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Reporte zur Charge UJ464AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 DC 1

VAERS 2289159

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ464AB

gering
Staat
DC
Alter
2,0
Geschlecht
F
Eingang
21.05.2022
Impfdatum
06.12.2021
Beginn
06.12.2021
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 Single component of a two-component product administered

Symptomtext

administration of PENTACEL without the Hib component, got the liquid component of PENTACEL without the lyophilized component with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 years old female patient who experienced administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without the hib component, got the liquid component of pentacel without the lyophilized 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 pneumococcal vaccine conj 7v (crm197) (Prevnar) for prophylactic vaccination; influenza vaccine (influenza) for prophylactic vaccination; and hepatitis a vaccine (hepatitis a) for Prophylactic vaccination. On 06-Dec-2021, the patient received a 4 dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ464AB; expiry date: 21-May-2022;, strength unknown) via intramuscular route in the right thigh as Immunization. On 06-DEC-2021, the diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component, got the liquid component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) without the lyophilized component with no reported adverse event (single component of a two-component product administered) (latency: same day). It was reported that she would like to know if she should start over the whole dose or if she could reconstitute the powder with something else and administer it. Action taken: not applicable. At time of reporting, the outcome was 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 1719424

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ464AB

gering
Staat
MI
Alter
0,4
Geschlecht
M
Eingang
21.09.2021
Impfdatum
23.08.2021
Beginn
23.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation issue Product reconstitution quality issue

Symptomtext

Pentacel was not reconstituted prior to administration.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
History Of Prematurity Trisomy 21 Secundum ASD Anemia of Prematurity
Andere Medikamente
Pediatric Multivitamin-Iron
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1678036

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ464AB

gering
Staat
-
Alter
1,0
Geschlecht
M
Eingang
07.09.2021
Impfdatum
13.08.2021
Beginn
13.08.2021
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 Underdose

Symptomtext

some vaccine left in the vial and that he hadn't received all of it/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-Sep-2021 from a Physician via Agency (Reference number- 00750478) and transmitted to Sanofi on 01-Sep-2021. This case involves a one-year-old male patient who reported some vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] left in the vial and that he hadn't received all of it with no reported adverse event (Underdose). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications VARICELLA ZOSTER VACCINE LIVE (OKA) (VARICELLA BIKEN) for prophylactic vaccination, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination and PNEUMOCOCCAL VACCINE (PNEUMOCIN [PNEUMOCOCCAL VACCINE]) for prophylactic vaccination. On 13-Aug-2021, the patient received a 0.5 ml (total) [1X(Once)] dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ464AB and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. It was reported, "That her son received a PENTACEL vaccination on 13AUG2021 and was contacted 13 days later and informed that the vaccine was expired. Caller states that she called back to confirm that product was expired and that she was told that the product was not expired. At this time, she was told that there was still some vaccine left in the vial and that he hadn't received all of it but that the product was not expired. Caller states that she has the lot number and would like to determine the expiration date. Caller also asked about the need to revaccinate her son if the product was expired or if he did not receive all of it. " It was case of an actual medication error due to vaccine underdose (latency was on the same day). At the time of reporting, 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
VARICELLA BIKEN; MMR; PNEUMOCIN [PNEUMOCOCCAL VACCINE]
Allergien
-
Vorherige Impfungen
-

VAERS 1478478

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ464AB

gering
Staat
MI
Alter
0,1
Geschlecht
M
Eingang
16.07.2021
Impfdatum
29.06.2021
Beginn
01.07.2021
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: nein
Abdominal X-ray Blood lactic acid Culture wound Differential white blood cell count Full blood count Ileal perforation Ileal stenosis Metabolic function test

Symptomtext

Bowel stricture and perforation (ileum)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Abdominal X-ray
Hospital-Tage
-
Labordaten
Abdominal X-rays CBC with differential CMP Lactate Wound cultures
Aktuelle Erkrankungen
None
Vorgeschichte
Possible hernia
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-