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Reporte zur Charge UJ876AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

15Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 5 TX 2 IL 2 CA 2 NJ 2 CO 1 CT 1

VAERS 2694937

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

mild
Staat
TX
Alter
1,3
Geschlecht
F
Eingang
12.10.2023
Impfdatum
09.10.2023
Beginn
10.10.2023
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia Urticaria

Symptomtext

fever to 101 and hives started on shoulder and spread to back and flanks

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
-
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2723615

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
IL
Alter
2,0
Geschlecht
F
Eingang
13.12.2023
Impfdatum
02.11.2023
Beginn
12.12.2023
Tage bis Beginn
40,0
Dosis
4
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect dose administered Product preparation error

Symptomtext

The Pentacel vaccine was not reconstituted. The patient only received the DTaP/IPV vial.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
N/A - will need additional vaccination
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
no known allergies
Vorherige Impfungen
-

VAERS 2709994

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
CA
Alter
0,2
Geschlecht
M
Eingang
06.11.2023
Impfdatum
03.11.2023
Beginn
03.11.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

PATIENT CAME IN TO MEDICAL GROUP ON 11/03/2023 TO RECEIVE 2 MONTH OLD VACCINES. DR ORDERED FOR THE FOLLOWING VACCINE TO BE ADMINISTERED: ROTARIX, HEP B, PENTACEL, AND PREVENAR 13. ALL VACCINES WERE GIVEN EXCEPT PREVENAR 13. PREVENAR 20 WAS GIVEN BY MISTAKE. OUTCOME: DR REVIEWED THE CDC GUIDELINES AND THE PATIENT WILL BE OKAY. OFFICE MANAGER: SPOKE WITH PATIENT'S MOTHER: TO UPDATE HER ON THE INCORRECT VACCINE THAT WAS GIVEN AND TO PROVIDE INSTRUCTION BY DR.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
NO MEDICATIONS.
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2698470

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
FL
Alter
0,2
Geschlecht
F
Eingang
19.10.2023
Impfdatum
26.07.2023
Beginn
01.08.2023
Tage bis Beginn
6,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into EMR on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where Vaccines should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and she is up to date with her vaccines and revaccination is not required for this patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2698468

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
FL
Alter
2,0
Geschlecht
F
Eingang
19.10.2023
Impfdatum
26.07.2023
Beginn
01.08.2023
Tage bis Beginn
6,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error

Symptomtext

An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and she is up to date with her vaccines and revaccination is not required for this patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error
Allergien
None
Vorherige Impfungen
-

VAERS 2698467

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
19.10.2023
Impfdatum
27.06.2023
Beginn
01.08.2023
Tage bis Beginn
35,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and he needs to catch up most likely. Might need a HIB alone and a DTap alone if preferred by parents. The patient has a follow up appointment on 12/04/2023 to discuss further.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
None
Vorgeschichte
-
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2698464

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
FL
Alter
0,3
Geschlecht
F
Eingang
19.10.2023
Impfdatum
26.06.2023
Beginn
01.08.2023
Tage bis Beginn
36,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error

Symptomtext

An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and she is up to date with her vaccines and revaccination is not required for this patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2698461

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
FL
Alter
0,3
Geschlecht
F
Eingang
19.10.2023
Impfdatum
19.07.2023
Beginn
01.08.2023
Tage bis Beginn
13,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error Underdose

Symptomtext

An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and she is up to date with her vaccines and revaccination is not required for this patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2677353

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
CO
Alter
0,3
Geschlecht
F
Eingang
28.08.2023
Impfdatum
24.08.2023
Beginn
24.08.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

None

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

VAERS 2675272

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ876AA

gering
Staat
CT
Alter
1,6
Geschlecht
M
Eingang
22.08.2023
Impfdatum
07.08.2023
Beginn
07.08.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect product formulation administered No adverse event

Symptomtext

consumer was only given Dtap and IPV component of the pentacel Vaccine, as doctor forgot to mix the HIB component with no reported adverse event; Initial information was received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old male patient who received only dtap and ipv component of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] as doctor forgot to mix the hib component with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Aug-2023, the patient received dtap and ipv component of the dose 4 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml (lot number: UJ876AA, expiration date: 19-Mar-2024) via intramuscular route in the left thigh for immunization (immunisation) as doctor forgot to mix the hib component with no reported adverse event (product preparation error) (latency: same day). No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event consumer was only given dtap and ipv component of the pentacel vaccine, as doctor forgot to mix the hib component with no reported 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
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2675267

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ876AA

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
22.08.2023
Impfdatum
08.08.2023
Beginn
08.08.2023
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 No adverse event

Symptomtext

did not receive both vials mixed with no reported adverse event; more than likely got the incorrect dose of PENTACEL, with no reported adverse event; Initial information was received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA254827 (CLUSTER). This case involves an unknown age and gender patient who did not receive both vials mixed and more likely got the incorrect dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2023, the patient received 0.5 mL, total (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024, unknown strength) via intramuscular route in unknown administration site for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (single component of a two-component product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the 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
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2675265

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ876AA

gering
Staat
NJ
Alter
0,7
Geschlecht
F
Eingang
22.08.2023
Impfdatum
08.08.2023
Beginn
08.08.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Medication error No adverse event Single component of a two-component product administered

Symptomtext

patient that more than likely got the incorrect dose of pentacel with no reported adverse event; did not receive both vials mixed with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2023SA254858 (Cluster). This case involves a 8 months old female patient who more than likely got the incorrect dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] and did not receive both vials mixed with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2023, the patient received 0.5 mL dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024) via intramuscular route in the left thigh for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (single component of a two-component product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for both the 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.

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

VAERS 2673057

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ876AA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
18.08.2023
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

two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 2 patients who were administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patients received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ876AA) (with an unknown strength, dosage and expiry date) via unknown route in unknown administration site for Immunization, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event (product preparation error) (latency- same day). Reportedly, Caller reporting two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water. Caller reporting, they had 2 extra doses of the DTAP/IPV, which led them to believe 2 patients were given only the HIB. Caller reporting, they are unsure which patients affected, they have narrowed it down to 4, meaning 2 of the 4 receiving only HIB/sterile water and the other 2 patients received the full dose of PENTACEL. caller that the two patients who received the doses with HIB reconstituted with sterile water would not be counted as a valid dose. Caller then asked if they need to be repeated. Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2672245

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
IL
Alter
0,5
Geschlecht
M
Eingang
16.08.2023
Impfdatum
25.07.2023
Beginn
25.07.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Underdose

Symptomtext

Received lower than recommended dose of moderna bivalent vaccine. Patient should have received 25 mcg, but instead received 10 mcg.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Underdose
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None known
Vorgeschichte
None
Andere Medikamente
None
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2599061

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ876AA

gering
Staat
CA
Alter
0,3
Geschlecht
M
Eingang
18.03.2023
Impfdatum
09.03.2023
Beginn
09.03.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

patient being administered only the DTAP-IPV component of PENTACEL without being reconstituted with the lyophilized ACTHIB component with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4 months old male patient who being administered only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without being reconstituted with the lyophilized acthib component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine and Pneumococcal Vaccine CONJ (Pneumococcal Conjugate Vaccine) for Immunisation. On 09-Mar-2023, the patient received dose 1 at 0.5mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (strength: standard) (lot number: UJ876AA; expiry date: 19-MAR-2024) via unknown route in unknown administration site for immunisation. On 09-Mar-2023 the patient being administered only the dtap-ipv component of pentacel without being reconstituted with the lyophilized acthib component with no reported adverse event (product preparation issue) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine. It was reported as Caller states that a medical assistant administered the liquid component (DTAP-IPV) of vaccine without reconstituting it with the powder component (lyophilized ACTHIB vaccine). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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 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
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