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Reporte zur Charge L4HN3

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

12Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TN 2 CO 2 CA 2 NY 2 MI 1 WA 1 MA 1 CT 1

VAERS 2256682

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

mild
Staat
TN
Alter
0,3
Geschlecht
M
Eingang
28.04.2022
Impfdatum
19.04.2022
Beginn
19.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Rash erythematous

Symptomtext

Developed four red spots on forehead and on one cheek- not raised, noted after giving vaccines, No distress, exam normal except noted above baby was given Benadryl, Rash resolved within a few minutes. Observed here for 30 minutes awake no distress or rash at discharge

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash erythematous
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Right Side Nasal Congestion
Vorgeschichte
Alpha Thalassemia, BW 2000-2500grams, Preemie 35wks
Andere Medikamente
Formula Neosure
Allergien
N/A
Vorherige Impfungen
-

VAERS 2245675

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

mild
Staat
TN
Alter
-
Geschlecht
M
Eingang
21.04.2022
Impfdatum
21.04.2022
Beginn
21.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Rash erythematous

Symptomtext

Developed four red spots on forehead and one on cheek- not raised, noted after giving vaccines. NO distress, exam normal, except for noted above, Baby was given Benadryl. Rash resolved within a few minutes. Observed for 30 minutes awake and no distress or rash before discharged.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash erythematous
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Righ Side Nasal Congestion
Vorgeschichte
Alpha Thalassemia, Birth Weight 2000-2500grams, Preemie 35wks
Andere Medikamente
Formula: Neosure
Allergien
N/A
Vorherige Impfungen
-

VAERS 2583249

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
CO
Alter
0,3
Geschlecht
F
Eingang
17.02.2023
Impfdatum
08.02.2023
Beginn
08.02.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Interchange of vaccine products

Symptomtext

1st dose Rotateq, 2nd Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 8th February 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received ROTATEQ. On 8th February 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 09-FEB-2023 Reporter's comment: The health department nurse reported that one of their staff members yesterday gave Rotarix vaccine to the patient who previously received a dose of Rotateq eight weeks after the Rotateq dose was give. The reporter reported that this was the patient's second dose of a rotavirus vaccine. The reporter consented to follow up. Additional supportive information: The patient received a dose of Rotarix and Rotateq, which led to interchange of vaccine products.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Interchange of vaccine products
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2580942

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
CO
Alter
0,3
Geschlecht
F
Eingang
13.02.2023
Impfdatum
08.02.2023
Beginn
01.02.2023
Tage bis Beginn
-
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Interchange of vaccine products No adverse event Product availability issue

Symptomtext

Patient received 2nd rotavirus vaccine. The second vaccine was a Rotarix, and 1st vaccine received on 12-01-2022 was a RotaTeq. Rotarix was given not related to RotaTeq being out of stock. No adverse event observed or reported. Patient's mother notified via telephone on 02-09-2023, but mother had to cut call short, she stated "I have to call you back later, my kids are crying" no further calls received. GSK was notified at approximately 11:10 AM, spoke to representative, who provided RN with information related to Rotarix to present to patient's mother.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Interchange of vaccine products
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Unkown
Allergien
No known allergies to food or medication
Vorherige Impfungen
-

VAERS 2530063

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
MI
Alter
0,3
Geschlecht
M
Eingang
13.12.2022
Impfdatum
31.05.2022
Beginn
31.05.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration

Symptomtext

Hep B vaccine was given too early.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2509719

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
WA
Alter
0,2
Geschlecht
F
Eingang
16.11.2022
Impfdatum
15.11.2022
Beginn
15.11.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered No adverse event

Symptomtext

Accidentally gave an extra hib with a pentacel. Pediarix was suppose to be the vaccine given. No symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
No
Allergien
no
Vorherige Impfungen
-

VAERS 2356141

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
CA
Alter
0,1
Geschlecht
F
Eingang
03.07.2022
Impfdatum
24.03.2022
Beginn
24.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Eye movement disorder Moaning Unresponsive to stimuli

Symptomtext

bilateral eye deviation to the left; moaning; Muscle tightness; Staring; Unresponsive to stimuli; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2204963-1. The original narrative from the sender is as below: Infant received routine vaccines at 6 week well check. Within 12 hours of vaccination, had one episode where baby moaned then turned head to the left, become very tight, accompanied by bilateral eye deviation to the left, staring off unresponsive to sound or movement. No generalized convulsion. Episode lasted 1-1.5 minutes. No repeat episodes. Current illness included Hyperbilirubinemia requiring phototherapy. Medications at time of vaccination included Polyvisol with Iron oral drops. Lab data none, history none and allergies none.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Eye movement disorder
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Hyperbilirubinemia (Hyperbilirubinemia requiring phototherapy)
Vorgeschichte
-
Andere Medikamente
POLYVISOL [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL; IRON ORAL
Allergien
-
Vorherige Impfungen
-

VAERS 2356134

UNKNOWN MANUFACTURER · ROTAVIRUS (NO BRAND NAME) · Charge L4HN3

gering
Staat
NY
Alter
-
Geschlecht
M
Eingang
03.07.2022
Impfdatum
18.03.2022
Beginn
18.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Erythema of eyelid Eyelid oedema

Symptomtext

ERYTHEMA OF EYELID; Eyelid oedema; This non-serious spontaneous case was received during monitoring on 11-APR-2022 with the following Primary ID 2188005-1. The original narrative from the sender is as below: 10 minutes after vaccine administration, physician noticed right eye lid edema and erythema. Patient sent to ED via ambulance for observation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema of eyelid
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
Medical History/Concurrent Conditions: Heart murmur
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2237227

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
MA
Alter
0,2
Geschlecht
F
Eingang
16.04.2022
Impfdatum
06.04.2022
Beginn
06.04.2022
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 Product preparation issue

Symptomtext

was administered only the diluent portion of Rotarix; was administered only the diluent portion of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 6th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 6th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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 Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: Certified medical assistant reported that the patient was administered with only the diluent portion of Rotarix, without being reconstituted. The consent to follow up was given. Additional Supportive Information: The patient received only the diluent portion of Rotarix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.

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

VAERS 2218106

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
CT
Alter
0,3
Geschlecht
M
Eingang
06.04.2022
Impfdatum
30.03.2022
Beginn
31.03.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Blood culture negative Fontanelle bulging Full blood count abnormal Magnetic resonance imaging head normal Metabolic function test normal Poor feeding infant SARS-CoV-2 test negative Scan with contrast normal Somnolence Ultrasound head abnormal White blood cell count increased

Symptomtext

Notable poor feeding and more sleepy and bulging anterior fontanelle on 3/31/2022 - send to the Pediatric ED for further evaluation - negative head US, admitted for sedated brain MRI - discharge on 4/1 after negative brain MRI and notable improvement

Weitere VAERSDATA-Felder
Praegender Schweregrund
Blood culture negative
Hospital-Tage
1,0
Labordaten
3/31/2022 - CBC with elevated WBC 19.4, negative blood culture, CMP within normal limits, negative covid swab, head US no hydrocephalus but with mild prominence of the extra-axial CSF spaces overlying the bilateral cerebral convexities 4/1/2022 - brain MRI with/without contrast - unremarkable
Aktuelle Erkrankungen
reflux - stopped prescribed pepcid on 3/2/2022 eczema - treated for 1 week with hydrocortisone 2.5% on 2/25/2022
Vorgeschichte
prematurity - 29.6 week twin - retinopathy of prematurity sickle cell trait hx of covid 12/29 - mild symptoms of congestion
Andere Medikamente
Poly- vi-sol drops
Allergien
None noted
Vorherige Impfungen
-

VAERS 2204963

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
CA
Alter
0,1
Geschlecht
F
Eingang
29.03.2022
Impfdatum
24.03.2022
Beginn
24.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Gaze palsy Moaning Muscle tightness Staring Unresponsive to stimuli

Symptomtext

Infant received routine vaccines at 6 week well check. Within 12 hours of vaccination, had one episode where baby moaned then turned head to the left, become very tight, accompanied by bilateral eye deviation to the left, staring off unresponsive to sound or movement. No generalized convulsion. Episode lasted 1-1.5 minutes. No repeat episodes.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Gaze palsy
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
Hyperbilirubinemia requiring phototherapy
Vorgeschichte
none
Andere Medikamente
Polyvisol with Iron oral drops
Allergien
None
Vorherige Impfungen
-

VAERS 2188005

GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge L4HN3

gering
Staat
NY
Alter
0,2
Geschlecht
M
Eingang
18.03.2022
Impfdatum
18.03.2022
Beginn
18.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Erythema of eyelid Eyelid oedema

Symptomtext

10 minutes after vaccine administration, physician noticed right eye lid edema and erythema. Patient sent to ED via ambulance for observation

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema of eyelid
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
heart murmur
Andere Medikamente
n/a
Allergien
no known allergies
Vorherige Impfungen
-