Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site swelling, No reaction on previous exposure to drug, Skin swelling
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old patient who on 02-JUN-2006 was vaccinated with his first dose of MMR II. The patient did not have an adverse reaction after receiving his first dose. On 10-MAR-2009 the patient was vaccinated  with his second dose of MMR II (lot # 661724/1365X; expiration date 30-SEP-2010) SQ in the left upper arm. Concomitant therapy included KINRIX (lot # AC20B103BC; expiration date 07-JUN-2010) in the left upper arm. The patient was seen on 12-MAR-2009 due to significant injection site reaction. The physician's note stated "moderate edema and erythema up the left shoulder and across the left chest, mildly tender with some firmness in the left deltoid area". The patient was prescribed AUGMENTIN and BENADRYL. The patient had also received in the past DTaP (manufacturer unspecified) and injectable POLIO (manufacturer unspecified) with adverse effects. The patient had visited physician's office for medical attention. At the time of reporting the patient's adverse events persisted. Follow-up information was received from the registered nurse via the physician's medical record. It was reported that the patient had no illness at time of vaccination, no pre-exiting allergies or birth defects or medical conditions. And the patient and his siblings had no adverse events following prior vaccination. On 10-MAR-2009 at 2:00 PM the patient was vaccinated SC with the second dose of MMR II (lot # 661724/1365X) into the left upper arm. At the same time, the patient was also vaccinated IM with the second dose of KINRIX (lot # AC20B103BC) into the left upper arm. On 11-MAR-2009, redness and swelling at the injection site started. The patient was given TYLENOL every four hours and put ice on it but did not give anything else. On 12-MAR-2009 at 6:00PM the patient was seen in the office for increased pain and with complaint of the onset of "left upper arm swollen and inflamed top of arm to elbow" for 2 days. The patient did not complain with itchy and denied the history of adverse reactions before (conflict information as adverse effects with other vaccine was reported previously). It was reported that the swelling had progressively gotten worse. The patient's left upper arm with moderate edema and erythema that was spreading up to shoulder and across to left chest. And there was mildly tender with some firmness in left deltoid area at the site of injection. The patient was diagnosed with vaccine reactions vs. cellulitis and rash/other nonspecified skin eruption. The patient was planned to treat with antibiotics for possible cellulitis as well as BENADRYL for exaggerated reaction to vaccines. Line was drawn around rash on that day. AUGMENTIN ES-600, 42.9 mg/ 5 ml, 3 ml PO BID was prescribed from 12-MAR-2009 to 19-MAR-2009. On 14-MAR-2009 the physician spoke with the patient's mother and the mother thought that redness was improving, "now a very light pink". It was still swollen right around the injection site. The patient was still a little uncomfortable but overall definitely better. The physician told the mother to do BENADRYL one more day and continued antibiotics. It was reported that there was no relevant diagnostic tests or laboratory data. The patient recovered on an unspecified date. Additional information is not expected.