Zurueck zur Suche

Reporte zur Charge U7197BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MD 2 MN 1 FL 1 OH 1

VAERS 2408272

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7197BA

gering
Staat
MD
Alter
0,8
Geschlecht
M
Eingang
11.08.2022
Impfdatum
01.08.2022
Beginn
01.08.2022
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 error

Symptomtext

Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Initial information was received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a Nurse Practitioner. This case involves a 9 months old male patient who experienced medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion 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. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination. On 01-Aug-2022, the patient received single 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U7197BA, expiry 28-jan-2024) (strength: unknown) via intramuscular route in the right thigh for routine prophylactic vaccination. On 01-AUG-2022 the patient developed a non-serious medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered) (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. It was reported that "This situation is reported as a medication error due to the liquid portion of PENTACEL being administered without re-constituting the powder portion'. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered) 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.; Sender's Comments: 01220255:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2408265

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7197BA

gering
Staat
MN
Alter
0,2
Geschlecht
M
Eingang
11.08.2022
Impfdatum
15.07.2022
Beginn
15.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event Product preparation error

Symptomtext

only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and it was noticed that the patient was only given the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination. On 15-Jul-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7197BA, expiration date: 28-Jan-2023 via intramuscular route in the left thigh as Immunization. On 15-JUL-2022 the patient developed a non-serious only gave the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event (incorrect dose administered) (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Nurse stated that a MA (medical assistant) was supposed to give a 2 month old patient VAXELIS, Prevnar, and Rotovirus, however the MA gave the 2 month old patient Rotovirus and PENTACEL instead. As a result the 2nd Hep B vaccine was not administered. The nurse believed that the confusion happened because they just recently switched from Glaxo Smith Klein to Sanofi. Upon attempting to give the patient PENTACEL, the MA only gave the liquid component of the DTAP and IPV. The ACTHIB portion was not administered. The nurse asked how the remaining ACTHIB portion could be administered. The nurse asked if Pedvaxhib and ACTHIB are equivalent. She asks if it safe to give PENTACEL at 18 months instead of just DTAP and HIB, because it would result in an extra IPOL injection. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for all. 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
-

VAERS 2405551

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7197BA

gering
Staat
MD
Alter
0,4
Geschlecht
F
Eingang
09.08.2022
Impfdatum
01.08.2022
Beginn
01.08.2022
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 error Product preparation issue

Symptomtext

gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event; the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portionthe liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2022SA320954(CLUSTER). This case involves a 5 months old female patient who experienced gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event and the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portionthe liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 01-Aug-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot U7197BA; expiry date: 28-Jan-2024) via intramuscular route in the right thigh for prophylactic vaccination. On 01-AUG-2022 the patient reported gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event (single component of a two-component product administered) and (product preparation error)following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event (single component of a two-component product administered and product preparation error) 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 error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2322968

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7197BA

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
17.06.2022
Impfdatum
03.06.2022
Beginn
03.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

diluent portion of Pentacel administered without using it to reconstitute the powder portion with no reported adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who administered diluent portion of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without using it to reconstitute the powder portion 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 rotavirus vaccine live reassort oral 5v (rotateq) and pneumococcal vaccine conj 13v (crm197) (prevnar 13) both for Prophylactic vaccination. On 03-Jun-2022, the patient received a dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) (lot U7197BA; expiry date: 28-Jan-2023) (strength, dose, formulation, route: unknown) in unknown administration site for prophylactic vaccination. On 03-JUN-2022 the patient developed a non-serious diluent portion of pentacel administered without using it to reconstitute the powder portion with no reported adverse event (Product preparation error) 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. 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
ROTATEQ; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 2289162

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7197BA

gering
Staat
OH
Alter
4,0
Geschlecht
M
Eingang
21.05.2022
Impfdatum
13.05.2022
Beginn
13.05.2022
Tage bis Beginn
0,0
Dosis
4
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

only the DTAP-IPV portion was given and not the Hib portion with no adverse event; Initial information received on 13-May-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 the dtap-ipv portion was given and not the hib portion with no adverse event while receiving 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 measles vaccine, mumps vaccine, rubella vaccine (MMR vaccine) for Immunization. On 13-May-2022, the patient received Dose: 4, 0.5 ml once of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection strength: standard, lot U7197BA, expiry date: 18-Jan-2023 via unknown route and administration site for immunization. On 13-May-2022 the patient developed a non-serious event as only the dtap-ipv portion was given and not the hib portion with no adverse event (single component of a two-component product administered). Caller mentioned that they discarded the Hib portion already to refrain from confusion. Action taken was not applicable. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-