Korle-Bu Teaching Hospital, P. O. Box 77, Korle-Bu, Accra, Ghana.
Drug Saf. 2013 Apr;36(4):259-66. doi: 10.1007/s40264-013-0037-7.
Cases of the A(H1N1) 2009 influenza were first recorded in Ghana in July 2009. In June 2010 when prioritized vaccination against the novel A(H1N1) 2009 influenza virus started in the country, health workers were among the selected groups to receive the vaccination.
The aim of this study was to determine the distribution and types of adverse events reported following immunization of healthcare workers at the Korle-Bu Teaching Hospital from the day vaccination started until 1 week after the end of vaccination.
Safety data collected during the A(H1N1) 2009 influenza vaccination of health workers at the Korle-Bu Teaching Hospital (Accra, Ghana) were used for this study. All workers aged 18 years and over were eligible for vaccination. For uniformity, 0.5 mL of Pandemrix(®) (equivalent to 3.75 μg of hemagglutinin antigen) was administered intramuscularly into the deltoid muscle of the left arm. Each vaccinee was issued with a card and was advised to report any adverse events following immunization (AEFI) to designated health workers for follow-up. Incidence rates of adverse events were estimated and compared with the Pandemrix(®) Summary of Product Characteristics (SPC) RESULTS: A total of 5870 people (64.9 % females) with a mean age of 34.0 years were vaccinated. In total, 140 vaccinees reported adverse events. The mean age among vaccinees reporting adverse events was 36.1 years. The overall incidence of vaccinees reporting adverse events and the overall incidence of adverse events was 232 (95 % CI 199-320) per 10,000 people and 930 (95 % CI 820-1070) per 10,000 people, respectively. In particular, we found no difference in the way males reported AEFI compared with females (Chi-squared [χ(2)] = 0.59; p > 0.2), and we did not find any association between age as a categorical variable and vaccine adverse event reporting (χ(2) = 5.24; p > 0.1). There were only three serious cases that led to hospitalization. All three cases occurred within 24 hours of receiving the vaccine. The incidence rates for the various reported events were all lower compared with those in the Pandemrix(®) SPC, but while injection-site pain was the most frequent in the SPC and other foreign studies, we recorded headache as the most frequent. Even fatigue, muscle/joint aches and fever had higher incidence rates compared with injection-site pain. Tachycardia (n = 6), tinnitus (n = 1) and decreased appetite (n = 4) were reported although were not included in the SPC.
The most prominent adverse events reported were headaches, dizziness, muscle and joint aches, weakness, fever and injection-site pain. Although similar events were reported in other studies, the incidence was different and there were a few differences in the most frequently reported events. More studies of a similar nature should be encouraged in low- and medium-income countries to bridge the information gap with the developed world.
2009 年甲型 H1N1 流感病例于 2009 年 7 月在加纳首次记录。2010 年 6 月，当该国开始优先接种新型甲型 H1N1 2009 流感病毒疫苗时，卫生工作者被选为接种疫苗的选定群体之一。
本研究旨在确定科勒布教学医院（加纳阿克拉）自接种疫苗开始至接种结束后 1 周期间，医护人员接种疫苗后报告的不良事件的分布和类型。
本研究使用了在科勒布教学医院（加纳阿克拉）接种甲型 H1N1 2009 流感疫苗的医护人员的安全性数据。所有年龄在 18 岁及以上的工作人员都有资格接种疫苗。为了统一，将 0.5 毫升的潘立酮（®）（相当于 3.75μg 血凝素抗原）肌肉内注射到左臂三角肌。每位疫苗接种者都会收到一张卡片，并被建议向指定的卫生工作者报告接种后任何不良反应（AEFI）以进行随访。估计不良事件的发生率，并与潘立酮（®）的产品特性摘要（SPC）进行比较。
共有 5870 人（64.9%为女性）接种疫苗，平均年龄为 34.0 岁。共有 140 名疫苗接种者报告了不良事件。报告不良事件的疫苗接种者的平均年龄为 36.1 岁。报告不良事件的疫苗接种者的总发生率和不良事件的总发生率分别为每 10000 人 232 例（95%CI 199-320）和每 10000 人 930 例（95%CI 820-1070）。特别是，我们发现男性报告 AEFI 的方式与女性没有差异（卡方[χ(2)]=0.59；p>0.2），我们也没有发现年龄作为分类变量与疫苗不良事件报告之间存在任何关联（χ(2)=5.24；p>0.1）。只有 3 例严重病例导致住院。所有 3 例均发生在接种疫苗后 24 小时内。与 SPC 相比，报告的各种事件的发生率均较低，但尽管注射部位疼痛在 SPC 和其他国外研究中最为常见，但我们记录的头痛最为常见。甚至疲劳、肌肉/关节疼痛和发热的发生率也高于注射部位疼痛。虽然 SPC 中未包括心动过速（n=6）、耳鸣（n=1）和食欲不振（n=4）等报告，但也有这些不良事件的报告。
报告的最突出的不良事件是头痛、头晕、肌肉和关节疼痛、乏力、发热和注射部位疼痛。尽管其他研究也报告了类似的事件，但发生率不同，报告的最常见事件也存在一些差异。应鼓励在低收入和中等收入国家进行类似性质的更多研究，以缩小与发达国家的信息差距。
