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Reporte zur Charge U6970BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 1 NJ 1 VA 1 KY 1

VAERS 2494690

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6970BA

gering
Staat
MI
Alter
0,5
Geschlecht
F
Eingang
01.11.2022
Impfdatum
18.10.2022
Beginn
18.10.2022
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 Single component of a two-component product administered

Symptomtext

Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who experienced pentacel vaccine was to be administered, but the nurse did not reconstitute the hib portion of the vaccine, the child received only the dtap/ ipv portion of the vaccine with no adverse events while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. 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), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 18-Oct-2022, the patient received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiry 31-Jan-2023, strength- standard) (formulation: unknown) was to be administered, but the nurse did not reconstitute the hib portion of the vaccine (product preparation error), the child received only the dtap/ ipv portion of the vaccine (single component of a two-component product administered) with no adverse events (latency same day) via intramuscular route in vastus lateralis site for prophylaxis vaccination. It was reported that "Treatment- separate ActHIB (lot-UJ659AA) will be administered". Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. 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 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
PREVNAR; HEPATITIS B VACCINE; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 2450442

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6970BA

gering
Staat
NJ
Alter
0,2
Geschlecht
F
Eingang
17.09.2022
Impfdatum
08.09.2022
Beginn
08.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product formulation issue Single component of a two-component product administered

Symptomtext

DTaP-IPV component of PENTACEL given without the Hib component with no reported adverse event.; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old female patient was given dtap-ipv component of pentacel given without the hib component with no reported adverse event, after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. 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) for Prophylactic vaccination. On 08-Sep-2022, the patient received a total dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiration date: 31-Jan-2023) at a dose of 0.5ml via intramuscular route in the right thigh for immunization. On 08-Sep-2022 (Latency: same day),the patient was given dtap-ipv component of pentacel given without the hib component with no reported adverse event(Product ingredient issue) following the administration. Action taken :not applicable It was not reported if the patient received a corrective treatment for the event. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2412688

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6970BA

gering
Staat
VA
Alter
0,5
Geschlecht
F
Eingang
18.08.2022
Impfdatum
15.08.2022
Beginn
15.08.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event Product storage error

Symptomtext

The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm; No adverse event; Vaccine was administer beyond the used by day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. Patient did not had any allergies. It was unknown if patient ever had COVID + test or diagnosis. Patient did not had any acute and chronic illnesses at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. On 15-Aug-2022 at 9:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Aug-2022 at 9:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm). No concomitant medication information provided. It was reported that patient was not immunocompromised. The vaccine was administered around 9:30 pm. The vial did not undergo any temperature excursions. Patient did not report having side effects. HCP was not aware of incident. Patient was not on medication according to nurse knowledge. No treatment information provided. This case was linked to MOD-2022-629215 (E2B Linked Report).; Sender's Comments: MOD-2022-629215:same reporter , patient 1 case

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Comments: Patient did not had any allergies. It was unknown if patient ever had COVID + test or diagnosis. Patient did not had any acute and chronic illnesses at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2363934

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6970BA

gering
Staat
KY
Alter
1,3
Geschlecht
M
Eingang
09.07.2022
Impfdatum
17.06.2022
Beginn
17.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation error

Symptomtext

Pentacel was administered to a patient without being mixed properly with no reported AE; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was administered the vaccine without being mixed properly with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Jun-2022, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine ( lot U6970BA and expiration date: 31-Jan-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination. On 17-Jun-2022 , it was reported that the Pentacel was administered to a patient without being mixed properly with no reported ae (product preparation error)(latency: same day). It was also reported that the patient was only administered the liquid component of Pentacel. Action taken: not applicable It was not reported if the patient received a corrective treatment for the event (Pentacel was administered to a patient without being mixed properly with no reported AE). At time of reporting, the outcome was Unknown for the event pentacel was administered to a patient without being mixed properly with no reported ae. 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
-