VAERS Reports UJ551AAA

VAERS 1947680

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ551AAA

mild

Staat: NJ
Alter: 1,3
Geschlecht: M
Eingang: 14.12.2021
Impfdatum: 14.12.2021
Beginn: 14.12.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein

Erythema Injection site urticaria Irritability Peripheral swelling

Symptomtext

as soon as the Pentacel was given patient immediately turned red, became irritable unconsolably, then few minutes later his right leg became swollen then left started to swell as well and he started to develop hives on his arm at the sight of injection

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site urticaria
Hospital-Tage: -
Labordaten: pulse ox 99% -pt sent to emergency room
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: multivitamins
Allergien: none
Vorherige Impfungen: -

VAERS 2210960

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ551AAA

gering

Staat: PA
Alter: 0,3
Geschlecht: M
Eingang: 01.04.2022
Impfdatum: -
Beginn: 28.03.2022
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product preparation issue Single component of a two-component product administered

Symptomtext

a dose of PENTACEL was administered without reconstituting with the HIB portion of the vaccine, reporting only the DTAP/IPV portion was administered with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus vaccine). On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine lot UJ551AAA via intramuscular route, expiry date- 05-Aug-2022 in unknown administration site. On 28-Mar-2022 the patient had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event (single component of a two-component product administered) (unknown latency). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -