Sex: M
Vaccine: RSV
Symptoms: Device leakage, Exposure via skin contact, Eye disorder, Occupational exposure to product
Clinical narrative: inverted the vial to withdraw the vaccine and it leaked down his hand; inverted the vial to withdraw the vaccine and it leaked down his hand; inverted the vial to withdraw the vaccine and it leaked down his hand; his eyes do not work like they used to; This is a spontaneous report received from a Nurse from product quality group, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: H764, Device Expiration Date: 01Jun2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), outcome "unknown" and all described as "inverted the vial to withdraw the vaccine and it leaked down his hand"; EYE DISORDER (non-serious), outcome "unknown", described as "his eyes do not work like they used to ".  Additional information: When the patient was supposed to be vaccinated, and when he placed the diluent in the vial and started withdrawing it, the medication spilled. He inverted the vial to withdraw the vaccine and it leaked down his hand. Clarified that the presentation of the product was that it had the diluent, antigen vial, and adaptor. Caller notified of replacement process. Product strength and count size dispensed: Abrysvo Kit Additional lot numbers: Abrysvo Carton NDC: 0069-0344-01 Lot: KC7884 Expiry Date: Sep2025 Manufacturer: Pfizer Abrysvo Antigen Vial: NDC: 0069020701, stated that his eyes do not work like they used to when providing the NDC. Lot: KC7884 Expiry Date: Oct2025 Manufacturer: Pfizer Abrysvo Diluent: NDC: 0069025001 Lot: HM8389 Expiry Date: Sep2025 Manufacturer: Pfizer Abrysvo Adaptor: NDC: Not on the packaging Lot: H764 Expiry Date: 01Jun2028 Manufacturer: West Pharma Services Is a sample of the product available to be returned, if requested (Y/N): Yes. Caller notified of possible mailer. Packaging sealed and intact? Yes. Consumer, patient, caregiver: Please provide the name and address of the pharmacy/dispenser of the product N/A All Other Customers (e.g., pharmacy): Please provide the name and address of the supplier/distributor of the product Address: Telephone: Description (Translated): N/A Additional Information: Client Report Type: initial Is Medical information?: true Suspect Product Name: Abrysvo Manufacturer: Pfizer Reporter Consent to Contact: Yes Reported Lot Number: KC7884 Samples Available?: Sample Availability Unknown Class: Container Sub-Class: Container Leaking During Prep/Us  Product Quality Group provided investigational results on 28Nov2024 for Abrysvo: Site investigation: The complaint for ?When he placed the diluent in the vial and started withdrawing it,the medication spilled. He inverted the vial to withdraw the vaccine and it leaked down his hand? of Abrysvo was investigated. The investigation included reviewing the involved batch records, deviation investigation, the returned complaint sample, an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample (s): one carton, one vial, one adapter, one WFI syringe. The reported defect was not present on the returned complaint sample. The complaint is not confirmed. No root cause or CAPA were identified asthe complaint was not confirmed. No related quality issues were identified during the investigation. There isno impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot KC7884. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Device investigation: This investigation is based on the information captured inthe Complaint Description and Report. TheComplaint Issue ?Leaking During Prep/Use? wasreported. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis (INX#, Version #). All complaint investigations are trended. There is no current trend alert documented. Investigation Summary Complete Date: 28Nov2024 COMPLAINT Is the original record of COMPLAINT.  Causality for "inverted the vial to withdraw the vaccine and it leaked down his hand" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Follow-up (09Nov2024): Follow-up attempts are completed.  Follow-up (28Nov2024): This is a spontaneous report received from a Nurse via Product Quality Group. Updated information: Device information (device available for evaluation, evaluation codes information), suspect drug information (expiry date), event (his eyes do not work like they used to) and product investigation results.