital tracheomalacia since 17-May-2014, Asthma since 09-Aug-2017 and Wheezing. Concomitant products included Salbutamol (Albuterol Hfa) from 09-Aug-2017 to an unknown date and Salbutamol sulfate (Albuterol) from 09-Aug-2017 to an unknown date for Wheezing. On 17-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of Influenza vaccine inact split 3v (Flulaval) (Intramuscular use) 1 dosage form and dose of Meningococcal vaccine B (MenB) (Intramuscular use) 1 dosage form. On 13-Dec-2024, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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). On 17-Dec-2024, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). On 15-Apr-2025, the patient experienced PECTUS EXCAVATUM (Pectus excavatum) (seriousness criterion medically significant). At the time of the report, PECTUS EXCAVATUM (Pectus excavatum) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (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) 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 PECTUS EXCAVATUM (Pectus excavatum) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (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) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). Another co-suspect vaccine included MenACWY vaccine which was given to patient on 17-Dec-2024 for unknown indication via intramuscular route in left deltoid and it's batch number was reported as ek7D6. Patient was not allergic to any medications, food, and other products. 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 respectively. On 13-Dec-2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range was reported as 16 minutes. No Moderna geriatric vaccine was stored in their refrigerator after 04-Feb-2025. No adverse events were reported in relation to the vaccination of 17-Dec-2024. No treatment medication was reported. 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: Significant follow-up received in which case was upgrade from non-serious to serious, no patient identifier classification was removed, updated reporter's occupation as nurse, patient demographic was added (initial, age, gender, height, weight, race, ethnic group), other relevant history was added, suspect product vaccination information was updated (vaccination date, anatomical location), new co-suspect of Flulaval, MenB and Menacwy was added, new concomitant medication of Albuterol Hfa and Albuterol was added, new event of Pectus excavatum was added, reported event verbatim was updated, case narrative was updated.; Reporter's Comments: PECTUS EXCAVATUM was assessed as not related to SPIKEVAX 2024-2025 PFS due to nature of reported event, which is commonly assessed as congenital defect. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787640:Master case
Asthma; Congenital tracheomalacia; Pseudostrabismus; Wheezing
Albuterol Hfa; Albuterol