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Reporte zur Charge UJ357AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
AL 2 TX 1 PA 1

VAERS 1653415

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AA

gering
Staat
TX
Alter
2,0
Geschlecht
M
Eingang
29.08.2021
Impfdatum
23.08.2021
Beginn
23.08.2021
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 No adverse event

Symptomtext

patient received expired powder portion of ACT-HIB/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Global Medical Information (GMI) (reference number- 00736119). This case involves a 24 months old male patient who administered expired powder portion of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 23-Aug-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (strength: standard, frequency: once) (powder: UJ357AA and expiry date: 26-JUL-2021) (diluent: lot number: U6849AA and expiry date: 22-JAN-2022)) via an intramuscular route in the left vastus lateralis for prophylactic vaccination. It was of actual medication error due to expired vaccine used (latency: same day). It was reported ''Stated that the vaccine was given, but the diluent portion expired on 01/22/2022, powder expired 07/26/2021 and she wants to know what the recommendations are.'' At the time of reporting, no adverse event 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 by the regulatory authority. 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 1653356

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AA

gering
Staat
AL
Alter
1,3
Geschlecht
F
Eingang
29.08.2021
Impfdatum
10.08.2021
Beginn
10.08.2021
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

Patient was given an expired vaccine/ no AE; Initial information was received on 10-Aug-2021 regarding an unsolicited valid non-serious case received from an Other health professional. This case involves a 16-month-old female patient reported that patient was given an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for prophylactic vaccination. On 10-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AA, expiry date 26-Jul-2021] via intramuscular route in the right thigh for prophylactic vaccination. It was reported that, "Caller wanted to know if consumer needed to be re-vaccinated". It was a case of actual medication error due to expired vaccine used (latency was on 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
DTAP VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1326275

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AA

gering
Staat
AL
Alter
1,0
Geschlecht
M
Eingang
18.05.2021
Impfdatum
-
Beginn
04.05.2021
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

patient received a dose of ACTHIB which was reconstituted with sterile water; Initial information was received on 04-May-2021 regarding an unsolicited non-valid non-serious case from other health professional (inquiry number: 00587326). It was reported that 0.5 mL of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ357AA and expiry date not reported) was administered to a one-year-old male patient which was reconstituted with sterile water via an unknown route at an unknown administration site for prophylactic vaccination (product preparation issue). It was a case of actual medication error due to inappropriate reconstitution technique. At the time of report, no adverse event 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1316714

PFIZER\WYETH · PNEUMO (PREVNAR13) · Charge UJ357AA

gering
Staat
PA
Alter
0,2
Geschlecht
M
Eingang
14.05.2021
Impfdatum
16.04.2021
Beginn
16.04.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Cognitive disorder Personality change

Symptomtext

Mom felt she noticed "an immediate difference in his personality. " He was smiling, communicative since "the first day in the hospital." Mom felt he became "subdued"- "eyes became blank." Mom described "he looked muted." "I dont know it it affected him neurologically." Mom felt it seemed like he wanted to smile, but could not. Mom felt this started the day of the vaccines. The morning of he was "bubbling," "beaming." 2-3 weeks he wasn't himself. Now is is back to himself, "fully recovered" 6 d ago. 2 month vaccines were given on 4/26. 12 yo sib has autism

Weitere VAERSDATA-Felder
Praegender Schweregrund
Cognitive disorder
Hospital-Tage
-
Labordaten
none Also got Pediarix T4Y35 Im, Act Hib UJ357AA and Rotateq po TO39454 that day
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
NKDA
Vorherige Impfungen
-