Sex: U
Vaccine: PNC13
Symptoms: Product quality issue
Clinical narrative: Patient was assigned Prevnar 13, when shaking the syringe, amber colored particles were observed floating in the product.; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (28Apr2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) was to receive (product was not administered to the patient) pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2019, Expiration Date: Dec2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT QUALITY ISSUE (non-serious), outcome "unknown", described as "Patient was assigned Prevnar 13, when shaking the syringe, amber colored particles were observed floating in the product.".  This is a follow-up report from Product Quality group providing investigation results on 28Apr2023:  Additional information: This is a notification generated from the system. PQC pertaining to AE: This event assessment is Reportable. You are receiving this notification because you have been identified as a Recipient for this record. A brief summary of this File is listed below: Reportability Determination: Upgraded Reportability: This is Medical Device Related. Reportability Determination: This complaint for "Amber colored particles were observed floating in the Prevnar-13 vaccines when shaking the syringe as per protocol. The affected dose was immediately placed in quarantine and team was notified for replacement request. Other two replacement syringes had similar particles and a total of three (3) vaccines were found to be damaged. The product was not administered to the patient." for PREVNAR 13V PFS SUSPENSION 0.5MLX10 is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. Product used for treatment. This is a 30 day reportable malfunction. Forward to Peer Reviewer. Withheld 04May2023 This is Medical Device Related. Reportability Determination: This complaint for "Amber colored particles were observed floating in the Prevnar-13 vaccines when shaking the syringe as per protocol. The affected dose was immediately placed in quarantine and team was notified for replacement request. Other two replacement syringes had similar particles and a total of three (3) vaccines were found to be damaged. The product was not administered to the patient." for PREVNAR 13V PFS SUSPENSION 0.5MLX10 is Not a reportable malfunction. If it were to recur, it could NOT likely cause or contribute to death or serious injury. Product used for treatment. Forward to Peer Reviewer. withheld 02May2023 ID: 8277493 Date of Contact (from the Complaint Contact): 28Apr2023 Responsible Person: withheld Triage Location / Country:  Status: PROCESSING Please use the following link to log into the system and view the full details of this.  Additional information: Before shaking, a clear liquid was observed with no floating particles. If any foreign particles were present at this time, they could not be identified because of the normal white vaccine deposits attached to the sides and plunger of the syringe. After shaking, it was observed a heterogeneous white suspension with amber colored particles (of different sizes) floating around the syringe. Syringes are vigorously shaken for approximately 5-10 seconds, until the white deposit is suspended and homogenous. Before shaking the vaccines appeared as a clear liquid with white deposit. After shaking they were observed as heterogeneous white suspension with amber colored particles floating around the syringe. The product was stored in equipment previously approved by the Sponsor for storage, specifically a refrigerator with serial number: 21-043. The temperature monitoring system used in this refrigerator is a Thermometer with serial number 2002384 and expiration date 31Mar2024. Temperature is monitored electronically and reported every five minutes. When temperature falls out of the range of 2-8 degree C, the alarms are set off with sound. Also, email notifications are sent to the responsible team members at site. The product was stored in the center of the second shelve, away from the cooling element. Product was not frozen at any time and every temperature excursion has been reported in a timely manner. Also, the affected was approved for use by the Sponsor/delegate after every temperature excursion and before assignment. Particles vary in size with an approximate diameter of less than or equal to 1mm (fine) up to 3mm. Particles are solid with irregular borders and scarce in quantity (about 2-7 particles of diverse sizes per syringe). Photos were attached. There is product available for return. Certificate of compliance manufacturers declaration: included: Product name: Prevnar 13 10x0.5 ml prefilled syringe (Pneumococcal conjugate vaccine; 13-Valent), Batch number: EW2019, Material no: F000042589, Date manufacture: Jan2021, and Expiration date: Dec2023. Quality assurance review: The batch documentation for the above listed lot of product has been reviewed and all aspects were found acceptable. All deviations have been thoroughly reviewed and approved. The results of all in-process testing meet the requirements. The batch has also been tested and confirms to all specifications and internal control targets. All batch documentation is retained at Pfizer manufacturing (withheld) and available for review. Manufacturing/ packing review: The batch documentation for the above listed lot of product has been reviewed and all aspects of the manufacturing and packaging were judges acceptable and consistent with the requirements outlined in the and master manufacturing documents. All manufacturing deviation have been thoroughly reviewed and approved.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.