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Reporte zur Charge J953N

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

38Reporte angezeigt
2Todesfaelle
4Hospitalisiert
0Lebensbedrohlich
1Bleibende Schaeden
FL 4 CA 4 WA 3 MT 2 OK 2 NM 2 WI 2 NC 2 CO 2 MN 2 MO 1 ME 1

VAERS 2339236

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

kritisch
Staat
MT
Alter
0,2
Geschlecht
M
Eingang
28.06.2022
Impfdatum
14.12.2021
Beginn
17.12.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / RL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Death Unresponsive to stimuli

Symptomtext

Infant died on 12/17/2021 (3 days after vaccines given) of unknown cause. Infant was found unresponsive in crib at home.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
no known allergies
Vorherige Impfungen
-

VAERS 1939585

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

kritisch
Staat
ME
Alter
0,2
Geschlecht
M
Eingang
10.12.2021
Impfdatum
12.11.2021
Beginn
12.11.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Autopsy Death Sudden infant death syndrome

Symptomtext

Patient passed away a few days later. at the time of the 2 mo wcc patient was well and no concerns noted, patient had been ill with cold sx on 11/04/2021 and at that time flu, rsv and covid negative

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
11/04/2021 and at that time flu, rsv and covid negative waiting on autopsy report- believed to have been from SIDS
Aktuelle Erkrankungen
cold sx
Vorgeschichte
no
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1889982

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

kritisch
Staat
IA
Alter
0,2
Geschlecht
F
Eingang
22.11.2021
Impfdatum
15.11.2021
Beginn
19.11.2021
Tage bis Beginn
4,0
Dosis
1
Route/Site
IM / LG
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: nein
Activated partial thromboplastin time Acute respiratory failure Amino acid level Ammonia Blood culture Blood fibrinogen Blood gases Blood lactic acid Blood pyruvic acid C-reactive protein CSF cell count CSF culture CSF glucose CSF protein Carnitine Culture urine Differential white blood cell count Full blood count

Symptomtext

Presented to ED 5 days post vaccine with acute respiratory failure with hypoxia and signs of sepsis including fever, tachycardia, and tachypnea, with lactic acidosis and hypoglycemia.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Acute respiratory failure
Hospital-Tage
-
Labordaten
11/20/2021: Blood culture, urine culture, respiratory filmarray, CBC with diff, CRP, CMP, procalcitonin, lactic acid, VBG. 11/21/2021: VBG, lactic acid, CMP, procalcitonin, CRP, CBC with diff, CSF cell count, CSF glucose, CSF protein, CSF filmarray, CSF culture, rental function panel, pyruvic acid, APTT, protime-inr, fibrinogen, ammonia, amino acids, acylcarnitines, organic acids urine.
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Probiotics, gripe water
Allergien
None
Vorherige Impfungen
-

VAERS 1880598

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge j953n

schwer
Staat
FL
Alter
0,5
Geschlecht
M
Eingang
18.11.2021
Impfdatum
09.10.2021
Beginn
09.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: ja ER: unbekannt Erholt: nein
Electroencephalogram abnormal Full blood count Magnetic resonance imaging normal Metabolic function test Partial seizures SARS-CoV-2 test negative Seizure Status epilepticus

Symptomtext

Patient with seizure at home 20-30 minutes later Admitted to Hospital with status epilepticus. Normal MRI, Abnormal EEG Started on Keppra and Phenobarbitol

Weitere VAERSDATA-Felder
Praegender Schweregrund
Partial seizures
Hospital-Tage
4,0
Labordaten
MRI - Normal EEG - Abnormal, Multiple Spikes, focal seizure disorder CMP, 10/9/21 CBC , 10/9/21 Covid test 10/9/21, neg
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1831621

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

schwer
Staat
VA
Alter
0,6
Geschlecht
F
Eingang
30.10.2021
Impfdatum
29.10.2021
Beginn
29.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Blood test Chest X-ray Dyskinesia Eye movement disorder Fatigue Febrile convulsion Irritability Pyrexia Seizure like phenomena Skin warm Somnolence

Symptomtext

At about 8:45 last night (on 10/29/21), she was a little fussy and fell asleep. She felt a little warm, but her fever was 99. Mom went ahead and gave her 1.25 mL of Ibuprofen. About 20 minutes later, dad was holding the baby and she looked like she was jerking, and her eyes rolled back. She had full body jerking. Dad called mom over and mom felt like it was a seizure, it lasted maybe 30-60 seconds. Afterwards she seemed to just lay there and was very tired and fell asleep. They took her to the hospital and her temp was 100 degrees. They did bloodwork and a chest X-ray. They tried to catch a UA but were unable. They watched her until about 2 am and the ER was watching her. They diagnosed her with a febrile seizure and sent her home.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
Unsure - no access to ER records.
Aktuelle Erkrankungen
Had a viral URI on 10/23/21 (tested COVID/Flu/Strep negative).
Vorgeschichte
None.
Andere Medikamente
Infant's Ibuprofen 50 mg/5 mL took 1.25 mL at 8:45 pm
Allergien
None
Vorherige Impfungen
-

VAERS 2595227

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
CA
Alter
0,3
Geschlecht
M
Eingang
09.03.2023
Impfdatum
28.12.2021
Beginn
28.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Rash

Symptomtext

Client, 4 month old, received Pediarix( DtaP, Ipv, Hep B), PCV13, and Hib. No reaction observed at the time when vaccine given. Mother of child reported that client started with rash on torso, arms and legs. No respiratory distressed observed. Symptoms re-evaluated and rash started to diminish. EMT called per clinic protocol. Transferred care at the time of arrival.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2593866

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
MN
Alter
51,0
Geschlecht
M
Eingang
09.03.2023
Impfdatum
26.02.2023
Beginn
26.02.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Asthenia Fatigue Impaired work ability Malaise Pain in extremity

Symptomtext

Arm pain, fatigue, weakness, general malaise x 2 days unable to report to work day following vaccination

Weitere VAERSDATA-Felder
Praegender Schweregrund
Fatigue
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2492692

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
MO
Alter
2,0
Geschlecht
M
Eingang
28.10.2022
Impfdatum
12.09.2022
Beginn
14.09.2022
Tage bis Beginn
2,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site reaction Injection site swelling Injection site warmth

Symptomtext

on 09/14/2022 Patient's mother reported swollen area "size of lemon" at injection site on left thigh. Reported area was hot and red. Client's mother reports that client was seen by a physician who did not diagnose infection. On 10/28/2022 mother reported that client was still having problems with injection site. She reports a "rubbery" appearing area at site. She feels like this area may be on the right thigh.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
unknown
Aktuelle Erkrankungen
unknown
Vorgeschichte
unknown
Andere Medikamente
unknown
Allergien
latex, milk, influenza vaccine
Vorherige Impfungen
-

VAERS 2298864

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
CA
Alter
3,0
Geschlecht
F
Eingang
27.05.2022
Impfdatum
13.05.2022
Beginn
13.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Peripheral swelling Pyrexia Skin warm

Symptomtext

Fever elevated to 104.7 starting on Fri 5/13/22 evening at 9:00pm through Sat 5/14/22 , then reduced to normal on Sun 5/15/22. Mom alternated with Tylenol and Advil for fever . Left deltoid was reported as swollen and warm by Mom. She did not observe any seizure activity. Patient returned to baseline on Sun 5/15/22.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1851248

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
WA
Alter
2,0
Geschlecht
M
Eingang
08.11.2021
Impfdatum
27.10.2021
Beginn
08.11.2021
Tage bis Beginn
12,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema

Symptomtext

Redness around injection site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
No
Allergien
Penicillins
Vorherige Impfungen
-

VAERS 1924291

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
NC
Alter
0,2
Geschlecht
F
Eingang
04.10.2021
Impfdatum
13.09.2021
Beginn
13.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Urticaria

Symptomtext

Rash: Hives

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

VAERS 1726315

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
NC
Alter
0,2
Geschlecht
F
Eingang
23.09.2021
Impfdatum
14.09.2021
Beginn
14.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Diarrhoea Feeling abnormal Occult blood negative Pyrexia

Symptomtext

Infant developed fussiness, low grade fever to 100, liquid watery stools as many as 10 per day beginning 9-14-21 evening. Infant seen in clinic 9-18-21 to assess fussiness, hydration. Hemoccult was negative. No blood seen in stool.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
Hemoccult 9-18-21 negative
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 1683081

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

mild
Staat
PA
Alter
0,5
Geschlecht
F
Eingang
08.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Urticaria

Symptomtext

Hives on face and neck 1 hour after vaccine given, treated with Claritin 1.25ml once, and hives resolved.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
Hives at age 4 months 7/6/21, vaccines given were Pediarix, Prevnar, Rotarix, and Pedvax HIB.

VAERS 2652175

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
WI
Alter
-
Geschlecht
M
Eingang
03.07.2023
Impfdatum
28.06.2023
Beginn
28.06.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient was accidentally administered an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis. On 28-JUN-2023, the patient received the 3rd dose of Pediarix. On 28-JUN-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was accidentally administered an expired dose). The outcome of the expired vaccine used 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: 28-Jun-2023 The registered medical assistant provided information about vaccines, dose, vaccination but declined to receive follow up information. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.

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

VAERS 2633285

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
NM
Alter
0,3
Geschlecht
F
Eingang
18.05.2023
Impfdatum
15.05.2023
Beginn
15.05.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Expired dose of Pediarix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis. On 15-MAY-2023, the patient received Pediarix. On 15-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose of Pediarix was administered). The outcome of the expired vaccine used 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: 15-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received an expired dose of Pediarix vaccine, which led to expired vaccine used.

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

VAERS 2632027

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
NM
Alter
0,3
Geschlecht
F
Eingang
15.05.2023
Impfdatum
15.05.2023
Beginn
15.05.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Vaccine administered on 5/15/2023; expired date of 5/11/2023

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NA
Vorgeschichte
NA
Andere Medikamente
NA
Allergien
NKA
Vorherige Impfungen
-

VAERS 2613045

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
WA
Alter
9,0
Geschlecht
F
Eingang
11.04.2023
Impfdatum
27.03.2023
Beginn
27.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event

Symptomtext

No adverse reactions or symptoms

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2613040

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
WA
Alter
7,0
Geschlecht
F
Eingang
11.04.2023
Impfdatum
27.03.2023
Beginn
27.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Product administered to patient of inappropriate age

Symptomtext

No adverse reactions or symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2559833

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge J953N

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
13.01.2023
Impfdatum
13.01.2023
Beginn
13.01.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered Inappropriate schedule of product administration

Symptomtext

Child was given vaccine combination Pediatrix ( DTAP-Hepatitis B- IPV ) along with a 2nd dose of IPV single dose IM -Sanofi Lot # VB901M . Hepatitis B #3 was too early . Child received 2 doses of IPV . Same day child was given on schedule Rotavirus (Rota-Teq) Prevnar 13.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
-
Vorgeschichte
none
Andere Medikamente
Tylenol
Allergien
none
Vorherige Impfungen
-

VAERS 2499172

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
MT
Alter
0,5
Geschlecht
M
Eingang
04.11.2022
Impfdatum
03.11.2022
Beginn
04.11.2022
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Client was given Pentacel instead of ActHIB and when the error was discovered, manager was notified and parents were contacted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2481648

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge j953n

gering
Staat
MS
Alter
3,0
Geschlecht
F
Eingang
18.10.2022
Impfdatum
11.10.2022
Beginn
13.10.2022
Tage bis Beginn
2,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Blister Erythema

Symptomtext

Current legal guardian reported to this nurse that 2 days after administration of vaccines patient developed a possible reaction to one of the vaccines. Aunt reports that patient had a red circular area with blisters in center of red circle to her Right leg near where the bandaid was placed. Aunt did not bring patient to a doctor due to issues with the insurance company. Advised patient to please follow up with a private doctor to determine if reaction was from the vaccine or not. Aunt voiced understanding.

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

VAERS 2424393

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
-
Alter
0,5
Geschlecht
F
Eingang
31.08.2022
Impfdatum
11.07.2022
Beginn
13.07.2022
Tage bis Beginn
2,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Body temperature increased Erythema Ultrasound scan

Symptomtext

Localized non-blanchable, calorous erythema, with a 1 inch radius circumferentially surrounding injection site of Pediarix on right anterior thigh. Area first noted by mother of patient approximately 43 hours following vaccine administration. Patient also had temperature of 101.4 F.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Body temperature increased
Hospital-Tage
-
Labordaten
Bedside ultrasound done on 13 JUL demonstrated some mild early cobblestoning in area of concern on right anterior thigh..
Aktuelle Erkrankungen
none reported
Vorgeschichte
none reported
Andere Medikamente
mineral oil/petroleum (topical); cholecalciferol 10mcg per day
Allergien
Egg: urticaria with skin contact and with ingestion
Vorherige Impfungen
-

VAERS 2135342

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
23.02.2022
Impfdatum
14.02.2022
Beginn
15.02.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Haematochezia Occult blood positive

Symptomtext

hematochezia the day after given the vaccine. It was streaks of blood in the stool x 2

Weitere VAERSDATA-Felder
Praegender Schweregrund
Haematochezia
Hospital-Tage
-
Labordaten
occult blood positive
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
Vitamin D3 400 IUs prescribed but wasn't taking at the time
Allergien
None
Vorherige Impfungen
-

VAERS 2085642

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
-
Alter
4,0
Geschlecht
M
Eingang
03.02.2022
Impfdatum
03.02.2022
Beginn
03.02.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

Patient was given two doses of DTAP and IPV on same day. No signs or symptoms at time of vaccination today around 2 pm. Follow up phone call with mother at 5 pm, child without signs or symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2058504

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
MI
Alter
0,3
Geschlecht
F
Eingang
24.01.2022
Impfdatum
07.01.2022
Beginn
07.01.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Seborrhoea Seborrhoeic dermatitis

Symptomtext

Patient Instructions will continue to observe and will recheck at the next exam visit Discussion Notes This breast tissue development is most likely from the maternal hormones that developed during mom's pregnancy. the breast tissue should gradually go away

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
NKDA
Vorherige Impfungen
mom assured that the rash is not related to the vaccine issue from Jan 7. Mom had several questions re vaccines from Jan 7, re-e

VAERS 2057538

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
WI
Alter
-
Geschlecht
F
Eingang
22.01.2022
Impfdatum
07.01.2022
Beginn
07.01.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Apnoea Bradycardia Mechanical ventilation Resuscitation

Symptomtext

Apneic/bradycardic event starting about 12 hours following immunizations needing positive pressure ventilation and chest compressions. Following this event she needed increase in respiratory support for about 12 hours continuing for approximately the next 24 hours.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Apnoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Former 28 6/7 week premature infant
Vorgeschichte
Chronic lung disease of prematurity
Andere Medikamente
Poly vi sol with iron
Allergien
-
Vorherige Impfungen
-

VAERS 2043533

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
OK
Alter
0,4
Geschlecht
M
Eingang
18.01.2022
Impfdatum
18.01.2022
Beginn
18.01.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

No adverse outcome. Gave IPV and Pediarix at same visit

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
Pediarix and Polio were given at same time
Allergien
no
Vorherige Impfungen
-

VAERS 2028342

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
OK
Alter
0,2
Geschlecht
M
Eingang
12.01.2022
Impfdatum
27.12.2021
Beginn
27.12.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Haematochezia

Symptomtext

Blood in stool

Weitere VAERSDATA-Felder
Praegender Schweregrund
Haematochezia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
lactose intolerant
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1985208

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
LA
Alter
0,5
Geschlecht
F
Eingang
28.12.2021
Impfdatum
28.12.2021
Beginn
28.12.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Inappropriate schedule of product administration No adverse event

Symptomtext

Pt was given the HPV vaccine outside of the schedule recommendations. Pt has shown no adverse effects from receiving this vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
ACTHIB, PEDIARIX, ROTATEQ.
Vorgeschichte
NONE
Andere Medikamente
FAMOTIDINE PO
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1928585

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
-
Alter
4,0
Geschlecht
M
Eingang
07.12.2021
Impfdatum
06.12.2021
Beginn
06.12.2021
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered

Symptomtext

Pediarix was given to patient (Dtap/IPV/Hep B) when Kinrix (Dtap/IPV) was all that was needed. Patient had already previously received an extra dose of Hepatitis B, so this was now the 5th dose of Hepatitis B that the patient received. Mother was notified before leaving, that child received an extra dose of Hepatitis B.

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

VAERS 1898022

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
MN
Alter
0,3
Geschlecht
M
Eingang
24.11.2021
Impfdatum
17.11.2021
Beginn
17.11.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Blood culture negative Culture urine negative Cyanosis Electrocardiogram normal Full blood count normal Hypotonia Metabolic function test normal Pallor Respiratory viral panel Viral test negative

Symptomtext

Infant appeared to tolerate vaccines well. At approximately 2100, Dad was reportedly carrying infant, infant had an episode of limpness, pallor, perioral cyanosis, improved with Dad positioning neck. EMS was called and arrived, infant was pale. Evaluated in ED, hospitalized for approximately 1.5 days for observation/testing, no clear cause found for event.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Blood culture negative
Hospital-Tage
2,0
Labordaten
11/17/2021: Negative respiratory viral panel, unremarkable CBC, unremarkable BMP, normal EKG, negative urine culture, negative blood culture.
Aktuelle Erkrankungen
Unilateral conjunctivitis 2 weeks prior, resolved at time of vaccines
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1832471

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge j953n

gering
Staat
FL
Alter
7,0
Geschlecht
M
Eingang
01.11.2021
Impfdatum
27.10.2021
Beginn
27.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

pediarix was administered to a 7 yr; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: Adose of pediarix was administered to a 7 yr patient, which led to inappropriate age at vaccine administration. No vaccination history available for the patient. The reporter consented to follow up. This case has been linked to US2021223563, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021223563:same reporter

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1832470

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge j953n

gering
Staat
FL
Alter
14,0
Geschlecht
M
Eingang
01.11.2021
Impfdatum
27.10.2021
Beginn
27.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

pediarix was administered to a 14 yr old; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The pediarix dose was administered to a 14 years old patient, which led to inappropriate age at vaccine administration. No vaccination history was available for the patient. The reporter consented to follow up. This case has been linked to US2021223565, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021223565:same reporter

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1808255

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
IL
Alter
0,4
Geschlecht
F
Eingang
22.10.2021
Impfdatum
20.10.2021
Beginn
20.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

The refrigerator that houses the vaccines experienced a temperature excursion. Per the program, the PEDIARIX vaccine was considered to be out of range and therefore invalid.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Eczema, gastroesophageal reflux disease, developmental delay, intrauterine drug exposure, child in foster care
Andere Medikamente
Vitamin D3, 400 unit per day
Allergien
None
Vorherige Impfungen
-

VAERS 1797758

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
FL
Alter
0,3
Geschlecht
F
Eingang
19.10.2021
Impfdatum
19.08.2021
Beginn
19.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Blepharospasm Crying Electroencephalogram Eye movement disorder Muscle twitching

Symptomtext

Vaccines given in office at appointment time around 1pm on 8/19/2021. No reactions noted in office and normal exam. 8/19/2021 around 9pm mom called and reports she has noticed patient doing some weird eye movements and a little twitch for about the past week. She did not think much of it and that is why she didn't mention it at todays appointment. However, patient did it again this evening and mom started googling and became concerned about "infantile spasms". Mom reports her eyes will roll back and to the side briefly and she will do a little twitch then cry. No loss of tone, no LOC, no color change or breathing changes. The episodes are very brief. She has had no vomiting, no fevers, no other symptoms. She had a normal exam in office today. I advised that if she has fever, loss of tone, syncope, color change, or the episodes last more than a few seconds to call 911 tonight. Otherwise will monitor closely and order a stat EEG and neurology referral in the morning. Mom agrees to plan. 8/20/2021 9:00am - Facility is unable to do a stat EEG today outpatient. I called the on call pediatric neurologist Doctor and she advised baby go to the ER for concerns of infantile spasms. Advised the ER doctor call the on call neurologist when baby gets there. I called and spoke with ER physician and advised why we were sending baby and what the neurologist said. Mom notified as well and will take baby now.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Blepharospasm
Hospital-Tage
-
Labordaten
Was admitted to hospital and would need to review hospital notes. She did receive EEG.
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1794523

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
CO
Alter
-
Geschlecht
M
Eingang
18.10.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Wrong product administered

Symptomtext

extra dose of Pediarix; was supposed to get a flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11th May 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong 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 details were provided as follows: Medical assistant reported that she accidentally administered a 2 year old an extra dose of Pediarix which led to extra dose administered. Patient was supposed to get a flu vaccine but got the Pediarix which led to wrong vaccine administered. Consent to follow up granted.

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

VAERS 1788603

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge J953N

gering
Staat
CO
Alter
0,8
Geschlecht
F
Eingang
15.10.2021
Impfdatum
28.09.2021
Beginn
28.09.2021
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Circumstance or information capable of leading to medication error

Symptomtext

Catch up IZs given: dtap #2, polio #2, hib #2, PCV #2, hep B #3 ** on chart review, determined that pt had IZs on schedule for 2m, 4m, and 6m. However these did not copy to the state reporting system 'CIS' utilized to determine if pt was up to date on IZ

Weitere VAERSDATA-Felder
Praegender Schweregrund
Circumstance or information capable of leading to medication error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
None
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1755687

GLAXOSMITHKLINE BIOLOGICALS · DTAP (INFANRIX) · Charge J953N

gering
Staat
-
Alter
3,0
Geschlecht
U
Eingang
02.10.2021
Impfdatum
21.09.2021
Beginn
21.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

received unnecessary dose; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 3-year-old patient who received Hib (Hiberix) (batch number 5ep38, expiry date unknown) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number J953N, expiry date unknown) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Infanrix (received the primary schedule on an unknown date before 21st September 2021) and hiberix (received the primary schedule on an unknown date before 21st September 2021). On 21st September 2021, the patient received Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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 details provided were as follows: Age at vaccination was not reported. The patient received unnecessary dose of Infanrix and Hiberix which led to extra dose administered.The patient's family was informed. The patient had already received the appropriate doses of these vaccines prior to 21st September 2021. No known adverse events due to error. The reporter consented to follow-up.

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