Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood urine absent, Blood urine present, Henoch-Schonlein purpura, Injection site rash, Joint swelling
Clinical narrative: This is a spontaneous report from a contactable registered nurse received through a Pfizer Sales representative. A 12-month-old male patient had received the fourth dose of PREVNAR 13, (LOT#: G13185) 0.5 ml intramuscular on right anterior thigh on 08Jan2013 at 09:30. The patient also received the first doses of MMR (Lot Number: H011907) vaccine subcutaneous on right anterior thigh, Hepatitis A vaccine (Lot Number: AH AUB667AB) subcutaneous on left anterior thigh and VARIVAX (Lot Number: H010559) subcutaneous on left anterior thigh on 08Jan2013. Relevant medical history included history of otitis media once on an unknown date. Relevant concomitant medications included an unspecified vitamin and he was taking it at the time of event onset. Vaccines taken within the last four weeks were none. The patient previously received the first dose of PREVNAR 13 at the age of 2 months on 06Mar2012 (Lot Number: 918173), the second dose at the age of 4 months on 10May2012 (Lot Number: F88044), and the third dose at the age of 6 months on 12Jul2012 (Lot Number: F92472) and experienced no adverse events. On 08Jan2013, the patient started with a small rash on shoulder. The rash was all over by the morning of 14Jan2013 and had gotten worse by the afternoon. On 13Jan2013, the patient experienced rash all over body (described as rash on one side of abdomen, rash on chest, rash on trunk, rash on face), hand was swollen, hand was purple and blood in urine was present. The patient was seen in the physician's office on 14Jan2013 with red maculopapular rash that was on the trunk and face. He did not have a high temperature, hive, itching or other symptoms. The patient's mother called later on 14Jan2013, and reported that there were rash, blanches and hive on hands and feet. Treatment was to observe and provide supportive care. On 18Jan2013, the rash was worse. The patient was seen in the office again on 18Jan2013 and the rash was all over and a little itchy especially the abdomen. On 18Jan2013, hands, feet, and ankles were swollen and purple. There were blanchable rash lesions on the face, abdomen, back, and legs. The patient was diagnosed with Henoch Shonlein purpura (HSP) on 18Jan2013. On 18Jan2013, a urine analysis dip showed questionable blood. Therefore, urine analysis was done on 18Jan2013 and on 21Jan2013 which was negative for blood. At the time of report, the patient was much better with the rash markedly decreased as well as the swelling of the hands and feet. The clinical outcome of the events, HSP and blood in urine, was recovered on an unknown date in 2013. The nurse reported that the causality of the event, HSP, was possibly related to MMR and varicella virus vaccines. Follow-up (12Feb2013): New information received from the same contactable nurse, on behalf of a physician includes: past medical history, vaccine history, suspect products data, reaction data (deleted events: "down with herpes simplex virus", rash all over body, hand was swollen, hand was purple; and added event, HSP), outcome, and causality of event, HSP. Follow up attempts completed. No further information expected.