Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U8265AA | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
No adverse event/ HCP confirmed that there were no symptomatic events; T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. See T/E case #02777949. HCP reported that VAXELIS and GARDASIL-9 were administered. HCP reported that PNEUMOVAX-23 was not administered to any patients.; This spontaneous report has been received from a Nurse Practitioner, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with an improperly storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) (lot number: U8265AA, which was determined to be valid, with an expiration date on 31-Aug-2027 (also reported to be 31-Oct-2026, conflicting information) both as prophylaxis. The administered Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) dose underwent a temperature excursion of 47.5 degrees Fahrenheit (F) for 36 minutes and 51 seconds with a previous one of 48 F for 1 hour and 13 minutes. For Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), it was reported that there was a temperature excursion but details were not given (within the product disclaimer administration allowance per the PI). HCP confirmed that there were no symptomatic events (no adverse event). Lot # is being requested and will be submitted if received.