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Reporte zur Charge U6986AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IN 1 MO 1

VAERS 1419965

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6986AA

gering
Staat
IN
Alter
1,3
Geschlecht
M
Eingang
23.06.2021
Impfdatum
15.06.2021
Beginn
15.06.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

MA accidentally injected a 15 month old patient, with only the Daptacel/Ipol portion of the Pentacel vaccine and the patient did not receive the ActHIB powdered portion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory authority (Reference number- 00642362) and transmitted to Sanofi on 15-Jun-2021. This case involves a 15-month-old male patient who only received the Daptacel/Ipol portion and did not received the Act-HIB powdered portion, while patient was receiving a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Diluent Vial: Lot number: U6986AA, expiry date: 22-Jul-2022, National Drug Code (NDC): 4928156005, Powder: Lot number: UJ529AA, expiry date: 22-Jul-2022, NDC: 4928154858, Box: Lot number: UJ529AAA, expiry date: 22-Jul-2022, NDC: 4928151005, Vaccine presentation: vial] on 15-Jun-2021 for prophylactic vaccination (product preparation issue). Medical history, medical treatment, vaccination and family history were not reported. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR). It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day) It was reported that, the medical assistant (MA) accidentally injected the only the Daptacel/Ipol portion of the suspect and patient did not received the Act-HIB powder portion. At the time of report, the MA wanted to know how she can give the ActHIB portion to patient and stated that, the error was occurred because she did not pay attention when she was getting the Pentacel out of the box and did not mix them together. The MA noticed the error after the patient was gone and when she was documenting. At the time, it was reported that, the patient did not had any adverse event as result and discussed the way to give Act-HIB portion to patient. 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
Allergien
-
Vorherige Impfungen
-

VAERS 1306240

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6986AA

gering
Staat
MO
Alter
0,2
Geschlecht
M
Eingang
11.05.2021
Impfdatum
21.04.2021
Beginn
21.04.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part and received both/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number-00573548) and transmitted to Sanofi on 22-Apr-2021. This case is linked to case 2021SA138518 (same reporter). This case involves a 2 months old male patient who was vaccinated with a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6986AA and expiry date 22-Jul-2022) once on 21-Apr-2021 and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on an unknown date, Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part, what issues might two doses of IPV cause (Extra dose administered). The patient's 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 HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) for prophylactic vaccination. This was an actual medication error case due to extra dose administered (latency was same day). At the 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 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; ENGERIX B
Allergien
-
Vorherige Impfungen
-