Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Myalgia, Neutrophil count increased, Oropharyngeal pain, Pneumonia
Clinical narrative: This is a spontaneous report from non-clinical-study program, from a contactable consumer, reporting for her husband, and from a contactable physician. A 67-year-old male patient received the first dose of PREVNAR 13 (lot number J49846, expiration date Feb2016) intramuscular in the left deltoid at 0.5 ml single on 17Nov2014 at 10:05 am. Relevant medical history included bad lungs, clarified as pneumonia in Dec2013, treated with Z-PAK, hypertension (HTN), hepatitis, hyperlipidemia, he had no drug allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to PREVNAR 13. Past vaccines for immunization included Influenza vaccine on 01Sep2014, 01Oct2013, 18Sep2012, TDAP in 2009, PNEUMOVAX on 07Aug2012. The patient experienced sore throat on 17Nov2014 with outcome of recovered on 23Nov2014, fever on 17Nov2014 with outcome of recovered on 24Nov2014, and pneumonia on 21Nov2014 recovered in 10 days. Course of events: on the same day of vaccination the patient got a sore throat and fever. He was diagnosed with pneumonia on 21Nov2014. He was spitting up mucous all day with cough (treated with NYQUIL), yellow sputum and myalgia. The consumer said that her husband had a temperature of 103 degrees Fahrenheit and 100 degrees Fahrenheit on unspecified dates in Nov2014. He went to clinic on 21Nov2014, complete blood count showed increased neutrophils at 10303, increased white blood cells at 13000, chest X-Ray showed pneumonia LL, urine test was performed with unknown results. Laboratory results obtained were consistent with pneumonia, patient was treated with Z-PAK (he started on azithromycin 250mg 2 tabs by mouth on first day, then one tab by mouth once a day until gone, he received a 2nd round of the azithromycin at same dosage for a total 12 pills) with significant resolution of symptoms, sore throat on 23Nov2014, fever by 24Nov2014. The patient recovered from pneumonia in 10 days. The physicians confirmed the occurrence of pneumonia but he assessed it as not related to PREVNAR 13 (he reported that there was a significant incidence of influenza in the area at the time patient presented and for the next several weeks). Investigation results for lot number J49846: Description of Complaint: husband was diagnosed with pneumonia after receiving the PREVNAR 13 vaccine. Consumer does not have lot number, NDC, or expiration date information. Conclusion: This summarizes the technical evaluation conducted for the Company 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 were 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 Company under this Adverse Event as the Adverse Event was reported for the interim drug product lot. An evaluation of the complaint history confirms that this is the first Adverse Event received at Company for this interim drug product lot. On the basis of this evaluation, there is no requirement to investigate this Adverse Event further or escalate to the Company Product Quality Complaint Trending Meeting. Conclusion: An evaluation of the complaint history confirms that this is the fourth complaint for this filled lot H38736 from packed lot J49846 and is the second complaint for this product complaint classification/ subclass for filled lot H38736 that has been received by Company for evaluation. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer. Company will continue to monitor complaint for this fill lot. No further action is required at this time. Complaint not confirmed. 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 was all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. The Lot History Report identified 1 complaint for an Adverse Event raised against Packed Lot: J49846. The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Global Safety Team. Reports of this nature will continue to be evaluated and monitored for trends. No further action is warranted at this time. Follow-up (29Dec2014): New information reported from a contactable physician includes: suspect product details (dose, dose number, route and time of administration, anatomical location of vaccination, lot number and expiration date), additional medical histories, past vaccines, laboratory results, updated date of diagnosis of pneumonia, physician confirmation of event pneumonia, causality assessment for this event. Follow-up (13Jan2015): New information reported from the same contactable consumer includes: treatment for the event. Follow-up (19Feb2015): New information received from product quality complaint group includes: investigation result for lot number J49846.