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Reporte zur Charge UJ601AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NC 1 TX 1

VAERS 2195946

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ601AAA

gering
Staat
NC
Alter
1,3
Geschlecht
M
Eingang
24.03.2022
Impfdatum
17.03.2022
Beginn
17.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration

Symptomtext

inadvertently administered PENTACEL to a 15 month old patient instead of DTaP, with no reported adverse event; 4th dose of IPV too early, with no reported adverse event; Initial information was received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center. This case involves a 15 months old male patient who experienced inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event and 4th dose of ipv too early, with no reported adverse event while receiving vaccines Poliomyelitis vaccine (INACTIVATED) and 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 HIB vaccine CONJ (OMPC) (PEDVAXHIB) and Hepatitis A vaccine (HEPATITIS A) for Immunisation. On 17-Mar-2022, the patient received 0.5 ml of suspect Diphtheria/tetanus/5 hybrid AC pertussis/ipv (MRC5)/HIB(PRP/T) vaccine (lot -UJ601AAA expiry -05-Dec-2022) via Intramuscular route in the left leg for immunisation. On an unknown date, the patient received a dose of suspect Poliomyelitis vaccine produced by unknown manufacturer (dose, lot, strength, formulation, and expiry: unknown) via unknown route in unknown administration site for immunization. On 17-MAR-2022 the patient developed "inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event (accidental exposure to product) (latency same day) and "4th dose of ipv too early, with no reported adverse event" (inappropriate schedule of product administration) (latency; unknown) following the administration of Diphtheria/tetanus/5 hybrid AC pertussis/ipv(MRC5)/HIB(PRP/T) vaccine and Poliomyelitis vaccine. Action taken-not applicable for both suspects Outcome- unknown for both events 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
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2091419

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ601AAA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
05.02.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product storage error

Symptomtext

cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics who had cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6852AA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7207AA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ601AAA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (formulation, strength: unknown) lot T1D482M in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5787AA in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2f with no reported adverse event" (product storage error) (unknown latency) following the administration of all suspect vaccines. It was reported "Caller states that a cold temperature excursion occurred because the refrigerator door was not closed. The total excursion time was for 54 minutes and the lowest temperature reached was 31.2F. The products involved were unopened: TENIVAC, MENACTRA, PENTACEL, IPOL, and ADACEL. Caller asked for stability information for these products." Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event). At time of reporting, the outcome was Unknown for the event cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2f 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 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
-