VAERS Reports UJ592AA

VAERS 2218315

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ592AA

mild

Staat: VA
Alter: 0,8
Geschlecht: F
Eingang: 06.04.2022
Impfdatum: 05.04.2022
Beginn: 05.04.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

Flushing Insomnia Irritability Rash Rash pruritic Skin warm Urticaria

Symptomtext

Patient came in on 4/6/2022 around 2:30pm. Mom states patient would not sleep last night, very fussy, and started with a itchy rash all over. No fever, but felt hot to touch. Gave Motrin 30 minutes before appointment today. Doctor examined patient and she indeed did have hives on both legs and on abdomen. Flushed face. Not sure which vaccine cause this since rash is all over. Patient is stable otherwise. 3.4ml of Benadryl given and patient sent home with return precautions.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None Known
Vorherige Impfungen: -

VAERS 2259776

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ592AA

gering

Staat: PA
Alter: 0,2
Geschlecht: F
Eingang: 30.04.2022
Impfdatum: 21.04.2022
Beginn: 21.04.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Incorrect dose administered Medication error No adverse event

Symptomtext

part of the medication combo was not administered (with no reported adverse event); Initial information received on 21-Apr-2022 regarding an unsolicited valid non-serious case received from Other Health Professional. This case involves a 2-month-old female patient for whom part of the medication combo was not 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 rotavirus vaccine (Rotavirus vaccine), hepatitis B vaccine (Hepatitis B vaccine), and pneumococcal vaccine CONJ13v (CRM197) (Prevnar 13), all for prophylactic vaccination. On 21-Apr-2022, the patient received the only DTAP/IPV portion of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine with unknown formulation, strength, (dose: 0.25 mL to 2 mL for vaccine) (lot UJ592AA, expiry date: 18-Dec-2022) via unknown route in the right thigh for Immunization. On 21-Apr-2022, physician gave the Dtap/IPV portion only of Pentacel to the patient and another part of the medication combo (ACT-HIB) was not administered (with no reported adverse event) (incorrect dose administered) (latency: same day). Action taken: Not applicable. It was not reported if the patient received a corrective treatment. Outcome: Unknown. 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: Incorrect dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTAVIRUS VACCINE; HEPATITIS B VACCINE; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2256742

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ592AA

gering

Staat: MI
Alter: 0,3
Geschlecht: M
Eingang: 28.04.2022
Impfdatum: 25.04.2022
Beginn: 27.04.2022
Tage bis Beginn: 2,0
Dosis: 2
Route/Site: IM / LL

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

Haematochezia Infant irritability

Symptomtext

Pt. had one episode of streak of blood in stool on 4/27/22 with increased fussiness.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Haematochezia
Hospital-Tage: -
Labordaten: No tests done. Mom did not bring diaper with stool into office.
Aktuelle Erkrankungen: Candidal diaper rash
Vorgeschichte: None
Andere Medikamente: Nystatin ointment started 4/19/22- to be used for 14 days
Allergien: None
Vorherige Impfungen: -