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Reporte zur Charge SKBYL9YN

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

11Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 11

VAERS 2623430

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,4
Geschlecht
M
Eingang
28.04.2023
Impfdatum
12.04.2023
Beginn
01.04.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter

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

VAERS 2623429

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
28.04.2023
Impfdatum
07.04.2023
Beginn
01.04.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 07-APR-2023, the patient received Rotarix lyophilized formulation. On 07-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter

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

VAERS 2623427

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,2
Geschlecht
M
Eingang
28.04.2023
Impfdatum
17.04.2023
Beginn
17.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 9-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter

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

VAERS 2623426

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,2
Geschlecht
M
Eingang
28.04.2023
Impfdatum
17.04.2023
Beginn
17.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter

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

VAERS 2623425

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
F
Eingang
28.04.2023
Impfdatum
17.04.2023
Beginn
17.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT; Not able to swallow full dose; Tasted very bad, appeared oily; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and product complaint (Verbatim: Tasted very bad, appeared oily). On an unknown date, the patient experienced regurgitation of medication (Verbatim: BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter

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

VAERS 2623424

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,4
Geschlecht
M
Eingang
28.04.2023
Impfdatum
14.04.2023
Beginn
14.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Dysgeusia Product complaint Regurgitation

Symptomtext

Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 14-APR-2023, the patient received Rotarix lyophilized formulation. On 14-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter

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

VAERS 2623423

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
28.04.2023
Impfdatum
21.04.2023
Beginn
21.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 21-APR-2023, the patient received Rotarix lyophilized formulation. On 21-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication, accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter

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

VAERS 2623422

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
28.04.2023
Impfdatum
18.04.2023
Beginn
18.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 18-APR-2023, the patient received Rotarix lyophilized formulation. On 18-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter

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

VAERS 2623421

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
F
Eingang
28.04.2023
Impfdatum
12.04.2023
Beginn
12.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter

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

VAERS 2623420

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,4
Geschlecht
F
Eingang
28.04.2023
Impfdatum
13.04.2023
Beginn
13.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059808:Same Reporter US-GSK-US2023AMR059807:Same Reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter

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

VAERS 2623419

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge SKBYL9YN

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
28.04.2023
Impfdatum
13.04.2023
Beginn
13.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Product complaint Regurgitation

Symptomtext

tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint. On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose. The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline. The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060516:Same reporter

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