Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site rash, Pyrexia, Rash, Rash macular, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician). A 5-month-old male patient received the second dose of PREVNAR 13; (lot M94708, expiry date 30Sep2017, NDC number 0005-1971-02) on 06Sep2016 at 12:44, in left thigh, at 0.5 ml single and the second dose of ACT HIB; (manufacturer: Sanofi Pasteur, lot UI550AAA, expiry date 12Mar2017) on 06Sep2016, in right thigh, at 1 DF single, both intramuscular, for immunisation. The patient medical history was not reported. There were no concomitant medications.  Birth weight 16.5 lbs, siblings 1. The patient previously took the first dose of hepatitis b vaccine (given in hospital at birth) on 27Mar2016, PEDIARIX, first dose on 17May2016, (lot number: 529PP, expiry date: 27May2018) intramuscular, in left thigh, second dose on 02Aug2016 (lot number 974JA, expiry date: 27Nov2017) intramuscular, in left thigh, oral ROTARIX first dose on 17May2016 (lot number: A41FB559A, expiry date: 27Aug2017) and second dose on 02Aug2016 (lot number: A41FB572A, expiry date: 29Aug2017), the first dose of haemophilus influenza type b vaccine (lot UI469AAB, expiry date: 23Apr2017) on 21Jun2016 intramuscular in right thigh, the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) on 21Jun2016 (lot number: M51192, expiry date: 31May2017) intramuscular in left thigh, all for immunisation, without adverse events. The patient experienced rash/ urticarial type of rash on 08Sep2016 with outcome of not recovered and fever on 06Sep2016 at night with outcome of recovered. Rash was considered medically significant, while fever was considered a non serious event. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 06Sep2016 and 98.6 Fahrenheit on 09Sep2016. Therapeutic measures were taken as a result of both events and included TYLENOL, probably 80 mg and BENADRYL. After taking paracetamol the fever never returned. The patient did not visit physician office due to fever. On 07Sep2016 the patient was fine, happy as a clam. On 08Sep2016 the patient developed a urticarial type of rash. The rash faded, then, on 09Sep2016 was full blown again. The baby was still happy as a clam and had no temperature on 09Sep2016, however the urticaria was quite impressive. The patient visited the physician due to rash. The reporting physician gave the baby diphenhydramine on 09Sep2016. He called the allergist and was waiting for them to call him back. The rash was on the front of both thighs and the back of the right upper arm. It was raised red blotches that were hive-like. The rash had started in one small area on the right thigh.  The patient will not be given pneumococcal 13-val conj vac (dipht crm197 protein) again until it is determined if the rash is a true allergic reaction. The physician was assuming the reaction was due to pneumococcal 13-val conj vac (dipht crm197 protein), not haemophilus influenza type b vaccine. Follow up (06Oct2016): New information obtained from a contactable Other HCP includes: patient's Birth weight and siblings, suspect vaccines details. Follow-up attempts completed. No further information expected. Company Clinical Evaluation Comment Based on the information currently available and known safety profile of the suspect product, the Company cannot exclude a reasonable possibility of an association between the events and the suspect product based on temporal relationship. Sender's Comments: Based on the information currently available and known safety profile of the suspect product, the Company cannot exclude a reasonable possibility of an association between the events and the suspect product based on temporal relationship.