VAERS 2275449
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6985AA
- Staat
- CA
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 13.05.2022
- Impfdatum
- 29.04.2022
- Beginn
- 29.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Symptomtext
Hib portion that was not given/not reconstituted with the Hib powder portion with no reported adverse event; Liquid portion DTaP-IPV of pentacel that was not reconstituted with the Hib powder portion with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 2 months old female patient who experienced hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event and liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination; and pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination. On 29-Apr-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml; lot U6985AA and expiry date: 10-Jul-2022, lot UJ543AA and expiry date: 10-Jul-2022 and lot UJ543AAA, expiry date: 10-Jul-2022 via intramuscular route in the left vastus lateralis for Immunization. On 29-Apr-2022 (latency: same day) the patient developed a non-serious hib portion that was not given/not reconstituted with the hib powder portion with no reported adverse event (incorrect dose administered) and also liquid portion dtap-ipv of pentacel that was not reconstituted with the hib powder portion with no reported adverse event (product preparation issue) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken: not applicable. Outcome: unknown for both the 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
- HEPATITIS B [HEPATITIS B VACCINE]; PREVNAR 13
- Allergien
- -
- Vorherige Impfungen
- -