- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.12.2023
- Impfdatum
- 01.08.2023
- Beginn
- 01.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Vomiting
Symptomtext
While administering RVl orally, patient vomited large amount of white (formula looking ) liquid.; Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl.; This spontaneous safety report, with reference number 2664173 (VAERS ID # 2664173-1), was received by a partner on 21-SEP-2023 and forwarded to Agency 25-SEP-2023, from a HCP. The reporter did not provide an assessment of causal relationship between Vaxelis and the event " While administering RVl orally, patient vomited large amount of white (formula looking) liquid" and the causal relationship between Vaxelis and the reported event " Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl" was assessed as not applicable due to the nature of these reported event No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vomiting
- Hospital-Tage
- -
- Labordaten
- Test Name: Body temperature; Result Unstructured Data: Test Result:99.1 ;Temporal temperature 99.1F
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.12.2023
- Impfdatum
- 01.08.2023
- Beginn
- 01.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Vomiting
Symptomtext
While administering RVl orally, patient vomited large amount of white (formula looking ) liquid.; Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl.; This spontaneous safety report, with reference number 2664173 (VAERS ID # 2664173-1), was received by a partner on 21-SEP-2023 and forwarded to Agency 25-SEP-2023, from a HCP. The reporter did not provide an assessment of causal relationship between Vaxelis and the event " While administering RVl orally, patient vomited large amount of white (formula looking) liquid" and the causal relationship between Vaxelis and the reported event " Patient received about half of the RVl dose. Mother of patient requested to not administer the rest of the RVl" was assessed as not applicable due to the nature of these reported event No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vomiting
- Hospital-Tage
- -
- Labordaten
- Test Name: Body temperature; Result Unstructured Data: Test Result:99.1 ;Temporal temperature 99.1F
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 16.11.2023
- Impfdatum
- 26.10.2023
- Beginn
- 28.10.2023
- Tage bis Beginn
- 2,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Gastrointestinal surgery
Infantile diarrhoea
Infantile vomiting
Intussusception
Symptomtext
Two days following vaccination, infant developed severe vomiting and diarrhea, which led caregiver to take her to a local ER, where she was airlifted to the nearest hospital, and she had emergency surgery for intussusception.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Infantile diarrhoea
- Hospital-Tage
- 7,0
- Labordaten
- 7 day hospital stay, emergency surgery
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- None
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 22.09.2023
- Impfdatum
- 20.09.2023
- Beginn
- 21.09.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Infant irritability
Rash
Symptomtext
24 hours after vaccination the patient was fussy and developed a generalized rash on her head, face, neck, arms , legs, chest, abdomena, the entire back, and the g/u area. It spared her mouth and palms and soles.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Acute URI 9/1/23 Cough 8/31/23
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 07.07.2023
- Impfdatum
- 03.07.2023
- Beginn
- 03.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Infant irritability
Product preparation issue
Pyrexia
Symptomtext
The Medical Assistant unknowingly reconstituted a vial of rotavirus (Rotarix Lot#379JY) with a ready-to-use syringe of rotavirus (Rotarix Lot#YL9YN). Thus, the patient received double the dose of the vaccine. This was discovered on Thursday 7/6/23 when there was a discrepancy of vaccine inventory of rotavirus vaccines. The system indicated that there were 9 Rotarix Lot#YL9YN, while the clinic Vaccine Inventory on indicated that there were 10 Rotarix Lot#YL9YN --meaning that the vaccine was not documented to a patient's chart. I found a diluent for reconstitution for Rotarix Lot#379JY on the counter where it usually is stored, but the vial of Rotarix Lot#379JY in the system and the transfer adapter were already used. I contacted the Medical Assistant who took care of the pt that day and Medical Assistant confirmed that they unknowingly used the ready-to-use syringe Rotarix Lot#YL9YN that was stored in the system to reconstitute the lyophilized vaccine component Rotarix Lot#379JY. Dr. contacted patient's mother and mother of patient reported that patient is fussy and takes a bit longer to eat. Patient had fever but has resolved for 2 days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- cholecalciferol (Vitamin D3) D-Vi-Sol 10mcg/mL (400 unit/mL) oral
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- PR
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 19.06.2023
- Impfdatum
- 12.06.2023
- Beginn
- 12.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Discomfort
Fatigue
Pyrexia
Rash
Symptomtext
Fever, Tiredness, Discomfort and Rash.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 16.06.2023
- Impfdatum
- 15.06.2023
- Beginn
- 15.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Irritability
Rash
Urticaria
Symptomtext
parent returned to clinic with baby, reporting rash/hives and irritability approximately 2 1/2-3 hours after vaccine administration - face, neck, torso, thighs; no respiratory symptoms; treated initially with Bendryl, sent home on Zyrtec; referred to Allergy for consultation
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- recent upper respiratory infection
- Vorgeschichte
- none
- Andere Medikamente
- breast milk and formula (unsure of type), acetaminophen, ? apple juice/graham crackers
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 15.06.2023
- Impfdatum
- 14.06.2023
- Beginn
- 14.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Immediate post-injection reaction
Rash
Symptomtext
Rash to R lower ext. noted almost immediately after administering vaccines. Grandmother pointed out that patient was starting to get more red spots to face, arms, and abdomen. Provider notified immediately. As per provider, to give 4ml prednisolone and 5ml of Benadryl. Patient did vomit after administering medication. Provider notified. Patient seen by provider 15 minutes after medication. Patient ok to leave. Reaction noted to be going away. Mother advised to give patient 5ml Benadryl OTC every 6 hrs as needed if the rash returns. Verbalized understanding.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- Tylenol 160mg/5ml
- Allergien
- Unknown Allergies
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 14.06.2023
- Impfdatum
- 13.06.2023
- Beginn
- 13.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pyrexia
Symptomtext
Fever with temp 98.8-101.3. Mom denies irritability or changes in rash. Advised Tylenol per weight dosage, tepid bath, hydration, continue to monitor symptoms and inform clinic of changes. Notified provider per message and will f/u with mom with further recommendations.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- Diaper Rash
- Vorgeschichte
- None
- Andere Medikamente
- Desitin
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 08.06.2023
- Impfdatum
- 30.05.2023
- Beginn
- 31.05.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Diarrhoea
Diarrhoea haemorrhagic
Haematochezia
Infant irritability
Laboratory test
Magnetic resonance imaging
Ultrasound scan
Symptomtext
SEVERE DIARRHEA WITH MUCUS AND BLOOD, CURRANT JELLY CONSISTENCY, PULLING KNEES TO CHEST WITH LOTS OF IRRITABILITY AND CRYING, CONCERN FOR INTUSSUSCEPTION,WITHIN 2 DAYS OF VACCINE, SENT TO HOSPITAL WITH 3 DAY STAY,
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- 3,0
- Labordaten
- ULTRASOUND, LABS, MRI
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 10.05.2023
- Impfdatum
- 08.05.2023
- Beginn
- 08.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site mass
Lethargy
Pyrexia
Symptomtext
3 cm X 4 cm indurated erythematous lumps at all 3 injection sites to bilateral thighs found by mom on the evening of 5/8/23. Mom also found her to be feverish and more lethargic on the evening of 5/8/23. Mom medicated her with infant's Tylenol at home and then brought her into see her pediatrician on 5/9/23.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 11.10.2023
- Impfdatum
- 14.07.2023
- Beginn
- 14.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Choking
Cyanosis
Immediate post-injection reaction
Oral administration complication
Wrong technique in product usage process
Symptomtext
Choked on vaccine; turned blue; This serious case was reported by a nurse via call center representative and described the occurrence of choking in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis. Concurrent medical conditions included irritability and crying. On 14-JUL-2023, the patient received Rotarix liquid formulation (oral). On 14-JUL-2023, immediately after receiving Rotarix liquid formulation, the patient experienced choking (Verbatim: Choked on vaccine) (serious criteria GSK medically significant) and cyanosis (Verbatim: turned blue). The outcome of the choking was resolved and the outcome of the cyanosis was not reported. It was unknown if the reporter considered the choking and cyanosis to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the choking and cyanosis to be related to Rotarix liquid 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: 04-OCT-2023 The reporter was a Certified Nurse Aide. Prior to administration the patient was fussy and crying and during entire administration. The reporter reported that patient choked during administration of Rotarix (liq) and turned blue. The patient started choking during administration, which was done while patient was lying down on table. The reporter reported that babies did not like it. The patient recovered after patting on back and sitting up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The case had been linked to the US2023136407 case, reported by same reporter.; Sender's Comments: US-GSK-US2023136407:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Choking
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Crying; Irritability
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 0,4
- Geschlecht
- M
- Eingang
- 19.09.2023
- Impfdatum
- 23.08.2023
- Beginn
- 23.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 15.09.2023
- Impfdatum
- 18.08.2023
- Beginn
- 18.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,1
- Geschlecht
- F
- Eingang
- 11.08.2023
- Impfdatum
- 03.08.2023
- Beginn
- 03.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Accidental underdose
Regurgitation
Symptomtext
patient spit up 5 to 10 minutes after the administration; patient spit up 5 to 10 minutes after the administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis. On 03-AUG-2023, the patient received Rotarix lyophilized formulation. On 03-AUG-2023, 5 min after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: patient spit up 5 to 10 minutes after the administration) and accidental underdose (Verbatim: patient spit up 5 to 10 minutes after the administration). The outcome of the regurgitation of medication and accidental underdose 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: 03-AUG-2023 A nurse reported that they administered the Rotarix(Liquid presentation) today on 03 August 2023 to a pediatric patient but the patient spit up 5 to 10 minutes after the administration. Nurse wanted to know if any recommendations re dosing for Rotarix(Liquid). The patient spit up 5 to 10 minutes after the administration which led to accidental underdose. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Accidental underdose
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 01.08.2023
- Impfdatum
- 31.07.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Incorrect dose administered
No adverse event
Symptomtext
No adverse reaction . He was over 14 wks. old
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- immune Throbocytopenia
- Andere Medikamente
- -
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 24.07.2023
- Impfdatum
- 11.07.2023
- Beginn
- 17.07.2023
- Tage bis Beginn
- 6,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Haematochezia
Irritability
Mucous stools
Occult blood positive
Symptomtext
Blood and mucous in stool, increased irritability around bowel movements. Positive occult blood test of stool at visit 7/17/23. F/U 7/19/23 - Negative occult blood in stool, still some fussiness Phone f/u 7/24/23 - fully resolved, back to normal self
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- Occult blood testing x 1 on 7/17/23 and 7/19/23
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Vitamin D supplement, 400 IU daily
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- ND
- Alter
- 0,1
- Geschlecht
- M
- Eingang
- 06.07.2023
- Impfdatum
- 15.06.2023
- Beginn
- 15.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 19.05.2023
- Impfdatum
- 19.05.2023
- Beginn
- 19.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Patient received 3 doses of Rotarix instead of 2.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 16.05.2023
- Impfdatum
- 21.04.2023
- Beginn
- 21.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Product administered to patient of inappropriate age
Symptomtext
a patient got an extra dose of Rotarix; inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number yl9yn, expiry date 20-APR-2025) for prophylaxis. Previously administered products included Rotarix (received 1st dose on 20th December 2022 by oral route, batch number 5279E, expiry date 25th February 2024). Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX). On 21-APR-2023, the patient received the 3rd dose of Rotarix lyophilized formulation (oral). On 21-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: a patient got an extra dose of Rotarix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the extra dose administered and inappropriate age at vaccine administration 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: 09-MAY-2023 The reporter was a practice administrator stating that a patient got an extra dose of Rotarix. They received their first 2 vaccines in the appropriate time frame and then got a 3rd dose of Rotarix. The reporter was consented to follow up. The patient received 3rd dose of Rotarix, which led to Extra dose administered. The patient received 3rd dose of Rotarix at 6 month of age, which led to Inappropriate age at vaccine administration. This case was identified as duplicate of case US2023066939. All future correspondence would be added in case US2023066941, which stands as case of record for this patient and the case US2023066939 would be deleted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 28.04.2023
- Impfdatum
- 18.04.2023
- Beginn
- 18.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- 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; Baby not able to swallow full dose due to spitting out; 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 female patient who received Rota (Rotarix lyophilized formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis. This case was associated with a product complaint. On 18-APR-2023, the patient received the 1st dose of Rotarix lyophilized formulation. On 18-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Baby not able to swallow full dose due to spitting out) 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/ 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 attempted to contact health care professional but did not received answer. The reporter stated that when nurse will call back need to obtain additional information like business name, confirm lot numbers and expiration dates for doses because 12 patients were affected but there are 10 doses in a package, confirm initials, gender, and date of birth for patients. The reporter wanted to know if suspect products can be returned, if there is any issue in appearance before administration. If yes then asked PQC questions description of approximate size, shape and color, what was different from other vials/syringes if it was cloudier deposit more difficult to put in suspension, color was different or any visible damage present on the vial/syringe, was there any temperature excursions during storage and was the product at room temperature when particle observed. 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-US2023AMR060476:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463: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
- -