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Reporte zur Charge UJ327AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 1 MN 1 MI 1 VA 1 PA 1

VAERS 1736208

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
IL
Alter
2,0
Geschlecht
F
Eingang
27.09.2021
Impfdatum
17.09.2021
Beginn
17.09.2021
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 Wrong product administered

Symptomtext

ACT-HIB was administered to a 2 year old but it was expired as of June of this year.- with no reported adverse event; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional and consumer non health care professional via Global Medical Information number: 00774839. This case involves a 2 years old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE VACCINE [ACT-HIB] (wrong product administered). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On 17- SEP -2021, the patient received a 0.50 mL dose of suspect HIB (PRP/T) VACCINE batch number: UJ327AA and expiry date: 30-SEP-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). IT was reported that "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy". At time of reporting, the patient was not recovered for the 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1512083

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
MN
Alter
0,5
Geschlecht
F
Eingang
29.07.2021
Impfdatum
09.07.2021
Beginn
09.07.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 22-JUL-2021 from a Physician and other healthcare professional (Reference number- 00693284) and transmitted to Sanofi on 22-Jul-2021. This case involves a 6-month-old female patient who was vaccinated with an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 09-Jul-2021, the patient received a 0.5ml of third dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (lot number: UJ327AA and expiry date: 28-Jun-2021 was reported) via intramuscular route at the left thigh for prophylactic vaccination. It was also reported that "if there was a grace period if an expired product was administered". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Outcome of event was unknown. 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
PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 1483671

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
18.07.2021
Impfdatum
08.07.2021
Beginn
08.07.2021
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 No adverse event

Symptomtext

The patient received an expired dose of Act-Hib vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00674336) and transmitted to Sanofi on 08-Jul-2021. This case involves a patient with unknown demographics who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, vaccination, family history and concomitant medications were not reported. On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ327AA, expiry date: 28-Jun-2021, diluent expiration date: 30-Sep-2021, other dosing details were not reported] for prophylactic vaccination. (expired product administered) (Latency: on the same day) It was a case of actual medication error due to expired vaccine used. It was reported that, reporter did not have any additional information, she was handed a box and requested to make call regarding validity of vaccine. (reporter wanted to know if this vaccine is considered viable or not) 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 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 1035946

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
-
Alter
1,3
Geschlecht
M
Eingang
17.02.2021
Impfdatum
16.02.2021
Beginn
16.02.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Wrong product administered

Symptomtext

An influenza vaccine was given when not needed, no treatment, parents reassured.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1025050

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
VA
Alter
0,9
Geschlecht
M
Eingang
12.02.2021
Impfdatum
29.01.2021
Beginn
-
Tage bis Beginn
-
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration

Symptomtext

patient received the 4th dose of ActHIB at 11 months old (instead of the recommended 12 months), no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00457196) and transmitted to Sanofi on 02-Feb-2021. This case involves an 11 months old male patient who received the 0.5 ml 4th dose of HIB (PRP/T) VACCINE [ACT-HIB] VACCINE (lot UJ327AA, expiry: 30-Jun-2021) via intramuscular route in the left thigh at 11 months old (instead of the recommended 12 months), for prophylactic vaccination on 29-Jan-2021 (Inappropriate schedule of product administration) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), INFLUENZA VACCINE (FLU) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination. It was a case of an actual medication error due to drug dose administration interval too short (latency same day) The caller stated that a patient has received the 4th dose of ActHIB early and would like to know how to proceed in caring for the patient. The actual day of the month was not available. The patient was supposed to receive the 4th dose of Acthib. The patient's birthday was XX-jan-2021 in the computer and his actual birthday is XX-feb-2020. He received his dose weeks early. 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 974042

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AA

gering
Staat
PA
Alter
0,1
Geschlecht
M
Eingang
26.01.2021
Impfdatum
25.01.2021
Beginn
25.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age

Symptomtext

Baby 34 days of age and given shots for infant at least 6 weeks of age. All immunizations were given too soon.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
NKA
Vorherige Impfungen
-