What are the swine flu vaccination side effects for pregnant women and children?

Getting yourself or your child vaccinated against swine flu has been a damned if you do, damned if you don’t situation. Parents and pregnant women have felt uncomfortable at what they consider to be a rushed job of getting a vaccine out and into vulnerable health groups, especially with no record of long or short term side effects. As well as worrying about our precious toddlers, for many, the Thalidomide tragedy will never be forgotten.

With the swine flu pandemic not quite the doomsday that was protected and the National Pandemic Flu Service to be wrapped up later this month, is the swine flu vaccination really worth the risks?

Chopsy Baby editor Jen Smith says: “I agonised for weeks over whether to have the swine flu vaccination myself or to let my toddler son have it. I couldn’t decide if it was worse to have regrets that we had gone for the vaccine, or maybe worse, regrets that we hadn’t.

“I only decided to have the vaccination done after my son was very ill with a high temperature and being pregnant myself, I was vulnerable to all the current stories about pregnant women who had died from swine flu.

“The nurse assured me there was no side effects from the vaccination other than a slightly sore arm.  I specifically asked if there was an increased risk of febrile convulsion in toddlers and told there was none.

“After a weekend of pure hell, I concluded she was lying through her teeth. My son had what appeared to be a mild form of flu and a raging temperature, whilst I was so ill I couldn’t move. My head was agony and I couldn’t open my eyes to light for up to three days. Despite eating a good quantity of chocolate and sugary food, I did detect a noticable reduction in the amount of movement I was getting from my unborn baby. These are considered to be the more mild side effects.”

As with any vaccination it will come down to a personal choice, it is clear from the childhood immunisation programme that vaccines can and do save lives. But parents need quick, clear access to information about the risks as well as the benefits.

The NHS Choices website says of the swine flu vaccine: ‘As with any new vaccine, rare and very rare side effects cannot be identified or excluded until the vaccines are used in much larger numbers of people in the general population’.

These are some of the facts about the swine flu adverse reactions monitored so far:

There are two swine flu vaccines in use:

Pandemrix is manufactured by GlaxoSmithKline. It has the highest number of reported adverse side effects because it is the most widely used vaccine.

The second vaccine Celvapan, is manufactured by Baxter and is for use in people who have a confirmed anaphylactic reaction to eggs. It is given in two doses with a three-week gap in-between.

Reported side effects:

According to the NHS, it is not actually possible to get swine flu from the vaccine as it does not contain a ‘live’ virus, but some people will experience side effects.

A mild fever up to 48 hours after the immunisation is normal. This is because the body’s immune system is responding to the vaccine, but it is not flu.

The Department of Health agency, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for making sure that medicines and medical devices are safe for people to use. As well as monitoring medicine and intervening where there is a problem, the agency also encourages to public and healthcare professionals to report any problems with medicines back to them.

A report by the MHRA released on 4 February 2010, collated all the reported adverse reactions to the swine flu vaccines Celvapan and Pandemrix, they received between Monday 15 October 2009 and Tuesday 19 January 2010.

Their findings showed 2,817 reports of adverse side effects, which included 7,487 suspected reactions within those reports.

The most common reactions were:

Pain, swelling and redness at the injection site
Nausea
Vomiting
Dizziness
Muscle pain
Fever
Fatigue
Headache
Swollen glands

These symptoms were considered to be ‘not serious’ and ‘short-lived’.

Two less common side effects included:

Nerve injury
Serious allergic or anaphylactic reaction  – rare but potentially fatal reaction believed to affect between one and ten cases for every million doses administered.

There have been 15 reported deaths in the UK following vaccination. All cases had ‘significant underlying illnesses’ and there has been no suggestion that the vaccine was actually responsible.

One adult death resulted from an epileptic fit following vaccination, but the vaccine was not considered to be responsible.

One teenager with an underlying hereditary muscle disease and heart condition is reported to have died following vaccination, though no evidence exists to suggest that the vaccine was the actual cause of death.

The dreaded Guillain Barre Syndrome (GBS) which plagued the 1976 US swine flu vaccination programme, has hit seven people people in the UK, though more information is being awaited to confirm this.

Adverse reactions in pregnant women

According to the World Health Organisation (WHO), a total of 7 – 10 per cent of swine flu hospital admissions are for women in their second or third trimester of pregnancy. Because of a naturally lowered immune system during this time, pregnant women are at a higher risk of complications when catching swine flu including pneumonia and breathing difficulties. They are ten times likely to end up in intensive care compared to a healthy non pregnant women. This is why they are a vaccination priority group.

Unless they have a known allergic reaction to egg products, pregnant women will be offered the Pandemrix vaccine.

Of the 132,000 pregnant women in England who have been vaccinated, 100 adverse reactions were reported by pregnant women.

A total of  77  per cent of cases affected just the mother and not the foetus. The reactions were mostly at the injection site and were common flu like symptoms.

The effects on the baby were reported as being ‘short-lived reduced foetal movements’.

There has also been:

Three cases of intra-uterine death/stillbirth
16 reports of miscarriage
and 1 report of premature labour following the vaccination.

The usual rate of intra-uterine death or stillbirth in the UK stands at around 5 in every 1000 pregnancies. Miscarriage in early pregnancy is estimated to be 20-25 per cent. The MHRA conclude that the stillbirths and miscarriage is consistent with these statistics and does not consider the swine flu vaccine to carry any risk to pregnancy or the unborn baby.

Adverse reactions in children

Young children under the age of five years, are part of the at-risk vaccination programme due to having a high rate of hospitalisation, intensive care or even infant death resulting from contracting swine flu.

There has been 266 reports of adverse reactions in children aged under 16 years.

The reported side effects included:

Reactions at the injection site
Flu-like illness
Muscle aches and pains
Rash
Headache
Dizziness
Nausea
Vomiting
Diarrhoea
Faints
Fever
Increased risk of febrile convulsion

There have been four reported cases of febrile seizures in young children after the body experienced a sharp rise in temperature. In all, 26 cases of seizures have been recorded, with nine happening to children under the age of 15.

The risk of febrile seizure is higher should a child have received the two dose Pandemrix vaccine.

On 4 December 2009, the European Medicines Agency had to issue a warning advising of the risk of fever in young children following a second vaccination with Pandemrix. Parents were advised to monitor the temperature of the child and take measures to lower fever. This could be done through giving paracetamol.

On 10 December, the Joint Committee on Vaccination and Immunisation (JCVI) recommended that children between the ages of six months and ten years only be given one dose of Pandemrix. The vaccine’s licence has been amended to reflect this.