With more and more uncertainty, information and disinformation circulating about the A(H1Ni) virus, various vaccinations and various vaccination programs it is becoming increasingly difficult to figure out what is going on. The global media and various conspiracy sites will soon be jumping all over Sweden where one person has died soon after receiving inoculation for the Swine flu and several other people have reported various other side effects to the vaccine.

Under these circumstances, however, I find it important to document the facts of what have been happening, since there will be plenty half-assed blogs echoing tabloid articles without any research or analysis.

The Swedish Medical Products Agency (MPA) released an official update and compilation of the side effects of the Panadermix vaccine on October 22, 2009. In this post, I have translated the update from the MPA which, amongst others, details that the person who died was a man with serious heart conditions and previous organ failures. Not to be down played, however, are the severe flu like symptoms and reactions reported by several health care staff who have received the vaccine. These reactions have been reported in Swedish media but are not specifically mentioned in the MPA report.

Click on “Read More” for the full translation of the report.

Original report in Swedish

Compilation of reported side effects of Panadermix – the vaccine against the influenza A(H1Ni)v

Published: 2009 October 22

According to the company, approximately 500 000 doses of Pandermix have been distributed in the country since the previous compilation from the 16th of October. In total, barely a hundred side effect reports have been filed from the healthcare system to the Medical Products Agency and just as many from consumers. The pattern of reporting is not deemed to have departed from the expected results.

There is an assessment of several reports regarding connections to the vaccine.

The majority of the reported cases of side effects had expected and known reactions, such as

• tenderness, redness and pain at the place of injection in the arm.
• flu-like symptoms of fever, chills, fatigue, severe headache, pain in the body and general feeling of being sick.

In fever instances there are reports about complaints such as nausea, vomiting, pain in the stomach, diarrhea, dizziness, rash and insomnia and a number of cases of allergic reactions.

Reports from the healthcare system

Below follows a more detailed compilation of the number of side effects reported from the healthcare system.

General symptoms and findings:

• General feeling of being sick, symptoms of having a cold and flu-like symptoms. Generally affected. – 16
• Allergic reactions such as redness, swelling, itching, warmth, tingling, rash, utricaria and angioedema. – 37
• Sweating – 2
• Fever – 25
• Chills – 22

Blood:

• Lymph node swelling, petechiae – 3

Circulation:

• Palpitation, drop off blood pressure, hypertension, feeling of tightness over the chest. – 5

Central nervous system:

• Nausea, tiredness, headache (often powerful), felling of fainting, fainting, distinct nerve pain in the head and lowered level of consciousness – 43

Skin related side effects:

• see allergic reactions above.

Respiratory airway related side effects:

• Dyspnoea, respiratory disturbance and hoarseness. – 4

Stomach – intestinal track:

• Nausea (freqvent), diarrhea, vomiting (frequent), tummy ache, vomiting. – 14

Musculoskeletal side effects:

• Pain: troubling pain in the arm, local irritations at the place of injection – 17
• Pain: ache in the back, neck, joints, body, soreness in the body – 10
• Pain: muscle ache – 7
• Numbness in the left arm and muscle weakness – 2

Psychological side effects:

• Insomnia, disturbed sleep, many dreams, nightmares. – 4

Eyes:

• Flashes, blurred vision, conjunctivitis.

Comments to individual case reports

Six cases, deemed more serious, are described below.

Amongst these is a case of death that occurred approximately 12 hours after vaccination. It happened to a man with a serious heart condition who previously had failure of his organs. He got sick with chest pains and deceased thereafter. An autopsy has been carried out which shows that the patient had general atherosclerosis also in his coronary and showed signs of several heart attacks. The case is under investigation but from what is known this far there is nothing supporting a connection between the vaccination and the death.

In general older people and individuals in higher risk categories run a higher risk for more serious complications. When these groups are inoculated, any form of sickness they develop during the coming period may lead to incorrect conclusions. Events after an inoculation are not automatically caused by the vaccine.

Allergic / anaphylactic reactions / angioedema

Five cases are reported where a connection to the vaccination is considered as a possible / probable. The patients in questions had single or several symptoms such as dizziness, red rashes, itching, chest tightness, respiratory disorder, swollen tongue / lips / cheeks / feet, and tingling in their hands and feet and all patients needed treatment in hospital with cortisone and / or adrenaline and antihistamine before their health improved.

Experiences from consumer reporting

To date, the MPA received 90 reports of cases regarding Pandemrix from consumers. A large majority of these, 80 reports, have not been deemed serious, and describe cases of, for example, transient flu symptoms, severe pain at the location of injection, pain in the arm and adjacent muscles.

The remaining ten were considered to be potentially serious, but no connection assessment has been carried out. Consumers have in these potentially serious cases described numbness of their fingers, stiff necks, and allergic reactions such as hypotension, breathing difficulty, and in one case, blisters in the mouth.

It is important to be note that many of those who have received vaccinations have belonged to risk groups, such as Asthma and diabetes patients.

These reports are important for safety work

Health care professionals are encouraged to continue their participation in the enhanced surveillance by the MPA by reporting suspected side effects, as per the following:

• all suspected adverse reactions other than those listed as common or very common in the SPC (see section 4.8 of the adverse SPC)
• all serious adverse events, including severe local reactions.
• reports relating to children are of special interest.
• if possible, report batch number with the vaccination report.
• for reports regarding to lack of desired effect, as with all other side effect reporting, the time frame is of great importance.

Reporting can be done both through the new e-service or the usual spontaneous reporting to the regional side effect centers. Link to the e-reporting service can be found to the right.

The MPA is closely monitoring the adverse development of the influenza vaccine and will be continuously publishing summaries of the current situation regarding side effects.