Report #2844597

Overview

Sex

Unknown

Age

Age unknown

State

MD

Recovered

Unknown

Vaccinated

Dec 16, 2024

Onset

Nov 1, 2024

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

Product storage error; Product administered to patient of inappropriate age. Patient is 59 years old; There were no adverse reactions to any of the vaccines adminstered; HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored.; This non-serious spontaneous safety report, with reference number 02815164 (Interaction Number 02815116), was received by partner on 02-JUN-2025 and forwarded on 03-JUN-2025 from a healthcare professional. Additional information was received by partner on 03-JUN-2025 and forwarded on 04-JUN-2025. This case was considered as non-valid due to no patient identifiers provided. Due to the nature of the event, the causality between the event ‘HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored.' and Vaxelis was not applicable. Further information is expected. SIGNFICANT FOLLOW-UP INFORMATION was received from a health professional on 06-JUN-2025 and was received by partner with reference number 02815164 on 09-JUN-2025 and forwarded on 09-JUN-2025 from a health professional. This case remains non-valid due to no patient identifiers being provided. Due to the nature of the events, the causality between the event "HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored" and "there were no adverse reactions to any of the vaccines administered" Vaxelis were not applicable. Further information is not expected. SIGNFICANT FOLLOW-UP INFORMATION was case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-JUL-2025 with the following reference number 2844597-1. The case is now valid. The original narrative from the sender is as below: HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored. No Additional information provided. No Additional AE/ No PQC. VAXELIS: U; No adverse event; This spontaneous report was received from an other health care professional and refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. It was reported that the following vaccines experienced multiple temperature excursions: Human Papillomavirus 9- valent Vaccine, Recombinant (GARDASIL 9) lot# Y010656, expiration date: 29-Nov-2026) 0.5 mL; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y007615, expiration date: 11-Apr-2026) 0.5 mL; sterile diluent (MERCK STERILE DILUENT), (lot #1973278, expiration date: 06-May-2026) 0.5 mL; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), (lot #U7970BA, expiration date: 30-Nov-2026) 0.5 mL; Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619, expiration date: 09-Mar-2026) 2 mL. The temperature excursions occurred as follows: on 16-DEC-2024, the lowest temperature of 34 F for 23 Hours and the highest of 41 F for 23 Hours; on 20-DEC-2024, the lowest temperature of 35 F for 16 Hours and the highest of 36 F for 16 Hours; on 23-DEC-2024, the lowest temperature of 34 F for 4 Hours and the highest of 37 F also for 4 Hours; on 30-DEC-2024, the lowest temperature of 37 F for 1 Hour and the highest of 64 F for 1 Hour. The vaccines were administered on 16, 20, 23, and 30-DEC 2024. It was unknown how many patients received products after being improperly stored (Product storage error). No additional information was provided. There was no additional AE (No adverse event). This is an invalid report due to multiple patients involved and lack of patients' identifiers. Follow-up information was received on 09-JUN-2025. The patient was currently 59 years old (product administered to patient of inappropriate age). Details regarding the vaccinations were not provided. It was reported that there were no adverse reactions to any of the administered vaccines. The case was no longer considered to be invalid.; Reporter's Comments: Keywords : ; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292822 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2292822. Due to the nature of the events, the causality between the event "HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored and "there were no adverse reactions to any of the vaccines administered, and product storage issue, and Product administered to patient of inappropriate age. Patient is 59 years old", and Vaxelis were not applicable. No further information is expected.

Current illness

Prophylaxis