The Irish Medicines Board, IMB, has received a total of 324 suspected adverse drug reaction, ADR, reports associated with the use of DTP vaccines since 1972, 87 of which are classified as serious in accordance with agreed international criteria.
A serious ADR is defined as one that is fatal, life threatening, results in persistent or significant disability/incapacity, or prolongs hospitalisation. This definition also includes serious adverse clinical consequences. Accordingly, some of the cases listed below are classified as serious because the children concerned were admitted to hospital for observation, or received treatment, which is classified as an intervention. The serious ADR reports received are consistent with those known to occur with the use of DTP vaccines.
The breakdown of these reports for the respective years is as follows:
Year
|
Cases
|
1973
|
1 case
|
1974
|
1 case
|
1975
|
2 cases
|
1976
|
1 case
|
1980
|
2 cases
|
1981
|
1 case
|
1982
|
2 cases
|
1984
|
2 cases
|
1985
|
1 case
|
1986
|
2 cases
|
1987
|
1 case
|
1988
|
3 cases
|
1991
|
3 cases
|
1992
|
4 cases
|
1993
|
1 case
|
1994
|
2 cases
|
1995
|
7 cases
|
1996
|
8 cases
|
1997
|
3 cases
|
1998
|
3 cases
|
1999
|
2 cases
|
2000
|
1 case
|
2001
|
3 cases
|
Since 2001, there is increasing use of combined vaccines, for example, Tetravac, Infanrix IPV Hib, Pentavac etc., which have replaced the DTP vaccines.
As the Deputy did not specify a particular brand of DTP vaccine, the IMB, when collating this information, included all ADRs for all DTP vaccines. Therefore, the total number of ADRs is different than that given in response to previous parliamentary questions, as those questions related to the use of one specific vaccine brand, for example, the question on Trivax answered on 18 October 2000.