The Swedish Medical Products Agency (MPA) released on November 12, 2009 an updated compilation regarding reported side effects of the A(H1N1) flu vaccine Pandemrix.

This compilation continues to detail allergic reactions along with neurological reactions. There is also reporting of side effects experienced by children who received the vaccination. The MPA recommends now that children with severe allergies or even children who have family members with sever allergies only receive vaccinations after consultation with a specialist.

There are still no evidence to indicate that the 8 people who have died a couple of days after taking the vaccine passed away because of taking the vaccination. These people were suffering from chronic diseases.

The original report in Swedish is available here

Read more for the translation of the whole article

Compilation of reported side effects of Pandemrix up to the 10th of November 2009

November 12, 2009

Approximately 2,1 million doses of Pandemrix have now been delivered to Sweden. A total of almost 600 side effect reports have been received by the MPA from the healthcare sector and almost 900 from consumers. The pattern of reporting coincides, to a large extent, to the side effect patterns observed during clinical trials.

This report will specifically comment on reports about allergic reactions, neurological reactions and reactions amongst the inoculated group of children. As it has been maintained before, the reports that are received by the MPA from the healthcare system and consumers are considered as part of a larger pattern where it is seldom possible to determine reactions to the vaccinations in individual cases. Thus it is important to highlight the following:

• The reports describe reactions that were manifested in close proximity to the time when the vaccination took place.
• The reaction can thus be caused by the vaccine but can also be signs of disease that the patient contracted regardless of the vaccination.
• Only after the reports have been carefully analyzed is it possible to say whether an eventual causality exists with the vaccination.

Since the start of the vaccination against the pandemic, the MPA has published compilations of reported side effects of Pandemrix. The compilations focus on reports about unknown or serious side effects while the known side effects are only accounted for in a general manner. All submitted reports are, however, examined and assessed in the appropriate manner.

Reports from the healthcare system

Almost 600 reports have been submitted from the healthcare system. The majority of the side effects reported deal with expected and known reactions such as tenderness, redness and pain at the place of injection and in the arm along with flu-like symptoms such as fever, chills, fatigue, powerful headache, ache in the body and a general feeling of being sick. Experiences from certain vaccination centers have shown that these reactions have been very common. In fewer cases there have been reports about nausea, vomiting, stomach ache, diarrhea, dizziness, rashes and insomnia. All these reactions are known from the studies that were carried out on Pandemrix.

Comments on certain reported side effects

Allergic reactions
76 patients reported 137 side effects that indicate allergic reactions in connection with being vaccinated with Pandemrix. Many of the patients who experienced serious over sensitivity had previously known allergies to allergens such as pollen, grass, medicine, foods such as eggs, nuts, fruits, peanuts, fish, etc. In most cases that were considered serious, the patient needed to be treated with antihistamines, adrenalin, cortisone and were hospitalized. In all cases of over sensitivity, the reactions wore off after a short period of time.

Two cases of anaphylactic shock have been reported. The first patient was known to be allergic to eggs and the other was allergic to foods including peanuts but not eggs.

The reported side effects show that not only allergies against substances that are included in the vaccine, such as eggs, may trigger allergic reactions but also other forms of allergic tendencies seem to be able to contribute to the onset of an allergic reaction. This should therefore be taken into consideration before vaccination.

Submitted side effect reports from the healthcare system regarding allergic reactions:

Reaction	Known allergies since before (number of patients)	Serious reactions	Not serious reactions	Total number of reported side effect reactions
Allergic reaction	12	4	14	18
Anaphylactic reaction	6	11	1	12
Anaphylactic shock	2	2		2
Angioedema	1	5	8	13
Swelling of the mouth and throath	1	1	9	10
Urticaria	1	1	20	21
Rash			12	12
Flush	2	1	8	9
Itching	4	1	16	17
Asthma – worsening	1	1	4	5
Difficulty to breath	2	4	14	18
Total	32	31	106	137

 

Neurological reactions
133 patients reported 177 neurological side effects. Many of these reactions can be partial symptoms of allergic reactions (such as nausea or headache). 32 side effect reports detail falling blood pressure/ fainting, sometimes along with other associated symptoms, such as dizziness, changes to seeing or tasting or blackouts. 44 cases of sensory changes were reported. This includes everything from local pain and/or numbness in the arm where the vaccination was given (sometimes the sensation moved towards the face) to a couple of cases where numbness was experienced in the half of the body where the vaccination was given. Generally speaking, the sensory changes disappeared after a couple of days, except in situations where only local pain in the inoculated arm was experienced. In these situations the pain could be experienced during several days.

Four cases of fallopian neuritis or similar symptoms have been reported – amongst three women and one man. In one case the symptom happened to a child and it is suspected that the triggering cause was a Borreli infection since the symptoms got better after treatment against Borreli. One of the persons was a pregnant woman who had light symptoms which got better after a couple of days. In two cases the fallopian neuritis was reported in connection to flu-like symptoms after vaccination and these persons symptoms disappeared after 10 hours and three days respectively. There is still an ongoing investigation around these cases. The number of reported cases is below what would be considered normal for the population size that has now received the vaccine.

There are reports about two cases of strokes, one with lethal outcome, three and four days respectively after vaccination. None of these cases are deemed to have any connection to the vaccination.

Facts about fallopian neuritis
Fallopian neuritis is a partial weakness/paralysis of the facial musculature that can be caused by something affecting the facial nerves or the brain. When using the term it often refers to the nerve that is being affected. Another phrase for the term is Bell’s paralysis. In Sweden, about 50 people in all ages fall sick with Bell’s paralysis each week. The reason’s for Bell’s paralysis are in most cases unknown but may be caused by certain infections such as Borreli, the varicella zoster virus or the herpex simplex virus. It is also more common with pregnant women. In the majority of cases it heals within a couple of months.

 

Reported side effects experienced by children
The following section details the experiences of children receiving vaccination under three years of age and who belong to some risk category. Approximately 5000 children in this group have been vaccinated up to November 5, 2009. The estimate is based on information received from the county of Stockholm’s vaccination register. Another 50 000 children between the ages 3-6 have received vaccinations in Sweden. Having gone through the vaccination side effect reports that have been submitted by the healthcare system up to Novmeber 6 2009, it is noteworthy that of the approximately 500 reports that have been filed, about 31 deal with children born in the year 2000 or later. Only 5 reports deal with children under the age of three. The patterns of side effects do not deviate from what has been seen with older children.

In light of the reports about allergic reactions, the vaccination of children who are allergic to eggs, have other serious allergies or have family members with severe allergies should only be carried out after consultation with a specialist.

The side effect reports that have been submitted from the healthcare system for children born 2000 or later:

	Born	Age	Gender	Diagnosis
1	07	2	m	fever
2	07	2	f	vomiting
3	07	2	f	local reactions
4	07	2	m	blackouts
5	06	2	m	collapse
6	06	3	m	Arthritis
7	06	3	m	Syncope, local reactions
8	06	3	f	rashes
9	06	3	m	fever, abdominal pain
10	05	4	m	vomiting
11	05	4	f	abdominal pain, vomiting
12	05	4	f	Bell’s paralysis
13	04	4	f	pain
14	04	5	f	nightmares
15	04	5	m	Urticaria
16	04	5	f	flu-like symptom
17	04	5	f	fever, headache, blurred vision
18	04	5	m	Varicella, nightmares
19	03	5	m	presyncope
20	03	5	m	over sensitivity reaction (rashes/red marks on arms)
21	03	6	f	fever, nausea and vomiting
22	02	7	m	abdominal pain
23	02	7	f	Urticaria
24	02	7	m	passing out
25	02	7	m	fever, nausea, ache in stomach and body
26	01	8	m	headache and nausea
27	00	8	m	angioedema
28	00	9	m	pain and pressure on chest
29	00	9	f	vomiting, abdominal pains
30	00	9	f	slightly pale the day after
31	00	9	m	Urticaria

 

Reported cases of fatalities
Another three cases, in addition to the five cases described previously, have been reported during the last two weeks where a time connection exists to the vaccination. The total number of reports of fatal incidents is thus 8. The time between vaccination and the passing away has varied between 12 hours and 4-5 days. All reported cases dealt with patients with chronic diseases such as cardiovascular diseases, chronic lung disease, diabetes, failed kidney, myotonic dystrophy and senile dementia. All patients received chronic medications. Autopsy reports are available for four cases and these show that any connection to the vaccination is unlikely. In the other cases there are not enough information available from the healthcare services or there aren’t any autopsy reports available which makes it difficult to draw any conclusions. In some instances, additional information will be requested and there are ongoing investigations, but from what is known so far, nothing shows a direct link between the vaccination and the deaths.

When making a decision about the number of reported cases of deaths, it is important to take into consideration that there are 200-250 fatalities in Sweden every day and that there is currently an ongoing vaccination of a large part of the population of, in particular, elderly and other risk groups. The majority of the fatalities that occur in Sweden on a daily basis happen to elderly people as a result of complications of chronic diseases.

 

Experiences from consumer reports

Since the vaccination with Pandemrix started, almost 900 individuals have reported side effects. The reports have been filed using the e-service available for consumers and regular post. More than 90 percent of the reports describe non-serious, expected and known reactions.

The reports of serious side effects are similar to those reported by the healthcare system. Amongst these is a case of Bell’s paralysis experienced by a young man, couple of cases of severe flu-like symptoms and allergic reactions. There has also been a fatality reported in connection to vaccination. The case is under investigation and additional information has been requested from the healthcare services.