Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash macular, Stomatitis, Tinnitus, Urticaria
Clinical narrative: Initial report was received on 18 April 2011 from another manufacturer, report number WAES 1103USA00040.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from an office manager/medical assistant concerning an approximately 12 month old female patient with allergy to ZITHROMAX developed rash and no pertinent medical history, who on 10-AUG-2007 was vaccinated with a dose of MMR II (Lot # 656428/0203U EXP 24-JUN-2009).  There was no concomitant medication.  The medical assistant reported that the patient was now experiencing hearing loss in her left ear.  "Shortly" after vaccination, the patient developed a rash and 1 day fever.  The patient was seen by an Otolaryngologist in November 2010 and received steroids as treatment.  At the time of the report, the patient had not recovered from hearing loss in her left ear.  The outcome of rash was unknown.  Follow up information has been received in the form of medical records concerning a 12 months old female patient who on 10-AUG-2007 received a dose of MMR II, a dose of VARIVAX (Merck), a dose of ACTHIB and a dose of PREVNAR.  On 12-AUG-2007 the patient developed a fever which was treated with TYLENOL and resolved in one day.  The patient had also developed a fine red rash with macules on her trunk, back, genital area and slightly down her legs on 12-AUG-2007 (also reported as 14-AUG-2007) along with diarrhea and was seen by her physician on 15-AUG-2007.  The patient was noted to have some yellow nasal congestion.  The patient was treated with BENADRYL and CLARITIN in the doctor's office.  The diagnosis was urticaria possibly secondary to immunization.  The patient was seen in the doctor's office on 20-AUG-2007.  On 18-AUG-2007 the rash returned to the patients trunk, back, genital area and around her mouth and neck, which had cleared up 2 days prior.  The fever also returned.  The patient had a sore on the roof of her mouth which the doctor thought might be fungal.  She was diagnosed with hives that were possibly viral.  The patient was prescribed nystatin (manufacturer unknown) swabs, and the patient was to restart the BENADRYL and the CLARITIN.  On 23-FEB-2011 the patient had a consultation with a physician for asymmetric sensorineural hearing loss and tinnitus in her left ear.  Steroid therapy had been unsuccessful.  On 11-MAR-2011 the patient was seen by a physician to follow up on her hearing loss which was felt to be unchanged from the prior visit.  The physician felt that the hearing loss would become progressive and recommended hearing aid placement.  As of the time of this report it is unknown the outcome of diarrhea, rash/hives possibly viral and fever.  The patient has not recovered from sensorineural hearing loss or tinnitus.  The patient's sensorineural hearing loss in her left ear was considered to be disabling by the medical assistant.  Additional information has been requested.  All available medical records will be provided upon request."  Documents held by sender: none.