Sex: U
Vaccine: DTP, HIBV, IPV
Symptoms: Apathy, Cough, Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of diarrhea in a child patient who received DTP (A or W not known) (batch number 20916002A ?, expiry date August 2019). Co-suspect products included IMOVAX POLIO (batch number M74982V, expiry date September 2018) and ACT-HIB (batch number N3H191V, expiry date Jun 2019). On an unknown date, the patient received the 3rd dose of DTP vaccine (intramuscular) .5 ml, the 2nd dose of IMOVAX POLIO (intramuscular) .5 ml and the 3rd dose of ACT-HIB (intramuscular) .5 ml. On 27th February 2018, unknown after receiving DTP vaccine, the patient experienced diarrhea (serious criteria hospitalization), dry cough (serious criteria hospitalization), subfebrile (serious criteria hospitalization), apathy (serious criteria hospitalization), urine output decreased (serious criteria hospitalization), vomiting (serious criteria hospitalization), appetite lost (serious criteria hospitalization), fever (serious criteria hospitalization) and runny nose (serious criteria hospitalization). On an unknown date, the outcome of the diarrhea, dry cough, subfebrile, apathy, urine output decreased, vomiting, appetite lost, fever and runny nose were recovering/resolving. The reporter considered the diarrhea, dry cough, urine output decreased, vomiting, appetite lost and runny nose to be possibly related to DTP vaccine. The reporter considered the subfebrile, apathy and fever to be probably related to DTP vaccine. Additional information: The age at vaccination was not reported. However, the patient was child at the time of reporting. The vaccination site was reported as left thigh (upper part) for DTP. The vaccination site was reported as right thigh for ACT-HIB. The vaccination site was reported as left thigh (bottom part) for IMOVAX POLIO. The reported lot number DTP vaccine batch number 20916002A does not match with any GSK lot number. The reporter considered the diarrhea, dry cough, urine output decreased, vomiting, appetite lost and runny nose to be unlikely related to IMOVAX POLIO and ACT-HIB. The reporter considered the subfebrile, and fever to be probably related to IMOVAX POLIO and ACT-HIB. The reporter considered the apathy to be possibly related to IMOVAX POLIO and ACT-HIB. Initial information was received from a physician via regulatory authority on 17th May 2018: Diarrhea, dry cough, urine output decreased, vomiting, appetite lost and runny nose. Sender comment: Fever is an adverse reaction listed in the Summaries of Product Characteristics of all three vaccines. Temporal relationship speaks for causal relationship. Diarrhea and vomiting and consequent loss of appetite and reduced urine output are expected adverse reactions only for DTP vaccine. Green stool is caused by bile acids, which are secreted into the gastrointestinal tract and there under the influence of bacteria undergo various changes. Faster passage or altered bacterial flora can cause stools to take such a color. Occurrence of upper respiratory tract infection and accompanying symptoms such as cough and runny nose are also expected adverse reactions only for DTP vaccine. Considering the children morbidity of upper respiratory tract infections in wintertime, it cannot be excluded that there was a coincidence of child's infection with vaccination. Apathy and anxiety are known reactions only for DTP vaccine, for other vaccines these are unexpected reactions. The child may be restless, querulous and irritable for a few days after vaccination. The reporter qualified AEFI as serious. Regulatory Authority assessed the case as serious.