Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: Case number PHHY2015US018080, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 553563) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352588) on 18 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352588) on 11 Mar 2015. This report refers to an 11 years old male patient. Concurrent condition included shellfish allergy and non-tobacco user. Concomitant medications included EPIPEN, SINGULAIR, PROVENTIL and ORAPRED. His vaccination history included administration of fifth dose of FLUZONE (batch number: unknown, other manufacturer) on 05 Sep 2014. On 22 Sep 2014, prior to vaccination, a routine child examination was performed. The patient's review of systems, interval history, nutrition, developmental assessment, key family checks, vital signs and general examinations resulted normal. The patient was vaccinated with first dose of MENVEO (batch number: M14044) intramuscularly into right arm along with second dose of GARDASIL (batch number: K008335, expiry date: 23 Jun 2016, other manufacturer) intramuscular into left arm on 22 Sep 2014 at 14:47. On the same day, couple of hours after vaccinations, the patient's right arm was hard and swollen, extending to below the elbow. On 25 Sep 2014, the patient consulted physician due to these events. The patient's review of systemic and vital signs was normal. On general examination, regarding extremities, it was reported that the patient experienced swelling from shoulder joint down to below the right elbow and circumference with redness to below the right elbow. The patient had a normal range of motion and limb was non-tender but hard throughout to palpation, no evidence of compartment syndrome was noted. The physician assessment was reported as cellulitis (primary). The patient was aseptic post immunization with MENVEO. The patient was treated with clindamycin hydrochloride capsule 300 mg, 1 capsule, orally, every 8 hours, for 10 days and MEDROL tablet, 4 mg, orally, for 7 days. The patient was instructed to follow up at the physician's office if the events worsened. At the time of the report, the patient's outcome was not provided. The case was assessed as non-serious. The relatedness between GARDASIL and adverse events was not provided. It was reported that these were allergies to MENVEO. Seriousness assessment of cellulitis was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M14044) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352588) on 18 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352588) on 04 Mar 2015: Updated MENVEO batch review report.