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Reporte zur Charge U7130AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WA 1 IA 1 TX 1 VA 1 CT 1 MI 1

VAERS 2516500

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7130AA

gering
Staat
WA
Alter
0,3
Geschlecht
U
Eingang
25.11.2022
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

staff member gave the liquid portion of PENTACEL to a 4 month old with no reported AE; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old patient of unknown gender to whom staff member gave the liquid portion of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Pentacle] portion and not HIB (PRP/T) Vaccine[ACT-HIB] portion 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 a staff member gave DTAP/IPV portion of the vaccine (lot - U7130AA) (strength, dose, route, formulation, expiry date not reported) via unknown route at unknown administration site for Immunization and not the ACTHIB portion to a 4 month old with no reported adverse event (Product preparation error) (unknown latency). 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2440272

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7130AA

gering
Staat
-
Alter
0,8
Geschlecht
F
Eingang
12.09.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

only the liquid portion of PENTACEL was administered to a pt with no adverse event; only the liquid portion of PENTACEL was administered to a pt with no adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 months old female patient who to whom only the liquid portion of pentacel was administered with no adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (dose, formulation, strength: unknown) lot U7130AA via unknown route in unknown administration site as prophylactic immunisation. On an unknown date the patient developed a non-serious event "only the liquid portion of pentacel was administered to a pt with no adverse event" (product preparation error) (single component of a two-component product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. 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 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
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2427640

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7130AA

gering
Staat
IA
Alter
1,3
Geschlecht
F
Eingang
02.09.2022
Impfdatum
18.07.2022
Beginn
18.07.2022
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Single component of a two-component product administered

Symptomtext

Patient was given a Pentacel vaccine, but did not receive the HIB portion of the vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Single component of a two-component product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
Amoxicillin
Vorherige Impfungen
-

VAERS 2285017

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7130AA

gering
Staat
TX
Alter
1,3
Geschlecht
M
Eingang
19.05.2022
Impfdatum
16.05.2022
Beginn
16.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

NA

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2266144

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7130AA

gering
Staat
VA
Alter
0,6
Geschlecht
F
Eingang
06.05.2022
Impfdatum
05.05.2022
Beginn
05.05.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Irritability

Symptomtext

irritable

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

VAERS 2217864

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7130AA

gering
Staat
CT
Alter
1,8
Geschlecht
M
Eingang
06.04.2022
Impfdatum
31.03.2022
Beginn
31.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

the two components of the vaccine, liquid DTaP-IPV component and the lyophilized Hib component, were not mixed together, but were administered as separate injections WITH NO REPORTED ADVERSE EVENT; Hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event; Initial information received on 31-Mar-2022 regarding an unsolicited valid non-serious case was received from other health professional. This case involves a 21 month old male patient for whom the two components of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered as separate injections with no reported adverse event and hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included water for injection (Sterile water); hepatitis a vaccine for immunization; and hepatitis b vaccine for Immunization. On 31-Mar-2022, the patient received third dose of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, once (lot Number: U7130AA (DTaP-IPV), Expiration Date :07-Dec-2022; Lot Number: UJ622AA (Hib), Expiration Date :07-Dec-2022; Lot Number: UJ622AAA (carton), Expiration Date :07-Dec-2022) via intramuscular route in unknown administration site for immunization. It was reported that on 31-MAR-2022, latency: same day, the two components of the vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered intramuscularly as separate injections with no reported adverse event (wrong technique in product usage process). The lyophilized Hib component was reconstituted with sterile water for injection. The Hib component was administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event (product preparation issue). This was the patient's third dose in the series, on a catch-up schedule. Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) was not applicable. It was not reported if the patient received a corrective treatment for the events (the two components of the vaccine, liquid DTaP-IPV component and the lyophilized Hib component, were not mixed together, but were administered as separate injections WITH NO REPORTED ADVERSE EVENT, Hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event). At time of reporting, the outcome was Unknown for the event the two components of the vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered as separate injections with no reported adverse event and was Unknown for the event hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with 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 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
STERILE WATER
Allergien
-
Vorherige Impfungen
-

VAERS 2182448

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7130AA

gering
Staat
MI
Alter
1,3
Geschlecht
M
Eingang
16.03.2022
Impfdatum
15.03.2022
Beginn
16.03.2022
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation issue

Symptomtext

Staff member administered Dtap and IPV only. Did not reconstitute with Hib. I called the health dept and was told dose is valid, Adjustments made in system. Patient is coming back in for nurse visit only to get HIB. Spoke to mom, patient is doing well. No concerns at this time. Injection site looks normal. No erythema.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation issue
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
skin infection, given Bactroban on 03/15/22
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-