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Reporte zur Charge UJ646AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 1 FL 1 OH 1 IN 1 PA 1 WA 1

VAERS 2630168

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
11.05.2023
Impfdatum
07.02.2023
Beginn
07.02.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Poor quality product administered Product storage error

Symptomtext

temperature excursion of acthib lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse events; 2 patients received ACTHIB post excursion with no reported adverse events; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patients of an unknown age and gender and reporter reported that temperature excursion of HIB (PRP/T) VACCINE [ACT-HIB] lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse event and 2 patients received acthib post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Feb-2023, the patients received suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (dosage, strength, route: not reported, Batch number: UJ646AAA and expiry date: 05-Mar-2023) via unknown route in unknown administration site for immunization (immunization) and temperature excursion of acthib lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse events (product storage error) and 2 patients received acthib post excursion with no reported adverse events (poor quality product administered) (latency: same day). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events. 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 guidelines. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2599046

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
FL
Alter
1,6
Geschlecht
F
Eingang
18.03.2023
Impfdatum
07.03.2023
Beginn
07.03.2023
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

expired dose of ACTHIB was administered with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who reported expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Mar-2023, the patient received a 0.5ml dose (dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UJ646AAA and expiry: 05-Mar-2023 via intramuscular route in the left thigh for immunization. On 07-Mar-2023, the patient developed a non-serious event expired dose of ACTHIB was administered with no reported adverse event (expired product administered) (same day) following the administration of HIB (PRP/T) vaccine. No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event expired dose of ACTHIB was administered with no reported 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2519685

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
OH
Alter
1,0
Geschlecht
M
Eingang
30.11.2022
Impfdatum
21.11.2022
Beginn
21.11.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental exposure to product Medication error No adverse event

Symptomtext

needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event; Initial information received on 23-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 1 years old male patient and it was reported that the needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event while receiving HIB (PRP/T) vaccine [ACT-HIB]. 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 (Daptacel); and pneumococcal vaccine conj 7V (CRM197) (Prevnar). On 21-Nov-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with lot number- UJ646AAA and expiry date: 05-Mar-2023 (strength: unknown) via intramuscular route in the right thigh for prophylactic vaccination. On 21-Nov-2022, the needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event (Inadvertent exposure to vaccine) (latency: same day) following the administration of HIB (PRP/T) vaccine. Lab tests were not reported. Action taken: Not applicable. At time of reporting, the outcome was unknown 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 guidelines. 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
Accidental exposure to product
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
DAPTACEL; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 2400277

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
IN
Alter
4,0
Geschlecht
F
Eingang
19.10.2022
Impfdatum
02.08.2022
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect product formulation administered No adverse event Product administered to patient of inappropriate age

Symptomtext

On 10/19/2022 was noted that patient had Pfizer Ped dose 5-11 instead of 6months to 4 year dose. Patients parent was aware, stated the nurse called him to explain in August. States no adverse reaction. CDC called to see what dose to give the patient for 2nd vaccine. CDC reply?If the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be as

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

VAERS 2405627

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
PA
Alter
2,0
Geschlecht
M
Eingang
09.08.2022
Impfdatum
08.08.2022
Beginn
09.08.2022
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

unknown

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

VAERS 2397781

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ646AAA

gering
Staat
WA
Alter
1,0
Geschlecht
F
Eingang
01.08.2022
Impfdatum
21.07.2022
Beginn
21.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event); Initial information received on 25-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 year old female patient who was receiving act-hib (HIB (PRP/T) VACCINE) that was reconstituted with sterile diluent (with no reported adverse event). 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); ELASOMERAN (MODERNA COVID-19 VACCINE); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) all for Prophylactic vaccination. On 21-Jul-2022, the patient received a dose of 0.25 ml (0.25 mL to 2 mL ) of suspect HIB (PRP/T) VACCINE lot UJ646AAA, expiration date: 05-Mar-2023, via intramuscular route in the left deltoid as Immunization. On 21-JUL-2022 the patient was receiving act-hib that was reconstituted with sterile diluent (with no reported adverse event) (product preparation error) same day following the administration of HIB (PRP/T) VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event)). At time of reporting, the outcome was Unknown 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 guidelines. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-