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Reporte zur Charge UJ580AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 MD 1 SC 1

VAERS 2329030

GLAXOSMITHKLINE BIOLOGICALS · DTAP + IPV (KINRIX) · Charge UJ580AAA

gering
Staat
MD
Alter
4,0
Geschlecht
F
Eingang
23.06.2022
Impfdatum
23.06.2022
Beginn
23.06.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Wrong product administered

Symptomtext

The child was mistakenly given Kinrix, when she was actually only supposed to receive a Dtap vaccine. The child did not have an adverse reaction. The child was due for her 3rd Dtap dose, and was not due for an IPV.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
unknown
Vorgeschichte
unknown
Andere Medikamente
unknown
Allergien
none
Vorherige Impfungen
-

VAERS 2109237

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ580AAA

gering
Staat
SC
Alter
-
Geschlecht
U
Eingang
12.02.2022
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

had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.; Initial information received on 27-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown demographics who had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler while having [DAPTACEL], [IPOL],[PENTACEL], [ADACEL], (D CONJ) [MENACTRA] and [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, with an unknown dose ,frequency, route (lot UT7356LA). On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with an unknown dose ,frequency, route (lot U7208AA). On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with an unknown dose ,frequency, route (lot C5854AA). On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with an unknown dose ,frequency, route (lot UJ580AAA). On an unknown date, the patient received a dose of suspect IPV (VERO) lot U1C571M via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with an unknown dose ,frequency, route (lot C5774BA). On an unknown date the patient had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler. (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.). At time of reporting, the outcome was Unknown for the event had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.

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

VAERS 1908662

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ580AAA

gering
Staat
MI
Alter
1,0
Geschlecht
M
Eingang
30.11.2021
Impfdatum
16.11.2021
Beginn
16.11.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Product preparation issue

Symptomtext

received only the HIB powder portion of PENTACEL, with no reported adverse event; PENTACEL that was diluted with normal saline, with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862514). This case is linked to case 2021SA388584 (CLUSTER). This case involves a 1 years old male patient (date of birth: 15-AUG-2020) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination. On 16-Nov-2021, the patient received a (fourth, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, total, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day). It was reported "Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility. Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4 percent NaCl saline solution." At the time of reporting, no adverse event 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 by the regulatory authority. 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
MMR
Allergien
-
Vorherige Impfungen
-

VAERS 1908661

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ580AAA

gering
Staat
MI
Alter
-
Geschlecht
M
Eingang
30.11.2021
Impfdatum
16.11.2021
Beginn
16.11.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation error Product preparation issue

Symptomtext

received only the HIB powder portion of PENTACEL with no reported adverse event; PENTACEL that was diluted with normal saline with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862445). This case is linked to case 2021SA388591(CLUSTER). This case involves a 4 months old male patient (date of birth: 9-JUL-2021) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 16-Nov-2021, the patient received a (second, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day). It was reported "Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4% NaCl saline solution. Caller states that the diluent used on the two patients were from vials containing 0.7 ml normal saline." Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility. 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 by the regulatory authorities. 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
Allergien
-
Vorherige Impfungen
-