Day 1: Friday 8 April 2012

You call Sarita Priya at the Chandra Medical Centre by telephone. Sarita has several years of experience conducting immunization programmes, mostly to children under 1 year old. This is only the second time that she has ever had to report an AEFI to her manager.

Sarita says:

"On Wednesday (6 April 2012) at 11:00 AM, Susan Chidawayo came into the clinic and told me that her daughter, Martha, became ill after she had been vaccinated on Monday (4 April 2012).

Before vaccination, I enquired from the mother and confirmed that the child had no medical problems, no history of allergies and she was taking food normally. On looking at her, Martha appeared healthy, and I remember there was nothing remarkable about the injection itself – she cried a little but there was no other problem. Afterwards, I told Susan that Martha could develop a temperature, but this would not last long and if so, she should give Martha some paracetamol. But apparently Susan noticed that Martha developed fever in the evening and later had some kind of twitching on the night (about 10.00 pm) after the vaccination – her arms and neck were jerking and her eyes were not focused properly, she also had a poor appetite:she was very restless for all of the next day. Susan said that Martha’s fever had subsided and she appeared to be getting better, and asked me if there was anything to give her. I told her to keep her under close observation and contact me if there is any aggravation in her condition. Anyway, she has not come back to the clinic again, so I presume she recovered.

I was using one of the multidose vials measles vaccines, which was constituted for that session using the diluent provided by the manufacturer, Martha was the second child vaccinated after the vial was reconstituted, 7 other children received vaccines from the same vial. I have heard of no problems with any of the other children from that session. The vial was discarded at 12.30 pm and I noted the discard time in my records.

If you need to contact Mrs Chidawayo you will find all the details in the register in the clinic."

You look up vaccine information from the Klinigen website and from the package insert.

The Klinigen ‘Oovivax’ measles mumps rubella varicella vaccine was licensed in June 2011. It is supplied in multidose vials which need to be reconstituted with 1 ml sterile diluent ‘Easydil’ from the manufacturer and used within 6 hours.

The freeze dried vaccine has a typical shelf-life of 1 year. It is intended for subcutaneous injection (0.5 ml) in children up to age 12, and 0.2 ml in adults. Each reconstituted vial contains sufficient vaccine for 10 children aged up to 12.

The recommended schedule is either a single injection as a booster, or for unimmunized people, two injections with an interval of 1 month. It is not suitable for children under 9 months old.It is recommended that it is not given to children who have fever. Some mild reactions may occur such as marginal temperature rise in 5% to 6% of the vaccinated children, mild rash in 1% to 2% children, occasionally mild rash and slight gastric disorders or short-lived rhinopharyngitis. Fever or rash, or both, generally appear between the 5^th and the 12^th day after vaccination and last for one to two days.

You decide that there could be a risk associated with the measles vaccine that you are using, and place a notice in the window of the clinic to say that the programme will be suspended for a few days. You also contact a number of community health workers, so that the information can be passed on directly to parents and carers of the children who were scheduled to come to the clinic on the Friday.