Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Incorrect dose administered, Injection site erythema, Injection site swelling, Rash erythematous, Syringe issue
Clinical narrative: This is a spontaneous report from a contactable physician and from a contactable nurse. A 12-year-old male patient of unspecified ethnicity received TRUMENBA (Lot# J29203, Exp date Jun2016), intramuscular in left deltoid, on 07Aug2015 at 11:45, at 0.5 ml single. Concomitant medications were not reported. At time of vaccination the patient was healthy. Last time he received a vaccine (unspecified) was in Dec2014. While the vaccine was administered on 07Aug2015 the liquid came out from the back side of the syringe, it spilled out (the patient did not receive the full dosage, infill was wasted onto the floor and the patient did not get the medication). The reporter was not sure how much vaccine was actually administered and how much fell on the floor. The reporter mentioned that syringe was not functional. On 07Aug2015, the patient had localized redness and little bit of swelling at the site of injection that disappeared within 5 minutes. On 07Aug2015 the patient experienced also a small local red rash. Red rash happened right after the injection. Small local red rash went away in about a minute. The patient recovered completely from redness, swelling and rash on 07Aug2015. The events did not require an emergency room or physician visit. No treatments were required. No lab tests were performed. The reporter considered there was a reasonable possibility the events were related to the suspect vaccine. Product quality investigation results for lot J29203: An initial reserve review of 368 reserve samples was carried out on 11Sep2015 for Lot J56434 under the current complaint. All samples were inspected for 'Physical damage to container' as per SOP-76241 "Reserve Retention Sample Reviews for Customer Complaints Investigations". No defects were identified. Refer to PCOM for the reserve evaluation form. Complaint Confirmed: No, as no sample has been returned for this complaint it has not been possible to determine the cause of the reported leak. It is not clear from the description where the leak occurred. If the sample is received at a later date the complaint will be re-opened in order that evaluation can be added as a supporting document to the PCOM record. This investigation will only be amended if the evaluation changes the original root cause and conclusion. A batch document review was completed. There were no planned deviations that could have caused the reported defect. The 3 incidents which occurred during the packaging of this lot were fully investigated and approved by a Qualified Person prior to release. Based on the evidence available it is concluded that this is not potentially attributable to a facility based root cause or a third party supplier quality issue and this complaint is unconfirmed. This complaint is unconfirmed and therefore no CAPA is required. Complaints of this type will continue to be monitored and investigated. Component: Packaged Lot; Lot Number J29203; Manufacturing site; Date of manufacture: N/A; Quantity: N/A. Component: Filled Batch; Lot Number: J56434; Manufacturing site; Date of Manufacture: 31Jul2014; Quantity released: 237,545 pre-filled syringes. Fill lot J56434 was packed into packaged lots: J28923, J29757, and J29203. A review for prior complaints related to these packaged lots was performed in PCOM on the 30Sep2015. An evaluation of the complaint history confirms that this is the third complaint received for investigation for fill lot J56434. This is the first complaint received for complaint subclass; container broken/cracked/leaking during prep/use. The sample was not returned prior to completion of this report. If the sample is received at a later date the complaint will be reopened and the investigation will be re-evaluated. This investigation will only be amended if the evaluation changes the conclusions of the investigation. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer therefore it was deemed that a regulatory notification is not required. Monitor complaints for this fill lot will continue. No further action is required at this time. Follow-up (07Aug2015): New information received from contactable physician includes: suspect drug details, reaction data and reporter details. Follow-up (21Aug2015, 21Aug2015, 21Aug2015): new information received from a contactable nurse includes: patient's details, events "Small local red rash" and "syringe was not functional" added, vaccination details, causality assessment for event "Small local red rash", medical history. Follow-up (15Sep2015): New information from the same contactable nurse includes: updated vaccination date and time, updated events onset/stop date and events details. Follow-up (05Oct2015): New information received from product quality complaint group includes: investigation results for lot J29203.