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Reporte zur Charge U7013AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NM 1 TN 1 AZ 1 MA 1 CO 1

VAERS 2397771

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7013AA

gering
Staat
NM
Alter
-
Geschlecht
U
Eingang
01.08.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given inappropriately, stated only the diluent was administered and not the powder 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 received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7013AA. On an unknown date, Pentacel was given inappropriately, stated only the diluent was administered and not the powder with no reported 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. The reporter stated that all the diluents they had were either sterile water or 0.9% normal saline , so they wanted to know how they would obtain the proper diluent (0.4% NaCl saline solution) . 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 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 2177102

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7013AA

gering
Staat
TN
Alter
1,3
Geschlecht
M
Eingang
12.03.2022
Impfdatum
02.03.2022
Beginn
02.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event

Symptomtext

ordered a 15 month old to have DTap and ActHIB separately but the person gave the child, Pentacel and Acthib( another brand) today, with no reported adverse event; Initial information received on 02-Mar-2022 regarding an unsolicited valid non-serious case received from a nurse practitioner. This case involves a 15 months old male patient for whom nurse practitioner ordered to have dtap and acthib separately but the person gave the child diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and HIB vaccine CONJ (TET TOX) [Acthib] (another brand) today, 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) (Prevenar 13) and HIB vaccine CONJ (TET TOX) (Acthib) for Immunisation. On 02-Mar-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (lot U7013AA, expiration date: 10-Sep-2022) unknown strength via intramuscular route in the right thigh for immunization and on same day nurse practitioner reported that she ordered to have dtap and acthib separately but the person gave the child, pentacel and acthib( another brand) today, with no reported adverse event (wrong product administered). The caller asked what to do. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1998625

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7013AA

gering
Staat
AZ
Alter
1,7
Geschlecht
M
Eingang
03.01.2022
Impfdatum
28.12.2021
Beginn
28.12.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

This case involves a 20 months old male patient who experienced administered pentacel to a patient without reconstituting it with no reported adverse event. while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and INFLUENZA VACCINE (INFLUENZA VACCINE). On 28-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U7013AA via intramuscular route in unknown administration site for prophylactic vaccination. On 28-DEC-2021 the patient developed a non-serious administered pentacel to a patient without reconstituting it with no reported adverse event. (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. 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 event (administered PENTACEL to a patient without reconstituting it with no reported adverse event.). At time of reporting, the outcome was Unknown for the event administered pentacel to a patient without reconstituting it 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. 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
PNEUMOCOCCAL CONJUGATE VACCINE; HEPATITIS A VACCINE; INFLUENZA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1978902

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7013AA

gering
Staat
MA
Alter
-
Geschlecht
M
Eingang
24.12.2021
Impfdatum
17.12.2021
Beginn
17.12.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

the portion given was the diluent part of the vaccine with no reported adverse event; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00903542). This case involves a six -month-old male patient who experienced the portion given was the diluent part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue). The patient past medical history, medical treatment, vaccination and family history were not provided. On 17-Dec-2021, the patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7013AA and expiry date: not reported, solution) (frequency: once) via intramuscular route in left leg for prophylactic vaccination. It was reported "They would like to know what to do as the parents do not want to repeat the ActHib. The ActHIB was mixed with and caller states nothing. Clarified the portion given was the diluent part of the vaccine. Caller wanted to know if they could use the diluent for the COVID vaccine since she thinks it is 0.4 % sodium chloride to mix with the powder that is left?". It was a case of actual medication error due to inappropriate reconstitution technique. At the time of report 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1952172

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7013AA

gering
Staat
CO
Alter
0,2
Geschlecht
M
Eingang
15.12.2021
Impfdatum
15.12.2021
Beginn
15.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
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

Hepatitis B vaccine (Recombivax HB) was ordered and signed for patient. Verbally communicated with MA the vaccines to be given: Pentacel, Hepatitis B, and Rotavirus vaccines. After MA gave vaccines, another MA was entering them into the system and noted that patient had been incorrectly given Vaqta (Hepatitis A) vaccine instead of Recombivax (Hepatitis B) vaccine as ordered. Supervising physician Dr. was immediately notified, and mother of patient was notified subsequently. Reviewed adverse symptoms to watch for with plan to follow-up via telephone tomorrow. No immediate adverse events or symptoms were noted with the patient in office. He was breastfeeding at time of re-assessment.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None.
Vorgeschichte
None.
Andere Medikamente
Vitamin D supplement
Allergien
None.
Vorherige Impfungen
-