Update on swine flu vaccine Pandermix side effects in Sweden

The Swedish Medlical Products Agency (MPA) released on October 29, 2009 an updated compilation regarding reported side effects of the A(H1N1) flu vaccine Pandermix.

The only side effect that was “unexpected”, and unreported by Pandermix, is the allergic reactions that have occurred. Although the report only says that 1,4 million doses of the vaccine have been delivered to Sweden, not how many people have actually received the inoculation, a total of 500-600 side effects have been reported with symptoms ranging from head aches to deaths.

There were five reported deaths all together that may have been linked to the vaccine. The deceased persons were all between the ages 54-74 and suffering from chronic diseases.

The original report in Swedish is available here

Read more for the translation of the report.

Compilation of reported side effects of Pandermix – the vaccine against the flue A(H1N1)

October 29, 2009

Approximately 1.4 million doses of Pandermix have been delivered to Sweden. A total of a couple of hundred reports of side effects have been submitted to the Medical Products Agency from the health care system and between 400 and 500 from consumers. The pattern of reporting is currently not deemed to deviate from the expected results – that is from the patterns of side effects that were observed during the clinical studies. There is, however, a special need to follow up reports on allergic reactions.

The reports that the MPA currently receives from the health care system shall be treated as part of a larger pattern where it is seldom possible to distinguish whether a single reported side effect was caused by the vaccine.

It is important to emphasize the following:

  • The reports describe reactions that have occurred in close conjunction to the time the vaccine was administered.
  • The reaction may therefore have been caused by the vaccine, but may also be signs of a disease that the patient was affected by regardless of the vaccination.
  • Any possible causality links to the vaccinations can only be determined once the report has been properly analyzed.

Since the vaccination against the pandemic commenced, the MPA has published compilations of reported side effects of Pandermix. The MPA will continue to review and asses all reports in it’s usual manner but in future compilations, it will primarily focus on reports about unknown and possibly serious  side effects while there will be only a brief reporting of known side effects.

Reports from the health care system

Approximately 200 reports have been filed by the healthcare system.

The majority of side effects deal with expected and known reactions such as tenderness, redness and pain at the place of injection on the arm along with flu-like symptoms such as fever, chills, fatigue, powerful headaches, pain in the body and general feelings of being sick. Experience from certain vaccination centers has shown that these reactions have been very common. There have been a fewer number of reports on nausea, vomiting, stomachache, diarrhea, dizziness, rashes and insomnia. All these reactions are known from the studies carried out by Pandermix.

A number of cases of allergic reactions have also been reported. These are described under the heading “Allergic reactions” below.

Comments on certain specific cases

Over 20 reports concern suspected side effects that have been classified as serious and where a connection to the vaccination has been deemed to exist. As presented below, the majority of these cases comprise of allergic reactions. Besides these reports, facial palsy (one case), paresthesia (three cases), sensitivity disorder (one case), hypertension (one case), absence sizures (one case) and temperature spikes (one case) were reported.

Allergic reactions/allergic symptoms reported in connection with vaccination with Pandermix

(Included in the SWEDIS database, 12-27 October, 2009)

Reaction Connection Serious connection No connection
Allergic reaction 10 (3) 2
Anaphylactic reaction 5 (5) 1
Angioedema 5 (3) 0
Urticaria 6 (2) 0
Exanthema 2 (0) 1
Flush 3 (0) 0
Swollen tongue 2 (0) 1
Shortness of breath 7 (2) 1
Cough 1 (0) 0
Total number of reactions (number of patients) 41(37) (15) 6

In total, 41 allergic reactions in 37 patients have been deemed to have a connection with the vaccination. Out of these, 15 cases have been deemed to be more serious.

Four of the five patients with anaphylactic reactions had previously known allergies to food or were allergic to some forms of medications. All cases occurred within an hour after the vaccination. In two cases there was noted drop of blood pressure and four patients reported dizziness, tingling sensations, swelling of their lips and throat along with limited difficulty to breath. None of the patients had an anaphylactic shock. All patients were restored after treatment with adrenalin, corticosteroids and antihistamines. Allergic reactions such as anaphylaxis, angioedema and urticaria are not specified in the product information for Pandemrix.

Two of the people in the subset of patients who were diagnosed with “allergic reaction” were known to be allergic to egg based products. One patient had a strong direct reaction to the vaccination, but the symptoms were treated quickly with adrenaline, cortisone and antihistamine. The second patient reacted with transient urticaria.

Reported cases of death
There have been five cases reported where there was a time connection to the vaccination. The time  [when the side effects symptoms emerged] varied between 12 hours and 4 days [after the inoculation]. These five patients had chronic diseases such as cardiovascular disease, diabetes, renal failure, Dystrophic muscle disease and senile dementia.

All patients were on chronic medication. Three of the patients were above 74 years and the two others were between 54-65. Autopsy results exist for the first reported case. This shows that the patient had suffered from generalized atherosclerosis, and previous heart attacks. Autopsy reports have not been finalized for the remaining persons, but nothing that has emerged so far supports a causality link between the vaccination and their deaths. The investigation into these cases continues.

In assessing the number of reported deaths, it is important to take into account that on average 200-250 people die in Sweden every day and that at present, a large proportion of the population, particularly the elderly and other risk groups, are being vaccinated. The majority of daily deaths in Sweden happens to older people as a result of complications of chronic diseases.

Experiences from consumer reports

Since the vaccination started with Pandermix, over 450 patients have filed side effect reports. The reports have been submitted both through the on-line service for consumer reporting and through regular mail.

90% of the reports still describe non-serious reactions, expected and known reactions. The potentially serious reports have been accounted for in the two previous compilations.

However, although a side effect may be known and assessed as not serious, it may still be experienced as something troubling for an individual. Some people have experienced that the reaction of this flu vaccination is different from previous seasonal flu vaccines as they experienced more pain at the place of injection and more intense flu-like symptoms. And for some people this has led to them having to take shorter sick leaves from work.

An updated version of the report from November 12, 2009 can be found on this link

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