Lareb Database

MMRVAXPRO+(BOF%2fMAZELEN%2fRUBELLAVACCIN)

  Attention: The results shown, apply for the ATC-group of drugs to which MMRVAXPRO+(BOF%2fMAZELEN%2fRUBELLAVACCIN) belongs. Click here for a complete overview of these drugs.
The below shown drugs belong to the same group (based on ATC code).

ATC-code Drug Form
J07BD52 MMRVAXPRO (BOF/MAZELEN/RUBELLAVACCIN) Injectie
J07BD52 MMRVAXPRO (BOFVACCIN/MAZELENVACCIN/RUBELLAVACCIN) Poeder voor injectie
J07BD52 PRIORIX () Injectie

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Publications Lareb

Publications, both in English and in Dutch, by the Netherlands Pharmacovigilance Centre Lareb

No information available.
Signals

Signals as submitted to Lareb to the Dutch Medicines Evaluation Board. Some of the articles are in Dutch only.

# Title Year Download
1 M-M-RVAXPRO and crying 2016
Overview of reports submitted to Lareb

To ensure a correct interpretation of the results, the data shown may only be used for publications or other media after consulting Lareb. Please read the disclaimer.

The reports shown on this website were received directly by the Netherlands Pharmacovigilance Centre Lareb. If you enter a brand name or generic name, all reports of products will be shown that contain the corresponding active substance. The selection that is shown is based on the ATC classification system of the World Health Organization.

The fact that a possible side effect of a drug or vaccine is reported, does not imply that the reported symptoms are actually caused by the drug or vaccine. Since the aim of a voluntary reporting centre is to detect new adverse drug reactions, we ask healthcare professionals and consumers to report suspicions of ADRs, even if the causal relationship has not been proven.

One single report may refer to multiple ADRs For this reason, the number of reports may be higher than the number of reports shown in the overview.

The number of reports shown does not necessarily reflect the actual change for an ADR to occur. It is therefore not possible to calculate an incidence rate of these ADRs based on these data.

Most recent update: 6/15/2021.

MAZELEN MET BOF EN RUBELLA, LEVEND VERZWAKT

Number of reports 3,967
Serious 477
Gender
Male
Female
Unknown
2,054
(52%)
1,908
(48%)
5
(0%)
Age
 
Year received
Calender year of reporting.
 
Year ADR
Calender year in which the possible ADR occured. If more events have been reported, the year in which the first event occurred is shown. Before 2002 the date, on which the report was received, was noted instead of the date of occurrence of the possible adverse drug reaction. For these reports the year in which the reaction actually occurred is not always known.
 
Reporter
 

Overview of reported side effects

Click on a side effect for more specific information

Blood and lymphatic system : 120
Abdominal lymphadenopathy : 1
Autoimmune haemolytic anaemia : 1
Anaemia : 3
Immune thrombocytopenia : 21
Lymph node pain : 1
Lymphadenitis : 6
Thrombocytopenia : 12
Thrombocytopenic purpura : 12
Lymphadenopathy : 63
Cardiac : 6
Cardiovascular insufficiency : 1
Palpitations : 1
Arrhythmia : 1
Tachycardia : 3
Ear and labyrinth : 20
Deafness : 2
Deafness bilateral : 1
Ear canal erythema : 1
Ear discomfort : 1
Ear pain : 11
Ear swelling : 1
Otorrhoea : 1
Hyperacusis : 1
Auricular swelling : 1
Endocrine system : 1
Hypothyroidism : 1
Eye : 158
Exophthalmos : 1
Eye movement disorder : 5
Dry eye : 1
Diplopia : 2
Erythema of eyelid : 2
Visual impairment : 6
Eye pruritus : 3
Photophobia : 2
Ocular discomfort : 2
Gaze palsy : 68
Eye discharge : 6
Eye irritation : 2
Eyelid oedema : 2
Eye inflammation : 13
Eye pain : 4
Eye swelling : 13
Excessive eye blinking : 1
Periorbital swelling : 1
Eyelid ptosis : 1
Conjunctival hyperaemia : 4
Ocular hyperaemia : 4
Strabismus : 1
Lacrimation increased : 6
Mydriasis : 1
Vision blurred : 1
Swelling of eyelid : 6
Gastrointestinal : 962
Gastrointestinal disorder : 6
Abnormal faeces : 6
Aphthous ulcer : 5
Anorectal discomfort : 1
Oral mucosal blistering : 2
Haematemesis : 1
Diarrhoea haemorrhagic : 1
Retching : 7
Vomiting : 433
Glossodynia : 2
Abdominal discomfort : 4
Abdominal pain : 95
Diarrhoea : 175
Intussusception : 1
Dysphagia : 5
Tongue ulceration : 1
Lip dry : 1
Lip blister : 3
Lip discolouration : 2
Lip swelling : 11
Gastrointestinal pain : 3
Nausea : 144
Constipation : 3
Stomatitis : 5
Breath odour : 2
Oral mucosal eruption : 4
Oral papule : 1
Abdominal pain upper : 10
Oral pain : 6
Vomiting projectile : 3
Mucous stools : 1
Gingival bleeding : 1
Tongue coated : 1
Tongue blistering : 1
Tongue discomfort : 1
Parotid gland enlargement : 4
Salivary hypersecretion : 4
Flatulence : 2
Faeces soft : 1
Mouth swelling : 2
Gingival swelling : 1
General disorders and administr. Site : 4714
General physical health deterioration : 1
Sense of oppression : 3
Injection site haemorrhage : 1
Developmental regression : 1
Thirst : 2
Thirst decreased : 1
Injection site eczema : 1
Enanthema : 1
Vaccination site erythema : 4
Localised oedema : 1
Drug ineffective : 10
Adverse drug reaction : 1
Injection site movement impairment : 1
Feeling abnormal : 4
Feeling of body temperature change : 2
Sensation of foreign body : 2
Face oedema : 2
Influenza like illness : 17
Feeling hot : 1
Feeling cold : 4
Hyperpyrexia : 154
Injection site dermatitis : 1
Crying : 601
Illness : 1
Injection site haematoma : 21
Injection site bruising : 4
Injection site hypersensitivity : 1
Injection site paraesthesia : 1
Injection site rash : 18
Injection site urticaria : 2
Injection site induration : 27
Injection site discolouration : 6
Injection site vesicles : 7
Injection site warmth : 71
Injection site pruritus : 28
Hangover : 1
Pyrexia : 2,176
Chills : 44
Moaning : 2
Hypothermia : 4
Asthenia : 20
Injection site scar : 1
Local reaction : 1
Gait disturbance : 39
Malaise : 266
Multiple organ dysfunction syndrome : 1
Injection site nodule : 5
Axillary pain : 8
Chest discomfort : 1
Injection site discomfort : 9
Inflammation : 82
Injection site inflammation : 213
Disease susceptibility : 1
Oedema peripheral : 1
Peripheral swelling : 8
Pain : 114
Injection site pain : 179
Injection site reaction : 9
Injection site erythema : 137
Screaming : 8
Foaming at mouth : 1
Injection site abscess sterile : 2
Extensive swelling of vaccinated limb : 34
Vaccination site inflammation : 1
Vaccination site pain : 1
Hyperthermia : 1
Injected limb mobility decreased : 22
Decreased activity : 2
Fatigue : 105
Condition aggravated : 1
Developmental delay : 3
Vaccination site warmth : 1
Sudden infant death syndrome : 2
Disease recurrence : 1
Swelling : 35
Swelling face : 44
Vaccination site swelling : 1
Injection site swelling : 124
Hepatobiliary : 3
Hepatic function abnormal : 1
Hepatosplenomegaly : 1
Hepatitis : 1
Immune system : 14
Autoimmune disorder : 1
Hypersensitivity : 9
Decreased immune responsiveness : 1
Food allergy : 3
Infections and infestations : 373
Abscess : 7
Peritonsillar abscess : 1
Injection site abscess : 2
Vaccination site abscess : 1
Abscess of salivary gland : 1
Meningitis bacterial : 2
Pneumonia bacterial : 1
Bacteraemia : 1
Cystitis : 1
Mumps : 8
Upper respiratory tract infection : 12
Respiratory tract infection : 14
Bronchitis : 1
Gastroenteritis : 11
Candida infection : 1
Cellulitis : 1
Exanthema subitum : 1
Pharyngitis : 23
Gastroenteritis viral : 1
Herpes zoster : 3
Influenza : 4
Hand-foot-and-mouth disease : 1
Encephalitis : 4
Meningitis : 1
Meningitis pneumococcal : 1
Skin infection : 2
Infection : 6
Ear infection : 24
Injection site cellulitis : 1
Injection site infection : 3
Herpes simplex : 1
Laryngitis : 1
Pneumonia : 14
Respiratory tract infection bacterial : 1
Lymphadenitis bacterial : 1
Lymph node abscess : 2
Gastrointestinal infection : 5
Measles : 12
Otitis media : 44
Nasopharyngitis : 78
Rhinitis : 3
Osteomyelitis : 1
Epididymitis : 1
Gingivitis : 1
Pyelonephritis : 3
Sialoadenitis : 2
Orchitis : 4
Conjunctivitis : 15
Eye infection : 1
Oral herpes : 1
Otitis media acute : 1
Injection site pustule : 1
Rash pustular : 4
Rubella : 3
Sepsis : 3
Parotitis : 12
Streptococcal infection : 1
Subglottic laryngitis : 5
Gianotti-Crosti syndrome : 1
Urinary tract infection : 1
Varicella zoster virus infection : 1
Viral infection : 2
Vulvovaginal candidiasis : 1
Vulvovaginal mycotic infection : 2
Varicella : 3
Molluscum contagiosum : 1
Injury and poisoning : 18
Fracture : 1
Joint dislocation : 2
Concussion : 2
Skin abrasion : 2
Contusion : 1
Medication error : 2
Metal poisoning : 1
Vaccination error : 2
Fall : 4
Wound : 1
Investigations : 136
Respiratory rate increased : 2
Respiratory rate decreased : 1
Electroencephalogram abnormal : 3
Blood urine present : 1
Blood pressure decreased : 1
Red blood cell sedimentation rate increased : 2
Weight decreased : 4
Blood glucose increased : 1
Heart rate irregular : 1
Heart rate increased : 1
Skin turgor decreased : 1
Body temperature abnormal : 1
Body temperature increased : 74
Body temperature decreased : 26
C-reactive protein increased : 11
Oxygen saturation decreased : 2
Body temperature fluctuation : 3
Oxygen saturation abnormal : 1
Metabolism and nutrition : 329
Diabetes mellitus : 6
Food refusal : 1
Weight gain poor : 1
Hypophagia : 10
Hypoglycaemia : 2
Lactose intolerance : 1
Poor feeding infant : 6
Increased appetite : 1
Type 1 diabetes mellitus : 3
Dehydration : 12
Polydipsia : 1
Oligodipsia : 24
Decreased appetite : 258
Appetite disorder : 1
Fluid intake reduced : 1
Food intolerance : 1
Musculoskeletal and connective tissue : 292
Arthropathy : 1
Arthritis : 14
Polyarthritis : 2
Arthralgia : 33
Joint stiffness : 1
Growing pains : 1
Growth retardation : 2
Juvenile idiopathic arthritis : 4
Trismus : 3
Musculoskeletal discomfort : 5
Mobility decreased : 3
Neck pain : 7
Axillary mass : 1
Synovitis : 1
Spinal osteoarthritis : 1
Systemic lupus erythematosus : 1
Pain in extremity : 61
Pain in jaw : 3
Polymyalgia rheumatica : 1
Limb discomfort : 7
Rheumatoid arthritis : 1
Back pain : 2
Musculoskeletal stiffness : 16
Bursitis : 1
Myalgia : 107
Muscle spasms : 4
Muscle rigidity : 1
Muscular weakness : 8
Neoplasms : 4
Haemangioma : 1
Neuroblastoma : 1
Lymphocytic leukaemia : 1
Pyogenic granuloma : 1
Nervous system : 1623
Disturbance in attention : 6
Narcolepsy : 1
Areflexia : 1
Ataxia : 9
Atonic seizures : 1
Bell's palsy : 1
Chorea : 1
Movement disorder : 1
Loss of consciousness : 135
Haemorrhage intracranial : 1
Burning sensation : 1
Cerebral ischaemia : 1
Hypotonic-hyporesponsive episode : 13
Developmental coordination disorder : 1
Cerebellar ataxia : 2
Drop attacks : 1
Dizziness : 87
Dizziness exertional : 1
Dyskinesia : 2
Dysstasia : 1
Hypotonia : 78
Epilepsy : 8
Balance disorder : 7
Syncope : 140
Focal dyscognitive seizures : 1
Hemiparesis : 1
Paresis : 1
Memory impairment : 1
Amnesia : 1
Guillain-Barre syndrome : 3
Encephalopathy : 2
Cerebral haemorrhage : 1
Headache : 397
Hypersomnia : 8
Intellectual disability : 1
Febrile convulsion : 232
Drooling : 37
Migraine : 2
Motor dysfunction : 1
Motor developmental delay : 1
Meningism : 2
Unresponsive to stimuli : 5
Muscle contractions involuntary : 2
Ophthalmic migraine : 1
Psychomotor hyperactivity : 8
Hyperaesthesia : 1
Partial seizures : 1
Partial seizures with secondary generalisation : 1
Petit mal epilepsy : 1
Postictal state : 11
Presyncope : 14
Psychomotor skills impaired : 4
Sensory integrative dysfunction : 1
Lethargy : 1
Somnolence : 105
Taste disorder : 1
Infantile spasms : 1
Myoclonus : 23
Speech disorder developmental : 5
Speech disorder : 1
Sensory disturbance : 2
Language disorder : 1
Paraesthesia : 5
Dystonia : 1
Seizure : 130
Tonic convulsion : 3
Slow response to stimuli : 1
Tremor : 4
Fontanelle bulging : 1
Hypertonia : 46
Paralysis : 1
Depressed level of consciousness : 34
Hypoaesthesia : 2
Status epilepticus : 12
Nervous system disorder : 1
Product issues : 2
Product complaint : 2
Psychiatric : 542
Attention deficit hyperactivity disorder : 1
Abnormal behaviour : 32
Abnormal dreams : 1
Lack of spontaneous speech : 1
Aggression : 4
Anxiety : 6
Apathy : 15
Autism spectrum disorder : 16
Breath holding : 11
Daydreaming : 3
Delirium febrile : 12
Depressed mood : 2
Derealisation : 1
Disorganised speech : 1
Dissociative disorder : 1
Eating disorder : 2
Emotional distress : 1
Affect lability : 1
Behaviour disorder : 8
Hallucination, visual : 2
Hallucination : 3
Head banging : 9
Hallucination, auditory : 1
Delirium : 3
Initial insomnia : 1
Listless : 217
Nightmare : 1
Agitation : 6
Panic attack : 1
Sleep terror : 1
Personality change : 1
Irritability : 12
Mental disorder : 1
Psychomotor retardation : 1
Restlessness : 14
Poor quality sleep : 20
Sleep disorder : 14
Insomnia : 77
Social avoidant behaviour : 2
Social (pragmatic) communication disorder : 1
Somnambulism : 1
Speech sound disorder : 1
Staring : 17
Mood altered : 1
Mood swings : 1
Stereotypy : 2
Disturbance in social behaviour : 1
Tic : 2
Euphoric mood : 1
Confusional state : 3
Anger : 3
Nervousness : 2
Renal and urinary tracts : 5
Incontinence : 2
Ketonuria : 1
Pollakiuria : 1
Oliguria : 1
Reproductive system and breasts : 5
Scrotal swelling : 1
Genital rash : 1
Testicular pain : 1
Scrotal oedema : 1
Gynaecomastia : 1
Respiratory and thoracic : 337
Apnoea : 27
Respiratory distress : 3
Respiratory arrest : 1
Respiration abnormal : 43
Apparent life threatening event : 2
Asphyxia : 1
Asthma : 6
Epistaxis : 14
Cyanosis central : 11
Respiratory failure : 1
Pharyngeal swelling : 1
Pharyngeal erythema : 1
Yawning : 1
Cough : 92
Stridor : 2
Interstitial lung disease : 1
Dyspnoea : 49
Lung disorder : 1
Rhinorrhoea : 21
Respiratory disorder : 2
Respiratory tract irritation : 1
Neonatal hypoxia : 1
Nasal discomfort : 1
Nasal oedema : 1
Nasal congestion : 5
Sneezing : 4
Irregular breathing : 1
Oropharyngeal discomfort : 4
Oropharyngeal pain : 23
Wheezing : 1
Productive cough : 3
Tachypnoea : 2
Sputum increased : 3
Dysphonia : 4
Tonsillar hypertrophy : 3
Skin and subcutaneous tissue : 1715
Acute haemorrhagic oedema of infancy : 1
Dermatitis allergic : 2
Angioedema : 21
Blister : 16
Dry skin : 7
Eczema : 70
Exfoliative rash : 2
Urticaria : 145
Urticaria vesiculosa : 1
Alopecia : 2
Henoch-Schonlein purpura : 4
Skin warm : 43
Lichen planus : 1
Skin erosion : 1
Skin odour abnormal : 1
Skin irritation : 1
Skin fissures : 1
Skin lesion : 1
Dermatitis : 1
Dermatitis bullous : 1
Rash : 656
Rash maculo-papular : 49
Rash morbilliform : 85
Rash papular : 79
Rash vesicular : 23
Skin discolouration : 15
Intertrigo : 1
Pruritus : 82
Rash pruritic : 44
Cold urticaria : 1
Livedo reticularis : 2
Dermatitis diaper : 1
Mechanical urticaria : 1
Purpura : 1
Night sweats : 1
Nail disorder : 1
Cutaneous vasculitis : 1
Hyperhidrosis : 24
Papule : 5
Perioral dermatitis : 1
Pigmentation disorder : 1
Pain of skin : 1
Petechiae : 25
Rash rubelliform : 1
Photosensitivity reaction : 1
Rash erythematous : 79
Erythema : 36
Urticaria chronic : 1
Vasculitic rash : 1
Skin exfoliation : 3
Rash macular : 157
Cold sweat : 14
Social circumstances : 1
Educational problem : 1
Vascular : 256
Cyanosis : 58
Pallor : 166
Haematoma : 7
Raynaud's phenomenon : 1
Circulatory collapse : 5
Peripheral coldness : 6
Hypotension : 1
Flushing : 4
Poor peripheral circulation : 1
Vasodilatation : 5
Kawasaki's disease : 2
Overview of reports submitted to EMA
All reports submitted to EMA can be found here.
Overview of reports submitted to World Health Organization

VigiBase® data

This data is sourced from VigiBase, the World Health Organization’s (the “WHO”) global database for suspected adverse drug reactions “ADRs”, maintained by Uppsala Monitoring Centre (“UMC”). UMC is the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden providing scientific leadership and operative support to the WHO Program for International Drug Monitoring (www.who-umc.org).

The data contains reports of suspected ADRs, so called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 120 countries and span over more than 100 000 different medicinal products. Thus, this database is only a repository of ICSRs provided for VigiBase, and shall not be considered as a systematic register of ADRs that have occurred or may occur.

The volume of ICSRs for a particular medicinal product may be influenced by many different factors, including but not limited to the extent of use of the product, publicity and the nature of the reactions. No information is provided on the number of patients exposed to a particular product, and it is therefore, based on the ICSRs, not possible to calculate frequency of any ADR. Moreover, collection of data is, due to e.g. differing national legislation and policies, heterogeneous between different countries. For these reasons, any interpretation of ADR data, and particularly those based on comparisons between various medicinal products, may be misleading.

Information on a suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always requires detailed evaluation and scientific assessment of all available data. The balance between benefit and risk of a specific medicinal product also varies between individual patients.

If you think that you may be experiencing a side-effect from a medicinal product, please seek advice from a health professional as soon as possible. Never stop or change the dose for prescription medicines without consulting your physician.

About the release of this data:
UMC takes great care to ensure that the data contained herein is an accurate record of data collected by the national drug authorities and transmitted to UMC. UMC does, however, not guarantee, warrant or make any representation whatsoever regarding the data contained herein, including but not limited to guarantees, warranties or representations of accuracy, reliability, completeness, currency, suitability, fitness or usefulness for any particular purpose or with respect to non-infringement of any third-party rights. In no event shall UMC be liable for any loss, damage, cost or other expense whatsoever (whether direct, indirect, punitive, incidental, special or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the district court of Uppsala as first instance.

MAZELEN MET BOF EN RUBELLA, LEVEND VERZWAKT

Number of reports 0

Overview of reported side effects

No information available.
Related drugs and vaccines
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