- Staat
- KS
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 15.09.2023
- Beginn
- 15.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site swelling
Vaccination site erythema
Vaccination site swelling
Symptomtext
Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2684685-1. The original narrative from the sender is the following: patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Vaccination site erythema and Vaccination site swelling". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Eczema
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 22.08.2023
- Beginn
- 23.08.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pyrexia
Symptomtext
Developed fever higher than expected - 103.9 without other symptoms; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2675644-1. The original narrative from the sender is the following: "Developed fever higher than expected - 103.9 without other symptoms." The causal relationship between Vaxelis and the event "Pyrexia", was assessed as related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- 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
- 2
- Route/Site
- IM / RL
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
- IM / RL
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
- VA
- Alter
- 1,3
- Geschlecht
- F
- Eingang
- 25.10.2023
- Impfdatum
- 23.10.2023
- Beginn
- 23.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Livedo reticularis
Peripheral coldness
Pyrexia
Symptomtext
Grandmother called stating the patient's arms were extremely cold the night after the vaccination. She states she noticed mottling the evening of and the day after. Patient also developed a 102 degree fever.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.09.2023
- Impfdatum
- 06.04.2023
- Beginn
- 07.04.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Irritability
Pyrexia
Vaccination site erythema
Symptomtext
Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2611990-1. The original narrative from the sender is the following: "Fever, localized redness on the thigh where vaccines were given, fussiness". The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " Fever, localized redness on the thigh where vaccines were given, fussiness". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 23.06.2023
- Impfdatum
- 19.06.2023
- Beginn
- 20.06.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Vomiting projectile
Symptomtext
Projectile vomiting within 24 hrs after vaccine. Unable to keep food down.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vomiting projectile
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 01.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Off label use
Product administered to patient of inappropriate age
Symptomtext
Product use in unapproved population (6 year old); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2688023-1. The original narrative from the sender is the following: N/A. Due to the nature of the event, the causal relationship between Vaxelis and Product use in unapproved population (6 year old) was not applicable. The case was classified as "Off Label Use" given that a 6 year old was administered with Vaxelis. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 10.08.2023
- Beginn
- 10.08.2023
- 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
Incorrect dose administered
Symptomtext
Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2677158-1. The original narrative from the sender is the following: "Incorrect dose administered (Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit)". Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and the event "Incorrect dose administered" was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis; Upper respiratory infection
- Vorgeschichte
- -
- Andere Medikamente
- ACETAMINOPHEN; CHOLECALCIFEROL; VITAMIN D3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 08.07.2023
- Beginn
- 07.08.2023
- Tage bis Beginn
- 30,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Circumstance or information capable of leading to medication error
Syringe issue
Underdose
Symptomtext
Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.; Adminstration issue; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667006-1. The original narrative from the sender is the following: "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit." This case was classified as a PQC to be databased given that the reported event was "Syringe issue" in which Vaxelis was reported as to a patient as a co-suspect vaccine. The reporter did not provide an assessment of causal relationship between Vaxelis and the events; "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue". Due to the nature of the event, the causal relationship between Vaxelis and "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue" was Not Applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Circumstance or information capable of leading to medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 28.07.2023
- Beginn
- 28.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Immediate post-injection reaction
Infant irritability
Pallor
Peripheral swelling
Irritability
Symptomtext
erythema after receiving Vaxelis vaccine in Left leg.; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; patient very fussy; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; Face and trunk became very pale; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2663996-1. The original narrative from the sender is the following: "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED." The reporter assessed the "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg", "Face and trunk became very pale" and "patient very fussy" as Related to Vaxelis as the patient experienced these events immediately after vaccination with Vaxelis as a co-suspect vaccine with RotaTeq and Vaxneuvance to suggest a causal relationship. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 05.07.2023
- Beginn
- 05.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658921-1. The original narrative from the sender is the following: " I administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early and did not realize until the end of the visit. Explained to mom what happened. Mother of patient did not return to clinic with any questions, concerns, or complaints of child feeling or having any reaction". The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.12.2023
- Impfdatum
- 21.09.2023
- Beginn
- 21.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE..Vaccines involved VAXERLIS and ROTATEQ.Temp:48F, Time frame:40min; This spontaneous non-serious safety report, with reference number 02477148, was received by a partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE. Vaccines involved VAXERLIS and ROTATEQ.Temp:48F, Time frame:40min" was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 03.10.2023
- Impfdatum
- 05.09.2023
- Beginn
- 05.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
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
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.09.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number 02475849 (Interaction number 02475710) was received by a partner on 20-SEP-2023 and forwarded on 21-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 13.09.2023
- Beginn
- 13.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation; This non-serious spontaneous safety report, with reference number 2023SA282138 (Inquiry# 01767327), was received by the partner on 14-SEP-2023 and forwarded on 15-SEP-2023, from a health professional. Due to the nature of the event, the causality between the event "patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation" Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.09.2023
- Impfdatum
- 19.06.2023
- Beginn
- 19.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no adverse event; Vaccines administered experienced a temperature excursion; This spontaneous report was received from a other health professional and refers to a patient (age and gender was unknown) The patient's medical history, concurrent condition, and concomitant therapies were not reported. On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, (lot #U7374BA, expiration date: 06-MAY-2025), administered for prophylaxis (strength, and route of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #W026137, expiration date: 05-FEB-2024), administered orally for prophylaxis (strength was not provided), after vaccines experienced a temperature excursion (8.74 C, time frame: 35 Minutes, had no previous temperature excursion) (Product storage error). There was no side effect reported (No adverse event), and no product quality complaint (PQC).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 3,0
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 01.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
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
- 4,0
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 01.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
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
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.09.2023
- Impfdatum
- -
- Beginn
- 21.06.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature :8.74 C ,Time frame:35 Min; This spontaneous non -serious safety report, with reference number 02475811, was received by a partner on 20-SEP-2023 and forwarded to company on 21-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.09.2023
- Impfdatum
- -
- Beginn
- 19.06.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature :8.74C , time frame: 35min; This non-serious spontaneous safety report, with reference number 02475789, was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.09.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.09.2023
- Impfdatum
- -
- Beginn
- 19.06.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature:8.74 C , Time frame:35min; This non-serious spontaneous safety report was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP. The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35 min." was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.09.2023
- Impfdatum
- 30.08.2023
- Beginn
- 30.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Wrong product administered
Symptomtext
receiving extra doses of Hib and Hepatitis B Vaccine; medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL; This non-serious spontaneous safety report, with reference number 2023SA268652, was received by the partner on 01-SEP-2023 and forwarded to company on 04-SEP-2023, from a health professional. Due to the nature of the event, the causality between the events "receiving extra doses of Hib and Hepatitis B Vaccine" and "medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL" and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- MMR; VARICELLA ZOSTER VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.09.2023
- Impfdatum
- 29.03.2023
- Beginn
- 31.07.2023
- Tage bis Beginn
- 124,0
- Dosis
- 1
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time;; Overdose; No reaction noted; This spontaneous safety report, with reference number 2023SA238061, was received by the partner on 03-AUG-2023 and forwarded to UBC on 04-AUG-2023, from a health care professional. Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose" and Vaxelis was not applicable. Further information is expected. Significant Follow-up information was received by the partner on 15-AUG-2022 and forwarded to company on the same day, from a physician. The case is maintained as non-serious. Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose, Overdose, and No reaction noted" and Vaxelis was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.09.2023
- Impfdatum
- 19.06.2023
- Beginn
- 19.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion.; No side effects reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) (V419) (lot number U7374BA has been verified to be a valid lot number, expiration date reported and validated as 06-MAY-2025) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) ) (lot number W026137 has been verified to be a valid lot number, expiration date reported and validated as 05-FEB-2024) after a temperature excursion (product storage error) at 8.74 centigrade degrees (C) with a timeframe of 35 minutes. Both vaccines were administered as prophylaxis (strength, dose, if a digital data logger was involved, vaccination scheme, route of administration and anatomical location were not provided). Additionally, there was no previous temperature excursion, and no effects were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.09.2023
- Impfdatum
- -
- Beginn
- 21.06.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No side effects reported; Vaccines administered experienced a temperature excursion; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. On 21-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) Injection, as prophylaxis (lot number: U7374BA, which was determined to be valid, with an expiration date on 06-MAY-2025) (strengths, doses, schemes, routes of administration were not reported) (Product storage error). The administered doses underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported. No additional adverse event was provided. This case is one of several reports from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.09.2023
- Impfdatum
- 21.09.2023
- Beginn
- 21.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No further AE Information. No PQC.; HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE. Permission to contact HCP given. No further AE Information. No PQC. ? Names of vaccines; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7374BA, expiration date: 06-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided). On 21-SEP-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968385, expiration date: 22-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). On 21-SEP-2023, HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given to the same patient, after the products had been through a TE (48 F for 40 minutes). Permission to contact HCP given. No further AE Information. No PQC.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.09.2023
- Impfdatum
- 28.06.2023
- Beginn
- 28.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No side effects reported; HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 28-JUN-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot number W026137 with expiration date 05-FEB-2024 (dose was not reported); and with a dose of toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS), lot number U7374BA with expiration date 06-MAY-2025 (dose and anatomical location were not reported); both vaccines for prophylaxis who were exposed to temperature excursion (product storage error). The vaccines were exposed to 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported. No side effects were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 14.09.2023
- Impfdatum
- 13.09.2023
- Beginn
- 13.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Symptomtext
pt showed no symptoms . vaccines was given around 9am by mself.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 01.09.2023
- Impfdatum
- 30.08.2023
- Beginn
- 30.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Wrong product administered
Symptomtext
Patient was administered Vaxelis instead of Quadracel giving the patient an extra Hep B and HIB
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- NA
- Andere Medikamente
- NA
- Allergien
- NA
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 08.08.2023
- Impfdatum
- 31.07.2023
- Beginn
- 31.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Contraindicated product administered
Medication error
No adverse event
Symptomtext
they had a patient who was accidentally administered with ACTHIB and VAXELIS at the same with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 months old male patient who was accidentally administered with hib (prp/t) vaccine [ACT-HIB] and vaxelis at the same with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Prophylactic vaccination. On 31-Jul-2023, the patient received a dose 1 of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot U7374BA, strength and expiry date unknown) via intramuscular route in right vastus lateralis for Immunization and they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse event (contraindicated product administered) (latency : same day). It is unknown if there were lab data/results available. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Contraindicated product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 01.08.2023
- Impfdatum
- 31.07.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / RL
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
- -
