Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse and subject's grandmother) and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included tubes in ears for infection. The subject had no adverse events following previous vaccinations. Concurrent vaccination included KINRIX; GlaxoSmithKline; unknown; unknown given on 27 June 2013. Concurrent medications included FLONASE. On 21 October 2013 at 13:00 the subject received 2nd dose of KINRIX (intramuscular, right thigh) and experienced extra dose administered and vaccine administered at inappropriate site. Per the nurse, the "office administered KINRIX again by mistake not knowing that the patient had already received the vaccine previously." The preferred site of administration for KINRIX is the deltoid of the upper arm. "Later in the evening" on 21 October 2013, 6 hours after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb and injection site irritation. Per the nurse "the injection site had swelled up, it was really ugly and got really irritated." The swollen area was about 2.5 inches by 2 inches (63.5 millimeters by 50.8 millimeters). On 2 November 2013, 12 days after vaccination with KINRIX, the subject experienced whining and feels aged. Per the nurse, the subject began "complaining and whining that she was feeling old." On 16 November 2013, the subject experienced bone pain. The nurse stated that the subject complained that her "bones were hurting, specifically her hands and feet." The nurse documented that the subject had not experienced a fever. At the time of reporting the outcome of the events of extensive swelling of vaccinated limb and injection site irritation were resolved on 24 October 2013. At the time of reporting, the outcome of the events of feels aged and bone pain were unresolved. At the time of reporting, the outcome of the event of whining was unknown. The healthcare professional considered the events of extensive swelling of vaccinated limb, injection site irritation, whining, feels aged, and bone pain were possibly related to vaccination with KINRIX. Follow up received from nurse (subject's guardian) on 28 January 2014. This case was assessed as medically serious by GSK. Per the nurse, the extensive swelling of vaccinated limb, injection site irritation, whining, feels aged, and bone pain were unresolved; however, the nurse also reported that the "leg site resolved within 3 days." The nurse also reported that the subject "still has complaints of pain in joints and limbs off and on". The nurse also reported that, within months of vaccination with KINRIX, the subject "has recently" complained of her heart hurts at different times and had rapid heart rate at that time." Per the nurse, there was no congenital anomaly or birth defect. The nurse reported that the events could have been related to erroneous administration and noted the following "RT computer program placement in patient history." The meaning of that statement was unclear.