Pertussis Vaccine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 5, 2026🚩 Report this page

Pertussis Vaccine

Active ingredient

Sold as VacPertagen

EU EMA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Pertussis Vaccine is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	March 5, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 5, 2026[1]

1). The use of this vaccine should be in accordance with official recommendations.

How to take

EUOfficial regulatory label

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006304 · revised March 5, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 5, 2026[1]

4%). The majority of the reactions were mild in severity and resolved within a few days of onset. Tabulated list of adverse reactions The safety of a single dose of VacPertagen was evaluated in 2 508 individuals 12 years of age and older including 150 adolescents, 2 318 non-pregnant adults and 40 pregnant women based on data from randomised controlled clinical trials (Table 1).
Adverse reactions are listed according to the following frequency categories:
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Rare (≥ 1/10 000 to < 1/1 000) Very rare (< 1/10 000) 6 Adverse reactions reported are listed per system organ class. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Frequency Adverse reactions Blood and lymphatic system disorders Common Lymphadenitis, lymphadenopathy Nervous system disorders Very common Headache Cardiac disorders Rare Palpitations Gastrointestinal disorders Very common Nausea Common Vomiting, diarrhoea, enteritis Skin and subcutaneous tissue disorders Common Rash, urticaria Musculoskeletal and connective tissue disorders Very common Myalgia, arthralgia General disorders and administration site conditions Very common Injection site pain, fatigue, malaise Common Injection site pruritus, injection site induration, injection site haematoma, chills, pyrexia Uncommon Injection site erythema, injection site swelling Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised March 5, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Prior to immunisation Vaccination should be preceded by a review of the medical history, in particular adverse reactions after past vaccinations.
Pertussis containing-vaccine If any of the following events have occurred after administration of a pertussis-containing vaccine, the decision to administer further doses of a pertussis-containing vaccine should be carefully considered: • Temperature of ≥ 40 °C within 48 hours, not attributable to another identifiable cause • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination • Persistent crying lasting ≥ 3 hours, occurring within 48 hours of vaccination • Convulsions with or without fever, occurring within 3 days of vaccination.
There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh the possible risks. 4 Hypersensitivity and anaphylaxis As with all injectable vaccines, appropriate medical care should be readily available in case of an anaphylactic event following the administration of the vaccine.
Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection.
It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia).
Bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals There are no clinical data with VacPertagen in immunocompromised individuals. The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.

This is not medical advice. Consult a qualified healthcare professional.