Anti-COVID-19 Vaccine Side Effects
Condition: Vaccine Adverse Reaction; Gender; COVID-19 Vaccine Adverse Reaction
MeSH terms: COVID-19
Study type: Observational

Summary: 
      In 2021 and following the COVID-19 (corona virus disease 2019) pandemic, different vaccines
      were initially authorized in Italy and Lebanon. Notably, vaccine side effects were poorly
      recorded. Thus, the investigator performed a survey study to monitor COVID-19 vaccine side
      effects among Italian and Lebanese citizens according to gender and age through a web-based
      questionnaire in Italian and Arabic languages including 21 items by "Google Form",
      investigating 13 symptoms, and employing social-media platforms
    

Detailed description: 
      The COVID-19 pandemic has presented a real challenge to the public health system worldwide
      since the year 2019, spreading to more than 200 countries and regions worldwide.The emergence
      and rapid spread of COVID-19 were caused by the coronavirus SARS-CoV-2. Worldwide, the use of
      COVID-19 vaccines was initially authorized for emergency use and the side effects were not
      stated clearly. Common side effects were expected but specific side effects linked with
      COVID-19 vaccines remained uncertain. In this context, survey studies are needed for a
      comprehensive evaluation of the relationships between vaccine administration, related
      undesired effects and vaccine safety.

      This study represents the first survey following early COVID-19 vaccines administration in
      two geographic areas, comparatively considering possible differences due to gender and age. A
      web-based survey was conducted on a cohort of 1975 Italian and 822 Lebanese people who
      received at least one dose of COVID-19 vaccine. The study was conducted between March and
      July 2021 on a voluntary basis, and by a tailored anonymous web-based questionnaire. The
      protocol was approved by the local Ethics Committee, University of Bari 'Aldo Moro' (study
      number 6752, protocol number 0031044). A specific questionnaire was designed in English and
      translated into Italian and Arabic. It contains 21 items including demographic data, the
      history of vaccine administration before COVID-19, the administration of the first and second
      dose of COVID-19 vaccine, and possible adverse effects.

      The survey link was shared by a "Google Form" employing social-media platforms or by personal
      interview.

      The questionnaire explored the presence of 13 possible symptoms appearing following the
      administration of the first and second dose of COVID-19 vaccine: pain at the injection site,
      redness at the injection site, swelling at the injection site, induration at the injection
      site, allergic-urticarial reaction, anaphylaxis, fever (>37 °C), diarrhea, vomiting,
      asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache,
      lymphadenopathy. The presence and intensity of symptoms were assessed semi-quantitatively by
      a Visual Analogue Scale (VAS). Besides symptoms, the following aspects were also evaluated:
      need of drug intake, consultation of a doctor, emergency admission to hospital, and possible
      hospitalization.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Random sample from the Italian and Lebanese population who received first or first and
        second dose of anti-COVID-19 vaccine