1. This Regulation prescribes the procedures by which a
medical practitioner reports on the complications caused by
vaccination in order to ensure the safety monitoring of
vaccinations, to operatively carry out the epidemiological
investigation of the cases related to complications and, where
necessary, to suspend the use of vaccines of doubtful quality or
prevent other vaccination risk factors.
2. The complications caused by vaccination on which a medical
practitioner shall report are specified in Annex to this
Regulation.
3. The complications caused by vaccination shall be reported
if they are found after vaccination within the time interval
indicated in Annex to this Regulation.
4. A medical practitioner shall report to the epidemiologist
of the relevant regional division of the Centre for Disease
Prevention and Control on a complication caused by the
vaccination or reasonable suspicion of complications caused by
the vaccination within 24 hours after finding the complication
via phone and in writing or electronically by filling in the
urgent notification form in accordance with the laws and
regulations regarding the procedures for keeping medical
documents.
5. In addition to the data required to be indicated in
accordance with the urgent notification form, the date and time
of complication arising shall be indicated.
6. [8 September 2009]
Prime Minister A. Kalvītis
Minister for Health G. Bērziņš
| Complications
Caused by Vaccination |
Explanation |
Time interval after
vaccination |
Vaccines |
| 1. Local reactions |
| 1.1. |
Abscess at the place of injection |
A confined
fluctuating or drained formation with content has formed in
tissues at the place of injection. With an increase in body
temperature or without it |
|
|
| 1.1.1. |
bacterial |
There are signs of
inflammation, pus, fever. Prevalence of inflammation agents -
gram-positive bacteria or neutrophils - in the content of pus
confirms the diagnosis of bacterial abscess. Lack of some of
the abovementioned indications does not exclude this
diagnosis. |
Few days/weeks |
Any parenterally
administered vaccine |
| 1.1.2. |
cold abscess |
Confined accumulation
of pus by forming a closed cavity in the diameter of more
than 1 cm without the signs of bacterial infection |
Few months |
Vaccine against
tuberculosis (BCG) |
| 1.2. |
Lymphadenitis |
At least one lymph
node is enlarged (in the diameter of at least 1 cm) on the
same side of the body (most often in the armpit) where the
vaccine against tuberculosis (BCG) was administered: |
|
|
| 1.2.1. |
enlargement of a
lymph node |
without fluctuation
or changed skin colour, unrelated to skin, pus is not
acquired through aspiration, without spontaneous perforation
of the lymph node and formation of non-healing hollow |
Up to 12 months |
Vaccine against
tuberculosis (BCG) |
| 1.2.2. |
purulent
lymphadenitis |
progressive
enlargement of lymph node with formation of pus and
fluctuation, with or without spontaneous perforation of the
lymph node and formation of non-healing hollow. Changed skin
above the swelling - erythema, oedema, pigmentation,
formation of pustules |
Up to 12 months |
Vaccine against
tuberculosis (BCG) |
| 1.3. |
Explicit local reaction |
Hyperaemia, infiltration and/or oedema at the place of
vaccine administration and one or several of the following
symptoms:
1) oedema under the nearest joint;
2) pains, hyperaemia, oedema for more than 3 days;
3) necessity for hospitalisation.
Note. Less intensive local reactions are rather often
observed in children, but usually they are not of clinical
significance, short-term (less than 3 days). For
epidemiological surveillance of the vaccination
complications the most explicit abovementioned local
reactions shall be notified.
|
Up to five days |
Any parenterally
administered vaccine |
| 1.4. |
Non-healing ulcer at the place of injection |
Wet skin damage at
the place of vaccine administration which does not heal
within 6 months |
Few months |
Vaccine against
tuberculosis (BCG) |
| 2. Complications of the central
nervous system (CNS) |
| 2.1. |
Paralytic poliomyelitis caused by a vaccine (acute
flaccid paralysis) |
Inflammation of grey matter of spinal cord with
neurological symptoms - acute flaccid paralysis which
remains for more than 60 days from the beginning of the
disease, or fatal outcome.
Note. Confirmed case - poliovirus similar to vaccine
strain has been isolated from a patient
|
4-30 days for a
person vaccinated with OPV or 4-75 days after contact with a
person vaccinated with OPV |
Oral vaccine against
poliomyelitis (OPV) |
| 2.2. |
Encephalopathy |
Serious, acute neurological disease with any of the
following symptoms:
1) seizures;
2) explicit consciousness disorders which last one or
several days;
3) explicit behaviour disorders which last one or
several days
|
Up to 48 hours |
Vaccines containing
pertussis component |
| 7-12 days |
Vaccines containing
measles component |
| 2.3. |
Encephalitis |
The symptoms referred
to in Sub-paragraph 2.2 and the signs of cerebral
inflammation are characteristic to the disease. In many cases
pleocytosis and/or virus is present in cerebrospinal
fluid |
Up to 4 weeks |
Vaccines containing
pertussis and measles component |
| 2.4. |
Meningitis |
Serious, acute
disease with an increase in temperature, rigidity of neck
muscles and positive meningeal (Kernig, Brudzinski) symptoms.
Symptoms may vary from light to clinical picture of
encephalitis. The result of investigation of cerebrospinal
fluid is the most significant in terms of diagnostics:
pleocytosis and/or presence of micro-organisms (Gram staining
and/or culture isolation) |
Up to 35 days |
Vaccines containing
mumps component |
| 2.5. |
Seizures |
Seizures without
neurological symptoms of focuses: |
Up to 2
days (vaccines containing pertussis component) |
Any
vaccine, more often vaccines containing pertussis and measles
component |
| 2.5.1. |
febrile seizure |
seizures on the
background of febrile temperature or hyperthermia |
| 2.5.2. |
afebrile seizure |
seizures without
increase in body temperature |
from 6 to 12 days
(vaccines containing measles component) |
| 3. Other complications |
| 3.1. |
Anaphylactoid reaction |
Serious, acute allergic reaction with one or several
following symptoms:
1) expiratory short breath caused by bronchospasm
(wheezing, difficult breathing);
2) laryngospasm/larynx swelling;
3) skin reaction - urticaria, angioedema (local or
general)
|
Up to 24 hours (most
often up to 2 hours) |
Any
vaccine |
| 3.2. |
Anaphylactic shock |
Acute blood
circulation disorders (low arterial blood pressure, low pulse
rate or nonpalpable, consciousness disorders, cold
extremities due to blood circulation disorders, face
cyanosis, increased sweat, loss of consciousness), with
bronchospasms and/or laryngospasms and larynx swelling that
cause insufficiency of breathing after vaccine
administration, or without them |
Up to 24 hours (most
often during the first hour) |
| 3.3. |
Episode of
hypothensia-adynamia (collapse) |
Sudden paleness, disturbed consciousness or
unconsciousness, hypotension of musculature or atension
which lasts from one minute to several hours. Most often
observed in children up to the age of 10 years The
following symptoms are characteristic:
1) weakness (hypotension);
2) sedentary (adynamia);
3) paleness or cyanosis
|
Up to 48 hours |
Any vaccine, more
often vaccines containing pertussis component |
| 3.4. |
Arthralgias: |
Pain in joints, most
often small periphery joints are affected |
Up to 40 days |
Vaccines
containing rubella component |
| 3.4.1. |
persisting |
more than 10
days |
|
| 3.4.2. |
transitory |
less than 10
days |
|
| 3.5. |
Generalised BCG
infection ("disseminated BCG-disease") |
Disseminated
infection (for persons with immunodeficiency) that is
confirmed by the isolation of Mycobacterium bovis BCG
strain from a patient |
Up to 12 months |
Vaccine against
tuberculosis (BCG) |
| 3.6. |
Osteitis/osteomyelitis |
Inflammation changes
in bones caused by the vaccine against tuberculosis (BCG).
Diagnosis is confirmed by the isolation of Mycobacterium
bovis BCG strain from a patient |
Up to 16 months |
Vaccine against
tuberculosis (BCG) |
| 3.7. |
Sepsis |
Serious, generalized
disease caused by bacterial infection with an acute
beginning. Diagnosis is confirmed by the isolation of the
pathogen from the blood of a patient. |
Up to 7 days |
Any parenterally
administered vaccine |
| 3.8. |
Toxic shock syndrome |
Sudden fever,
vomiting and watery diarrhoea during the after-vaccination
period, often with fatal outcome within 24-48 hours |
Up to 24 hours |
Any parenterally
administered vaccine |
| 3.9. |
Increase in body temperature (fever) |
1) 38.5-39.4 °C for two days-and-nights and more;
2) 39.5 °C and more
|
Up to 3
days-and-nights. Vaccines containing measles component - up
to 12 days-and-nights |
Any vaccine |
| 3.10. |
Thrombocytopenic purpura |
Clinically -
subcutaneously haematomas, bleeding mucus tissues (mouth,
nose, gastro-intestinal tract), haematuria. Laboratory - the
number of thrombocytes is less than 50000 |
From 15 days up to 35
days |
Vaccines containing
measles component |
| 3.11. |
Vaccine-associated measles infection to a person
with immunodeficiency |
Clinical picture of
measles |
Up to 6 months |
Vaccines containing
measles component |
| 3.12. |
Continuous sharp screaming |
Continuous crying
accompanied by sharp, monotone scream for 3 hours and
more |
Up to 24 hours |
Vaccines containing
pertussis component |
| 3.13. |
Brachial neuritis |
Dysfunction of the
innervation nerve of the arm/shoulder without involvement of
the rest of nervous system. Lasting, sharp, often very strong
pain in the shoulder and upper arm. After several days or
weeks exhaustion and weakness of arm-shoulder muscles may
develop. Sensation disorders, even loss of it, may also be
present, however they are less explicit. Brachial neuritis
may be on the side of the injection or on the opposite side
of the body. Sometimes both hands are affected |
Up to 28 days |
Vaccines containing
tetanus component |
| 3.14. |
Fatal case |
Fatal outcome for a
vaccinated person if other cause of death is unknown |
Up to 60 days |
Any vaccine |
| 3.15. |
Other serious complications |
In the view of any medical practitioner or patient, a
serious* complication in after-vaccination period other
than abovementioned.
Note. * Causes the death of a patient or endangers the
life of a patient, or hospitalisation of a patient or
prolongation of the existing hospitalisation is necessary,
or causes permanent or significant incapacity for work or
disability of a patient, or causes teratogenic effect.
|
Up to 60 days.
Possible teratogenic effect shall be notified upon
establishing it before or after the birth of a child
|
Any vaccine |
Minister for Health G. Bērziņš
