Research Article

Examining Socioeconomic and Computational Aspects of Vaccine Pharmacovigilance

Table 5

BCG reaction profile: our approach allows producing easily and systematically comprehensive vaccine safety profiles. BCG findings were all verified in labels and other educational material. The profile included also non-reaction terms like ‘POLYMERASE CHAIN REACTION’, a laboratory procedure used for rapid diagnosis of tuberculosis. BCG was reported in 421 VAEs only, indicating reduced VAE risk—also, percentage representation of symptoms’ occurrence with BCG should be interpreted with respect to the context of the vaccine’s overall use and not only as reported in VAERS.

ReactionNum of VAEs (total)Num of VAEs (BCG)PRR%BCG’s VAEs

BOVINE TUBERCULOSIS151420178.73.32542
TUBERCULOSIS3212864.82.85036
DYSURIA5002060.14.7
LYMPHADENITIS3551354.83.1
POLLAKIURIA4161450.23.3
RESPIRATORY RATE INCREASED5661744.64
INJECTION SITE ABSCESS10321216.92.8
POLYMERASE CHAIN REACTION13441314.13.1
HAEMOGLOBIN NORMAL12581112.72.6
DEATH27662010.54.8
HAEMATOCHEZIA2058117.72.6
LYMPHADENOPATHY7759336.27.8
PNEUMONIA3310135.73.1
COUGH13116363.98.6
LABORATORY TEST ABNORMAL6327153.43.6
IRRITABILITY7757122.22.9
INFECTION13014192.14.5
CHILLS19150241.85.7
DIARRHOEA16105201.84.8
PYREXIA1004531071.525.4
VOMITING28847301.57.1