PloS one · 2025
Evaluation of adverse events and comorbidity exacerbation following the COVID-19 booster dose: A national survey among randomly-selected booster recipients.
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Frankenthal Dvora, Zatlawi Miri, Karni-Efrati Ziv, Keinan-Boker Lital, Glatman-Freedman Aharona, Bromberg Michal
Аннотация
BACKGROUND: 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).
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.