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Reporte zur Charge 29EY3/ adjuvant

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 1 AZ 1 PA 1 FL 1 IN 1 GA 1 MN 1

VAERS 2695815

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

mild
Staat
CA
Alter
64,0
Geschlecht
F
Eingang
13.10.2023
Impfdatum
01.06.2023
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
- / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Diarrhoea Pain in extremity

Symptomtext

Diarrhea; Her arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis. Concurrent medical conditions included allergy (Cephalexin, Morphine, Codeine and Sulfa albendazole). Concomitant products included alprazolam. On 01-JUN-2023, the patient received the 1st dose of Shingrix (right deltoid). On 01-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her arm hurt really bad). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea). The outcome of the pain in arm was resolved (duration 3 days) and the outcome of the diarrhea was not resolved. The reporter considered the pain in arm and diarrhea to be possibly related to Shingrix. The company considered the pain in arm and diarrhea to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. The patient experienced diarrhea before receiving 2nd dose of Shingrix vaccine. The reporter consented to follow up. Follow information received on 05-OCT-2023 It was reported that patient received 2nd dose on 30th August 2023 on left deltoid with batch number 7L777 and expiry date 22 August 2025. The patient had allergies with Cephalexin which caused GI upset and diarrhea, Morphine which caused itching, Codeine which caused nausea, vomiting and Sulfa albendazole which caused nausea, vomiting. It was reported that the clinic was unaware of the adverse events occurred after 1st dose. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender's Comments: US-GSK-US2023AMR122939:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Allergy (Cephalexin, Morphine, Codeine and Sulfa albendazole)
Vorgeschichte
-
Andere Medikamente
ALPRAZOLAM
Allergien
-
Vorherige Impfungen
-

VAERS 2646682

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

mild
Staat
AZ
Alter
62,0
Geschlecht
F
Eingang
18.06.2023
Impfdatum
16.06.2023
Beginn
01.06.2023
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Pain in extremity

Symptomtext

ERYTHEMA OR REDNESS AROUD THE INJECTION SITE. NO SWELLING. NO FEVER. SORE ARM.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NO KNOWN ALLERGIES
Vorherige Impfungen
-

VAERS 2643494

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

mild
Staat
PA
Alter
71,0
Geschlecht
F
Eingang
09.06.2023
Impfdatum
19.05.2023
Beginn
19.05.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site pain Injection site warmth Lethargy Pyrexia

Symptomtext

injection site very sore and very warm to the touch for several days; mild fever for one day; lethargy for several days ibuprofen seemed to ease the worst of the symptoms

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2640565

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29ey3

gering
Staat
FL
Alter
77,0
Geschlecht
M
Eingang
04.06.2023
Impfdatum
19.05.2023
Beginn
01.05.2023
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

Patient did not have an adverse reaction the Professional Director wants me to report this incident. On 05/19/2023 We had an Off-Site Immunization.The patient was given and adjuvant for shingrix ,the pharmacist realized that it was not mixed she explained it to the patient and was given the shingrix vaccine.(mixed with adjuvant) Patient was counselled about the side effects of the vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation issue
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
NONE
Vorgeschichte
PAIN
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2622765

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

gering
Staat
IN
Alter
61,0
Geschlecht
M
Eingang
28.04.2023
Impfdatum
15.03.2023
Beginn
15.03.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Product preparation error

Symptomtext

Vaccine reconstituted with sterile water; Received vaccine reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis. On 15-MAR-2023, the patient received the 2nd dose of Shingrix. On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Received vaccine reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 21-APR-2023 The reporter reported that the patient received Shingrix vaccine which was reconstituted with sterile water. The reporter did consent to follow up via email. Shingrix vaccine reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.

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

VAERS 2608002

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

gering
Staat
GA
Alter
51,0
Geschlecht
F
Eingang
02.04.2023
Impfdatum
31.03.2023
Beginn
01.04.2023
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Erythema Peripheral swelling

Symptomtext

arm is swollen and red

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

VAERS 2599677

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 29EY3

gering
Staat
MN
Alter
74,0
Geschlecht
F
Eingang
20.03.2023
Impfdatum
20.03.2023
Beginn
20.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation error Single component of a two-component product administered

Symptomtext

diluent injected prior to mixing with powder

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