Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife) and from another contactable consumer (the patient). A 78-year-old male patient of unspecified ethnicity received, at the age of 77 year-old, PREVNAR 13 (lot/batch number L04915, expiry date 01Jun2016) via an unspecified route of administration at 0.5 ml single dose on 13Mar2015. Relevant medical history and concomitant medications were not reported. The patient experienced community acquired pneumonia on 22Mar2016. The patient was hospitalized due to the event on 09Apr2016 and was treated with intravenous vancomycin and intravenous ROCEPHIN due to the event. He did not recover at the time of the report. Information for Lot # L04915 were received from a Product Quality Complaint: Description of Complaint: The reporter stated that her husband was in the hospital, he (husband) had the PREVNAR 13 shot last year in Mar and this year in Apr he was back in the hospital because of pneumonia, so she was asking what are the different strains that it covers or it not covers. Limited information as the reporter was not willing to share the information. Product details were not available over the call. E-mail ID was not available over the call. Additional information: Name 29Jul2016 11:06:21 Lot number obtained from received QAEF. QAEF form attached to complaint per #. Complaint to be forwarded for investigation. Name 20Jun2016 16:53: 15 efficacy sent. Name 20Jun2016 16:44:18 follow up under PCOM# stating The call was transferred from Pfizer medical information by Name. NTID was not available over the call. The transferring agent mentioned that the consumer received PREVNAR 13 vaccine in Mar2015 and last month he was hospitalized with pneumonia. She mentioned that the reporter was asking how many times adult patient should receive the vaccine and the transferring agent addressed the question. She mentioned that she was transferring for lack of effect because the patient received pneumonia and ended up with pneumonia. The reporter mentioned that she did not know that her husband had the PREVNAR 13 vaccine last year in Mar2015 and he ended up in the hospital with pneumonia this year in Apr. Product details and pharmacy details were not available over the call. Limited information available as the reporter hung up abruptly. Reportum System 17Jun2016 09:45:52 Client Report Type: initial. Product Complaint results were provided as follows: Root cause: ((Name): no evidence was found to indicate the complaint occurred as a result  of activities conducted at Pfizer (Name). Product Desc: PREVNAR 13V PFS Suspension 0.5 ML X 1 EA; SAP/Unique identifier: 0005-1971-05; Classification: Product Use Attributes; Subclass: Lack of effect; Sample status: Not requested; Lot Number: L04915; Expiration date: Jul2016; UDI: N/A. Additional information: (Name) 01 Aug2016 04:50:49 Initial compliance checks completed. Conclusion An evaluation of the complaint history confirms that this is the 1st complaint for filled lot J56516 for complaint class/subclass; Product Use Attributes/Lack of effects. A trend was not identified. The batch record and manufacturing investigation review found no evidence to suggest that this complaint is related to manufacturing activity at Pfizer (name) therefore it was determined that a regulatory notification is not required. (Name) will continue to monitor complaints for this fill lot. No further action is required at this time. Root Cause and 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. During packaging operations there was an excursion in the bulk time out of cold storage allowance however there is no quality impact as stability data supports the excursion. The cold chain temperature control data for bulk received at (name) and for the finished batch during its journey to the markets distribution Centre were all satisfactory. Suitable storage conditions were maintained at all time with no impact to product quality, safety or efficacy. There are no other complaints for the reported packed lot regarding lack of effect. The root cause has not been determined and the complaint is unconfirmed. A trend has not been identified by the Global Safety Team. Corrective Actions/Preventive Actions (CAPA): CAPA Required: No [If NO provide rationale]. Reports of this nature will continue to be evaluated and monitored for trends. Follow-up (13Jul2016): New information reported from a contactable consumer (the patient) includes: patient's age, lot/batch number and expiry date, onset date, date of hospitalization, treatment for the event, outcome. Follow-up (29Jul2016): New information reported from a Product Quality Complaint included: exact lot/batch # (not LO4915); dosage; information for Lot # L04915. Follow-up (08Sep2016): New information from Product Quality Complaints includes: additional investigational result. Follow-up (20-DEC-2016): Follow-up attempts are completed. No further information is expected.