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Reporte zur Charge UJ356AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
UT 2 NE 1 TX 1 AL 1

VAERS 1692824

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ356AA

gering
Staat
NE
Alter
1,9
Geschlecht
M
Eingang
11.09.2021
Impfdatum
31.08.2021
Beginn
31.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Expired product administered No adverse event

Symptomtext

Patient was administered with an expired act-hib vaccine with no A/E; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other Health Care Professional via consumer Reference number: 00750051). This case involves a 23-months old male patient who was administered with an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (Expired product administered). Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and hepatitis for prophylactic vaccination. On 31-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ356AA and expiry date: 25-Jul-2021 via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency: same day). It was reported "The caller is requesting recommendations for a patient that had received an expired ACT HIB vaccination. Emergency Room/Doctor's visit and date 8/31/2021." Frequency: once. 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1483669

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ356AA

gering
Staat
TX
Alter
76,0
Geschlecht
M
Eingang
18.07.2021
Impfdatum
07.07.2021
Beginn
07.07.2021
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 administered to patient of inappropriate age Product label on wrong product Wrong product administered

Symptomtext

The nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of ActHIB and mistakenly thought that meant it was a vaccine against tetanus with no adverse event; ActHIB was administered in error to a 76 year old patient instead of a tetanus shot with no reported adverse event; ActHIB was administered in error to a 76 year old patient instead of a tetanus shot with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional (Reference number- 00674134) and transmitted to Sanofi on 08-Jul-2021. This case involved 76 years old male patient who administered HIB (PRP/T) VACCINE [ACT-HIB] instead of a TETANUS VACCINE (wrong product administered and product administered to patient of inappropriate age) and it was reported as the nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of acthib and mistakenly thought that meant it was a vaccine against tetanus (product label on wrong product) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 07-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot UJ356AA) via unknown route in left deltoid site prophylactic vaccination. On 07-JUL-2021,76 years old male patient administered HIB (PRP/T) VACCINE [ACT-HIB] instead of a TETANUS VACCINE (wrong product administered and product administered to patient of inappropriate age) (latency same day, non-serious) On an unknown date it was reported as the nurse who pulled the vaccine from stock saw conjugated with tetanus toxoid on the label of HIB (PRP/T) VACCINE [ACT-HIB] and mistakenly thought that meant it was TETANUS VACCINE (product label on wrong product) (non-serious) It was reported that, "The caller reports that ACTHIB was erroneously administered to a patient. The caller would like to know of any possible adverse events or side effects this may cause. The caller also would like to know what the next steps should be regarding the patient. Are there any contraindications or waiting period needed to give the correct vaccine, either (td) diphtheria tetanus or Tdap (tetanus, diphtheria, and acellular pertussis)? She currently only has Tdap in stock from both Sanofi and GSK (GlaxoSmithKline). Referred to non-Sanofi manufacturer for possibility of Boostrix. Adacel case for medical information provided for Adacel. There is no adverse event information in the Adacel case". It was an actual medication error case (wrong vaccine administered, inappropriate age at vaccine administration and product label on wrong product) 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 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. There will be no information available on the batch number for this case.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1399278

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ356AA

gering
Staat
UT
Alter
0,2
Geschlecht
F
Eingang
22.02.2021
Impfdatum
29.09.2020
Beginn
29.09.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Infant irritability

Symptomtext

Irritable for 24 hours

Weitere VAERSDATA-Felder
Praegender Schweregrund
Infant irritability
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
omeprazole
Allergien
-
Vorherige Impfungen
-

VAERS 1399274

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge UJ356AA

gering
Staat
UT
Alter
0,3
Geschlecht
F
Eingang
22.02.2021
Impfdatum
30.11.2020
Beginn
30.11.2020
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Infant irritability

Symptomtext

Irritable for 24 hours

Weitere VAERSDATA-Felder
Praegender Schweregrund
Infant irritability
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
No
Vorgeschichte
No
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
09/29/2020~DTaP + HepB + IPV (Pediarix)~1~0.00~Patient|09/29/2020~Hib (ActHIB)~1~0.00~Patient|09/29/2020~Pneumo (Prevnar13)~1~0.

VAERS 1006201

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ356AA

gering
Staat
AL
Alter
0,5
Geschlecht
F
Eingang
05.02.2021
Impfdatum
05.02.2021
Beginn
05.02.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Unevaluable event

Symptomtext

Both ActHiB and Pentacel were given in one round of shots. No symptoms have been reported.

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