In the period from 12 to 18 December, the Danish Medicines Agency received 48 new side effect reports covering a total of 121 suspected side effects (adverse reactions). Most of the adverse reaction reports are not serious and describe already known adverse reactions. Three of the reports are classified as serious. The Danish Medicines Agency concludes that the adverse reactions seen so far after vaccination with Pandemrix® correspond to expectations, which is also in line with observations made by the European Medicines Agency, which receives all adverse reaction reports from the European countries.
The number of adverse reaction reports submitted since 4 November totals 515, covering altogether 1617 adverse reactions.
We also refer to the fourth weekly list of adverse reactions reported for H1N1 influenza vaccines from the European Medicines Agency (EMEA). See link in the factbox to the right.
|
Period |
Number of reports (number of adverse reactions) |
|
4 - 10 November 2009 |
13 (34) |
|
11 - 16 November 2009 |
73 (280) |
|
17 - 20 November 2009 |
87 (310) |
|
21 - 27 November 2009 |
149 (475) |
|
28 November - 4 December 2009 |
77 (224) |
|
5 - 11 December 2009 |
68 (173) |
|
12 - 18 December 2009 |
48 (121) |
|
Total |
515 (1617) |
The Danish State Serum Institute has dispensed approx. 1,000,000 vaccine doses. The exact number of vaccinees is unknown, but is estimated to involve at least 380,000 individuals. 75,000 of these are vaccinated with a second dose.
Who have reported the side effects?
Since 4 November, 84 % of the adverse reaction reports have been submitted by doctors and other healthcare professionals, while 16 % have been submitted by the vaccinees.
Age distribution
The age distribution is as follows (based only on reports where age was disclosed):
|
Group |
Age in years |
Number |
|
Infants |
0-1 |
7 |
|
Children |
2-12 |
35 |
|
Adolescents |
13-18 |
20 |
|
Adults |
19-64 |
355 |
|
Elderly |
65+ |
61 |
Gender distribution
|
Women |
352 |
|
Men |
162 |
|
Unknown |
1 |
From 12 to 18 December, three reports are classified as serious, the reports involve:
- One case of affected breathing and facial swelling occurring a few minutes after vaccination.
- One case of general malaise and muscle weakness occurring one week after the first dose and worsening after the second dose.
- One case of pain and decreased mobility in the arm in which the vaccine was injected.
In the first case, the symptoms are interpreted as a strong allergic reaction, and the Danish Medicines Agency assesses that it is connected to the vaccination.
In the second case, it is more likely that the patient’s chronic heart disease, and cancer, caused the symptoms. The Danish Medicines Agency awaits additional information.
In the third case, the Danish Medicines Agency assesses that there may be a connection between the symptoms and the needle injection, but it is unlikely that there is a connection between the symptoms and the vaccine itself. The Danish Medicines Agency awaits additional information.
Categorisation of side effects (adverse reactions) from 4 November to 18 December
The tables below contain the total number of side effects distributed on different organ systems:
|
Organ systems |
Number |
General symptoms and reactions at the vaccination site
General symptoms are fever, sleepiness, discomfort, pain, sweat bursts, irritation, chills, oedema, etc. Reactions at the vaccination site are swelling, pain, redness, itching, bruising, etc. |
591 |
|
Symptoms from the nervous system
Headache, dizziness, sensory disturbances, fainting, seizures, shaking, loss of voice, facial paralysis, inclination to crying (without wanting to cry), syndrome with paralysis of the nerves (Guillain-Barré syndrome), memory loss, etc. |
247 |
Symptoms from muscles and skeleton
Aching muscles, muscular stiffness, pain in arms and legs, decreased mobility, arthralgia, muscle spasms, bone pain, muscle weakness, worsening of arthritis symptoms, etc. |
221 |
|
Symptoms from stomach and intestines
Nausea, diarrhoea, vomiting, stomach pain, swelling in tongue and mouth, dry mouth, dyspepsia (discomfort in the upper part of the stomach) and constipation. |
188 |
|
Symptoms from the skin
Hives, redness, itching, rash, cold sweat, blister around the eye, skin disease caused either by an allergic reaction or infection (erythema multiforme), bruising of the skin, facial swelling, etc. |
146 |
|
Airway symptoms
Cough, shortness of breath, sore throat, altered breathing, asthma, nosebleed, increased mucus production, tightness of the throat, worsening of existing asthma etc. |
77 |
Symptoms from vessels
Flushing sensation of the face, paleness, high or too low blood pressure, etc. |
23 |
|
Emotional symptoms
Insomnia, restlessness, anger, depressive symptoms, fever hallucinations, nervousness, etc. |
17 |
|
Symptoms from eyes
Affected vision, photosensitivity, pain in the eye, swelling around the eye, watering eye, redness of the eye, etc. |
16 |
|
Symptoms from the heart
Palpitations, worsening of heart flutters, chest pain, etc. |
15 |
|
Infections
Pneumonia, cold, herpes zoster, fever blisters on the lip, etc. |
13 |
|
Change of test results
High blood sugar, high blood pressure, weight increase due to fluid retention, etc. |
12 |
|
Symptoms from the blood and lymphatic system
E.g. swollen lymph glands. |
10 |
|
Metabolism and symptoms related to nutrition
E.g. reduced appetite. |
9 |
|
Incidences related to pregnancy
Spontaneous abortion, Braxton Hicks contractions, bleeding during pregnancy, etc. |
8 |
|
Symptoms from the immune system
Allergic reactions, anaphylactic shock, etc. |
8 |
|
Symptoms from the ears
Ear pain, buzzing in the ears, audiosensitivity, etc. |
5 |
|
Kidney and urinary tract symptoms
Kidney disease (glomerulonephritis), need to urinate, etc. |
5 |
|
Symptoms from the genitalia
Breast tissue soreness, heavy menstrual bleeding, swollen testicle, etc. |
4 |
|
Symptoms from liver and biliary tract
Affected liver function. |
1 |
|
Damages and intoxication
Tendency to fall after dizziness. |
1 |
General information about adverse reaction data
An adverse reaction report contained in the pharmacovigilance database does not necessarily imply that the adverse reaction is associated with the medicine (causality).
- The Danish Medicines Agency registers information about an adverse reaction in the database even if it is only suspected that there might be an association between the medicine and the adverse reaction. Therefore, the information in the database may include true adverse reactions of a medicine as well as coincidental events e.g. due to a disease in the patient or another medicine which the patient is taking at the same time.
- The Danish Medicines Agency is only notified of a small proportion of all adverse reactions. Therefore, the information in the pharmacovigilance database cannot indicate the frequency of the adverse reactions.
- A single adverse reaction report may contain more than one adverse reaction. Therefore, the number of registered adverse reactions is usually higher than the number of adverse reaction reports.
- An adverse reaction is considered to be serious if it leads to the patient’s death, disability, hospitalisation, or if the patient is unable to work or go to school.
- The Danish Medicines Agency sends information about all serious adverse reactions to the marketing authorisation holder, to the European pharmacovigilance database and to the WHO.
- All reports must form part of the periodic safety update reports which the marketing authorisation holder must regularly send to the Danish Medicines Agency. A periodic safety update report describes all reported adverse reactions from all countries in which the medicine is marketed. The periodic safety update reports thus provide a good overview, and they form an important basis for continuous updates of the summary of product characteristics and the package leaflet.
In connection with the current pandemic, the Danish Medicines Agency discusses the adverse reaction reports at weekly meetings with the Danish National Board of Health and the State Serum Institute.
Both doctors and patients are encouraged to continue reporting adverse reactions to the Danish Medicines Agency.
The next adverse reactions update will be published in week 2 2010.
For further information, please contact Chief Medical Officer Doris I. Stenver, Consumer Safety Division, tel.: +45 4488 9247 or mobile +45 2246 0979.
Danish Medicines Agency, 23 December 2009
