Age: 0.34
Sex: M
Vaccine: PNC13, RV5
Symptoms: Decreased appetite, Full blood count, Irritability, Pyrexia, Somnolence
Clinical narrative: This is a spontaneous report from a contactable nurse who reported on behalf of physician. This nurse reported similar events for two patients. This is first of two reports. A 4-month-old male patient received the second dose of PREVNAR 13 (Wyeth, Lot# H08091 and Expiration Date: 02Feb2015) intramuscular in left thigh at 0.5 ml single dose on 09May2014 at 11:00 am. Relevant medical history included reflux since an unknown date in 2014. The patient birth weight was 7-6 Oz and had one sister. The patient received also the first dose of PREVNAR 13 and Rotavirus vaccine on unknown date. The patient previously (within four weeks prior to 09May2014) received the second dose of hepatitis B vaccine (Merck, Batch/Lot#: J007298 Exp date: 2May2016), and the first dose of DTAP-HIB-IPV (Sanofi, Batch/Lot#: C4637AA; Exp date 13Sep2015) both intramuscular on 08Apr2014. Relevant concomitant medication was ZANTAC since an unknown date in Apr2014 (about six weeks) at dose of 1ml two times a day for reflux and the second dose of rotavirus vaccine (Merck manufactured, Lot J008383, exp. date 28Nov2014) oral on 09May2014 at 11:00 am. On 09May2014 the patient was sleeping more than usual. On 10May2014 the patient had high fever, experienced cranky and was not eating. The patient visited the doctor on 10May2014 because of reported adverse events. Relevant laboratory data included complete blood count (CBC) test (unknown results) and negative urine analysis on an unknown date in May2014. Therapeutic measures taken in response to the event high fever included TYLENOL since an unknown date in May2014 at an unknown dose and frequency however the therapeutic measures taken in response to the other reported events were not provided. The patient recovered from fever, irritability and decreased appetite on 11May2014 and from sleeping more than usual on an unknown date in May2014, in 24-48 hrs. The reporter was informed regarding the reported adverse events with the use of the product and confirmed them. The reporter considered there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up attempts completed. No further information expected. Follow-up (02Jul2014): Follow-up attempts completed. No further information expected. Follow-up (14Oct2014): New information from the same contactable nurse who reported on behalf of physician includes: confirmation of the events, administration date modified, route of administration, vaccination history, onset date and recovery dates of the events, causality assessment. Follow-up (07Nov2014): New information received from a contactable Nurse on behalf of physician includes: vaccines manufacturer; birth weight; family history; reporter confirmation of AE occurrence and contactability. Follow-up (13Nov2014): New information reported from a contactable office manager reporting on behalf of a physician includes: new healthcare professional reporter information. Follow-up (09Jan2015): Follow-up attempts completed. No further information expected. Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.