Frankenthal Dvora, Zatlawi Miri, Karni-Efrati Ziv, Keinan-Boker Lital, Glatman-Freedman Aharona, Bromberg Michal
Ministry of Health, The Israel Center for Disease Control, Ramat Gan, Israel.
Center for Research and Study of Aging, University of Haifa, Haifa, Israel.
PLoS One. 2025 Jul 11;20(7):e0326231. doi: 10.1371/journal.pone.0326231. eCollection 2025.
Periodic vaccination against COVID-19 persists with a recommendation to vaccinate especially older people and the chronically ill. However, vaccination compliance is low, likely due to concerns regarding adverse events (AEs).
To systematically and proactively evaluate the occurrence, onset, duration, and severity of self-reported AEs and comorbidities exacerbations that appeared up to 21-30 days following the third (booster) Pfizer BNT162b2 vaccine dose, and to examine the associations between the occurrence of any AEs and sociodemographic and pre-existing comorbidities.
A cross-sectional telephone survey among a nationally representative sample of Israeli vaccinated adults aged ≥18 was conducted from September through October 2021. Sociodemographic data was extracted from the Ministry of Health vaccination database, and data on AEs and comorbidities were collected using a structured questionnaire.
Overall, 2,049 participants completed the survey (71.4% response rate). A total of 1360 (66.4%) reported at least one AE following the booster vaccine. The most frequently reported AEs were local (55.7%) and mild systemic (48.6%) reactions (i.e., fatigue, headache, fever), followed by neurological (4.5%) and allergic (3.9%) reactions. Exacerbation of comorbidities following the booster dose was most frequently reported by individuals with autoimmune or mental conditions. Most local (80.1%) and systemic (69.5%) reactions lasted up to three days. Only 8.3% sought medical care. Menstrual changes were reported by 9.6% of women aged <54 years. The occurrence of any AEs was associated with younger age, female gender, higher socioeconomic status, and living in suburban communities. AEs were not associated with pre-existing comorbidities.
Most AEs were mild to moderate and transient. They were associated with younger age, but not with pre-existing chronic diseases. Since the primary target population for vaccination consists of older individuals and those with comorbidities, we believe the current findings may assist in reducing COVID-19 vaccine hesitancy among these populations.
针对新冠病毒的定期疫苗接种仍在持续进行，特别建议老年人和慢性病患者接种。然而，疫苗接种的依从性较低，这可能是由于对不良事件（AE）的担忧所致。
系统且主动地评估在接种第三剂（加强针）辉瑞BNT162b2疫苗后21至30天内出现的自我报告的不良事件和合并症加重的发生情况、发作时间、持续时间和严重程度，并研究任何不良事件的发生与社会人口统计学特征及既往合并症之间的关联。
2021年9月至10月，对以色列≥18岁接种疫苗的成年人进行了一项具有全国代表性的横断面电话调查。社会人口统计学数据从卫生部疫苗接种数据库中提取，关于不良事件和合并症的数据通过结构化问卷收集。
总体而言，2049名参与者完成了调查（应答率为71.4%）。共有1360人（66.4%）报告在接种加强针疫苗后至少出现了一种不良事件。最常报告的不良事件是局部（55.7%）和轻度全身性（48.6%）反应（即疲劳、头痛、发热），其次是神经（4.5%）和过敏（3.9%）反应。合并症在加强针接种后加重的情况最常出现在患有自身免疫性疾病或精神疾病的个体中。大多数局部（80.1%）和全身性（69.5%）反应持续时间长达三天。只有8.3%的人寻求医疗护理。年龄<54岁的女性中有9.6%报告了月经变化。任何不良事件的发生与年龄较小、女性、较高的社会经济地位以及居住在郊区社区有关。不良事件与既往合并症无关。
大多数不良事件为轻至中度且短暂。它们与年龄较小有关，但与既往慢性病无关。由于疫苗接种的主要目标人群包括老年人和合并症患者，我们认为当前的研究结果可能有助于减少这些人群对新冠病毒疫苗的犹豫。
