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Reporte zur Charge NK245

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

10Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OH 3 TX 2 TN 1

VAERS 1753836

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

mild
Staat
TN
Alter
0,1
Geschlecht
M
Eingang
01.10.2021
Impfdatum
27.09.2021
Beginn
27.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia

Symptomtext

fever

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

VAERS 2699272

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

gering
Staat
OH
Alter
0,5
Geschlecht
M
Eingang
20.10.2023
Impfdatum
29.09.2022
Beginn
29.09.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis. On 29-SEP-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 29-SEP-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)). The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2699257

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

gering
Staat
OH
Alter
0,5
Geschlecht
M
Eingang
20.10.2023
Impfdatum
20.05.2022
Beginn
20.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

child was given 3 doses of Rotarix/extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis. On 20-MAY-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 20-MAY-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix/extra Dose).The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2699256

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

gering
Staat
OH
Alter
0,5
Geschlecht
F
Eingang
20.10.2023
Impfdatum
21.10.2022
Beginn
21.10.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

child was given 3 doses of Rotarix /Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis. On 21-OCT-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 21-OCT-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix /Extra Dose). The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023130319:different patient, same reporter US-GSK-US2023AMR142498:different patient, same reporter US-GSK-US2023AMR142502:different patient, same reporter US-GSK-US2023AMR142500:different patient, same reporter US-GSK-US2023AMR142501:different patient, same reporter US-GSK-US2023AMR142496:different patient, same reporter US-GSK-US2023AMR142499:different patient, same reporter US-GSK-US2023AMR142512:different patient, same reporter US-GSK-US2023130319:same reprter, different patient

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2696510

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge NK245

gering
Staat
-
Alter
0,5
Geschlecht
M
Eingang
16.10.2023
Impfdatum
24.05.2022
Beginn
24.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

A thrid dose of Rotarix was given to child. First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine guidelines- 3rd dose however was inadvertently given. No adverse event was reported by parent or guardian. As vaccine was given outside of label instructions, it is being reported today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2696508

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge NK245

gering
Staat
-
Alter
0,5
Geschlecht
F
Eingang
16.10.2023
Impfdatum
21.10.2022
Beginn
21.10.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

A thrid dose of Rotarix was given to child. First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine guidelines- 3rd dose however was inadvertently given. No adverse event was reported by parent or guardian. As vaccine was given outside of label instructions, it is being reported today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2696507

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge NK245

gering
Staat
-
Alter
0,5
Geschlecht
M
Eingang
16.10.2023
Impfdatum
20.05.2022
Beginn
20.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

A thrid dose of Rotarix was given to child. First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine guidelines- 3rd dose however was inadvertently given. No adverse event was reported by parent or guardian. As vaccine was given outside of label instructions, it is being reported today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2696505

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge NK245

gering
Staat
-
Alter
0,5
Geschlecht
M
Eingang
16.10.2023
Impfdatum
29.09.2022
Beginn
29.09.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Off label use

Symptomtext

A thrid dose of Rotarix was given to child. First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine guidelines- 3rd dose however was inadvertently given. No adverse event was reported by parent or guardian. As vaccine was given outside of label instructions, it is being reported today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1810158

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

gering
Staat
TX
Alter
0,2
Geschlecht
F
Eingang
23.10.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Product preparation error

Symptomtext

wrong diluent used for the reconstitution of Hiberix and Rotarix; wrong diluent used for the reconstitution of Hiberix and Rotarix; Rotarix vaccine was injected and Hiberix was given orally.; Vaccine Administered at Inappropriate site/ Hiberix given orally; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27th June 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis. On 18th October 2021, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix (oral). On 18th October 2021, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Hiberix, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered, inappropriate route of vaccination and intramuscular formulation administered by other route were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter called from medical facility to report that a Medical assistant at the facility used the diluent for the Rotarix vaccine to reconstitute the Hiberix vaccine and the diluent for the Hiberix vaccine was used to reconstitute the Rotarix vaccine, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered for both the vaccines. Then the Rotarix vaccine was injected and the Hiberix vaccine was given orally, which led to inappropriate route of vaccination and intramuscular formulation administered by other route respectively. The patient did not experience any adverse effects. The reporter asked for recommendations on what she should do. The reporter consented to follow up.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1795767

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge NK245

gering
Staat
TX
Alter
0,2
Geschlecht
F
Eingang
18.10.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / OT
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

vaccines where administered to patient. After patient left the clinic and vials where going to be discarded, MA noticed that the Rotarix oral applicator used to withdraw diluent was attached to HIB vaccine diluent applicator. As soon as she noticed, she notified the Manager.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
NDKA
Vorgeschichte
None
Andere Medikamente
None
Allergien
NDKA
Vorherige Impfungen
-