Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Initial information for this unsolicited case was received from a physician and a nurse via another manufacturer on 25 February 2015. A nine month old male patient, with a history of "hypotonic developmental delays" was vaccinated intramuscularly into the left side with the third dose of HIB (PRP/T) VACCINE, batch UI047AA, on 06 August 2014. He also received on the same day intramuscularly into the right side the first dose of PEDIARIX, SKB batch E4594 and a third dose of PCV13 PREVNAR 13 intramuscularly into the left side, Wyeth H06518. He received a Hepatitis B vaccine, manufacturer not reported on the date of birth. He was vaccinated with Dose 1 of Prevnar 13 on 12 February 2014 and dose 2 on 06 June 2014. He received Daptacel, batch not reported on 12 February 2014. The patient has a history of taking lactulose and poly-VI-FLOR, but it is not clear if these are considered concomitant medications. On 07 August 2014, at 05:00 AM, i.e. one day post vaccination, he experienced a seizure and fever. The fever was reported as 101.6 by the ER, but the mother reported 106 degrees F rectally. The patient was not hospitalized, but was seen at the ER. The seizure lasted 10 minutes. He was treated with Motrin and Tylenol alternately for 24 hours as per the ER physician. The patient outcome is unknown. Follow-up information was received on 16 March 2015 from a nurse. It was reported that the patient did not have any ongoing illness at the time of vaccination and had not experienced seizures in the past. The patient did not experience any adverse events following vaccination in the past. Relevant medical history is developmental delay. The patient was not taking any concomitant medications. No vaccines were administered within four weeks prior. Illness at the time of vaccination was reported as hypotonia. The patient recovered from fever and seizures within 24 hours. The event of seizure was previously reported as recovered in ten minutes. The third dose of Act-Hib was administered into the left thigh, previously reported as left arm. He received two previous doses of Act-Hib on 12 February 2014 and on 06 June 2014. Pneumococcal Conjugate vaccine was administered into the left thigh, previously reported as left arm. He received two previous doses of Pneumococcal Conjugate vaccine on 12 February 2014 and 06 June 2014. Pediarix lot number was reported as E4T92, also reported as E4594 and was administered into the right thigh, previously reported as right arm. He did not have any previous doses of Pediarix. The patient outcome was recovered. Documents held by sender: None. Follow-up received from a physician on 10 April 2015. Patient had no other vaccine within four weeks prior to the vaccination and no other medications. No new additional information reported. Documents held by sender: None. Follow-up information received from a non-healthcare professional on 1 May 2015. It was reported that the patient was still continuing corrective treatment with Tylenol and Motrin and also received antipyretics for fever. The stop date for Lactulose was reported as January 2015. It was also reported that POLY-VI FLOR was discontinued date not specified. Sender's Comments: Follow-up information received on 10 April 2015 and 01 May 2015 does not change the medical assessment of this case. A case of a 9 month old male patient with a history of developmental delays who was vaccinated with Act-Hib, Prevnar 13 and Pediarix on the same day and experienced a fever and seizure the next day. Fever and febrile seizures are listed events in the current company reference safety information. The patient had an ongoing illness reported as hypotonia at the time of vaccination. There is no way to definitively determine which vaccine, if any, may have triggered the event in this case.