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Reporte zur Charge UJ528AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 2 MI 1 IN 1 NY 1

VAERS 2387781

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ528AAA

gering
Staat
MI
Alter
0,2
Geschlecht
M
Eingang
24.07.2022
Impfdatum
14.07.2022
Beginn
14.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

gave an expired dose of PENTACEL, with no reproted adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 weeks old male patient who was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero), with no reproted adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq); and Hepatitis B Vaccine (Hep [Hepatitis B Vaccine]) for Prophylactic vaccination (Immunisation). On 14-Jul-2022, the patient received a 0.5 ml dose once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot: UJ528AAA; expiry date -10-Jul-22) via intramuscular route in the right thigh for prophylactic vaccination. On 14-Jul-2022 the patient was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, with no reproted adverse event (expired product administered) (latency: same day). Action taken with Diphtheria,Tetanus, AC Pertussis, IPV AND HIB Vaccine (Pentacel (Vero)) 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2322963

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ528AAA

gering
Staat
IN
Alter
4,0
Geschlecht
M
Eingang
17.06.2022
Impfdatum
02.06.2022
Beginn
02.06.2022
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

only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who experienced only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event while receiving vaccine 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 HEPATITIS A VACCINE (HEPATITIS A); and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD). On 02-Jun-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ528AAA (10-Jul-2022) via intramuscular route in the right thigh for prophylactic vaccination. On 02-JUN-2022 (latency: Same day) the patient developed a non-serious only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event). At time of reporting, the outcome was Unknown for the event only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; PROQUAD
Allergien
-
Vorherige Impfungen
-

VAERS 1756417

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ528AAA

gering
Staat
IL
Alter
0,2
Geschlecht
U
Eingang
02.10.2021
Impfdatum
20.09.2021
Beginn
20.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Wrong product administered

Symptomtext

Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00776955). This case involved 2 months old (unknown gender) patient who was given a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and extra dose administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for prophylactic vaccination. On 20-Sep-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5743AA and expiry date: 06-Jun-2022) (Frequency: once) via unknown route in unknown administration site by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ528AAA and expiry date: 10-Jul-2022) via intramuscular route in the deltoid for prophylactic vaccination (wrong product administered and extra dose administered). It was reported "dose of DAPTACEL (not ordered). Patient was given a dose of Daptacel by mistake and would like to know how to proceed. Caller also had questions on if the double dose of DTaP was okay for the patient? Two siblings were getting routine childhood vaccinations first Sibling had an order for Daptacel and Sibling second had an order for Pentacel. Only Sibling second received two doses of DTaP." This case was an actual medication error due to wrong vaccine administered and extra dose administered (latency: same day). At the time of reporting, no 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. 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
ROTATEQ; PREVNAR 13; RECOMBIVAX
Allergien
-
Vorherige Impfungen
-

VAERS 1716372

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj528aaa

gering
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
20.09.2021
Impfdatum
20.09.2021
Beginn
20.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

n/a

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1713162

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ528AAA

gering
Staat
NY
Alter
-
Geschlecht
U
Eingang
18.09.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

vaccine were exposed to 19.8 Fahrenheit and were out of range for 2 hour and 16 minutes/no ae; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional via under Medical Information Inquiry Number: 00764523. This case is linked to case US-SA-2021SA303376(CLUSTER). This case was considered as non-valid due to no involvement of patient. This case involved vaccines IPV (VERO) (lot number: R1F973M and expiry date: 10-MAR-2021), (lot number: T1E871M and expiry date: 10-OCT-2022), (lot number: T1D482M and expiry date: 25-FEB-2022), (lot number: R1F97 and expiry date: 10-MAR-2021), (lot number: T1E87 and expiry date: 10-OCT-2022) HIB (PRP/T) VACCINE (lot number: UJ661AAA and expiry date: 05-JUN-2022), (lot number: UJ526AAA and expiry date: 06-MAR-2022), (lot number: CC5788BA and expiry date: 14-OCT-2022) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5829BA and expiry date: 03-JAN-2031) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ528AAA and expiry date: 07-OCT-2022), (lot number: UJ435AAA and expiry date: 17-MAY-2022), (lot number: UJ421AAA and expiry date: 03-AUG-2022) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: CC5788BA and expiry date: 07-OCT-2022) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6951AA and expiry date: 06-JUN-2022) that were exposed to negative 19.8 degrees Fahrenheit degree for an undetermined period (product storage error). It was potential medication error case due to product storage error temperature too low. It was reported "Caller stated they had a temperature excursion of unknown cause". 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-