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Reporte zur Charge UJ529AAAo

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MD 1 VA 1 ND 1

VAERS 2359433

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AAA

gering
Staat
MD
Alter
1,0
Geschlecht
F
Eingang
06.07.2022
Impfdatum
23.06.2022
Beginn
23.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

received a dose of Pentacel and PedvaxHIB on the same day, which resulted in an extra dose of the HIB component for the patient with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who had received a dose of pentacel and pedvaxhib on the same day, which resulted in an extra dose of the hib component for the patient with no reported adverse event while receiving vaccines PEDVAXHIB and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 23-Jun-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UJ529AAA and expiry date: 22-Jul-2022) via intramuscular route in unknown administration site for Immunization. On an unknown date, the patient received an unknown dose of suspect PEDVAXHIB not produced by Sanofi Pasteur (strength, formulation was unknown, lot UJ529AAAo and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination. On 23-Jun-2022 the patient developed a non-serious event received a dose of pentacel and pedvaxhib on the same day, which resulted in an extra dose of the hib component for the patient with no reported adverse event (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (latency: unknown) following the administration of PEDVAXHIB. 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1774863

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ529AAA

gering
Staat
VA
Alter
0,2
Geschlecht
F
Eingang
09.10.2021
Impfdatum
01.10.2021
Beginn
01.10.2021
Tage bis Beginn
0,0
Dosis
UNK
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

gave only the powder HIB portion/ DTaP-IPV portion of Pentacel was not administered, with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via consumer via phone (under Medical Information Inquiry Number: 00794918). This case involves a two-month-old female patient who was given only the powder hib portion/ dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was not administered (product preparation error). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination. On 01-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot UJ529AAA and expiry date: 22-Jul-2022 via unknown route in the left thigh for prophylactic vaccination. It was an actual medication error due to wrong diluent used (same day). It was reported "Caller reported giving PENTACEL to a child and only used the HIB portion with a diluent. Caller was asking what to do from here. A Medical Assistant gave only the powder HIB portion. The diluent that was used was sterile water. The DTaP-IPV portion of Pentacel was not administered. The caller asked what should be done. Was there any adverse effect of giving the HIB portion diluted with sterile water. Later, another Medical Assistant went to the vaccination supply and found that there was an extra Pentacel diluent by itself in there without the powder, and that was how the error was discovered." At the time of reporting, no adverse event 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 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 1050092

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AAA

gering
Staat
ND
Alter
0,2
Geschlecht
F
Eingang
23.02.2021
Impfdatum
23.02.2021
Beginn
23.02.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Crying Erythema Feeling abnormal Peripheral swelling Skin warm

Symptomtext

Red/swelling to entire thigh on right side. Warm to touch, patient very upset and crying in pain for several hours. Benadryl given to treat reaction.

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