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Reporte zur Charge UJ405AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OK 1 IL 1 TX 1

VAERS 1813084

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ405AAA

gering
Staat
OK
Alter
1,5
Geschlecht
M
Eingang
23.10.2021
Impfdatum
14.10.2021
Beginn
14.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

Expired vaccine administered- with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from an other health care professional and non health care professional via Medical Information (MI) number: 00813275. This case involves a 18 months old male patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was unknown if the patient had any additional concomitant disease or risk factor On 14-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ405AAA and expiry date:08-OCT-2021 via intramuscular route in the left thigh for prophylactic vaccination. It was unknown if the patient experienced any additional symptoms/ event It was unknown if there were lab data/results available. It was case of an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, 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 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 1713157

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ405AAA

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
18.09.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A temperature excursion because the dial in the refrigerator was turned too low, reached up to Negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds/no AE;Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (Reference number- 00762504). This case involves vaccines that undergoes a temperature excursion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot UJ414AAA, expiry date 12-MAR-2022), HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ405AAA, expiry date 08-OCT-2021 ) and IPV (VERO) [IPOL] (lot R1G101M, expiry date 08-OCT-2021) because the dial in the refrigerator was turned too low reached up to negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds (product storage error). It was reported, "caller states that a temperature excursion occurred because the dial in the refrigerator was turned too low. The lowest temperature reached was Negative 3.4C for a total of 17 hours, 7 minutes, and 30 seconds. The products involved were a punctured MDV of IPOL as well as unopened: ACTHIB, IPOL, and PENTACEL. Caller requested stability information for these products". It was a case potential medication error due to product storage error temperature too low (same day). At time of reporting no adverse 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 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1294751

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ405AAA

gering
Staat
TX
Alter
0,2
Geschlecht
F
Eingang
07.05.2021
Impfdatum
12.04.2021
Beginn
12.04.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

The patient received only the diluent of ACTHIB, no AE; Initial information was received on 26-Apr-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a 2 months old female patient who received only the diluent of HIB (PRP/T) VACCINE [ACT-HIB] 0.5 ml (lot UJ405AAA, expiry date: 08-Oct-2021) via intramuscular route in the right thigh for prophylactic vaccination on 12-Apr-2021 (Product preparation issue) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day) At the time of report, no adverse event was reported. One of the nurse gave only gave the diluent of ACTHIB and asked if they could give the HIB with another diluent. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PEDIARIX; ROTATEQ; PREVNAR 13
Allergien
-
Vorherige Impfungen
-