Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | B0005 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 45546 | IM |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | B4J4B | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | ek7D6 | IM / LA |
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; Pectus excavatum; This serious case was reported by a nurse via other manufacturer and described the occurrence of pectus excavatum in a patient who received Men B NVS (Meningococcal B vaccine) (batch number B4J4B) for prophylaxis. Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 45546) for prophylaxis, Elasomeran (Spikevax) (batch number B0005, expiry date 28-MAY-2025) for prophylaxis and Meningococcal vaccine A/C/Y/W (Men acwy) (batch number ek7D6) for prophylaxis. Concurrent medical conditions included pseudostrabismus, congenital tracheomalacia, asthma and wheezing. Additional patient notes included The patient was not allergic to medications, food, and other products. Concomitant products included salbutamol (Albuterol Hfa) and salbutamol (Albuterol). On 17-DEC-2024, the patient received Meningococcal B vaccine (intramuscular), FluLaval 2024-2025 season (intramuscular), Spikevax (intramuscular) and Men acwy (intramuscular, left deltoid). On 15-APR-2025, 119 days after receiving Meningococcal B vaccine, FluLaval 2024-2025 season, Spikevax and Men acwy, the patient experienced pectus excavatum (Verbatim: Pectus excavatum) (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: 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). The outcome of the pectus excavatum was not resolved and the outcome of the incorrect storage of drug was not applicable. It was unknown if the reporter considered the pectus excavatum to be related to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The reporter considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. The company considered the pectus excavatum to be unrelated to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 The nurse reported multiple excursions in their refrigerator over a period ranging from 03rd December 2024. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes, respectively. On 13th December 2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range was reported as 16 minutes and the vaccines were administered after excursion, which led to incorrect storage of drug. The patient had pectus excavatum after receiving vaccinations. No Moderna geriatric vaccine was stored in their refrigerator after 04th February 2025. No adverse events were reported in relation to the vaccination of 17th December 2024. No treatment medication was reported.; Sender's Comments: A case of Pectus excavatum, 119 days after receiving Meningococcal B vaccine, Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE, FluLaval 2024-2025 season and FluLaval PRE-FILLED SYRINGE DEVICE in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (concurrent congenial tracheomalacia).
Asthma; Congenital tracheomalacia; Pseudostrabismus; Wheezing
Comments: The patient was not allergic to medications, food, and other products
ALBUTEROL HFA; ALBUTEROL