Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. The nurse reported similar events for two patients. This is the second of two reports. A patient of an unspecified age, gender and ethnicity received, on an unknown date, PREVNAR 13, (Lot. M35760) single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced reactions such as swelling and welting at the injection site. Clinical outcome of the events was unknown at time of this report. Investigational results about vaccine lot M35760 included the following information. Certificate of Analysis (CoA): The CoA for the batches as listed were reviewed prior to batch disposition and confirm that QC release results were within specification and supported further processing of the Monovalent Bulk Conjugates. Conclusion: This summarises the technical evaluation conducted for the GC bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event complaint. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Batch Records and testing results were reviewed prior to Product Release and were deemed satisfactory. Based on the review of associated investigations there is no requirement to repeat these reviews for the Drug Substance manufacture. An evaluation of the reserve sample and complaint sample was not applicable to this (Organization name) Drug Substance investigation and this will be carried out as part of the Drug Product investigation. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation therefore no regulatory notification is required. An evaluation of the complaint history for this interim Drug product lot on 26Oct2016 confirms that this is the 1st Drug Substance adverse event-FDA 15 day reportable event received for investigation at (Organization name) for this interim drug product Lot. (Organization name) will continue to monitor adverse events for this interim Drug Substance Lot.  No further action is required at this time. Conclusion: An evaluation of the complaint history confirms that this is the 1st complaint for Filled Lot L30191 for complaint subclass; Adverse Event Safety Request for Investigation. No defects were observed during the reserve inspection of 324 samples from Batch L30191. A review of batch records and manufacturing investigations found no issues that might have affected   the identity, strength, purity or quality of  the product and therefore it was determined that a regulatory notification is not required. (Organization name) will continue to monitor adverse event complaints for Fill Lot L30191. No further action is required at this time. Risk Assessment: QTS incident required: No, Preliminary report required: No, Root cause conclusion: Complaint confirmed: No. The batch records were reviewed and there were no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received at (Place Name), the packed stock stored at (Place Name) and during its journey to the markets distribution centre were all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. The Pcom Lot History Report identified no other complaints for adverse events for this packed lot. The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Global Safety Team. Corrective Actions/Preventive Actions (CAPA): CAPA required: No Reports of this nature will continue to be evaluated and monitored for trends. No further action is warranted at this time. Follow-up (14Oct2016): Follow-up attempts are completed. No further information is expected. Follow-up (28Oct2016): New information from a Product Quality Complaint Included: investigation results; Sender's Comments: Linked Report(s): US-PFIZER INC-2016390388 Same reporter/drug, different patient/AE.