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Reporte zur Charge UJ440AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NV 1 KS 1 CO 1 WV 1

VAERS 1774869

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ440AA

gering
Staat
NV
Alter
43,0
Geschlecht
F
Eingang
09.10.2021
Impfdatum
04.10.2021
Beginn
04.10.2021
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 Wrong product administered

Symptomtext

Patient accidentally received PENTACEL instead of their TDap vaccine in the office with no adverse event; 43 year old patient accidentally received PENTACEL instead of their TDap vaccine, with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a physician and consumer/ non-healthcare professional via Media Information (under reference 00796958). This case involves a 43 years old female patient who accidentally received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] instead of their DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE in the office (wrong product administered and product administered to patient of inappropriate age). Patient did not receive other concomitant vaccines. The patient's medical history, past medical treatment(s), past vaccination (s) and family history were not provided. On 04-Oct-2021, the patient received a 0.5 mL dose of suspect PENTACEL (VERO) (Total, lot UJ440AA and expiration date: 29-May-2022) via intramuscular route in the left arm for prophylactic vaccination. It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration (same day latency). It was reported "Doctor states that a 43 year old patient accidentally received PENTACEL instead of their TDap vaccine in the office on 04OCT2021 and asked for recommendations on how to proceed. Doctor states that she could not find any information online other than for children that inadvertently received the vaccine. Doctor states that no Adverse Events have occurred and that they will continue to monitor the patient." 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 1653321

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ440AA

gering
Staat
KS
Alter
1,6
Geschlecht
F
Eingang
29.08.2021
Impfdatum
03.08.2021
Beginn
03.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

Patient received only liquid DTAP-IPV portion of PENTACEL with no AE; Initial information regarding an unsolicited non-valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708617) and transmitted to Sanofi on 03-Aug-2021 in United States. This case involves an 1 years old female patient who received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue). The patient's medical history, past medical treatment, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 03-Aug-2021, the patient received a 0.5 mL dose of received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Oral solution, DTAP-IPV: lot UJ440AA, ACTHIB: lot UJ502AA and expiry date: 29-MAY-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination. This was an actual medication error case due to inappropriate reconstitution technique (on same day). It was reported that "Nurse asking how she should proceed." It was not reported whether any patient had received the product and experienced any 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 1588519

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ440AA

gering
Staat
CO
Alter
4,0
Geschlecht
F
Eingang
19.08.2021
Impfdatum
19.08.2021
Beginn
19.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

Patient received Pentacel and IPV in error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
cetirizine
Allergien
none
Vorherige Impfungen
-

VAERS 1340537

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ440AA

gering
Staat
WV
Alter
0,5
Geschlecht
M
Eingang
22.05.2021
Impfdatum
20.04.2021
Beginn
20.04.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Medication error Product preparation issue

Symptomtext

patient was given only the liquid portion of Pentacel with no reported AE; HPV vaccine was given by mistake; Initial information was received on 04-May-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (GMI Inquiry number: 00586863). It was reported that a 6 months old male patient received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) (lot number: UJ440AA, expiry date: 29-May-2022)on 20-Apr-2021 via an unknown route at van unknown administration site for prophylactic vaccination (product preparation issue). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HPV VACCINE (HPV VACCINE). HPV VACCINE was given by mistake (wrong vaccine administered). It was a case of actual medication error due to inappropriate reconstitution technique and wrong product administered. 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 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
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; ROTAVIRUS VACCINE; HPV VACCINE
Allergien
-
Vorherige Impfungen
-