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Reporte zur Charge U7238AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MO 1 VA 1

VAERS 2506582

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7238AA

gering
Staat
MO
Alter
0,3
Geschlecht
F
Eingang
12.11.2022
Impfdatum
25.10.2022
Beginn
25.10.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

administered only the liquid portion of the pentacel to a patient with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who administered only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 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. Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation. On 25-Oct-2022, the patient received a 0.4 ml dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: Once) (Strength: Standard) (lot number: U7238AA) (Expiration: 04/May/2023) (formulation unknown) via intramuscular route in the left thigh as Immunization. On 25-OCT-2022 the patient administered only the liquid portion of the pentacel to a patient with no reported adverse event (product preparation error) (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 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
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VAERS 2409557

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7238AA

gering
Staat
VA
Alter
-
Geschlecht
F
Eingang
12.08.2022
Impfdatum
03.08.2022
Beginn
03.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

The Pentacel powder was not mixed with the liquid portion. The liquid portion only was given to a patient with no reported adverse event; ACT-HIB portion that was left after mistakenly administering the product without giving the lyophilized powder portion of the product with no reported AE; Initial information received on 03-Aug-2022 and live follow-up received on 04-Aug-2022 (processed together: 03-Aug-2022) regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient and reported stated that the pentacel powder was not mixed with the liquid portion. the liquid portion only was given to a patient with no reported adverse event and act-hib portion that was left after mistakenly administering the product without giving the lyophilized powder portion of the product with no reported ae(adverse event) involving 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. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 03-Aug-2022, the patient received a 0.5ml, once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot U7238AA and expiry date: 31-May-2023) via unknown route in right vastus lateralis site for prophylactic vaccination. On 03-Aug-2022 the patient developed a non-serious event of the pentacel powder was not mixed with the liquid portion. the liquid portion only was given to a patient with no reported adverse event (wrong technique in product usage process) (Latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. On 03-Aug-2022 the patient developed a non-serious event of act-hib portion that was left after mistakenly administering the product without giving the lyophilized powder portion of the product with no reported ae (product preparation error) (Latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Reporter was asking what need to be done for the dosing, Is there any particular time frame for the patient to return to receive the HIB dose. They are now requesting instruction on how to give the ACT-HIB portion. Agent advised to reconstitutes with 0.4% NaCl. This situation was reported as a medication error due to improper preparation and administration of the product reconstitution was not done and only the liquid portion was administered. HCP (Healthcare Professional) stated a 4-month-old was supposed to receive PENTACEL. HCP stated the powder wasn't mixed. HCP wanted to know if the baby needs all three or just Acthib. First time product used : No 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 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 issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-