VAERS Reports UJ635AAB

VAERS 2462466

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj635aab

mild

Staat: TX
Alter: 1,1
Geschlecht: M
Eingang: 27.09.2022
Impfdatum: 15.09.2022
Beginn: 26.09.2022
Tage bis Beginn: 11,0
Dosis: 4
Route/Site: IM / RL

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

Rash maculo-papular

Symptomtext

Maculopapular Rash through out body. Treatment: Cetirizine oral solution 2.5 ml daily Outcome: Stable Date of visit 9/27/2022

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash maculo-papular
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: Diaper Rash
Vorgeschichte: No
Andere Medikamente: Tylenol 160/5 3.75 ml
Allergien: NKA
Vorherige Impfungen: -

VAERS 2527395

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAB

gering

Staat: TX
Alter: -
Geschlecht: U
Eingang: 09.12.2022
Impfdatum: 01.12.2022
Beginn: 01.12.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

patient received expired ACT-HIB with no reported adverse event; Initial information received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient received expired act-hib with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Dec-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, (Dose number :1)Dose: 0.5 ML (millilitre) 1X and Drug Treatment Duration: ONCE lot UJ635AAB , Expiry date : 30-NOV-2022 ( strength, dose site, route: unknown, ) for Immunisation On 01-DEC-2022 the patient received expired act-hib with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE. Reportedly "Vaccine Coordinator reporting a patient received expired ACT-HIB. The caller advised the product expired on 30Nov2022 and a patient received the vaccine on 01Dec2022. Should the patient be revaccinated or was the product viable" Action taken was not applicable.. 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 guidelines. 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2147466

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AAB

gering

Staat: NY
Alter: 0,3
Geschlecht: F
Eingang: 27.02.2022
Impfdatum: 21.02.2022
Beginn: 21.02.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

No adverse event Product preparation error

Symptomtext

ACT-HIB reconstituted with sterile water rather than the diluent provided with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old female patient who got act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 21-Feb-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ635AAB,30-Nov-2022) via intramuscular route in the right vastus lateralis for iimunization. On 21-FEB-2022 the patient developed a non-serious event "act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event" (product preparation error)(latency-Same day) following the administration of HIB (PRP/T) VACCINE. It was reported "ACT-HIB vaccine was reconstituted with sterile water rather than the diluent provided with the ACT-HIB". Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse 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 guidelines. 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: PEDIARIX; PREVNAR 13; ROTATEQ
Allergien: -
Vorherige Impfungen: -