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All patients treated at least with 1 SARS-CoV-2 vaccine

SARS-CoV-2 vaccines

Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson \& Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Transverse Myelitis Related to SARS-CoV-2 Vaccines

Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

University Hospital, Caen

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Pulmonary nodules/lung cancer patients who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)

Healthy people who have been vaccinated against the SARS-CoV-2 (with any type/brand of vaccine)

Pulmonary nodules/lung cancer patients who are not vaccinated against the SARS-CoV-2

Inoculation with any type of approved vaccines according to the standard or recommended dose

Vaccine inoculation against SARS-CoV-2

The objective of this study is to assess the inoculation-related symptoms and long-term effects of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting. The investigators aim to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

This study will enroll lung cancer/pulmonary nodule patients or healthy people who had undergone standard vaccination procedures against SARS-CoV-2/COVID-19. This observatory study will apply an electronic questionnaire to collect general information and post-vaccination symptoms or adverse events of vaccinated pulmonary nodules/lung cancer patients and healthy control. The researchers will further analyze whether the vaccine will promote the progression of primary tumors/pulmonary nodules through long-term follow-up. The investigators aim to assess the adverse events and long-term impact of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting, to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor

Safety and Long-term Effects of COVID-19 Vaccines in Patients With Lung Cancer or Indeterminate Pulmonary Nodule--A Real World Study

Raw anonymized data are available from corresponding investigator upon reasonable request.

Occurence rate of vaccination-related adverse effects in case group and healthy control group

Time calculated from the date of vaccine inoculation to the date of reported progression of pulmonary nodules by CT scan

Time calculated from the date of vaccine inoculation to the date of reported recurrence of lung cancer confirmed by pathological examination

The period of time calculated from the occurrence of vaccination-related adverse effects to the time of remission

The severity of vaccination-related adverse effects is defined as three grades: Grade 1 (self-remission without any intervention); Grade 2 (Remission only after medical intervention/s); Grade 3 (Adverse event-related Hospitalization)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transverse Myelitis Related to SARS-CoV-2 Vaccines	NCT05178264	Vaccine Adverse...	SARS-CoV-2 vacc...	-	University Hospital, Caen
Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor	NCT04894682	Lung Cancer Pulmonary Nodul... Pulmonary Nodul... COVID-19 Pneumo... Vaccine Adverse... SARS-CoV-2 Acut...	Vaccine inocula...	18 Years - 85 Years	Guangdong Provincial People's Hospital
Transverse Myelitis Related to SARS-CoV-2 Vaccines	NCT05178264	Vaccine Adverse...	SARS-CoV-2 vacc...	-	University Hospital, Caen

Spots Global Cancer Trial Database for vaccine adverse reaction