Age: 0.08
Sex: F
Vaccine: PNC13
Symptoms: Crying, Immunisation, Product quality issue, Syringe issue
Clinical narrative: crying; This is a spontaneous report from a contactable nurse. A 7-week-old female patient received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot no: X93809, expiration date: Feb2021, NDC no: 0005-1971-01), administered intramuscularly in right vastus lateralis on 24Jun2019 at 0.5 ml, single for routine vaccination in physician's office.  The patient had no relevant medical history. Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX, lot no: 2HC47, expiration date: 13Dec2020) administered intramuscularly in right vastus lateralis at 0.5 ml, single; hib vaccine conj (ompc) (PEDVAXHIB, lot no: S006043, expiration date: 25Mar2021) administered intramuscularly in left vastus lateralis at 0.5 ml, single; and rotavirus vaccine live oral 1v (ROTARIX, lot no: H5T99, expiration date: 20Sep2020) orally at an unknown dose (reported as 0.5 ml or 1 ml); all given for routine vaccination on 24Jun2019 in physician's office. The nurse reported an attempted administration of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) to this patient where needle was injected and when administration of product was attempted, the medication shot out of the syringe through a pinhole and the patient did not receive any of the medication. In response to this event, the patient was successfully administered the entire prescribed dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the right vastus lateralis with last effect of crying on 24Jun2019. She believes these events are a result of faulty prefilled syringe. The affected prefilled syringe was the first product used from a newly opened 10 count package of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), and the successfully administered product was the second product used from that same newly opened 10 count package of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The nurse further described that the faulty prefilled syringe had the medication that did not come through the needle like it should, and did not leak from the connection point of the needle and hub, it appeared to leak from further up the top side of the syringe barrel above the hub but below the needle connection point. If this had occurred when she and the patient were close enough it could have gotten medication right in their eyeballs. This was the first in a 3 dose series prescribed for routine vaccination. No further dose changes made, scheduled to receive next dose in 2 months and another in 6 months. The nurse reported that she has had this event occur like 4 previous times in approximately the last 6 months, the last one approximately 2 months ago, where attempted administration of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) to those patients where needle was injected and when administration of product was attempted the medication shot out of the syringe through a pinhole and the patients did not receive any of the medication. She has previously reported those events to Pfizer. The patient recovered from the event on 24Jun2019.