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Reporte zur Charge U6940BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 2 OH 1 SC 1 TX 1

VAERS 2215646

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6940BA

gering
Staat
FL
Alter
1,3
Geschlecht
U
Eingang
05.04.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

The patient received an extra dose of Polio with no adverse event; Initial information received on 31-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 15 months old and unknown gender patient who received an extra dose of polio with no adverse event while receiving vaccines IPV (VERO) [IPOL] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot U6940BA, expiry date: 21-May-2022, dose, form, strength: not reported) and received suspect IPV (VERO) (lot U6940BA, expiry date, dose, form, strength: not reported) both via unknown route in unknown administration site for Immunisation. On an unknown date the patient received an extra dose of polio with no adverse event (extra dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (unknown latency) following the administration of IPV (VERO). It was reported that they gave a 15 month old the pentacel because he needed the DTap but he was not overdue for the Polio. Action taken: not applicable. Outcome: 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2215646

SANOFI PASTEUR · POLIO VIRUS, INACT. (IPOL) · Charge U6940BA

gering
Staat
FL
Alter
1,3
Geschlecht
U
Eingang
05.04.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

The patient received an extra dose of Polio with no adverse event; Initial information received on 31-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 15 months old and unknown gender patient who received an extra dose of polio with no adverse event while receiving vaccines IPV (VERO) [IPOL] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot U6940BA, expiry date: 21-May-2022, dose, form, strength: not reported) and received suspect IPV (VERO) (lot U6940BA, expiry date, dose, form, strength: not reported) both via unknown route in unknown administration site for Immunisation. On an unknown date the patient received an extra dose of polio with no adverse event (extra dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (unknown latency) following the administration of IPV (VERO). It was reported that they gave a 15 month old the pentacel because he needed the DTap but he was not overdue for the Polio. Action taken: not applicable. Outcome: 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1831427

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6940BA

gering
Staat
OH
Alter
1,0
Geschlecht
M
Eingang
30.10.2021
Impfdatum
26.08.2021
Beginn
26.08.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Product preparation issue Underdose

Symptomtext

Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Media Information (under reference- 00824421) and transmitted to Sanofi on 22-Oct-2021. This case involves a one-year-old male patient while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event (Product preparation error and Underdose). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). On 26-Aug-2021, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination. It was a case of actual medication error due to Active ingredient not added to diluent and Vaccine underdose (latency was on same day). At the time of reporting, patient had 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1653345

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6940BA

gering
Staat
SC
Alter
0,3
Geschlecht
F
Eingang
29.08.2021
Impfdatum
06.08.2021
Beginn
06.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation error

Symptomtext

they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACTHIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00715707) and transmitted to Sanofi on 09-Aug-2021. This case involves a 5 month old female patient for whom they only gave the dtap/polio part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because it was not mixed with ACTHIB (product preparation issue). The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. On 06-Aug-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date: not reported] via an unknown route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to product preparation issue (Latency: on the same day). It was reported that, Caller stated they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACT-HIB. AE symptoms or no AE (adverse event). ActHIB lot: UJ472AA expiry date: 21-May-2022. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. At the 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; HEPATITIS B VACCINE; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 1483651

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6940BA

gering
Staat
TX
Alter
1,2
Geschlecht
F
Eingang
18.07.2021
Impfdatum
02.07.2021
Beginn
02.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Off label use Product preparation error

Symptomtext

only the diluent portion of Pentacel was administered to patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Global Medical Information (GMI) (Reference number- 00667263) and transmitted to Sanofi on 02-Jul-2021 and live follow up received on 06-Jul-2021. This case involves a 14-months old female patient who only had the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE INJECTION [PENTACEL] was administered (product preparation error) on 02-Jul-2021 (lot number: U6940BA and expiry date: 21-May-2022) at a dose of 0.5 ml via unknown route in the left thigh for prophylactic vaccination. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]). It was a case of an off-label use and active ingredient not added to diluent (latency same day). At the time of report, no adverse event was reported. It was unknown if there were lab data/results available. 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; ROTAVIRUS VACCINE; HEP [HEPATITIS B VACCINE]
Allergien
-
Vorherige Impfungen
-