Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 7
HOS-114557 · Präparat HOS-094113
In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12
through 23 months of age. The children in these studies received either the current refrigerator-stable
formulation or an earlier formulation of ProQuad. Children in these studies were monitored for six
weeks post vaccination. The safety profiles were comparable for the two different formulations after a
single dose. The only vaccine-related systemic adverse reactions reported at a significantly greater rate
in individuals who received the earlier formulation of ProQuad compared to individuals who received
the measles, mumps, and rubella vaccine manufactured by MSD and Varicella Vaccine live
(Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles -like rash. Both fever
and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short
duration and resolved with no long-term sequelae. Pain/tenderness/soreness at the injection site was
reported at a statistically lower rate in individuals who received ProQuad.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage f1a31eecba0d59c9cd598a2c6a73d3dbb5d95c26b56a43671c528a1f127e64b8 · Zeichen 34–1103 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 7–8
HOS-114558 · Präparat HOS-094113
7
The only vaccine related injection site adverse reaction that was more frequent among recipients of
ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and
rubella vaccine manufactured by MSD was rash at the injection site.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 9ed0d8f34e20ac15fcb4c1391ca55a8ac46e988b314bb6de3ee377b7763ca23c · Zeichen 1159–1425 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114559 · Präparat HOS-094113
Following ProQuad given alone in 7 clinical trials, the observe d rates of fever (≥39.4°C rectal
equivalent) ranged from 10.1% to 39.4%. In comparison, following ProQuad given concomitantly
with Prevenar and/or hepatitis A vaccine in 3 clinical trials, the observed rates of reported fever
(≥39.4°C rectal equivalent) ranged from 15.2% to 27.2%.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 2a2e714c5ba5bda60e8effecc54ef714b173f7c16614741a4718d04ed5220c58 · Zeichen 1427–1772 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114560 · Präparat HOS-094113
In a clinical trial of ProQuad administered concomitantly with Infanrix Hexa, the rates of fever
(≥38.0°C rectal equivalent) were 69.3% following concomitant administration, 61.1% following
ProQuad alone, and 57.3% following Infanrix Hexa alone; the rates of fever (≥39.4°C rectal
equivalent) were 22.6% following concomitant administration, 20.5% following ProQuad alone, and
15.9% following Infanrix Hexa alone.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 095b8c2e33807e0f9d9a3712d845ef108b112d8932c77c48f7ee4bebbb40642d · Zeichen 1774–2187 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114561 · Präparat HOS-094113
The overall safety profile of ProQuad was comparable whether it was administered concomitantly or
alone.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage e08cac70192f66d3680ee3f5902ae2a08577dc19c955b2332346281f52f6cf00 · Zeichen 2189–2293 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114562 · Präparat HOS-094113
Children who received a second dose of ProQuad
In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were
generally similar to, or lower than, those seen with the first dose. In three of these studies, the rates of
injection site erythema and swelling were statistically significantly higher after the second dose than
after the first dose; however, in the remaining five studies, the rates of each of these reactions were
similar after the first and second dose. The fever rate in all eight studies was lower after the second
dose than after the first dose.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage c505c3c9852b5e2fdb43e6a6018dedc5445a1da91181a729982ead2469d7b737 · Zeichen 2295–2896 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114563 · Präparat HOS-094113
Children who received ProQuad intramuscularly
The general safety profiles of the IM and SC administration routes were comparable; however, fewer
subjects experienced injection site adverse reactions in the IM group after each dose (see section 5.1
for study description).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage bd644610c7808745234a6ff2517df6b35ecec42073af3670d446d6128f927d50 · Zeichen 2898–3169 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114564 · Präparat HOS-094113
Children who received ProQuad at 4 through 6 years of age after primary immunization with Varicella
Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by MSD
The rates and types of adverse reactions seen in the study group that received ProQuad were generally
similar to those seen in the groups that received Varicella Vaccine live (Oka/Merck) and the measles,
mumps, and rubella vaccine manufactured by MSD (see section 5.1 for study description).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 92b6c112c33faec9b71ebd8fd2443f3f775a9e25ee693a8f1c94d281811a6c7c · Zeichen 3171–3651 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114565 · Präparat HOS-094113
No specific studies have been conducted in individuals from 2 years of age who had not previously
received measles, mumps, rubella, and varicella vaccines.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage afaf3ef1d4ad18ec097e63c968c2c80f27da643f6d028aa429feb7795a3cfc4f · Zeichen 3653–3808 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114566 · Präparat HOS-094113
The most common adverse events reported with the use of ProQuad were: injection site reactions
including pain/tenderness/soreness, redness, swelling or bruising; fever ( ≥39.4°C rectal equivalent);
irritability; rash (including measles-like rash, varicella-like rash, and injection site rash); upper
respiratory infection; vomiting and diarrhoea.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage bf2e920db1d2fe14a26a9337596fcc04cc063fb8a400848ebb9513e1cbdb11ae · Zeichen 3810–4156 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114567 · Präparat HOS-094113
b. Tabulated list of adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 2081df2febacacc51e93efc6cafe36524905f5abe9552f4c5e960596fbba1e4b · Zeichen 4158–4196 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8
HOS-114568 · Präparat HOS-094113
The following adverse reactions were reported as vaccine related by the investigator in individuals
after a single dose of ProQuad. Several adverse events were solicited in the clinical studies and are
designated with the symbol (‡). Additionally, other adverse events have been reported with post-
marketing use of ProQuad and/or in clinical studies and post-marketing use of either the measles,
mumps, and rubella vaccine manufactured by MSD, the monovalent component vaccines of the
measles, mumps, and rubella vaccine manufactured by MSD, or Varicella Vaccine live (Oka/Merck).
The frequency of these adverse events is qualified as "not known" when it cannot be estimated based
on the available data.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 21f6f3754bab0a6ea9d2067b02438f34fde0918f0218748784e3141e77b58d9f · Zeichen 4198–4902 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 8–9
HOS-114569 · Präparat HOS-094113
8
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1 000, <1/100); Rare (≥1/10 000,
<1/1 000); Not known (cannot be estimated from the available data)
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 56e142cf42b0dce5fd0cf1675b46b1b40af85ff9021af0aeacc494e9619e9794 · Zeichen 4961–5121 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 9
HOS-114570 · Präparat HOS-094113
Adverse reactions Frequency
Infections and infestations
Ear infection, Gastroenteritis, Otitis media, Pharyngitis, Viral infection,
Uncommon
Viral rash
Cellulitis, Respiratory tract infection, Skin infection, Tonsillitis,
Rare
Varicella+ ‡, Viral conjunctivitis
Aseptic meningitis*, Encephalitis*, Epididymitis, Herpes zoster*,
Not known
Infection, Measles, Orchitis, Parotitis
Blood and lymphatic system disorders
Leukocytosis, Lymphadenopathy Rare
Lymphadenitis, Thrombocytopenia Not known
Immune system disorders
Hypersensitivity Rare
Anaphylactoid reaction, Anaphylactic reaction, Angioedema, Face oedema,
Not known
and Peripheral oedema
Metabolism and nutrition disorders
Decreased appetite Uncommon
Dehydration Rare
Psychiatric disorders
Irritability Common
Crying, Sleep disorder Uncommon
Apathy, Clinging, Restlessness Rare
Nervous system disorders
Febrile seizure*, Somnolence Uncommon
Ataxia, Seizure, Headache, Hyperkinesia, Hypersomnia, Lethargy, Tremor Rare
Bell’s palsy, Cerebrovascular accident, Dizziness, Encephalopathy*,
Guillain-Barré syndrome, Measles inclusion body encephalitis (see section
Not known
4.3), Ocular palsies, Paraesthesia, Polyneuropathy, Subacute sclerosing
panencephalitis*, Syncope, Transverse myelitis
Eye disorders
Conjunctivitis, Eye discharge, Blepharitis, Eye irritation, Eye swelling,
Rare
Ocular hyperaemia, Increased lacrimation, Ocular discomfort
Eyelid oedema, Optic neuritis, Retinitis, Retrobulbar neuritis Not known
Ear and labyrinth disorders
Ear pain Rare
Neurosensory deafness Not known
Vascular disorders
Flushing, Pallor Rare
Extravasation Not known
Respiratory, thoracic, and mediastinal disorders
Cough, Respiratory tract congestion, Rhinorrhoea Uncommon
Sinus disorder, Sneezing, Wheezing Rare
Bronchospasm, Bronchitis, Pneumonitis (see section 4.3), Pneumonia,
Not known
Rhinitis, Sinusitis, Oropharyngeal pain
Gastrointestinal disorders
Diarrhoea, Vomiting Common
Abdominal pain upper, Nausea, Stomatitis Rare
Abdominal pain, Haematochezia Not known
Skin and subcutaneous tissue disorders
Measles-like rash‡, Rash, Varicella-like rash‡ Common
Dermatitis (including contact and atopic), Rubella-like rash‡, Urticaria,
Uncommon
Erythema
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 49f45ad04143abef3b40499962c8e90c93982b16b18e23fdceba211cb2ba3f55 · Zeichen 5124–9018 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 9–10
HOS-114571 · Präparat HOS-094113
9
Adverse reactions Frequency
Cold sweat, Exfoliative dermatitis, Drug eruption, Henoch-Schönlein
purpura, Papular rash, Pruritus, Skin discolouration, Skin lesion, Rare
Zosteriform rash
Erythema multiforme, Panniculitis, Purpura, Skin induration, Stevens-
Johnson syndrome, Skin granuloma (associated with vaccine derived Not known
rubella virus)
Musculoskeletal and connective tissue disorders
Arm pain, Musculoskeletal stiffness Rare
Arthritis, Arthralgia*, Musculoskeletal pain, Myalgia, Swelling Not known
General disorders and administration site conditions
Fever‡, Erythema‡ or Pain/Tenderness/Soreness‡ at the injection site Very common
Ecchymosis or Swelling‡ at the injection site, Injection site rash‡ Common
Asthenia, Fatigue, Injection site haemorrhage, Injection site induration,
Uncommon
Injection site mass, Malaise
Influenza like illness, Injection site exfoliation, Injection site
discolouration, Injection site pruritus, Injection site reaction, Injection site Rare
scar, Hyperthermia, Pain
Injection site complaints (Pain, Oedema, Urticaria, Haematoma, Induration,
Not known
Mass, Vesicles), Inflammation, Papillitis
Investigations
Weight loss Rare
Injury, poisoning and procedural complications
Contusion Rare
Social circumstances
Activities of daily living impaired Rare
+
Varicella caused by vaccine strain was observed in post-marketing use with Varicella Vaccine live
(Oka/Merck).
‡
Adverse events solicited in clinical trials.
* See section c
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 3d471e5feb735500072a665e2890960380231b010a39c0494fbb3330d9052a3e · Zeichen 9076–11063 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 10
HOS-114572 · Präparat HOS-094113
c. Description of selected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 478337f23356496b72595d08683efc9da8520a2741fe9f8251c1dd2396754822 · Zeichen 11065–11109 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 10
HOS-114573 · Präparat HOS-094113
Aseptic meningitis
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has
been shown, there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 550e8762dbd2cb9dadf98ac481db776b0b9b0da41cef057967c208c4c7af8484 · Zeichen 11111–11413 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 10
HOS-114574 · Präparat HOS-094113
Complications associated with varicella
Complications of varicella from vaccine strain including herpes zoster and disseminated disease such
as aseptic meningitis and encephalitis have been reported in immunocompromised and
immunocompetent individuals. A few cases of encephalitis with a fatal outcome have been observed
following vaccination with live attenuated varicella vaccines, especially in immunocompromised
people (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 05883fef49ca198b3b9ca3c6ff1316b3f94011b84bb6859cc99ca2d009a23771 · Zeichen 11415–11856 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 10
HOS-114575 · Präparat HOS-094113
Febrile seizures
Febrile seizures have been reported in children receiving ProQuad. Consistent with clinical study data
on the timing of fever and measles-like rash, a post-marketing observational study in children 12 to 60
months of age revealed an approximate two-fold increase (0.70 per 1 000 vs. 0.32 per 1 000 children)
in the risk of febrile seizures in the 5- to 12-day timeframe after a first dose of ProQuad (N=31 298)
compared with concomitant administration of the measles, mumps, and rubella vaccine manufactured
by MSD, and the Varicella Vaccine live (Oka/Merck) (N=31 298).These data suggest one additional
case of febrile seizure per 2 600 children vaccinated with ProQuad compared with separate
administration of the measles, mumps, and rubella vaccine manufactured by MSD, and the Varicella
Vaccine live (Oka/Merck). These data were confirmed by a post-marketing observational study
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage f94bf9c0aaa3530a3ce1a20446b28f4db379a1413147af3d420d6f98306a7ec8 · Zeichen 11858–12757 im Abschnitt
Nebenwirkungen · ProQuad
ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). · Abschnitt 4.8 · PDF-Seite 10–11
HOS-114576 · Präparat HOS-094113
10
sponsored by the U.S. Centers for Disease Control and Prevention. In the 30-day timeframe following
vaccination, no increased risk of febrile seizures was observed (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-25T13:47:00Z · SHA-256 10f5a1e20845cc2273c111fca146c4950a4ba676fc814ddf4efcc5e150ea48b9 · Passage 1c003eb33e76f8f87b745aeae69e8be63d9ba3f0170e37edeac824c84ad6f307 · Zeichen 12812–12998 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.