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Reporte zur Charge UJ325AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 2 IN 1 TX 1 PA 1

VAERS 1653366

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
IN
Alter
0,3
Geschlecht
F
Eingang
29.08.2021
Impfdatum
10.08.2021
Beginn
10.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

received expired dose of Pentacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00722325) and transmitted to Sanofi on 12-Aug-2021. This case was linked to case-2021SA270105 (cluster). This case involves a four-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 10-Aug-2021, the patient received a second dose (0.5ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA; expiry date: 13-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Caller states that 2 patients received expired doses of PENTACEL in the practice on 10AUG2021 and 11AUG2021 respectively. Caller asked about how to proceed after administering expired doses to these patients." No adverse events were reported at the time of this report. At the time of this report, the outcome of the event was unknown. 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
Allergien
-
Vorherige Impfungen
-

VAERS 1483655

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
FL
Alter
0,4
Geschlecht
U
Eingang
18.07.2021
Impfdatum
05.07.2021
Beginn
05.07.2021
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

A patient was vaccinated with an expired PENTACEL vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (Reference number- 00669933) and transmitted to Sanofi on 06-Jul-2021. This case involves a 5 months old patient (unknown gender) who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Expired product administered) Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines On 05-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ325AA, expiry date: 13-Jun-2021 and strength: 0.5 ml) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day) It was reported ''Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021'' At the time of report, 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 1483643

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
FL
Alter
-
Geschlecht
U
Eingang
18.07.2021
Impfdatum
05.07.2021
Beginn
05.07.2021
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

Symptomtext

patient was given expired PENTACEL vaccinations with no reported adverse event; Initial information received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2021SA225602 and inquiry number 00669898 (same reporter). This case involves an infant patient who was given expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered). It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 05-Jul-2021, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA and expiration date: unknown) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency: same day). 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 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 1483642

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
-
Alter
-
Geschlecht
U
Eingang
18.07.2021
Impfdatum
05.07.2021
Beginn
05.07.2021
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

Symptomtext

were given expired pentacel vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via medical information (Reference number- 00669898) and transmitted to Sanofi on 06-Jul-2021. This case is linked with 2021SA225602. This case involves an infant patient (gender not reported) who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 05-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ325AA, expiry date not reported] via an intramuscular route at right thigh for prophylactic vaccination (expired product administered) (latency: on the same day). It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event was reported. It was reported that "Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. linked to case : 2021SA225602 and linked to Inquiry Number: 00669898 Case created for 2nd patient It is unknown if the patient experienced any additional symptoms/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 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.; Sender's Comments: US-SA-2021SA225602: 00669898:

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

VAERS 1072203

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
TX
Alter
-
Geschlecht
M
Eingang
04.03.2021
Impfdatum
02.03.2021
Beginn
02.03.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Musculoskeletal stiffness Staring

Symptomtext

body became stiff, baby looking away/staring, lasted 5-6 seconds

Weitere VAERSDATA-Felder
Praegender Schweregrund
Musculoskeletal stiffness
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
neonatal acne, seborrheic dermatitis
Vorgeschichte
none
Andere Medikamente
Vitamin D oral supplement
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1032604

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ325AA

gering
Staat
PA
Alter
1,5
Geschlecht
F
Eingang
15.02.2021
Impfdatum
10.02.2021
Beginn
12.02.2021
Tage bis Beginn
2,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Gait disturbance Sleep disorder

Symptomtext

On 2/12/201: the night prior, woke up many times during the night; at daycare, was sleepy and did not want to bear weight and had to hold onto someone to walk; was sent to hospital. Vital signs were normal, was given apple juice to drink and perked up. Stayed for observation for 2 hours, ate applesauce and was discharged home. Symptoms have resolved and was checked in the office today 2/15/2021 and was fine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Gait disturbance
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
diaper rash COVID-19: 1/19/2021
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-