Age: 1.15
Sex: F
Vaccine: PNC13
Symptoms: Incorrect dose administered, Irritability
Clinical narrative: This is a spontaneous report by a contactable nurse. This female nurse reported on behalf of a 13-month-old female patient who received the 4th dose of PREVNAR 13 at single dose on 13 DEC 13 and then received a 5th dose of PREVNAR 13 (lot # F11149, expiration date 28 FEB 2014) at 0.5 ml single dose on 16 JAN 14, both intramuscular. Relevant medical history and concomitant were none. Birth weight: 7 lbs 8 ounces, illness at the time of vaccination was none. Previously, the patient received the first dose of PREVNAR 13 on 01 FEB 2013 Batch/lot # and expiration date: F11149 ex 28FEB2014, patients age at administration: 10 weeks, anatomical location: Left thigh: Route: IM; the second dose of PREVNAR 13 on 21MAR2013, Batch/lot# and expiration date: G15074 exp 31MAY2014, Patient's age at administration: 4 months, Anatomical location: Right thigh, Route: IM, the third dose of PREVNAR 13 on 31MAY2013, Batch/lot# and expiration date: G75010 exp 30OCT2014, Patient's age at administration: 6 months, Anatomical location: Left thigh; Route: IM and the fourth dose of PREVNAR 13 on 13DEC2013, Batch/lot# and expiration date: H39262 exp 30JUN2015, Patient's age at administration: 1 year, Anatomical location: Right thigh, Route: IM. Other vaccines administer4ed on 13DEC2013: QUAD, Batch/lot# and expiration date: U4779AA exp 30JUN2013, Site: Left thigh, Manufacturer: Sanofi; Route: IM. No. of previous doses: None and MMR, Batch/lot # and expiration date: J006453 exp 07JUN2015, Site: Left thigh: Manufacturer: Merck; Route: IM, No. of previous doses: None.  On an unknown date the patient was given fifth dose of PREVNAR 13 a month after the fourth dose and patient had been fussy at night but that had ended. Relevant sibling information included 1 sister and lab data were none. No treatment received. The outcome of the event fussy at night was recovered. The nurse was looking for information on patients who have received a 5th dose of PREVNAR 13, whether there is any risk to the patient. The reporter was aware that when the transition was made from PREVNAR 7 to PREVNAR 13 and the 5th dose for those patients added. The reporter stated they have a number of patients that have received 5 doses. The reporter also asked if it was a problem that the doses were only a month apart. This nurse confirmed that event occurred with only one patient.   Follow up (20JAN2014): New information received from a contactable nurse includes: PREVNAR 13 dose numbers/dates, nurse query.  Follow up (29JAN2014): This is a follow-up report combining information from duplicate reports 2014017209 and 2014020142. The current and all subsequent follow-up information will be reported under manufacturer report number 2014017209. The new information reported from the same nurse included PREVNAR 13 fifth dose details and confirmation that event occurred with only one patient.  Follow-up (10FEB2014): New information obtained from contactable nurse includes: patient's gender, route of administration, lot # and expiration date; previous vaccinations, birth weight, sibling; no treatment; additional event fussy at night and outcome.   Company Clinical Evaluation Comment: Based on the information currently available, a causal relationship between the administration of PREVNAR 13 and the occurrence of the reported event cannot be completely excluded based on the temporal relationship.