HPV vaccine Side Effects

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Answer the side-effect intent for hpv vaccine without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of vaccines & immunisation side effects.

What is HPV vaccine?

HPV vaccines covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• Human Papillomavirus 9-valent Vaccine — GARDASIL 9, MSD (Pty) Ltd (Injection)
• Recombinant AS04 adjuvanted — CERVARIX, GlaxoSmithKline South Africa (Pty) Ltd (Suspensions for injection.)

Common side effects of HPV vaccine

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Recombinant as04 adjuvanted (CERVARIX)

• pain or discomfort at the injection site
• redness or swelling at the injection site
• headache
• aching muscles, muscle tenderness or weakness, not caused by exercise
• tiredness
• gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
• itching, red skin rash, hives
• joint pain
• fever ( 38 °C)
• upper respiratory tract infection
• dizziness
• swollen glands in neck, armpit and groin

The leaflet lists 3 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

Cautions from each medicine’s approved leaflet.

Human papillomavirus 9-valent vaccine (GARDASIL 9)

Do not use it at all if:

• Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine]
• Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]
• Repevax [Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine, (adsorbed, reduced antigen(s) content) (dTap-IPV)] however GARDASIL 9 should not be mixed in the same syringe with any other vaccines or solutions. Please inform your doctor or healthcare provider if you or your child are taking or have recently taken any other medicines, even those not prescribed. Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines)

Use with care, and tell your doctor, if:

• has had an allergic reaction to GARDASIL or GARDASIL 9
• has a bleeding disorder and cannot receive injections in the arm
• has any illness with a fever higher than 37,8 °C
• is pregnant or is planning to get pregnant
• takes or plans to take any medicines, including over-the-counter medicines
• has a weakened immune system e.g. due to Human Immunodeficiency Virus (HIV) infection or a genetic defect, or if you take medicines that affect your immune system. What are cervical cancer, pre-cancerous lesions and genital warts? Cancer of the cervix is a serious and sometimes life-threatening disease. Nearly 100 % of cervical cancer is caused by HPV. Cervical cancer begins when a female catches certain types of Human Papillomavirus. These HPV types can cause the cells in the lining of the cervix to change from normal to abnormal or pre-cancerous lesions. These lesions are usually detected by a Pap test. If these lesions are not treated, they can turn cancerous. HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 cause approximately 90 % of cervical cancers and 75 to 85 % of advanced cervical pre-cancers. You or your child cannot get cervical cancer without first having a Human Papillomavirus infection. Cervical cancer is a leading cause of cancer among women worldwide. Genital warts are caused by certain types of Human Papillomavirus. HPV types 6 and 11 cause over 90 % of genital warts. They commonly appear as skin-coloured, irregular growths. They are found on the inside or outside of the genitals in both males and females. They can hurt, itch, bleed and cause discomfort. Sometimes they can come back after treatment. What are vulvar and vaginal cancers and pre-cancerous lesions? Approximately 25 % of vulvar and 70 % of vaginal cancers are caused by HPV. HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 cause 85 to 90 % of HPV-related vulvar cancers, 80 to 85 % of HPV-related vaginal cancers, 90 to 95 % of HPV-related advanced vulvar pre-cancers, and 75 to 85 % of HPV-related advanced vaginal pre-cancers. There are no routine screening tests for these cancers. What are anal cancer and anal pre-cancerous lesions? HPV infection is strongly associated with anal cancer and the pre-cancerous anal lesions that precede cancer. The great majority of anal cancers are squamous cell carcinoma (SCC) and 90 % of these cancers are HPV positive. HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 cause 90 to 95 % of HPV-related anal cancers and 85 to 90 % of HPV-related advanced anal pre-cancers. There are no routine screening tests for this cancer in healthy people. What is Human Papillomavirus? Human Papillomavirus is a common virus. Of the many different types of Human Papillomavirus, some are harmless, and others can cause diseases of the genital areas. While most people clear the virus, those who do not can develop cervical cancer, pre- cancerous lesions or genital warts. Will I receive any benefit from GARDASIL 9 if I am already infected with Human Papillomavirus? GARDASIL 9 helps prevent the diseases caused by some types of papillomavirus but will not treat them. If you are already infected with one type of HPV contained in the vaccine, GARDASIL 9 will help protect you against the other eight types. Talk to your healthcare provider for more information. Children GARDASIL 9 can be used in children as young as 9 years of age

Recombinant as04 adjuvanted (CERVARIX)

Do not use it at all if:

• If you have previously had any allergic reaction to CERVARIX, or any ingredient contained in CERVARIX. The active substances and other ingredients in CERVARIX are listed in section 6 – What CERVARIX contains. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue

Use with care, and tell your doctor, if:

• have a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first
• have a bleeding problem or bruise easily. People with a weakened immune system may not get the full benefit from CERVARIX. Fainting can occur following, or even before, any needle injection, therefore tell your doctor or nurse if you fainted with a previous injection. Other medicines or vaccines with CERVARIX: Always tell your healthcare professional if you are taking any other medicine (this includes complimentary or traditional medicines). CERVARIX may be given with other normally recommended vaccines at a seprate injection site (another part of the body e.g. the other arm) at the same visit. Ask your doctor for advice about which vaccines may be given at the same time as CERVARIX. CERVARIX may not have an optimal effect if used with medicines that suppress the immune system. In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by CERVARIX

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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