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Reporte zur Charge UJ851AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

11Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
VA 2 MI 2 OH 1 IL 1 PA 1 NJ 1 CA 1 AL 1 IN 1

VAERS 2609098

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ851AA

mild
Staat
OH
Alter
1,3
Geschlecht
M
Eingang
04.04.2023
Impfdatum
30.03.2023
Beginn
31.03.2023
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / OT
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Circumstance or information capable of leading to medication error Rash Rash erythematous Rash papular Vaccination site erythema

Symptomtext

Erythematous raised rash on entire skin surface. On the right lateral upper thigh, there are two larger patches of erythema about the size of a clementine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
The vaccine site was recorded as right deltoid for the COVID vaccine but dad stated it was given in the right vastus lateralis and the needle mark was noted in the skin. The vaccine site was recorded as the left deltoid for the pentacel vaccine but dad stated it was given in the left vastus lateralis.
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2724185

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ851AA

gering
Staat
IL
Alter
1,0
Geschlecht
M
Eingang
14.12.2023
Impfdatum
06.12.2023
Beginn
06.12.2023
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 Product preparation issue

Symptomtext

powder component was administered with sterile water and the liquid part was not administered with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient where reporter reported that powder component of vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] was administered with sterile water and the liquid part was not administered 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 pneumococcal vaccine conj 13v (crm197) (prevnar 13) for Prophylactic vaccination. On 06-Dec-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 (lot UJ851AA and expiration date- 01-Apr-2024) via intramuscular route in the left thigh (strength: not provided) for Immunisation (poor quality product administered) (latency- same day). 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
Allergien
-
Vorherige Impfungen
-

VAERS 2712331

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ851AA

gering
Staat
VA
Alter
0,3
Geschlecht
F
Eingang
10.11.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
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 Product preparation error

Symptomtext

PENTACEL being administered as two separate doses. Caller states the DTap/IPV portion was administered to the patient, however it was not reconstituted with the ActHib lyophilized portion with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old female patient who was being administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion 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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation. On 30-Oct-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the thigh nos as Immunization as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion with no reported adverse event (single component of a two-component product administered) (Latency: same day). It was reported "She would like to know if the lyophilized ActHib portion can be reconstituted with normal saline and administered to the patient? She would like to know if the 0.4% saline solution can be any they have on hand or does it have to be specific?" 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
PREVNAR 20
Allergien
-
Vorherige Impfungen
-

VAERS 2708172

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj851AA

gering
Staat
VA
Alter
0,3
Geschlecht
F
Eingang
01.11.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation error

Symptomtext

Pentacel was not reconstituted prior to administration, only the vial containing liquid was administered. Patient's mother was informed about error and to receive correct vaccination at upcoming appointment with the health department.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2708126

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ851AA

gering
Staat
MI
Alter
1,0
Geschlecht
M
Eingang
01.11.2023
Impfdatum
31.10.2023
Beginn
31.10.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered

Symptomtext

Patient was given double dose of DTAP & IPOL because of being given Pentacel as well. No issues as of now that we are aware of.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Acute suppurative otitis media (10/11/2023)
Vorgeschichte
None
Andere Medikamente
No current medications
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2692724

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ851AA

gering
Staat
PA
Alter
0,5
Geschlecht
M
Eingang
09.10.2023
Impfdatum
06.10.2023
Beginn
06.10.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered Wrong product administered

Symptomtext

Pt received Pentacel vaccine instead of HIB vaccine, which meant he got 2 doses of Dtap at this same visit

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2679165

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ851AA

gering
Staat
NJ
Alter
0,2
Geschlecht
F
Eingang
05.09.2023
Impfdatum
31.08.2023
Beginn
31.08.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

patient received only the DTAP-IPV component of PENTACEL and that they did not reconstitute the HIB component so the patient did not get that part (with no reported adverse event); patient received only the DTAP-IPV component of PENTACEL and that they did not reconstitute the HIB component so the patient did not get that part (with no reported adverse event); Initial information received on 31-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 2-month-old female patient received only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and that they did not reconstitute the hib component so the patient did not get that part (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 hepatitis B vaccine for Prophylactic vaccination; pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination; and rotavirus vaccine for Prophylactic vaccination. On 31-Aug-2023, the patient received a 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ851AA, expiry date: 01-Apr-2024) via intramuscular route in the right thigh for Immunization and patient received only the dtap-ipv component of pentacel and that they did not reconstitute the hib component so the patient did not get that part (with no reported adverse event) (product preparation issue and incorrect product formulation administered) (latency: same day). Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (VERO)) was 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; PREVNAR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2671026

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ851AA

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
14.08.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
2
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves 4 months old female patient for whom HIB component of HIB (PRP/T) vaccine [ACT-HIB] was used with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and administered it to a patient 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 patient was administered a standard dose 2 (0.5 ml) of HIB component of HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ8566AA, expiry date- 26-MAR-2024) with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ851AA, expiry date- 04-JAN-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency- same day). Reportedly, Patient care supervisor called to ask if the HIB components of ACT-HIB and PENTACEL were the same because a medical assistant used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2662179

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ851AA

gering
Staat
AL
Alter
0,3
Geschlecht
F
Eingang
27.07.2023
Impfdatum
23.06.2023
Beginn
23.06.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

accidentally administered PENTACEL to a patient without reconstituting it; reports that they only administered the liquid part of PENTACEL; the patient did not receive the powder HIB part with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old female patient who was accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] to the patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part 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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for Prophylactic vaccination. On 23-Jun-2023, the patient received a dose 3 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the left vastus lateralis for immunization. On 23-Jun-2023 the patient developed a non-serious "accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine to a patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part with no reported adverse event (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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2659071

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ851AA

gering
Staat
IN
Alter
5,0
Geschlecht
F
Eingang
20.07.2023
Impfdatum
14.07.2023
Beginn
14.07.2023
Tage bis Beginn
0,0
Dosis
5
Route/Site
OT / LL
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

pentacel was administered to a 5 year old instead of the intended kinrix with no reported adverse event; pentacel given to a 5 year old patient with no reported adverse event; Initial information received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient for whom vaccine Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered instead of the intended kinrix 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Zoster Vaccine for Immunisation. On 14-Jul-2023, the patient of 5 year old received a dose of 0.5 ml (frequency: once) of standard strength dose 5 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] suspension for injection (lot: UJ851AA, Expiry date: 01-Apr-2024) via intramuscular route in the left thigh for Immunization, instead of the intended kinrix with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day). 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 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 2657708

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ851AA

gering
Staat
MI
Alter
1,3
Geschlecht
F
Eingang
18.07.2023
Impfdatum
14.07.2023
Beginn
14.07.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect product formulation administered

Symptomtext

Provider ordered Pentacel, only the liquid was given. Patient family is aware to return to the office for ActHIB. Reeducation was given to staff members

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