Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Hypersensitivity, Hypoaesthesia oral, Oedema mouth, Oedema peripheral
Clinical narrative: Information has been received from local health agency concerning six cases of anaphylaxis following an enhanced immunization program. Patient six out of six, a 25 year old female with environmental ("cats and mold, gets hives with mold") allergy who on 22-NOV-2007 was vaccinated with MMR II (Lot # 655813/1529U), 0.5 ml, subcutaneously on left arm at 11b45. On 22-NOV-2007 at 11h50, the patient experienced anaphylaxis, mouth and tongue felt itchy + tingling and numbness, mouth felt swollen, hands were puffy and red and felt warmth run up her arms into her neck and scalp and face was red and puffy. at 12h10 the patient presented back to public health nurse. Numbness and tingling had subsided. Swelling of hands continued. The patient's respirations "were fine", no shortness of breath. The patient was observed for 40 minutes. The patient left clinic and presented (on her own) to emergency. At 12h54 the patient was triaged in emergency room (Triage Score 3): blood pressure measurement 129/89 mmHg; body temperature measurement: 36.6 c; respiratory rate measurement: 29 min; and total heartbeat count: 131 BPM. The patient's skin appeared flushed, denied problems swallowing. The patient reported that when she "arrived in ER her symptoms had peaked": had hives on abdomen and legs. At 14h19 therapy with diphenhydramine hydrochloride (BENADRYL), 30 MG, IM was administered. The patient felt better within 30 minutes of injection. The patient was discharged at 15h09 with a prescription for diphenhydramine hydrochloride (BENADRYL). On 26-NOV-2007 the patient's update was as follows: "puffiness remained behind ears for 2 days, and took diphenhydramine hydrochloride (BENADRYL), PRN, throughout that time. Comments: the patient was originally coded as "allergic reaction". Record was re-examined on 11-DEC-2007 and determined to also meet Provincial case definition for anaphylactic reaction." Upon internal review, anaphylaxis, mouth and tongue felt itchy + tingling and numbness, mouth felt swollen, hands were puffy and red and felt warmth run up her arm into her neck and scalp and face was red and puffy were determined to be an other important medical event. This is one of six reports received from the same source. The reporter also discussed the experience of a 19 year old male (WAES 0712CAN00028), 30 year old, female (WAES 0712CAN0029), an 18 year old, female (WAES 0712CAN0030), 22 year old, female (WAES 0712CAN0031) and 20 year old female (WAES 0712CAN0032) while vaccinated with MMR II Lot # 655813/1529U. The reporter indicated that the date of first adverse events following immunization occurred on 22-NOV-2007 and the date of last adverse events following immunization occurred on 07-DEC-2007. The description of adverse events following immunization was "anaphylaxis" and met the provincial agency definition of anaphylaxis: An event occurring within 24 hours following immunization with one or more of the following symptoms: -Progressive painless swelling around face or moth. -New onset of wheezing, shortness of breath and/or stridor. -Hypotension/collapse The immunization campaign: The vaccinations took place during the provincial Enhanced Mumps Immunization Campaign. Phase one of this campaign targeted students and staff in post secondary institutions between the ages of 17 and 37 and began as early as 01-NOV-2007 in one region. There were approximately 62,800 doses of MMR II administered in this campaign to date (07-DEC-2007), resulting in a rate of suspected anaphylaxis of approximately 96/1,000,000. The generally accepted rate of anaphylaxis after immunization is between 0.4-1.8/1,000,000 (CIG 2006). All suspected anaphylaxis cases received the same lot of MMR II vaccine. Of the six cases of suspected anaphylaxis, two were reported from a central urban region and four from a central rural region. These region delivered 23,029 and 2.642 doses respectively. The age range of the suspected cases were from 18-30 year, five of six (5/6) were female, and all cases had a background of allergies to the environment, animals, seafood or antibiotics. One case reported as having an anaphylactic reaction to seafood. Symptoms were variable; however most cases had swelling and numbness in or around the mouth or face +/- shortness of breath/stridor/throat swelling within 10 to 15 minutes after immunization. Of the six suspected cases, epinephrine was provided within 10 minutes from the onset of symptoms in five cases, which may explain the lack of development of symptoms in other organ systems (Vaccine, 2007). All cases were transported by ambulance to the nearest emergency room (ER) and were seen by a physician. All cases occurred at different clinic sites with different staff administering the vaccine and treatment, and all cases saw different staff administering the vaccine and treatment, and all cases saw different ER physician. Following questions asked by Health Wellness agency: At this time responses were received from the central rural region who stated no latex products were used in any clinic, and no changes had been made to nurses training or vaccine storage and handling procedures. Information from the central urban region was still pending. At the time of this report attempts were being made for all cases to see an allergist in the central urban region with experience testing for allergens following immunization. In addition, would persue immunization history to determine if immunization with hepatitis B virus vaccine was administered previously. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the government and was released by the regulatory agency. No further information is available.