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Reporte zur Charge UJ390AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IN 2 WV 1 NY 1

VAERS 929725

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj390aa

mild
Staat
WV
Alter
0,5
Geschlecht
M
Eingang
08.01.2021
Impfdatum
06.01.2021
Beginn
06.01.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site swelling Pyrexia

Symptomtext

Injection site swollen and red size of a quarter and fever

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
No
Vorgeschichte
Congenital laryngomalacia, GERD, Laryngopharyngeal reflux
Andere Medikamente
Famotidine 0.4ml BID
Allergien
N/A
Vorherige Impfungen
red swollen injection site, low garde fever. Pentacel 11/04/2020 4 months old

VAERS 1950825

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ390AA

gering
Staat
NY
Alter
-
Geschlecht
F
Eingang
15.12.2021
Impfdatum
03.12.2021
Beginn
03.12.2021
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

expired Pentacel was administered, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00884020) and transmitted to Sanofi on 03-Dec-2021. This case involves an unknown age female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 03-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ390AA and expiry date: 12-Oct-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered). It was reported "Caller wants to know if there will be any side effects, if they need to repeat the dose and if so, how long do they need to wait before re-administering. Caller stated she was told that the product is still viable for 6 months after the expiration date and wants us to confirm if that is true or not. She asks if there is a grace period past expiration? What are safety concerns? Can it be repeated immediately? This is inactivated vaccine, right? What is (vaccine adverse event reporting system) VAERS reporting"? This case was an actual medication error 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1876143

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ390AA

gering
Staat
IN
Alter
0,5
Geschlecht
M
Eingang
17.11.2021
Impfdatum
04.11.2021
Beginn
04.11.2021
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 Medication error No adverse event

Symptomtext

expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health care professional via Medical Information (MI) (Reference number- 00850122) and transmitted to Sanofi on 09-Nov-2021. This case involves a 6-month-old male patient receiving expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was inadvertently administered (expired product administered). The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Nov-2021, the patient received a 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Frequency: once, lot UJ390AA, expiry date: 15-Oct-2021, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD 0.25mL] via intramuscular route in the right thigh for prophylactic vaccination. This case is medication error due to expired vaccine used (latency same day). It was reported "medical assistant reporting that an expired dose of PENTACEL was inadvertently administered, on 04-Nov-2021 an expired dose of pentacel was given and the product expired on 15Oct2021." At time of reporting, 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 943147

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ390AA

gering
Staat
IN
Alter
-
Geschlecht
M
Eingang
14.01.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 15-Dec-2020. This case involves a 9 month-old child who was supposed to receive a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar). On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 mL daily via intramuscular route right thigh (lot number: UJ390AA; Expiration date: 10-Dec-2021) for prophylactic vaccination. On an unknown date, it was reported that the 9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error) (non-serious event) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. No laboratory tests were reported. It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the event. Disclaimer: 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR
Allergien
-
Vorherige Impfungen
-