Zurueck zur Suche

Reporte zur Charge UJ337AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 TX 1

VAERS 1512064

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ337AA

gering
Staat
MI
Alter
0,6
Geschlecht
F
Eingang
29.07.2021
Impfdatum
14.07.2021
Beginn
14.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

child was given an expired dose of PENTACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and other health care professional via Regulatory authority (Reference number- 00683484) and transmitted to Sanofi on 15-Jul-2021. This case involved 7 month old female patient was given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Prophylactic vaccination. On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: U6842BA and UJ337AA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered) It was reported that, "Caller is wanting to know if it is a valid dose and if child needs another injection". This case was an actual medication error case (expired vaccine used) (latency same day) At the time of reporting, no adverse event 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
ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1474530

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ337AA

gering
Staat
MI
Alter
0,6
Geschlecht
F
Eingang
15.07.2021
Impfdatum
14.07.2021
Beginn
-
Tage bis Beginn
-
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Patient was given vaccine and had left the clinic. I went to put the shots that was given into my system that's when I notice the expiration day. I in formed my office manager and the doctor of what happen and apologized for it, then I tried reaching out to the parent's. But the number we have on file is not in service, so we though it would be good to mail a letter out.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
N/A
Allergien
-
Vorherige Impfungen
-

VAERS 1019175

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ337AA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
10.02.2021
Impfdatum
01.12.2020
Beginn
01.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient (unspecified age and gender) for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination]. Details of laboratory data not reported. It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines. It was not reported if the patient received a corrective treatment. At the time of report, no adverse event was 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. There will be no information available on the batch number for this case.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-