VAERS 2494690
UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6970BA
- Staat
- MI
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 01.11.2022
- Impfdatum
- 18.10.2022
- Beginn
- 18.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who experienced pentacel vaccine was to be administered, but the nurse did not reconstitute the hib portion of the vaccine, the child received only the dtap/ ipv portion of the vaccine with no adverse events while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. 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), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 18-Oct-2022, the patient received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiry 31-Jan-2023, strength- standard) (formulation: unknown) was to be administered, but the nurse did not reconstitute the hib portion of the vaccine (product preparation error), the child received only the dtap/ ipv portion of the vaccine (single component of a two-component product administered) with no adverse events (latency same day) via intramuscular route in vastus lateralis site for prophylaxis vaccination. It was reported that "Treatment- separate ActHIB (lot-UJ659AA) will be administered". Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. Outcome: unknown, for both events 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; HEPATITIS B VACCINE; ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -