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Reporte zur Charge UJ355AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
SC 1 MI 1 IA 1 WI 1

VAERS 1674439

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ355AA

gering
Staat
SC
Alter
61,0
Geschlecht
M
Eingang
04.09.2021
Impfdatum
27.08.2021
Beginn
27.08.2021
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

patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 27-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00744399) and transmitted to Sanofi on 27-Aug-2021. This case involves a 61-year-old male patient who administered an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (Expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Aug-2021, the patient received a dose (once) of suspect HIB (PRP/T) VACCINE [lot UJ355AA, expiry date 24-Jul-21] via an unknown route in unknown administration site for prophylactic vaccination. It was reported, "A patient has been administered expired ACTHIB today. The caller would like to know how to proceed. The caller would like to know if the patient must be revaccinated". It was a case of actual medication error due to expired vaccine used (latency was on the same day). At the time of reporting, patient had 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 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 1525186

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ355AA

gering
Staat
MI
Alter
1,0
Geschlecht
F
Eingang
04.08.2021
Impfdatum
27.07.2021
Beginn
27.07.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

patient was administered an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional. This case involved 1 year old female patient was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination. On 27-Jul-2021, the patient received fourth 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ355AA and expiry date: 24-Jul-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered) It was reported that,"Caller wanted to know if that dose could be considered valid if blood work were drawn and analyzed on the patient." This case was an actual medication error case due to 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
PREVNAR 13; DTAP; HEPATITIS A
Allergien
-
Vorherige Impfungen
-

VAERS 1440972

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ355AA

gering
Staat
IA
Alter
-
Geschlecht
F
Eingang
01.07.2021
Impfdatum
08.06.2021
Beginn
08.06.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

KINRIX was administered to four month old. No adverse side effects reported or noted as of 7/1/21.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 1130508

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ355AA

gering
Staat
WI
Alter
1,0
Geschlecht
F
Eingang
24.03.2021
Impfdatum
18.12.2020
Beginn
05.01.2021
Tage bis Beginn
18,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Immunoglobulin therapy Platelet count decreased Thrombocytopenia

Symptomtext

Patient developed thrombocytopenia on 1/5/21 and was seen in my office on 1/6/21 with platelet count of 2,000 and referred to heme. Because platelets remained low - she received IVIG and gradually platelet count recovered

Weitere VAERSDATA-Felder
Praegender Schweregrund
Immunoglobulin therapy
Hospital-Tage
1,0
Labordaten
platelets 2,000 on 1/6/21 - recovered gradually after IVIG and last count was 170,000 on 3/18/2021
Aktuelle Erkrankungen
fever illness 12/13/20 - was seen in office 12/14/20 and diagnosed with viral illness
Vorgeschichte
eczema
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-