Observational studyEuropean journal of hospital pharmacy : science and practice2023
Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021.
Observational study in European journal of hospital pharmacy : science and practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A systemic review and recommendation for an autopsy approach to death followed the COVID 19 vaccination.Forensic science international · 2022Pooled it
- Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.The journal of headache and pain · 2022Pooled it
- Characteristics of Oral Adverse Effects following COVID-19 Vaccination and Similarities with Oral Symptoms in COVID-19 Patients: Taste and Saliva Secretory Disorders.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2025Review
- Adverse event reporting following immunization of hepatitis B vaccine: A 13-year review.Human vaccines & immunotherapeutics · 2024Article
- Medical occurrence and safety of SARS-CoV-2 vaccination outside of the hospital setting.Internal and emergency medicine · 2024Article
- Safety monitoring of precautionary third dose of COVID-19 vaccines in a district in Northern India.Journal of family medicine and primary care · 2024Article
- Article
- The immunobiology of SARS-CoV-2 infection and vaccine responses: potential influences of cross-reactive memory responses and aging on efficacy and off-target effects.Frontiers in immunology · 2024Review
- AstraZeneca COVID-19 Vaccine and Diabetes Mellitus: A Prospective Clinical Study Regarding Vaccine Side Effects.Cureus · 2024Article
- Deciphering the Immunogenicity of Monkeypox Proteins for Designing the Potential mRNA Vaccine.ACS omega · 2023Article
- Exacerbations of Idiopathic Systemic Capillary Leak Syndrome following BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech).Internal medicine (Tokyo, Japan) · 2023Review
- Adrenal Crisis Associated With COVID-19 Vaccination in Patients With Adrenal Insufficiency.JCEM case reports · 2023Article
- Adverse events following immunisation (AEFI) of COVISHIELD vaccination among healthcare workers in Ghana.BMJ open · 2023Article
- Prevalence and risk factors of adverse effects after the first COVID-19 booster dose: evidence from Greece.Vacunas · 2023Article
- Side effects of Pfizer/BioNTech (BNT162b2) COVID-19 vaccine reported by the Birzeit University community.BMC infectious diseases · 2023Article
- Covid-19 vaccination reported side effects and hesitancy among the Syrian population: a cross-sectional study.Annals of medicine · 2023Article
- The effect of BNT162b2 SARS-CoV-2 mRNA vaccine on menstrual cycle symptoms in healthy women.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2023Article
- COVID-19 vaccination and liver disease.World journal of gastroenterology · 2022Review
- Article
- Evaluation of Short-Term Symptoms Associated With COVID-19 Vaccines Used Among Adolescents in Saudi Arabia.Cureus · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesOn 21 December 2020 the European Commission granted conditional marketing authorisation in the European Union for the anti-COVID-19 mRNA vaccine Bnt162b2 (Comirnaty, Pfizer/BioNTech). The main endpoint of this epidemiological, observational, prospective and monocentric study was to identify the number, types, and severity of adverse events following immunisation that occurred in subjects who had been previously infected with COVID-19, and in those who had not, after vaccination with Comirnaty, and to compare the two groups of subjects looking at events that occurred within a month after the first and the second dose.
methodsData were gathered by a questionnaire. The results included the responses of all healthcare workers (2030) of the IRCCS Sacro Cuore Don Calabria Hospital (Italy) vaccinated between 1st January and 28th February 2021. Adverse effects of the vaccine were reported after the first and the second doses.
resultsThere was a statistically significant increase (p<0.001, χ
conclusionsMost of the side-effects identified in this trial were also reported by the manufacturer and the US Food and Drug Administration. Active surveillance should always continue to constantly check the vaccine's risk/benefit ratio over time.
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