VAERS Reports UJ391AAA

VAERS 1294474

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ391AAA

mild

Staat: AL
Alter: 0,2
Geschlecht: M
Eingang: 06.05.2021
Impfdatum: 26.04.2021
Beginn: 26.04.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

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

Breath sounds normal Heart rate normal Hypotonia Oxygen saturation normal Pallor Pyrexia

Symptomtext

2-3 minutes after the shots were givenm mom approached my assistant because of change in baby's color. Wfen I came in a few seconds later, baby is awake,limp, pale, dusky but not cyanotic, breathing, clearbreath sounds, heart rate 100/min. , regular in rhythm, no seizure movement and afebrile. Stimulated baby to cry by patting feet and about 1-2 minutes later, he pinked up,heart rate went up to 180's (crying) and 02 sat was 98%. Baby was observed in the room was observed x 1 hour before he was sent home, was feeding well. A phone follow-up was done in the afternoon and per dad, baby was fine. Anothe phone call was done the following day and per dad, baby had a fever and was advised to give acetaminophen.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: rash,dry skin
Vorgeschichte: none
Andere Medikamente: none
Allergien: Vitamin D drops 400 units
Vorherige Impfungen: -

VAERS 1774825

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ391AAA

gering

Staat: HI
Alter: 1,5
Geschlecht: U
Eingang: 09.10.2021
Impfdatum: 27.09.2021
Beginn: 27.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

expired dose of ACTHIB was administered to ONE patient with no AE; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via Medical information (MI) number: 00787391. This case involves a 18-month- old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The Patient's concomitant medications include DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), INFLUENZA VACCINE (INFLUENZA) for prophylactic vaccination respectively. The patient's medical history, past medical treatments vaccinations and family history were not provided. On 27-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE[ACT-HIB] (lot number: UJ391AAA and expiration date 10-Aug-2021) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired product administered (latency same day). It was reported "Physician called to report that an expired dose of ACTHIB was administered to ONE patient. The caller would like to know whether the dose is valid or whether it should be re-administered". At the time of reporting, no adverse event was reported. 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: DTAP; INFLUENZA
Allergien: -
Vorherige Impfungen: -