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Reporte zur Charge UJ406AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OK 1 TX 1 VA 1

VAERS 1144790

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ406AA

mild
Staat
OK
Alter
0,2
Geschlecht
F
Eingang
29.03.2021
Impfdatum
24.03.2021
Beginn
25.03.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema multiforme Injection site erythema

Symptomtext

Classic erythema multiforme lesions developed on bilateral hands and feet starting 24 hours after immunizations, then spread up to legs, surrounding both vaccine sites, trunk, arms and by 5 days post-immunizations, present on cheeks. Raised erythematous target lesions. Afebrile, good output, no swelling.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
None, confirmed by clinical exam.
Aktuelle Erkrankungen
None reported.
Vorgeschichte
None reported.
Andere Medikamente
Vitamin D supplemenation.
Allergien
No known allergies.
Vorherige Impfungen
-

VAERS 1300543

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ406AA

gering
Staat
TX
Alter
0,3
Geschlecht
F
Eingang
08.05.2021
Impfdatum
08.04.2021
Beginn
09.04.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Bacterial test negative Culture stool negative Haematochezia Mucous stools Occult blood positive

Symptomtext

bloody streaks with mucous in stools for just one day that began the day after the vaccines were administered and resolved by the following day.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Bacterial test negative
Hospital-Tage
-
Labordaten
Positive stool guaiac test confirmed presence of blood. Stool culture for bacterial infection (sal/shig/campy, culture and shiga toxin, EIA w/rfl to E.coli, culture) was negative/normal.
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1235843

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ406AA

gering
Staat
VA
Alter
0,3
Geschlecht
U
Eingang
21.04.2021
Impfdatum
25.03.2021
Beginn
25.03.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation issue

Symptomtext

a child received a Pentacel vaccine, but the DTaP/ IPV liquid was not mixed with the HIB component, with no reported AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-month-old (unknown gender) patient who received a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine, but the DTAP/ IPV liquid was not mixed with the HIB component (product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 25-Mar-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ406AA, 09-Oct-2021) via an intramuscular route in the right leg for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (latency same day). It was reported that, the child will be brought back in for an Act-HIB vaccine as a corrective. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-