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Reporte zur Charge UJ349AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 2161862

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ349AAA

gering
Staat
MA
Alter
1,3
Geschlecht
F
Eingang
05.03.2022
Impfdatum
12.07.2021
Beginn
12.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

was administered the PENTACEL that expired 3 weeks ago; Initial information was received on 12-Jul-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00677892). This case involves a 15 month old female patient who received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that expired 3 weeks ago (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ349AAA, expiry date: 22-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination (expired product administered) (latency: 1 day). It was a case of actual medication error due to expired vaccine used. At the time of reporting, no adverse event was reported. It was reported that "Nurse reports that a patient was administered the PENTACEL that expired 3 weeks ago, should they revaccinate the 15 month old? They were confused with the date." 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1376296

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ349AAA

gering
Staat
IN
Alter
0,8
Geschlecht
F
Eingang
05.06.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

patient was given the liquid part of Pentacel and not the powder part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520 Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional in the United States. This case involves a 10 months and 2 weeks old female patient who was given 0.5 ml liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Batch number: UJ349AAA and expiration date: 22-Jun-2021, DTAP-IPV- Lot: U6841AA, expiry date: 22-Jun-2021, and ActHib- Lot: UJ349AA, expiry: 22-Jun-2021) and not the powder part via intramuscular route in the left thigh for prophylactic vaccination on an unspecified date (PT: product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. It was an actual medication error case due to inappropriate reconstitution technique (same day latency). No adverse event reported at the time of reporting. The medical assistance (MA) stated the nurse gave the liquid part of Pentacel with the blue top and not the powder part with the green top, the ActHib. The Caller was asking what to do if they only gave the liquid part of Pentacel and not the powder. Can they mix it with anything other than 0.4% NaCl (sodium chloride), what about water or they have 0.7% NaCl, where do they get the 0.4% NaCl. Can Sanofi supply it and how much 0.4% NaCl will they have to use. The caller was told that since the liquid part was 0.5ml they will have to use that much to reconstitute the powder. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
INFLUENZA VACCINE; PREVNAR
Allergien
-
Vorherige Impfungen
-