Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Drug hypersensitivity, Injection site papule, Rash papular
Clinical narrative: This is a spontaneous report received from a contactable physician. A 5 month-old male patient received the second dose of PREVNAR 13 (lot number: T94430, expiry date: 30Apr2020), on 14Jun2018 via an unspecified route of administration in the right thigh at 0.5 ml, single for routine vaccination. The patient also received polysorbate 80 and aluminum phosphate in the right thigh on 14Jun2018. The patient's concomitant medications were not reported. The patient was born small for gestational age, at 38 weeks, with low glucose and diagnosed with a patent foramen ovale. In Mar2018 at the age of 7 weeks, the patient developed a rash - a generalized rash on his face and neck then arms, legs, and chest and back that was itchy, and had finer papules. Diet of the patient's mother was changed and papules got better over the course of few days. The patient had received for immunization the first doses of PENTACEL and of rotavirus vaccine at the age of 2 months in Mar2018. The patient had received in Apr2018 at the age of 3 months the first dose of PREVNAR 13 for immunization, polysorbate 80 and aluminum phosphate, without any papule. On an unspecified date in May2018 the patient was administered a second dose of PENTACEL (lot number: C5439AA, expiry date: 29Oct2018) in the left thigh and he had developed an area around the injection site, that had 1mm to 2mm size papules, with white heads, and penicillin injection with occurrence of some papules in his right thigh. On 14Jun2018 the patient received the second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and after that, on 15Jun2018, it was reported that the patient had little papules/papular rash, with the papules that had appeared after penicillin injection spreading to the rest of his right thigh. Physician said the papules were of the size of a nickel or a quarter. After the administration of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid, it had been thought that it might be a normal injection site reaction, but then the reporter thought that the patient might be having a reaction to the additives of pneumococcal 13-valent conjugate vaccine, specifically Aluminum Phosphate and Polysorbate 80. The events were assessed as medically significant. The patient was not recovered. Follow-up (18Jun2018): New information reported from the same contactable physician includes: clarification on suspect products (the first doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), polysorbate 80 and aluminium phosphate were not suspect products), reaction data (event of 'condition aggravated' added).; Sender's Comments: Considering that hypersensitivity/anaphylaxis is the known adverse event profile for PREVNAR 13 and Aluminum Phosphate and Polysorbate 80 are listed excipients for PREVNAR 13, from current information it cannot be fully excluded that the vaccination may play a contributory role towards the occurrence of reactions to both excipients presented with "papules/papular rash".  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.