Meet the Team

Prevalence of Otalgia in
Patients with Temporo-mandibular Disorders

Patient Satisfaction 18 months After a Two-day Quadruple Therapy for Helicobacter Pylori

The Prevalence of Hepatitis B Carrier State

Total Quality Management for Turkish Primary Care Current Status and Suggestions

Vaccination Practice in Saudi Arabia: Is it Safe?

Change in Medical Students’ Opinions and Attitudes Towards Mental Illness

First Annual International Primary Care Conference-Abu Dhabi-UAE

Announcement of the Second Course of the MEAMA

Launch of 'World CME'

Antibiotic Sensitivity Profile of Common Bacterial Pathogens in Dubai
– A study of 107 cases

Women's Health Week in Rawalpindi, Pakistan

Middle East Academey for Medicine of Aging First Course

Pan Arab Congress for Evidence Based Medicine

Childhood Emergencies


Dr Abdulrazak Abyad
Editorial office:
Abyad Medical Center & Middle East Longevity Institute
Azmi Street, Abdo Center,
PO BOX 618
Tripoli, Lebanon

Phone: (961) 6-443684
Fax:     (961) 6-443685


Lesley Pocock
medi+WORLD International
572 Burwood Road,
Hawthorn 3122
: lesleypocock


Vaccination Practice in Saudi Arabia: Is It Safe?


Bader Almustafa, ABFM
Consultant Family Physician
Qatif Primary Health Care,
P.O. Box 545, Qatif 31911, Saudi Arabia
Tel: +966 3 852 6834
Fax: +966 3 855 1332
Email: bader@alqatif.org

Abdul Rauf Mohammed, DIH (Ireland)
Coordinator, Immunization Services
Qatif Primary Health Care
Email: arkullu@yahoo.com

Ghazi Al-Qatari, PhD
Director, Qatif Primary Health Care
Email: gqatari@hotmail.com


A pre-stratified systematic random sample of 836 children of less than 2 years was selected in 6 primary health care (PHC) centers in Qatif district. Companions were instructed to monitor adverse events for 3 consecutive days following diphtheria, tetanus and pertussis (DTP) immunization. There was one or more adverse events (AE) noted in 96.9 % vaccinees. Local reactions at the injection site were reported in 91.7%. Systemic reactions including fever, prolonged crying, vomiting, and hypotonicity were reported in 79 %, 24.3%, 9.9% and 1.1%, respectively. Behavioural reactions including sleepiness, anorexia and fussiness (irritability) were reported in 42.2 % of vaccinees. High fever, severe swelling and severe redness occurred in 5 %, 1 % and 1 % of cases, respectively. No serious adverse events were noted.

In conclusion, incidence and nature of AE following DTP are similar to those of internationally reported figures. No cases of local abscess were reported. This reflects a comparable safety of vaccination practice in Saudi Arabia.

Key Words: DTP; Saudi; adverse events; vaccine;, immunization; safety; Qatif


Saudi Arabia has achieved, during the last three decades a tremendous achievement in terms of basic vaccination coverage.1 This has been carried out, mainly, by structured vaccination programs delivered, mainly, through a wide network of primary health care centers.

However, a debate is rising about the safety of this program, especially, in the absence of effective surveillance of adverse events.

This study was undertaken to survey the adverse encounters following DTP vaccination and to compare them with the internationally published figures.2-13 This comparison may serve as an indicator for safety of the practice.

In Saudi Arabia, the incidence of such reactions related to licensed vaccines has not been determined before.


A population of more than 350,00014 individuals is served by 26 PHC centers in Qatif District. All of these centers provide vaccination services for whole population in their assigned catchment areas. A total number of 18,898 doses of DTP vaccine were given to children 0 to 2 years old, in the year preceding the study.15

A weighted, systematic, random sample of 6 (23%) PHC centers were chosen after stratification by the total number of doses of DTP vaccine given in the year preceding the study, in each center.
In each sampled center, one out of four Saudi infants and children aged 0 to 2 years routinely attended for DTP vaccination, and were included using systematic random sampling, in the period from 2 Sep 2000 until 1 Sep 2001.

Informed consent was obtained from parents or companions to conduct the surveillance of adverse events following immunisation (AEFI.) A leaflet was handed to the companion for introduction of the study, as well as instructions for monitoring AEFI. Companions who refused to be included in the study were not replaced.

A study nurse filled a basic data questionnaire (no. 1) at the time of vaccination. The questionnaire contained 37 elements about demographic data, type of feeding, past and present medical history, weight, temperature, previous AEFI, education level of the mother, dose number of DTP, experience of vaccine provider, timing of vaccination, site of vaccination, needle size and manufacturer, any medication given pre or post vaccination, and any massage given to the child post vaccination. Preferable timing of phone calls was agreed upon with the companion.

The companion was asked to monitor the child for fever, change in mood and behavior, general appearance, and local reactions for 3 days post-vaccination. A study nurse telephoned, daily, each family for 3 consecutive days, interviewing the mother or the guardian for AEFI in the preceding 24 hours and completing a questionnaire (no. 2.) This questionnaire contained 24 elements about occurrence of local and systemic AEFI as defined by the WHO 10, their temporal occurrence and period. Any visit to medical services for this purpose was traced, as well as the use of local applications or antipyretics.

Non-responding telephone calls were repeated, at least twice on the same day, or in the next few days, to inquire about AEFI.

One fourth of the sample was directly observed by a study nurse, to validate the observations of the mother or the guardian. For this purpose, companions were told to visit the PHCC the day following the day of vaccination.

A pilot study of the surveillance was held in a different PHCC in the Qatif area for one month. Questionnaires and methodology were modified accordingly.

Study nurses and physicians were trained on collection of data. Study PHC centers were visited frequently, to solve any obstacle facing data collection. Study nurses had frequent meetings collectively with the authors to share the experience with each other and get guidance from the authors. Data filling was verified twice by the authors.

Data were coded, entered and analyzed by the authors using SPSS package, version 10.

Data collection was interrupted in one PHCC for 6 months due to administrative obstacles in that center.

Schedules of vaccination are predetermined as per the Saudi MOH guidelines for vaccination.

Non-Saudis were excluded, due to difficulty to contact by phone and language barrier. However they constitute a small fraction of the vaccine in Qatif.14


Vaccine used was adsorbed diphtheria, tetanus, and pertussis vaccine, Pasteur Merieux SV. It was licensed and supplied by the MOH.


A total number of 4,457 injections of DTP vaccine were given to children, age 6 weeks to 2 years, in the selected six PHC centers in the period of the study out of which, 836 (18.8%; 397 females and 439 males) had been enrolled in the study. However, post vaccination clinical reaction data were collected for 749 (89.6%) injections; 47.3% of them were female. The remaining 87 (10.4%) injection recipients did not respond to repeated phone calls or had out-of-service phone lines. They did not differ, significantly, in their basic demography as well as the DTP dose.

All recipients were given one of four primary immunizations, given usually to children below 2 years of age. The number of injections given as 1st, 2nd, 3rd and 4th dose were 183 (24.4%), 182 (24.3%), 196 (26.2) and 188 (25.1), respectively. The dominant ages of recipients in each dose were 6 to 8 weeks (96.1%), three months (93.4%), five months (94.9%) and 18 months (90.8%), respectively. Trivalent oral polio vaccine and hepatitis b vaccine were simultaneously given to all and 24.1% of recipients, respectively.

The data were collected from mothers in 93.7% of the cases. Their level of education was high school or above in 429 (57.3%), while illiterates constituted 3.9%.

There was one or more AE noted following injections in 726 (96.9%) vaccinees. Local, systemic and behavioural reactions were reported following 687 (91.7%) injections, 619 (82.6%) injections, and 316 (42.2%) injections, respectively. These were further described in Table 1.

No anaphylactic reaction, anaphylactoid reaction, hypotonic hypo-responsive episode nor DTP-associated convulsion occurred. However, hypotonicity, alone, has been reported in 8 (1.1%) cases.

Incidence of excessive crying is shown in details in Table 2.

Perceived high fever and severe swelling and redness (circumferential) each occurred following less than 5% , 1%, and 1%, respectively. No abscess was reported at injection site.

Table 3 presents the temporal occurrence of AEFI with DTP vaccine. The majority (93.4%) of AE were reported in the first 24 hours following immunization.

Eight recipients had consulted a physician within the first 24 hours. Five were for fever; one for induration and redness; one for runny nose; and one for sleepiness.


Safety of vaccination practice has been questioned, and many effects have been proposed, such as lower or higher incidence of known AEFI, or the presence of unusual AE.

DTP vaccine was chosen for this purpose for many reasons. The first is that DTP-associated reactions are well studied and published in the literature, over the last fifty years. 1-9,11,12,15,17-20 Secondly, DTP is the most frequently administered vaccine to children.

In this study, identification of findings was made primarily via the caregiver. Daily contact to the caregiver might ensure reporting of adverse events of short duration that might take place. It might be argued that the caregiver might not be educated enough to report reliable data. However, no significant differences were noted between different educational levels in reporting adverse events, as shown in Table 1. On the other hand, similar methods of reporting have been used previously by many researchers.1-4,8,21

On the other hand, quantifying adverse events objectively is difficult, resource consuming, and does not cover the whole period post immunization. Adverse events, in our study, occurred throughout all time intervals in the first forty-eight hours following immunization, and were of brief duration.

The compliance rate, in this study, was high, approaching 90% of vaccinees involved.

The vast majority (91% - 96%) of them were age-appropriately immunised. Age was constant in more than 90% of each dose. This makes differentiation of incidence of AE on age not possible.
More than 96% of DTP vaccine recipients had some effect of immunisation noted. This is comparable with incidences of 93% - 96% reported in other studies. 2,25

On the contrary, few studies and reports have shown significantly lower incidence of adverse events.1,4,5,8,12,21 These differences are attributable to different methodologies or being retrospective or, merely passive reporting. Many other variables however, might add to these differences. These include differences in vaccine preparation, batch numbers, age of the child, dose schedule, and degree and timing of observation.

Most adverse events occurred in the first twenty-four hours. The majority of them were in the first six hours. These figures are comparable with similar results shown by Long and colleagues in northern America.

Local reactions were more frequent than fever, other systemic effects, and behavioural effects, in this study, and in other studies, as well.2,3,8,11

Serious adverse events, including seizures and encephalopathy were not noted. The absence of any seizure might be attributed to an insufficient sample size to trace such events, which were estimated to be less than one in every 1500 recipients.3,11

However, few studies have described similar results to this study, in higher sample size, even.2,22 Permanent neurological damage is however much less in prevalence and not within the scope of this study. It has been reported to occur once in 32,000 to 1.24 million doses. 9,11,24

Prolonged crying, defined in this study as excessive continuous crying or screaming, occurred after 24.3% of injections, while few other studies have described non-specific definition after 30 to 63% of injections.25-27

According to our definition, crying for more than 30 minutes and crying for more than 3 hours occurred in our study, after 2.9% and 0.8% of injections, respectively. These figures are comparable with other studies that showed incidence of 2 to 6% and 0.1 to 3%, respectively.3,28

Series number of DTP dose appears to affect the incidence and type of AE. Fever, local swelling and redness, anorexia, fussiness, and hypotonia occurred maximally after DTP4, with slight decrease in their incidence after DTP2. These findings are comparable with similar findings in other studies.2,3,23,25,27


Incidence and nature of adverse events following DTP vaccination in Qatif PHCC are similar to internationally reported figures. They are common, and worth considering by health workers, in order to orient caregivers for their possible occurrence at time of vaccination.

The absence of any serious AE might necessitate a larger sample size to be traced.


We are grateful to all parents and caregivers who contributed to this work. We thank all the nurses involved in collection of data, namely S. Safar, M. Saleh, E. Turaifi, M. Hawwaj, A. Rababi, A. Mahroos, Z. Abu Shaheen, H Abu Kaboos, T. Hani, I. Jishi, N. Hazim, M. Ma', A. Sabaa, S Keshkesh, I. Ghawwas, A. Jamed, Z. Ismail, S. Abandi, and Z. Rashid. Thanks are extended to A. Abdul-Aal for his secretary work and A. Bu-Saeed for her contribution in the pilot study


1. Ministry of Health. Vaccination coverage and incidence of diseases targeted by the expanded program of immunization, 1996-1999. In: Health Statistical Year Book 1420/1421 H (Arabic version). Riyadh, Saudi Arabia: Ministry of Health, 2000; 35-36.
2. Feery BJ. Incidence and type of reactions to triple antigen (DTP) and DT (DT) vaccines. Med J Australia. 1982;2:511-515.
3. Long SS, Deforest A, Smith DG, Lazaro C, Wassilak GF. Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy. Pediatrics 1990;85(3):294-302.
4. Cody CL, Baraff LJ, Cherry JD, Marcy SM, Manclark CR. The nature and rate of adverse reactions associated with DTP and DT immunization in infants and children. Pediatrics 1981;68:650-60.
5. Pollock TM; Miller E; Mortimer JY; Smith G. Post-vaccination symptoms following DTP and DT vaccination. Dev Biol Stand. 1985;61:407-410.
6. Mansoor O, Pillans PI. Vaccine adverse events reported in New Zealand 1990-5. N Z Med J. 1997 Jul 25;110(1048):270-2.
7. Stetler HC, Mullen JR, Brennan JP, Orenstein WA, Bart KJ, Hinman AR. Adverse events following immunization with DTP vaccine. Dev Biol stand 1985;61:411-21.
8. Morrison H, et al. Vaccine adverse reactions in young children in Ontario. Can J Public Health, 1988 Nov-Dec;79(6):459-60
9. Floyd CB, Freeling P. Survey to establish the incidence of minor side effects in infants following protective immunization. J R Coll Gen Pract. 1989 Sep;39(326):359-63.
10. Portoian-Shuhaiber S and Al Rashid AA. First reporting cases of permanent neorological damage after pertussis vaccine among children born and vaccinated in Kuwait. Saudi Medical Journal 1986; 7(3): 270-4.
11. List of definitions for monitoring of adverse events following immunization. Appendix A in Surveillance of adverse events following immunization. WHO/EPI/TRAM/93.02 Rev.1
12. Jessica T et al. Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions: Recommendations of the Advisory Committee on immunization practices. MMWR 45(RR-12):1-35, 1996.
13. C. P. Howson and H. V. Fineberg. Adverse events following pertussis and rubella vaccines. Summary of a report of the Institute of Medicine. JAMA 1992 January 15;267(3):392-6.
14. Annual Census. Qatif Primary Health Care. Qatif, Saudi Arabia 1999.

15. Report of Immunization of infants in Qatif district. Qatif primary health care, Saudi Arabia 1999.
16. Sauer L. Whooping cough: A study in immunization. JAMA 1933;100:239.
17. Lapin JH. Immunization against whooping cough. J Pediatr 1946;29:90.
18. Butler NR, Voyce MA, Burland WL, Hilton ML. Advantages of aluminum hydroxide adsorbed combined diphtheria, tetanus, and pertussis vaccines for the immunization of infants. BMJ 1969;1:663.
19. Cooverji ND, D'Sa JA. Reactions to adsorbed triple vaccine. Indian Pediatr 1975 Sep;12(9):875-7.
20. Strom J. Further experience of reactions, especially of a cerebral nature, in conjunction with triple vaccination: a study based on vaccinations in Sweden 1959-65. BMJ 1967 Nov 11;4(575):320-3.
21. T Freeman, W Cuff, P Duclos, MA Stewart, B Morris, D Cloutier-Fisher. A comparison of local reactions to two formulation of DPT Vaccine. The Canada Communicable Disease Report 1994; 20(15):129-32.
22. M. R. Griffin, W. A. Ray, E. A. Mortimer, G. M. Fenichel, W. Schaffner. Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. JAMA 1990 Mar 23;263(12):1641-5.
23. Baraff LJ, Cody CL, cherry JD. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions, and dose. Pediatrics 1984;73:31-39.
24. Miller DL, Alderslade R, Ross EM. Whooping cough and whooping cough vaccine: the risks and benefits debate. Epidemiol Rev 1982;4:1-24
25. RM Barkin and ME Pichichero. Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products. Pediatrics 1979;63:256-60.
26. Barkin RM, Samuelson JS, Gotlin LP. DTP reactions and serologic response with a reduced dose schedule.
J Pediatr 1984 Aug;105(2):189-94.
27. Ipp MM, Gold R, Greenberg S, et al. Acetaminophen prophylaxis of adverse reactions following vaccination of infants with diftheria-pertusis-tetanus toxoids-polio vaccine. Pediatr Infect Dis J 1987;6:721-5
28. A Deforest, SS Long, HW Lischner, JA Girone, JL Clark, R Srinivasan, TG Maguire, SA Diamond, RP Schiller, and EP Rothstein. Simultaneous administration of measles-mumps-rubella vaccine with booster doses of diphtheria-tetanus-pertussis and poliovirus vaccines. Pediatrics 1988;81:237-46.