Age: 1.12
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray abnormal, Febrile convulsion, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable other health care professional and contactable physician. A currently 13-months-old female patient of an unspecified ethnicity received the fourth dose  of PREVNAR 13, intramuscular on 14Nov2011; the third dose on 06Jul2011; the second dose on 04Apr2011; the first dose on 01Dec2010 and single dose of FLUZONE, intramuscular on 14Nov2011. Family history included: mother states she had history of febrile seizures. The patient's concomitant medications were not reported. The patient experienced febrile seizure on 14Nov2011 with outcome of recovered on 16Nov2011. The patient was taken to Hospital ER; Chest x ray + lung markings consistent with pneumonia (on unknown date). The patient was treated with ROCEPHIN IM. The outcome of the event pneumonia was unknown. Follow-up (09Oct2012): New information received from a contactable physician includes: patient's age and gender, doses received of PREVNAR 13 and FLUZONE, lot number, medical history, new event pneumonia, treatment. Follow-up attempts completed. No further information expected. Follow-up (03Dec2012): This is a follow-up spontaneous report from the product complaint group. New information reported by this group includes: Pre Complaint Number: PCOM-2012-01098880-US; Complaint Number: 2012-10-0074952-US; Product Desc: PREVNAR 13V PF SUSPENSION 0.5MLX10 - USA; UPC/NDC# : 00005-1971-02; Lot Number: E88939; Expiration Date: 4 / 2012; Description of Complaint: Pt was taken to hosp E/R, Chest xray and lung marking consistent w/Pneumonia. Conclusion: This summarizes the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation. An evaluation of the reserve sample and complaint sample was not applicable to agency under this Adverse Event as the Adverse Event was reported for the interim drug product lot. Greater than two adverse events have been received by Agency for evaluation for this interim drug product lot. (Name mentioned) will continue to monitor adverse events for this interim lot. Conclusion/Summary: The plant has reviewed all investigations associated with this batch from a manufacturing and technical perspective and all investigations were appropriately closed and addressed. No quality issues were identified in this review of batch related documents and review of release testing. No product was returned for examination, product has expired and was not on stability. Conclusion: This summarizes the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, safety, purity or quality of the product were identified during the technical evaluation.