VAERS Reports UJ382AAA

VAERS 957106

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ382AAA

mild

Staat: CA
Alter: 0,2
Geschlecht: F
Eingang: 19.01.2021
Impfdatum: 19.01.2021
Beginn: 19.01.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

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

Lethargy Rash Rash macular Somnolence

Symptomtext

Within 5 minutes of giving patient her vaccination patient broke out into a macule rash mainly on her forehead and upper R cheek. oxygen sat level at 100% room air, 158 for pulse. Slightly lethargic & sleepy but no acute distress noted, no difficulty breathing or SOB noted.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: Patient was sent to Hospital via EMS
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: unknown
Vorherige Impfungen: -

VAERS 1824747

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ382AAA

gering

Staat: WA
Alter: 1,0
Geschlecht: M
Eingang: 28.10.2021
Impfdatum: 11.10.2021
Beginn: 11.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Expired product administered No adverse event

Symptomtext

expired Pentacel was adminstered with no adverse event;Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional and physician via Media Information (under reference 00818759). This case involves a 1 years old male patient who received an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) via unknown route in an unknown administration site for prophylactic vaccination. On 11-Oct-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Total, lot UJ382AAA and expiration date: 01-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to an expired vaccine used (same day latency). It was reported "Caller stated that expired Pentacel was adminstered to patients. Caller would like to know what to do next. She would like to know if Pentacel is considered a live vaccine." At time of reporting, no adverse event 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: PNEUMOCOCCAL CONJUGATE VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 1391215

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ382AAA

gering

Staat: -
Alter: 0,5
Geschlecht: M
Eingang: 11.06.2021
Impfdatum: 28.04.2021
Beginn: 28.04.2021
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / -

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

No adverse event Product preparation issue

Symptomtext

Patient was inadvertently administered only the DTap-IPV component of the Pentacel without reconstituting with HIB/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (reference number- 00609599) and transmitted to Sanofi on 20-May-2021. This case involves a 6 months old male patient who was inadvertently administered 0.5 mL only of DTap-IPV component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [ third dose, batch number: UJ382AAA and expiry date: 10-Jan-2021 via an intramuscular route at thigh (left or right thigh not reported) administration site] as the product was not first mixed with the Hib component (product preparation issue) on 28-Apr-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination. It was an actual medication error case due to inappropriate reconstitution technique (latency: same day). Reporter want to know if the DTAP and Polio portion are still valid or if some other protocol needs to be followed at this point. Healthcare professional also asked if there were any special safety issues to look out for if only the DTap-IPV portion of the Pentacel vaccine was administered, without the Hib. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -