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Reporte zur Charge UJ858AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NH 3 FL 2 MI 1

VAERS 2722608

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ858AA

gering
Staat
NH
Alter
0,6
Geschlecht
M
Eingang
11.12.2023
Impfdatum
24.11.2023
Beginn
24.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Contraindicated product administered Medication error No adverse event

Symptomtext

PENTACEL and Pediarix are given at the same time, with no reported adverse event; Initial information received from Regulatory Authority on 29-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and pediarix are given at the same time, 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 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination. On 24-Nov-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ858AA, strength and expiry date not reported) via intramuscular route in the left thigh as Immunization and at the same time patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as Prophylactic vaccination with no reported adverse event (contraindicated product administered) (Latency: same day). 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
Contraindicated product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2722240

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ858AA

gering
Staat
NH
Alter
0,5
Geschlecht
M
Eingang
08.12.2023
Impfdatum
24.11.2023
Beginn
24.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered No adverse event Wrong product administered

Symptomtext

Pentacil (instead of HIB) and Pediarix provided at the same time. This was realized when doing vaccine counts the day after. Discussion with manufacturing companies and CDC- no adverse reactions found in literature but to discuss with MOC and place in VAERS. Discussion with MOC- no adverse reactions after vaccination observed 5 days later and to this day as well

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
presumed RAD flare
Vorgeschichte
none
Andere Medikamente
Tylenol Advil Budesonide inhalation via neb
Allergien
None
Vorherige Impfungen
-

VAERS 2693902

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ858AA

gering
Staat
NH
Alter
5,0
Geschlecht
F
Eingang
11.10.2023
Impfdatum
29.09.2023
Beginn
29.09.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

Pentacel was given to a five-year-old with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient for whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was given to a five-year-old 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 varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination. On 29-Sep-2023, the five-year-old patient received a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ858AA, expiry date- 29-MAR-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Reportedly, Caller is asking What is recommendation for this? Do she need further vaccination or would this be her completed dose. This would have been patient last dose. Action taken was 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 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
VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2686461

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ858AA

gering
Staat
MI
Alter
1,0
Geschlecht
M
Eingang
26.09.2023
Impfdatum
08.09.2023
Beginn
08.09.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Wrong product administered

Symptomtext

Client was given MMRV and Varicella in opposite out thighs. He was supposed to get MMR and Varicella, was given MMRV by mistake.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
no known illness
Vorgeschichte
none reported
Andere Medikamente
no known medications
Allergien
no known allergies
Vorherige Impfungen
-

VAERS 2658332

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ858AA

gering
Staat
FL
Alter
0,2
Geschlecht
M
Eingang
17.08.2023
Impfdatum
06.07.2023
Beginn
09.07.2023
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: unbekannt
Haemoglobin Petechiae Platelet count decreased Immunoglobulin therapy Thrombocytopenia

Symptomtext

Patient was taken to Medical Center on 7/9/2023, had petechiae and after labs of hemoglobin 8.8 & Platelets of 11, was transferred to Hospital. Followed by Dr. of Hematology and Oncology. He was discharged from on 7/14/2023. Had follow up on 7/25/2023.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Immunoglobulin therapy
Hospital-Tage
4,0
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2652260

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ858AA

gering
Staat
FL
Alter
0,2
Geschlecht
F
Eingang
04.07.2023
Impfdatum
29.06.2023
Beginn
29.06.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event

Symptomtext

some of the vaccine came out during injecting the dose of Pentacel with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who experienced some of the vaccine came out during injecting the dose of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 Immunisation. On 29-Jun-2023, the patient received dose of 0.5 ml dose 1 of standard strength of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot: UJ858AA) via intramuscular route in the left leg upper thigh for Immunization and some of the vaccine came out during injecting the dose with no reported adverse event (incorrect dose administered) (latency: same day). 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
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-