Age: 0.27
Sex: F
Vaccine: PNC13, RV5
Symptoms: Decreased appetite, Injection site swelling, Irritability, Pyrexia, Somnolence
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is second of two reports. A 3-month old female patient received the second single dose of PREVNAR13, Wyeth, lot # H08091 and expiration date: FEB2015) intramuscular in the left thigh at a dose of 0.5 ml and the second dose of ROTATEQ (Merck, batch/lot# J008383; Expiration date: 28NOV2014) orally, both on 23MAY2014 at 11:00 AM, at private doctor's office/hospital, purchased with private funds. Medical history was none; has one sister; birth weight 6 lbs 3 oz. The patient previously received the first dose of hepatitis B vaccine on 15FEB2014, the first dose of PREVNAR 13 on 07APR2014 and the first dose of ROTATEQ on 07APR2014. Relevant concomitant medication included the second dose of hepatitis B vaccine (Sanofi, Batch/Lot # JJ07298; Exp. Date: 15FEB2016) intramuscular in the left thigh and the second dose of DPAT, HiB; IPV (Sanofi, Batch/Lot #C4683AA, Expiration Date 02NOV2016) intramuscular in the right thigh both on 25APR2014, at an unknown dose. On 23MAY2014 the patient was not eating and sleeping more than usual, and on 24MAY2014 had high fever, experienced yeading cranky (irritability) and leg swollen at injection site. Relevant laboratory data were unknown. The patient visited the door on 24MAY2014 because of reported adverse events. Therapeutic measures taken in response to the events, high fever and leg swollen at injection site, and 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 had recovered from fever, yeading cranky, and leg swollen at injection site on 25MAY2014 and from the events, not eating and sleeping more than usual, on an unknown date in MAY2014, within 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 PREVNAR13. 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 and new event added, 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 includes on behalf of the physician: vaccines trade names; birth weight; hepatitis B vaccine and DPAT, HIB, IPV vaccination sites; vaccination privately done. Follow-up (13NOV2014): New information reported from the contactable office manager reporting on behalf of a physician includes: new healthcare professional reporter information. Follow-up (08JAn2015): Follow-up attempts completed. No further information expected. Follow-up (21JAN2015): New information reported includes confirmation that DPAT, HIB, IPV was considered as a single vaccine according to information provided.