| Total of 2300 Reports of Adverse Reactions
From Pandemrix Vaccine in Sweden
Almost 3.4 million adult doses of the Pandemrix
vaccine have been delivered to Sweden as of November 17. According
to data from the Swedish Institute for Infectious Disease Control
(SMI), by November 15 approximately 1.9 million individuals in
Sweden have been vaccinated. In total, the Medical Products Agency
has received close to 1000 adverse event reports from Health Care
Professionals and about 1300 reports from consumers. The reporting
pattern is generally consistent with what has been seen from previous
clinical trials, with the exception of allergic reactions.
Since the vaccination campaign began, the Medical Products Agency
has continuously published summaries of adverse events reported
with Pandemrix. The summaries focus on reports relating to unknown
and suspected serious side effects while the known adverse events
are reported only briefly. In addition, this summary specifically
addresses allergic reactions, neurological reactions, reactions
in children and in pregnant women.
It is important to stress the following:
* The reports describe reactions that have occurred in close
connection to when the vaccine was given.
* The reaction can thus be caused by the vaccine, but can also
be signs of illness the patient suffered from regardless of the
vaccination.
* Causality assessment can only be made after the report has been
carefully assessed
Health Care reports
Almost 1000 reports have been received from Health Care Professionals.
The majority of the adverse events reported are expected and known
reactions such as injection site reactions and flu-like symptoms.
Cases of nausea, abdominal pain, swollen lymph glands, palpitations,
chest pain, rashes, insomnia, nightmares, eye irritation, and
shingles have also been reported.
Allergic reactions
In total, 296 reports of allergic reactions have been received
from health care providers. These reactions have occurred in 246
patients shortly after vaccination with Pandemrix. In cases deemed
serious, the patients needed treatment with antihistamines, adrenaline
and cortisone and in some cases also supervision in emergency
room/hospital. In all cases, the hypersensitivity reactions resolved
completely within a short time.
Three cases of anaphylactic shock have been reported. In one
case the patient had a known egg allergy; in the second case the
patient was allergic to several foods, including nuts, but not
to eggs; the third patient had no previous history of allergy
reported.
Of the 246 patients reporting allergic reactions, 14 patients
had egg allergy while 32 patients reported allergy to other substances
such as pollen, grass, drugs, nuts, peanuts, fruit, fish or fur,
etc.
Allergic reactions not previously seen in the clinical trials
are now being reported as adverse reactions to Pandemrix. Similar
allergic reactions have also been reported in other countries
in Europe using Pandemrix.
Neurological reactions
A total of 287 neurologic adverse events have been reported of
which 56 were assessed as serious. Many of these reactions may
be part of an allergic reaction. 88 of the events represent dizziness
and fainting, while 66 describe paresthesia, or “tingling”
or “pins and needles” sensations, occurring in one or
several extremities or in the region of the lips, tongue or other
parts of the face. Some reports indicate sensation of metallic
taste. Most of these events occurred at the time of vaccination.
In 22 reports, “numbness”, “loss of sensation”,
or “burning sensation” are described. Locations of such
symptoms were noted in arms, with extension to hand and fingers;
legs and feet; face; and occasionally the entire side of body.
In a smaller number of patients, these symptoms were accompanied
with motor weakness. These events have occurred from 45 minutes
to 5 days after vaccination.
In addition, there have been seven cases of visual disturbances,
such as "blurred vision" and “floaters”, which
occurred 1-2 days after vaccination. Most of these cases were
associated with fever, chills and headache and the vision changes
were short-lived.
Facial palsy or similar symptoms have been reported in 7 patients
aged 4-43 years. The number of reported cases is below what would
normally be expected in a population the size of the now vaccinated.
Three cases of stroke are reported, one of them fatal. None of
these cases is considered to have a casual association with the
vaccination.
Reactions in children
As of November 15, at least 26 000 children younger than 3 years,
and at least 430 000 children aged 3 years up to 13 years, have
been vaccinated in Sweden. This estimate is based on data from
the Swedish Institute for Infectious Disease Control (SMI). Since
November 12, the recommendation in Sweden has been to vaccinate
all children between 6 months and 3 years (i.e. also including
children that do not belong to any risk group).
Through November 20, twenty eight reports with serious reactions
have been received from health care professionals. Two of these
cases occurred in children under 3 years, 10 cases in children
aged 3-9 years and 16 cases between 10-17 years. Adverse events
assessed as non-serious were reported for 7 children less than
3 years, 42 cases in children aged 3-9 years and 45 cases of children
between 10-17 years.
The two serious cases reported in children less than 3 years
were:
* A girl who the day after vaccination was vomiting up to 20
times/day and was hospitalised. The girl is fully recovered.
* A boy with insulin treated diabetes who two days after the vaccination
was unresponsive and his blood sugar level was low. The boy is
fully recovered.
Reactions in pregnant women
As of now, based on data from the Swedish Institute for Infectious
Disease Control (SMI), at least 31 000 pregnant women are vaccinated
with Pandemrix.
In 4 women spontaneous abortions have occurred in temporal association
with vaccination. In yet another woman, intrauterine foetal death
(gestational age week 24) occurred two days after vaccination.
In none of these cases a casual association between the vaccination
and the event could be established.
Deaths reported
As of November 20, a total of 12 deaths have been reported, of
which 4 are new reports since the previous summary published November
12.
* Summary
of ADR reports in Sweden with Pandemrix (received up to November
10) (2009-11-12)
Three of the four new cases involve elderly patients (79, 92
and 94 years) with concomitant chronic disease. The time between
vaccination and death has varied between 2-13 days. In one case
the autopsy report shows a previous major myocardial infarction
and acute heart failure. For the second case autopsy is requested
and additional information awaited. Autopsy has not been performed
in the third case. From what has emerged so far, there is nothing
to confirm a causal association between the vaccination and the
deaths in these three cases.
The fourth new fatal case concerns a 67-year-old man who underwent
a heart transplant 19 years ago and 13 days after vaccination
had a transplant rejection reaction. It is possible that the rejection
was influenced by the vaccination, since the rapporteur suspects
incomplete treatment of the patient's underlying disease. This
case is being further investigated.
Experience from consumer reporting
Since the vaccination campaign with Pandemrix began in Sweden
on October 12, about 1300 consumer reports of suspected adverse
reactions have been received by the Medical Products Agency. A
large majority of the reported adverse events are judged to be
non-serious. Since the previous summary published November 12,
eighteen consumer reports with serious reactions have been received.
Of these reports 5 concern allergic/anaphylactic reactions and
six concern influenza like illness.
Among the other serious reactions are reports of abdominal pain,
pneumonia and shingles. The reported non-serious reactions are
mainly flu-like symptoms (including isolated headache or diarrhea),
injection site reactions, and various forms of allergic symptoms.
No deaths are reported by consumers during this period. Reactions
in children and pregnant women relate primarily to previously
known or anticipated adverse events with this vaccine.
*
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Reference Source: lakemedelsverket.se
November 30, 2009
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