Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Oropharyngeal pain, Pneumonia, Product quality issue, Pyrexia
Clinical narrative: This is a spontaneous report from a non clinical study program Pfizer Sponsored Program, by a contactable consumer and a contactable nurse. A 67-year-old male patient of an unspecified ethnicity received first dose of PREVNAR 13 (Batch 0005-1971-01; Lot # L99262; Expiration date 16Feb2017), intramuscular at 0.5 ml, single in the left deltoid on 16Sep2015. Medical history included diabetes, hypertension, hyperlipidaemia. Concomitant medication included LIPITOR, lisinopril, STENDRA, levothyroxine, ZOLOFT, JANUVIA, trazodone, TRICOR, HUMALOG 75/25. The patient experienced right lower lobe pneumonia on 05Nov2015. Chest x-ray performed on 05Nov2015, results: right lower lobe pneumonia. The patient received an unspecified treatment. The event resolved on an unknown date. 13Oct2015 onset symptom of weakness, dizziness (balance), fever, diaphoresis, sore throat, cough. Labs and CT of head were performed. On 05Nov2015 returned to office for chest tightness, cough, shortness of breath, decrease weight 11 lbs. A diagnosis of pneumonia was made. The reporting nurse stated that it was a community acquired pneumonia. Additional information received from a Product Quality Complaint includes product complaint investigational results for lot L99262. Conclusion: An evaluation of the complaint history confirms that this is the 1st complaint for filled batch L557945 for complaint class/subclass: Product use attribute/Lack of Effect. 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 therefore it was determined that a regulatory notification is not required. No evidence was found to indicate this complaint occurred as a result of activities conducted at Pfizer. Pfizer 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. The cold chain temperature control data for the bulk stock received, the packed stock stored 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. 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/Preventative Actions (CAPA): CAPA Required: No. Reports of this nature will continue to be evaluated and monitored for trends. Follow-up (04Apr2016): New information from the same contactable consumer includes: Patient age and gender, vaccination partial date, information that patient was not taking any other product, event onset partial date, outcome, treatment received. Follow-up (04May2016): New information obtained from a contactable nurse includes: Date of vaccine administration updated, lot/batch and exp. date, anatomical locations, medical history, concomitant drugs, symptoms, lab tests, onset and outcome of the event. Follow-up (12Jul2016): Additional information received from the same contactable nurse includes lot number corrected and dose of vaccine administered. Follow-up attempts completed. No further information expected. Follow-up (25Aug2016): Additional information received from a Product Quality Complaint includes product complaint investigational results for lot L99262.