Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Diarrhoea, Disturbance in attention, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-year-old female patient who received KINRIX. Co-suspect products included  DTaP vaccine. On 6th March 2017, the patient received KINRIX. On an unknown date, the patient started DTaP vaccine at an unknown dose and frequency. On 6th March 2017, immediately after receiving KINRIX, the patient experienced injection site pain, injection site swelling, fever, dehydration, constipation and interchange of vaccine products. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, dehydration, constipation and interchange of vaccine products were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, fever, dehydration and constipation to be related to KINRIX. Additional details were provided as follows: The case was reported by the patient's mother. The patient received KINRIX on the left arm. On Monday, 2 days before the reporting date, the patient received KINRIX, after having previously had a series of DTaP vaccine doses which were not GSK INFANRIX or PEDIARIX products, which led to an interchange of vaccine product. Almost immediately after receiving the KINRIX, the patient complained of left arm pain at the injection. Less than a day after receiving KINRIX, the patient experienced injection site swelling, slight fever, became dehydrated and was constipated for two days. The left arm pain continued throughout the night. The patient already contacted the prescribing health care professional (HCP) and that the patient was doing fine at the time of reporting. The reporter later refused to provide any further related details regarding the patient's KINRIX vaccination or further patient demographics like date of birth and also did not provide her mailing address. The reporter gave permission to contact her via cell phone if the GSK department needs to contact her for any reason. Follow up information was received from consumer on 23rd march 2017: This case was previously reported to a doctor. The patient had drug allergies like Amoxicillin and Azithromycin, also had food allergies like Soy, coconut, nuts, egg whites, chicken and anaphylaxis to cod fish. The reporter was upset with physician interchange of vaccine with KINRIX when her daughter (patient) had previously had DAPTACEL. The mother of the patient stated she also asked for two separate shots instead of one, knowing her daughter had a lot of allergies. The mother of the patient had contacted Centers for Disease Control (CDC) and was told it was not recommended to interchange vaccines. She did not wish for physician to be contacted by safety at this time. The previous reported issues had resolved and the patient experienced new events after that report was made, as noted with this report, which some had resolved also and others had improved but not resolved. In this report, it was reported that the patient also experienced diarrhea (3 days after vaccination). In March 2017, less than a month after vaccination, the patient experienced stomach hurt, crying, headache, neck pain, irritability, hyperness, shouting and decreased attention. In March 2017, lhe outcomes of the crying, headache, neck pain, stomach pain and were recovered. The outcome of the diarrhea was unknown and outcome of the irritability and shouting were recovering. The outcome of the hyperness and decreased attention were not recovered. It was unknown if the reporter considered the diarrhea, stomach pain, crying, headache, neck pain, irritability,  hyperactivity, aggression and attentiveness decreased to be related to KINRIX.