VAERS 2479460
UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ598AAA
- Staat
- VA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 15.10.2022
- Impfdatum
- 07.10.2022
- Beginn
- 07.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Symptomtext
administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 4-month-old male patient to whom administered the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] to a patient and reconstitute the hib portion with sterile water and administer to a patient as well and administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. On 07-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength: standard) (lot number: UJ598AAA expiry date: 05-Dec-2022) via intramuscular route in the left thigh (leg) for Immunization and on the same day, administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well with no reported adverse event (product preparation error) (single component of a two-component product administered). Reportedly, Pharmacy director wants to know if the doses are valid. This is reported as potential AE because of use against local labelling. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. At time of reporting, the outcome was 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PREVNAR 13; ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -