- Staat
- KS
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 22.02.2022
- Beginn
- 22.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Agitation
Cellulitis
Erythema
Exophthalmos
Eye movement disorder
Injection site cellulitis
Injection site erythema
Feeling abnormal
Musculoskeletal stiffness
Peripheral swelling
Pyrexia
Seizure
Injection site swelling
Symptomtext
Became stiff; Agitation; 'cellulitis' to right calf area; Very faint pinkness noted to right calf; her eyes buldged; EYE MOVEMENT DISORDER; very fussy and inconsolable; Some swelling to the R thigh; pt had a low grade fever; Eyes fluttered a little (she described this as a seizure).; This non-serious case was received from a parent and a nurse via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2134584-1. The original narrative from the sender is available: "Mother reported that pt had a low grade fever, very fussy and inconsolable, her eyes bulged and became stiff, then her eyes fluttered a little (she described this as a seizure). Some swelling to the R thigh.". In addition: "Seen in ER. Pt put on Amoxicillin for 'cellulitis' to right calf area. Pt was visualized by this reporting nurse on 02.23.2022. Very faint pinkness noted to right calf. There was ink markings noted below knee from where medical staff outlined redness at time seen in ER."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 06.06.2022
- Impfdatum
- 23.05.2022
- Beginn
- 24.05.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Body temperature increased
Electroencephalogram
Fatigue
Full blood count
Gaze palsy
Human rhinovirus test positive
Joint contracture
Laboratory test
Magnetic resonance imaging head
Metabolic function test
Muscle twitching
Respiratory tract congestion
Respiratory viral panel
Retching
Seizure
Tremor
Symptomtext
Patient received her vaccines on the morning of 5/23/22. She was in her usual state of health. The following morning as she was breastfeeding mom noted that seemed congested. This was about 6 am. She fell back to sleep after eating. At about 6:30 am she heard her gagging and when she checked on her, her left arm was shaking and the right side of her face was twitching. Her fists were clenched and she was gazing upwards. After she fell asleep and seemed tired. The entire episode lasted approximately 2 minutes. She was taken to the ER for evaluation. After she arrived home she had a low grade temperature of 99. 2 days later she had a temperature of 100.2 . Clinically she seemed well. An upper respiratory panel was positive for human rhinovirus. However, 5 days later she had another episode of seizure and was admitted for further evaluation. She was started on Keppra. She had labwork done including an EEG and MRI of her brain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- 3,0
- Labordaten
- CBC, BMP, and Upper respiratory panel done on 5/26/22 EEG 5/29/22 MRI 5/31/22
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- No allergies
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 17.02.2022
- Impfdatum
- 01.02.2022
- Beginn
- 01.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Cyanosis
Drug hypersensitivity
Electroencephalogram
Laboratory test
Seizure
Seizure like phenomena
Viral infection
Symptomtext
Pt. was reported to have 'turned blue' was seen at ER. Possible seizures. Pt transferred to hospital per private vehicle with 'seizure like' activity. Reported by grandmother, that the patient had 'some sort of virus'. She also reported that he had 'a reaction to some sort of medication' that was given at the hospital. Also states he had a seizure while there and team 'checked him for an infection in the brain'
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- 2,0
- Labordaten
- EEG, benadryl, fluids.lab work
- Aktuelle Erkrankungen
- na-questionable hx of seizures. not diagnosed at time of service
- Vorgeschichte
- na
- Andere Medikamente
- na
- Allergien
- na
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 06.12.2021
- Beginn
- 15.12.2021
- Tage bis Beginn
- 9,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Pain
Vaccination site induration
Vaccination site mass
Symptomtext
Child is moving the left leg less; Pain when using the leg; Hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated; Hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1956185. The original narrative from the sender is the following: Parent reports hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated. Parents reports that child is moving the left leg less and is in pain when using the leg. Reports no redness site or respiratory distress or fever. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "child is moving the left leg less", "pain when using the leg" and "hard lump on left leg of child at the vaccination site, not visible until by site but can be felt if the site is palpated". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 06.12.2021
- Beginn
- 15.12.2021
- Tage bis Beginn
- 9,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Pain
Vaccination site induration
Vaccination site mass
Symptomtext
Child is moving the left leg less; Pain when using the leg; Hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated; Hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1956185. The original narrative from the sender is the following: Parent reports hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated. Parents reports that child is moving the left leg less and is in pain when using the leg. Reports no redness site or respiratory distress or fever. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "child is moving the left leg less", "pain when using the leg" and "hard lump on left leg of child at the vaccination site, not visible until by site but can be felt if the site is palpated". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 12.06.2023
- Beginn
- 12.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Administration site erythema
Administration site swelling
Swelling
Injection site erythema
Injection site swelling
Symptomtext
Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; This non-serious spontaneous safety report with reference number # 2307USA011814 (VAERS ID 2644679-1) was received by a partner on 25-JUL-2023 and forwarded to company on 27-JUL-2023 from a health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh". Further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 12.06.2023
- Beginn
- 12.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Administration site erythema
Administration site swelling
Swelling
Injection site erythema
Injection site swelling
Symptomtext
Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; This non-serious spontaneous safety report with reference number # 2307USA011814 (VAERS ID 2644679-1) was received by a partner on 25-JUL-2023 and forwarded to company on 27-JUL-2023 from a health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh". Further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 28.11.2022
- Beginn
- 28.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Infant irritability
Injection site erythema
Injection site pain
Injection site swelling
Pyrexia
Symptomtext
Extreme fussiness and unconsolable; Tenderness from the knee to the thigh; after receiving VAXELIS swelling at the injection site on the thigh and fever; Fever/ Pt reported a 100.9 temp; Redness & swelling at the site where vaccine was given/ from knee to the thigh; This non-serious spontaneous safety report with reference number 02320717 was received by a partner on 19-JAN-2023 and forwarded on 20-JAN-2023 from a health care professional. This case was considered non-valid given that no patient identifiers were provided (the reporter was not sure of the patient's age). The reporter did not provide an assessment of the causal relationship between Vaxelis and the event "after receiving VAXELIS swelling at the injection site on the thigh and fever". Further information is expected. FOLLOW-UP Information was received by partner on 25-JAN-2023 and forwarded on 26-JAN-2023 from a health care professional. The case is considered valid (Patient identifiers provided). The reporter assessed the events, "after receiving VAXELIS swelling at the injection site on the thigh", "Redness & swelling at the site where vaccine was given/ from knee to the thigh" and fever/ Pt reported a 100.9 temp" as related to Vaxelis. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events, "Extreme fussiness and unconsolable" and "Tenderness from the knee to the thigh". Follow up information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 23.05.2022
- Beginn
- 23.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site induration
Injection site swelling
Peripheral swelling
Symptomtext
Leg is also swollen; Bump at the injection site. Bump is hard; This spontaneous safety report, with reference number 2022SA261502, was received on 21-JUL-2022, from a health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events: "Bump at the injection site. Bump is hard" and "Leg is also swollen". Further information is expected. For reference purposes the case is linked to MCM-003723 (parent case/ same reporter).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site induration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 12.11.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Discomfort
Injection site erythema
Injection site induration
Injection site warmth
Pyrexia
Symptomtext
Overall uncomfortable after the administration of VAXELIS; Warm to touch; 3.5 cm of redness induration and also warm to touch; Red spot at the VAXELIS injection site; Crying more than usual; Significant fever; This non-serious spontaneous safety report with agency reference #02151156 was received via partner on 20-APR-2022 and forwarded to agency on 21-APR-2022, from a Health Care Professional. The reporter did not assess the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever'. It was reported that the PCV 13 Vaccine was administered the same day (on the opposite thigh) as VAXELIS. It was considered as co-suspect given that the patient experienced 'crying more than usual', and 'significant fever'. Nonetheless, PCV 13 was concomitant for the other reported adverse events. Further information is expected. Significant follow-up was received via fax by agency on 12-MAY-2022, from a Health Care Professional. The reporter confirmed that the events were not serious. First dose of Vaxelis was administered on 12-NOV-2021. Second dose was administered on12-JAN-2022. End date and outcome of events were provided. The patient was treated with analgesic for pain, and cool or warm compresses. The reporter assessed the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever' as related. This case is maintained as non-serious. 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
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 12.02.2022
- Beginn
- 12.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Injection site erythema
Symptomtext
EXTRA DOSE ADMINISTERED; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2189860-1. The original narrative from the sender is as follows: Two Hib containing vaccine were given to patient on the same day. Vaxelis (DTaP+Hib+IPV+HepB) and PedvaxHib were administered on 02/12/2022 by on-call MA. Vaxelis was given in left thigh and Hib in right thigh. Adverse events after prior vaccinations included redness on Right thigh injection site.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 09.03.2022
- Beginn
- 10.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cyanosis
Pyrexia
Symptomtext
Lips turned blue; Temp at that time was 97, then with in ten minutes, temp was 103; This non-serious spontaneous case was received from a non-Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2184373-1. The original narrative from the sender is available and included in the source document: "Mom states that she thought he had a fever so she put him in a warm bath, his lips turned blue temp at that time was 97, then with in ten minutes his temp was 103". The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events: Lips turned blue, and Temp at that time was 97, then with in ten minutes, temp was 103. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Ear infection
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 09.03.2022
- Beginn
- 10.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / OT
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cyanosis
Pyrexia
Symptomtext
Lips turned blue; Temp at that time was 97, then with in ten minutes, temp was 103; This non-serious spontaneous case was received from a non-Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2184373-1. The original narrative from the sender is available and included in the source document: "Mom states that she thought he had a fever so she put him in a warm bath, his lips turned blue temp at that time was 97, then with in ten minutes his temp was 103". The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events: Lips turned blue, and Temp at that time was 97, then with in ten minutes, temp was 103. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Ear infection
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 08.11.2021
- Beginn
- 09.11.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site mass
Injection site swelling
Symptomtext
Red, swollen lump at injection site, 3cm in diameter; Injection site erythema; Red, swollen lump at injection site, 3cm in diameter; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2062020-1. The original narrative from the sender is as below: Red, swollen lump at injection site, 3cm in diameter. Redness and swelling lasted approximately 3 weeks. Lump palpable 2 months post-vaccine The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Injection site mass, Injection site erythema and Injection site swelling". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D [VITAMIN D NOS]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 08.11.2021
- Beginn
- 09.11.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site mass
Injection site swelling
Symptomtext
Red, swollen lump at injection site, 3cm in diameter; Injection site erythema; Red, swollen lump at injection site, 3cm in diameter; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2062020-1. The original narrative from the sender is as below: Red, swollen lump at injection site, 3cm in diameter. Redness and swelling lasted approximately 3 weeks. Lump palpable 2 months post-vaccine The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Injection site mass, Injection site erythema and Injection site swelling". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D [VITAMIN D NOS]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 0,6
- Geschlecht
- M
- Eingang
- 09.08.2021
- Impfdatum
- 02.08.2021
- Beginn
- 03.08.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Adenovirus infection
Blood electrolytes
Clostridium difficile infection
Culture stool positive
Decreased appetite
Escherichia infection
Full blood count
Hypovolaemia
Laboratory test
Lethargy
Polymerase chain reaction positive
Pyrexia
Symptomtext
Patient developed fever, decreased appetite and lethargy the day after vaccination. Eventually, was admitted for IVVD and fever.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- 3,0
- Labordaten
- Had numerous electrolyte, CBC, and other lab studies. Stool positive for C diff antigen and E. coli. Respiratory PCR positive for adenovirus before discharge.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 27.09.2023
- Beginn
- 27.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Off label use
Wrong product administered
Symptomtext
Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP.; Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP.; This non-serious spontaneous safety report with reference number 2023SA394450 (Inquiry number: 01883052) was received by a partner on 19-DEC-2023 and forwarded to UBC on 20-DEC-2023, from a HCP. This case was considered off-label use as Vaxelis was administered by mistake to an 11-year-old patient. Due to the nature of the event, the causality between the events; "Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP." and Vaxelis was assessed as not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Off label use
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- HPV VACCINE; INFLUENZA VACCINE; MENINGOCOCCAL VACCINE CONJ
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 18.12.2023
- Impfdatum
- 18.10.2023
- Beginn
- 18.12.2023
- Tage bis Beginn
- 61,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Medication error
No adverse event
Underdose
Symptomtext
NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 8 oz = to 5.22 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs. Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per RA and CDC guidelines
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- BEYFORTUS
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 18.12.2023
- Impfdatum
- 18.10.2023
- Beginn
- 18.12.2023
- Tage bis Beginn
- 61,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Underdose
Symptomtext
NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 4 oz = to 5.1 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs. Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per state and CDC guidelines
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 28.09.2023
- Impfdatum
- 30.08.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct; Male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022.; This non-serious spontaneous safety report, with case Number 2023SA202003 (Inquiry Number 01674630), was received by partner, on 30JUN2023 and forwarded on 03JUL2023 from a healthcare professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. "Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct and, male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022." 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
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 19.10.2022
- Beginn
- 19.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb; Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2490934-1. The original narrative from the sender is the following: Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb. The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Wrong Product Administered," and "Overdose." 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
- IN
- Alter
- 0,4
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 22.11.2022
- Beginn
- 09.11.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C; This spontaneous safety report, with reference number 2022SA509263 (Inquiry Number 01407148) was received by the partner on 14-DEC-2022 and forwarded to Agency on 16-DEC-2022, from a health professional. Due to the nature of the event, the causality between the event "Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C" and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- PNEUMOCOCCAL VACCINE 13V
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 31.08.2022
- Beginn
- 31.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Depressed level of consciousness
Symptomtext
After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping.; Cry and was easily aroused; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2425360-1. The original narrative from the sender is the following: After giving immunizations instructed Mom to wait with both children for 15 mins in our vaccination room and when returning to give mother the visit summary at 11:40am , baby was sitting in infant seat sound asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping. Mother reported that baby's nap time is usually around this time of day and she had been up since 6 am and last feeding was at 10:30am . Asked RN to please hold baby and stay with mom , retrieved our NP and our volunteer to please help assess baby in vaccination room. Applied child size bp cuff on left thigh to obtain bp reading and then baby began to cry and was easily aroused. Baby was then placed in mother's arms and baby was smiling and awake. Informed with help from translating RN that should mother see any changes in baby's respirations or behavior to please go to er or call emergency services for evaluation . Let her know that usually in the first 15 mins post vaccination that is when a reaction is likely to occur. Baby Awake and alert and responding to her mother. Discharged in stable condition with mom. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping." and "cry and was easily aroused". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Crying
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 22.08.2022
- Beginn
- 22.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
provider ordered DTAP-IPV but DTAP-IPV-Hib-HepB(Vaxelis) was given; Vaccine administered to a 5year old child; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2443227-1. The original narrative from the sender is the following: Provider ordered DTAP-IPV, but DTAP-IPV-Hib-HepB (Vaxelis)was given. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Wrong product administered". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.09.2022
- Impfdatum
- 23.08.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Nurse calling for TE evaluation states 3 doses of VAXELIS in PFS involved in the excursion have been administered to patients; This non-serious spontaneous safety report reference #02238017/ interaction #02237963 was received by a partner on 01-SEP-2022 from a Nurse, and forwarded on 02-SEP-2022. Due to the nature of the event, the causality between Vaxelis and the reported event of "Nurse calling for TE evaluation states 3 doses of VAXELIS involved in the excursion have been administered to patients" was not applicable. 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
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.09.2022
- Impfdatum
- -
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963, was received by the partner on 01-SEP-2022 and forwarded to Agency on 02-SEP-2022, from a health professional. Due to the nature of the event, the causality between the event "Nurse calling for TE evaluation on refrigerated products state 3 doses of Vaxelis in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 6 hours 40 minutes", and Vaxelis was not applicable. Further information is expected. For reference purposes cases is linked to: MCM-003974 and MCM-003975.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 23.05.2022
- Beginn
- 23.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Vaccination error
Symptomtext
Thought I needed to give the patient vaxelis. Misunderstood the NP orders.; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290529-1. The original narrative from the sender is as below: Thought I needed to give the patient vaxelis. Misunderstood the NP orders. Child didn't have no reaction or distress after the vaccine was administered. Pt mother was aware of the vaccine given.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 31.05.2022
- Beginn
- 31.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Circumstance or information capable of leading to medication error
No adverse event
Wrong product administered
Symptomtext
While checking inventory that Pediarix was documented as given, but vaxelis was actually adminstered; Received 2 doses of Hib in error; No adverse reaction was reported; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2312795-1. The original narrative from the sender is the following: No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian of child was telephone on 6/1/2022, at number provided in patient's record, but message ""not accepting calls"" was received. Her voice mail box was full, so no message was left.
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
- LA
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 31.05.2022
- Beginn
- 31.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
While checking inventory that Pediarix was documented as given, but vaxelis was actually adminstered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2312794-1. The original narrative from the sender is the following: No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian of child was telephoned on 6/1/2022, at number provided in patient's record, but message "not accepting calls" was received. Her voice mail box was full, so no message was left.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- DC
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 20.05.2022
- Beginn
- 20.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Circumstance or information capable of leading to medication error
No adverse event
Wrong product administered
Symptomtext
Vaccine given in error; No adverse reaction to vaccine; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2307076-1. The original narrative from the sender is the following: Vaccine given in error. Order was for Varicella (Varivax) which was misread and Dtap IPV HIb HepB (Vaxelis) administered. Pt had no adverse reaction to vaccine and will receive correct vaccine during 15 month well child check. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vaccine given in error". 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
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.09.2022
- Impfdatum
- -
- Beginn
- 11.07.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
A vaccine that experienced a supported temp excursion was administered to patients; This non-serious spontaneous safety report was received with reference numbers 02202408 / 02202359 on 11-JUL-2022 and forwarded on 12-JUL-2022 from another health care professional. The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" 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
- LA
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 31.05.2022
- Beginn
- 31.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Wrong product administered
Symptomtext
Extra dose administered; Wrong product administered; No adverse event; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2312796-1 . The original narrative from the sender is as below: No adverse event was reported. It was discovered on 6/1/2022 while checking inventory that pediarix was documented as given but vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian if child was telephoned on 6/1/2022, at number provided in patients record, but message "not accepting calls" was received. her voice mail box was full, so no message was left.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 28.03.2022
- Beginn
- 28.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect route of product administration
No adverse event
Product administration error
Product preparation error
Symptomtext
2 month baby received rotarix vaccine by IM instead of orally; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; No adverse event noted for about 2 hours and the next two days; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2231142-1. The original narrative from the sender is as below: Vaccine administartion error** 2 month baby received rotarix vaccine by IM instaed of orally. Rotarix reconstituted using sterile water and administered IM. No any adverse reactions noted for about 2 hrs and the next two days. We haven't heard anything from parent that baby developed any adverse reaction after that up until now as of 4/13/2022. Parent brought the baby to ED that afternoon not because of adverse reaction but because they wanted to make sure if everything was okay and received counselling regarding vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 14.03.2022
- Beginn
- 21.03.2022
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Haematochezia
Symptomtext
Product use in unapproved population; Blood in stools for a week.; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2220967-1. The original narrative from the sender is as below: Blood in stools for a week. No further information expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrioventricular canal (Repair of atrioventricular canal at birth); Chromosomal anomalies (8p23. 1 duplication); Feeding tube user (for feeding difficulty)
- Vorgeschichte
- Medical History/Concurrent Conditions: Coarctation of aorta (Coartctation of aorta at birth)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 14.03.2022
- Beginn
- 21.03.2022
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Haematochezia
Symptomtext
Product use in unapproved population; Blood in stools for a week.; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2220967-1. The original narrative from the sender is as below: Blood in stools for a week. No further information expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrioventricular canal (Repair of atrioventricular canal at birth); Chromosomal anomalies (8p23. 1 duplication); Feeding tube user (for feeding difficulty)
- Vorgeschichte
- Medical History/Concurrent Conditions: Coarctation of aorta (Coartctation of aorta at birth)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 13.09.2022
- Impfdatum
- 22.08.2022
- Beginn
- 22.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Wrong product administered
Symptomtext
Provider ordered DTAP-IPV, but DTAP-IPV-Hib-HepB (Vaxelis) was given.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 31.08.2022
- Impfdatum
- 31.08.2022
- Beginn
- 31.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Unresponsive to stimuli
Symptomtext
After giving immunizations instructed Mom to wait with both children for 15 mins in our vaccination room and when returning to give mother the visit summary at 11:40am , baby was sitting in infant seat sound asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping. Mother reported that baby's nap time is usually around this time of day and she had been up since 6 am and last feeding was at 10:30am . Asked RN to please hold baby and stay with mom , retrieved our NP and our volunteer to please help assess baby in vaccination room. Applied child size bp cuff on left thigh to obtain bp reading and then baby began to cry and was easily aroused. Baby was then placed in mother's arms and baby was smiling and awake. Informed with help from translating RN that should mother see any changes in baby's respirations or behavior to please go to er or call 911 for evaluation . Let her know that usually in the first 15 mins post vaccination that is when a reaction is likely to occur. Baby Awake and alert and responding to her mother. Discharged in stable condition with mom.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Crying
- Hospital-Tage
- -
- Labordaten
- none ordered Baby responded awake, alert and responsive to noxious stimuli, bp cuff , bright lights pupils PERRLA.
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- nnkda
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 05.04.2022
- Beginn
- 05.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
VAXELIS was administered to a patient after his 5th birthday; This non-serious spontaneous safety Report with reference number 2022SA161948, was received by Sanofi, on 03-May-2022 and forwarded on 05-May-2022 from a HCP. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported off-label event, "VAXELIS was administered to a patient after his 5th birthday". No further information is expected because HCP does not want to be contacted
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
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 12.01.2022
- Beginn
- 12.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Symptomtext
EXTRA DOSE ADMINISTERED; NO ADVERSE EVENT; This case was retrieved during the ICSR monitoring on Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2028440-1. The original narrative from the sender is: No adverse reaction, gave two doses of Hep B at time of vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Otitis media; Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- 06.01.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Interchange of vaccine products
No adverse event
Symptomtext
9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old.; This non-serious spontaneous safety report with reference #02144115 was received by a partner on 08-APR-2022 and forwarded on 11-APR-2022 from a health care professional. The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old" is assessed as not applicable due to the nature of the event. Further information is expected. FOLLOW-UP information was received by a partner on 18-APR-2022 and forwarded on 19-APR-2022 from a health care professional. The case is maintained as non-serious. The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old" remains not applicable due to the nature of the event. Further information is expected. SIGNIFICANT FOLLOW-UP information was received on 18-MAY-2022 from a health care professional. The case is maintained as non-serious. It was reported that no adverse reactions occurred due to the interchange of vaccines (event onset date 06-JAN-2022). Patient's concomitant vaccinations at 6 months appointment were Prevnar, RotaTeq, and Influenza along with Pediarix. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Interchange of vaccine products
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 10.02.2022
- Beginn
- 05.02.2022
- 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
Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022; This non-serious case was received from a Health Care Professional via the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2178992 and databased on 13-APR-2022. The original narrative from the sender is the following: "No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported. On 10 FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported." Due to the nature of the reported event, the causality between Vaxelis and the events "Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS, and The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 25.01.2022
- Beginn
- 25.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
NO ADVERSE EVENT; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This case was retrieved during the monitoring on the Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2178210-1. The original narrative from the sender is as follows: Dose of Vaxelis given to an 11 year patient (out of recommended age range). This was not noted until approx 6 weeks later. Pt had no adverse events or symptoms reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 25.01.2022
- Beginn
- 25.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
NO ADVERSE EVENT; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This case was retrieved during the monitoring on the Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2178210-1. The original narrative from the sender is as follows: Dose of Vaxelis given to an 11 year patient (out of recommended age range). This was not noted until approx 6 weeks later. Pt had no adverse events or symptoms reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 04.01.2022
- Beginn
- 05.01.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Haematochezia
Occult blood positive
Symptomtext
HAEMATOCHEZIA; OCCULT BLOOD POSITIVE; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2011217-1. The original narrative from the sender is as below: Developed hematochezia 24 hours after first dose of Rotavirus.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Heart murmur; Pulmonary valve stenosis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 07.06.2022
- Impfdatum
- 31.05.2022
- Beginn
- 31.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian of child was telephone on 6/1/2022, at number provided in patient's record, but message "not accepting calls" was received. Her voice mail box was full, so no message was left.
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
- -
- Staat
- DC
- Alter
- 1,2
- Geschlecht
- F
- Eingang
- 02.06.2022
- Impfdatum
- 20.05.2022
- Beginn
- 20.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
Vaccine given in error. Order was for Varicella (Varivax) which was misread and Dtap IPV HIb HepB (Vaxelis) administered. Pt had no adveres reaction to vaccine and will receive correct vaccine during 15 mon well child check.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- none
- Andere Medikamente
- No
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 23.05.2022
- Impfdatum
- 23.05.2022
- Beginn
- 23.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Thought I needed to give the patient vaxelis. Misunderstood the NP orders. Child didn't have no reaction or distress after the vaccine was administered. Pt mother was aware of the vaccine given
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- No
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- no
- Andere Medikamente
- no
- Allergien
- no
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2022
- Impfdatum
- 25.02.2022
- Beginn
- 05.02.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Temperature: 0.8?C (Temperature Excursion had occurred on 02/05/2022. On 02/25/2022, patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS.; This non-serious spontaneous safety report, with reference number 02125903 (and interaction # 02125857), was received by the partner on 10-MAR-2022 and forwarded to Agency on 15-MAR-2022, from a Nurse. Due to the nature of the event, the causality between the reported event "Temperature: 0.8?C (Temperature Excursion had occurred on 02/05/2022. On 02/25/2022, patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS." and Vaxelis was assessed as not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2022
- Impfdatum
- 09.02.2022
- Beginn
- 09.02.2022
- 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
Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored; This non-serious spontaneous safety report with reference number 02125902 was received by a partner on 10-MAR-2022 and forwarded to Agency on 15-MAR-2022 from a health care professional. The causal relationship between Vaxelis and the reported event Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored is 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
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2022
- Impfdatum
- 20.02.2022
- Beginn
- 20.02.2022
- 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
Patient was administered both improperly stored Vaxelis and Rotateq; This non-serious spontaneous safety report with reference number 02125894 was received by the partner on 10-Mar-2022 and forwarded to Agency on 15-Mar-2022 from another health care professional. The causal relationship between Vaxelis and the reported event is 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
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2022
- Impfdatum
- 10.02.2022
- Beginn
- 05.02.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This non-serious spontaneous safety report with reference number 02125895 was received by a partner on 10-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional. The causal relationship between Vaxelis and the reported event of "On 10-Feb-2022, patient was administered both improperly stored ROTATEQ, and improperly stored VAXELIS (product temperature excursion happened on 05-Feb-2022)" is 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
- 0,2
- Geschlecht
- U
- Eingang
- 01.04.2022
- Impfdatum
- 18.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incomplete course of vaccination
Symptomtext
The patient did not receive his/her 4 month or 6 month dose of VAXELIS.; This non-serious spontaneous safety report with reference number 02126618 was received by a partner on 11-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional. The causal relationship between Vaxelis and the reported event 'The patient did not receive his/her 4 month or 6 month dose of VAXELIS' was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incomplete course of vaccination
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 01.04.2022
- Impfdatum
- 30.11.2021
- Beginn
- 30.11.2021
- 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
Product administered to patient of inappropriate age
Symptomtext
Received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth.; The baby missed his vaccinations at TWO months old; This non-serious spontaneous safety report with reference number #2022SA024585 was received by a partner on 25-JAN-2022 and forwarded to regulatory authority on 27-JAN-2022 from a health care professional. The causal relationship between Vaxelis and the reported events "received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth" and "the baby missed his vaccinations at two months old" was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- PNEUMOCOCCAL CONJUGATE VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 1,7
- Geschlecht
- F
- Eingang
- 01.04.2022
- Impfdatum
- 19.10.2021
- Beginn
- 19.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE; PRODUCT STORAGE ERROR; This case was retrieved during the VAERS-ICSR monitoring in FDA on 12-JAN-2022 with the following reference number: 1827116-1. The original narrative from the sender is as below: "No additional AE was reported; temperature excursion for VARIVAX; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 19-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024287,expiration date 15-JUL-2022, 0.5 milliliter, route and strength were not provided) for prophylaxis (product storage error). The vaccine administered experienced temperature excursion of 8 Degree Celsius for 1 hour 47 minutes. There was no previous temperature excursion. No additional adverse event was reported. Follow up information has been received from vaccine coordinator on 26-OCT-2021. Information has been received regarding a 20-month-old female patient who weights 6lb 12Oz at the time of birth. She had 2 sisters. On 19-OCT-2021, she was vaccinated with an improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously (SQ) through right arm; with the first dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (dosage regimen not provided), lot# U7124AA, expiration date 13-JUL-2024 administered intramuscularly (IM) through left thigh; with the first dose of hepatitis A vaccine (dosage regimen not provided), lot# 2JD3Y, expiration date 04-DEC-2022, IM through left thigh; and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (dosage regimen not provided), lot# S039316, expiration date 04-DEC-2021, SQ through left arm. All vaccines were storage in clinical practice administered as prophylaxis. On that day, second dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) (dosage regimen was not provided) lot# DL2971, expiration date 30-NOV-2022, IM through right thigh for prophylaxis. It was reported that the operator was trained, and the vaccine was used according to the instruction's leaflet; however, the vaccine was not available for return because was used. On that day, the clinic lost power and the vaccine was administered to the patient before being cleared by manufacturer for use. On 20-OCT-2021, the manufacturer was contacted and were cleared all affected vaccines for use. The patient involved had not reported any adverse reactions to immunization. All staff clinic was aware to have vaccines cleared by manufacturer after a temperature excursion. The temperature excursion occurred as a result of a reading from the digital data logger." Notes: Based on the available information, the events were not related to Vaxelis but to Varivax vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.04.2022
- Impfdatum
- -
- Beginn
- 20.10.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Off label use
Product use issue
Wrong product administered
Symptomtext
Wrong product administered; Administered Vaxelis, Hep B, and PCV; Product use in unapproved population; No adverse event; This case was retrieved on 12-JAN-2022 with the following reference number: 1801803. The original narrative from the sender is as below: Patient came in for a well child check today and the provider ordered the administration of Vaxelis, PCV-13, and Rotavirus vaccine. While I was taking these out of the fridge, I got distracted and pulled out Hep B by mistake instead of rotavirus. I administered Vaxelis, Hep B, and PCV. Within one minute of administration, I realized that I gave Hep B by mistake and forgot to administer the rotavirus vaccine. I immediately informed the provider, and she spoke with the patient's mother. Patient did not experience any symptoms or signs while in the office, and the provider advised mother to monitor for any concerning signs or symptoms. The case was considered off-label use, since product was administer in unapproved population (patient 1 month old).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Off label use
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 01.04.2022
- Impfdatum
- 09.12.2021
- Beginn
- 09.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
The caller said that 1 patient received Rotateq and Vaxelis after a temperature excursion; This non-serious spontaneous safety report with reference number 02082971 and 02082963 was received by a partner on 04-JAN-2022 and forwarded to regulatory authority on 07-JAN-2022 from a health care professional. The causal relationship between Vaxelis and the reported event of a patient received Rotateq and Vaxelis after a temperature excursion was assessed as not applicable due to the nature of the event. Further information is expected. SIGNIFICANT follow-up information was received by Fax from a HCP on 24-Jan-2021. The case is maintained as non-serious. The reporter confirmed that the patient did not experience any Adverse Event following the administration of Vaxelis. The temperature excursion occurred because a vaccine box did not allow the refrigerator to be closed completely. The vaccine box was moved and the door was closed completely. No 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
- UT
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.04.2022
- Impfdatum
- 26.10.2021
- Beginn
- 27.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Vaccination site erythema
Vaccination site warmth
Symptomtext
Vaccination site warmth; Vaccination site erythema; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1840096. The original narrative from the sender is the following: Mild erythema and warmth surrounding vaccine site of bilateral thighs. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "mild erythema and warmth surrounding the vaccine site of both thighs". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vaccination site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Candidiasis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- U
- Eingang
- 31.03.2022
- Impfdatum
- 25.01.2022
- Beginn
- 25.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
11 year old receiving Vaxelis; This spontaneous safety report was received by the partner on 14-Mar-2022 and forwarded to Agency on 15-Mar-2022 from an other health care professional. Due to the nature of the event, the causality between the event "11 year old receiving Vaxelis" and the product is not applicable. 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
- TN
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 31.03.2022
- Impfdatum
- 09.09.2021
- Beginn
- 09.11.2021
- Tage bis Beginn
- 61,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Interchange of vaccine products
No adverse event
Symptomtext
Received dose of Pediarix at 2 months and Vaxelis at 4 months; This non-serious spontaneous safety report case #02087821 and Interaction #02087770 was received from a Medical Assistant by the partner on 10-Jan-2022 and forwarded on 11-Jan-2022. Due to the nature of the event, the causality between Vaxelis and the reported event: "the patient received a dose of Pediarix at 2 months followed by a dose of Vaxelis at 4 months" was not applicable. Further information is expected. FOLLOW-UP INFORMATION case #02087821 was received from a Medical Assistant by the partner on 28-Jan-2022 and forwarded on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient and that the Department of Health recommended Vaxelis at the 6 month visit. Due to the nature of the event, the causality between Vaxelis and the reported event: "the patient received a dose of Pediarix at 2 months followed by a dose of Vaxelis at 4 months" remains not applicable. Further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Interchange of vaccine products
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- POLYVISOL [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 14.12.2021
- Beginn
- 02.11.2021
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product storage error
Symptomtext
Patient received V AXELIS after it experienced a temperature excursion of 8.5?C for 30 min.; This non-serious spontaneous safety report with Agency reference# 02080038 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021. Due to the nature of the event, the causality between Vaxelis and the reported event of Temperature excursion' was not applicable. For reference purposes this case is linked to MCM-002954, MCM-002953, MCM-002957 due to same reporter. Further information is expected. FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded to Agency on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient. Due to the nature of the event, the causality between Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 31.03.2022
- Impfdatum
- 21.12.2021
- Beginn
- 02.11.2021
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product storage error
Symptomtext
Patient received Vaxelis after it received temperature excursion of 8.5 degrees for 30 mins; This non-serious spontaneous safety report with Agency reference# 02080037 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021. Due to the nature of the event, the causality between Vaxelis and the reported event of 'Temperature excursion' was not applicable. For reference purposes this case is linked to MCM-002953, MCM-002956, MCM-002957 due to same reporter. Further information is expected. FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded to Agency on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient. Due to the nature of the event, the causality between Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable. No 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
- WA
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 11.11.2021
- Beginn
- 02.11.2021
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product storage error
Symptomtext
The patient received Vaxelis after it experienced a temperature excursion 8.5 degree for 30 minutes; This non-serious spontaneous safety report was received by regulatory agency reference# 02080012 on 22-DEC-2021 and forwarded on 23-DEC-2021 from a Health Care Professional. Due to the nature of the event, the causality between Vaxelis and the reported event of 'Temperature excursion' was not applicable. For reference purposes this case is linked to MCM-002954, MCM-002956, MCM-002957 due to same reporter. Further information is expected. FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient. Due to the nature of the event, the causality between the event "Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min" and Vaxelis remains not applicable. No 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
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 10.12.2021
- Beginn
- 10.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Patient given additional HIB; This case was retrieved during Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1940251. The original narrative from the sender is the following: Patient was given additional HIB as medical assistant unaware that HIB was also present in Vaxelis. The causal relationship between Vaxelis and the event "patient given additional HIB" was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- VITAMIN D 3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 29.09.2021
- Beginn
- 29.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Patient received ProQuad and Varicella at this visit; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2022 with the following reference number: 1745229-1. The original narrative from the sender is as following: "Patient received ProQuad and Varicella at this visit." The causal relationship between Vaxelis and the event "Patient received ProQuad and Varicella at this visit" was assessed as not applicable due to the nature of the event. Of note, the event do not concern Vaxelis, but rather ProQuad and Varicella vaccines. Vaxelis should had been considered as concomitant. However, the case was databased to mirror what was reported in VAERS. 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
- WA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 21.03.2022
- Impfdatum
- 12.02.2022
- Beginn
- 12.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
Symptomtext
Two Hib containing vaccine were given to patient on the same day. Vaxelis (DTaP+Hib+IPV+HepB) and PedvaxHib were administered on 02/12/2022 by on-call MA. Vaxelis was given in left thigh and Hib in right thigh.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- Redness on Right thigh injection site
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.03.2022
- Impfdatum
- 09.02.2022
- Beginn
- 09.02.2022
- 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 addittional adverse events reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported. On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) 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) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 09-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported. This is one of multiple cases received from the same reporter.; Sender's Comments: USA-009507513-2203USA003814: USA-009507513-2203USA003938: USA-009507513-2203USA003853: USA-009507513-2203USA003841: USA-009507513-2203USA003951: USA-009507513-2203USA003955:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.03.2022
- Impfdatum
- 25.02.2022
- Beginn
- 25.02.2022
- 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 additional AE reported; Patient was administered both improperly stored ROTATEQ and improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported. On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) 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) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 25-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported. This is one of multiple cases received from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.03.2022
- Impfdatum
- 20.02.2022
- Beginn
- 20.02.2022
- 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 additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-FEB-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # 1741817, has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 30-JUL-2022) (strength, dose, route of administration and anatomical location were not provided) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (lot # U7124AA, expiration date reported as 13-JUL-2024) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 0.8? Celsius (C) for 35 minutes respectively. If a digital data logger was involved was not reported. The vaccines experienced a previous temperature excursion. No adverse event reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,7
- Geschlecht
- F
- Eingang
- 12.01.2022
- Impfdatum
- 12.01.2022
- Beginn
- 12.01.2022
- 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
No adverse event
Symptomtext
no adverse reaction, gave two doses of Hep B at time of vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- otitis media
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.01.2022
- Impfdatum
- 12.09.2021
- Beginn
- 12.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no adverse event; patient received ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report as received from a Licensed Practical Nurse to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided. On 12-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T040207, expiration date of 18-JUL-2022, orally 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) lot# u7124AA expiration date of 13-JUL-2024, after a temperature excursion (product storage error) for prophylaxis. The temperature excursion was 49F and lasted 1 hour 24 minutes. There was no previous temperature excursion. No adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 03.01.2022
- Impfdatum
- 20.12.2021
- Beginn
- 20.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
no adverse symptoms were reported; Wrong Drug Administered/inadvertently administered VAXELIS; extra dose simultaneously of Hepatitis B; HepB was not deleted from orders and was administered along with Vaxelis; This spontaneous report as received from a nurse practitioner and medical assistant via company representative concerning a 2-month-old patient, gender unspecified with no illness at the time of vaccination. There was no information about the patient's medical history or concurrent conditions. Concomitant medication include: First dose of : rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13),administered on the same date. Medical assistant reported that the patient was inadvertently vaccinated with a first dose of diphtheria 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: U7124AA, expiration date: 13-JUL-2024, intramuscularly, in the right deltoid (dose was not reported)for prophylaxis in combination with a second dose of hepatitis b vaccine rhbsag (yeast)(ENGERIX), in the left deltoid (lot number: FB9RH, expiration date: 21-JAN-2024) (dose was not reported) for prophylaxis instead of the originally reported Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, route of administration, lot number and expiration date were not reported), on 20-DEC-2021 in separately locations. No additional information provided. No additional adverse events reported. No product quality complaints reported. No further details provided. No digital data logger was reporter. The medical assistant mentioned that while ordering new vaccines for the well visit , and the Hepatitis B was not deleted from the orders (product prescribing error) and the vaccines were administered along 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) (wrong product administered, extra dose administered), on 20-DEC-2021. The medical assistant immediately reported to provider after vaccines were administered. The nurse practitioner reported that poison control and the company was notified: the Toxicologist and the physician with the poison control alone with the company representative reported that hepatitis B to be a very safety vaccine with no expected adverse events, for receiving an extra dose simultaneously. The nurse practitioner spoke with the paternal grandmother and the mom regarding with the information received. It was stated that the patient was that the patient to be sleeping comfortably. No reports of fever or significant changes behaviors reported by the mother and maternal grad mother. The mother was advised to monitor and call if changes in behaviors, redness to injection site and fever would be presented.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- ROTATEQ; PREVENAR 13
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 31.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
Patient inadivertently admnistered Vaxelis and Engerix; This non-serious spontaneous safety report with the following reference numbers #02078030 and #02078019 was received by a partner on 20-DEC-2021 and forwarded to Agency on 21-DEC-2021 from a health care professional. The causal relationship between Vaxelis and the reported event "Patient inadvertently administered Vaxelis and Engerix" was assessed as not applicable due to the nature of the event. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.12.2021
- Impfdatum
- 10.11.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Temperature excursion; This spontaneous non-serious safety report was received on 03-Dec-2021 via Fax by the reporter, from a nurse. A source case was databased with the following number: MCM-002828. Due to the nature of the event (temperature excursion only), the causality between the event and Vaxelis was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 31.12.2021
- Impfdatum
- 22.11.2021
- Beginn
- 22.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
Patient received Vaxelis plus PEDVAXHIB in error. PREVENAR was intended to be given instead of PEDVAX; Received 2 doses of HIB (Vaxelis and PEDVAXHIB); This spontaneous safety report was received by the partner on 22-Nov-2021 and forwarded on 23-Nov-2021 from a health care professional. Due to the nature of the event, the causality between "patient received Vaxelis plus PedvaxHIB in error" and Vaxelis was not applicable. No further information is expected. FOLLOW-UP INFORMATION was received by partner on 02-DEC-2021 and forwarded on 03-DEC-2021 and ADDITIONAL INFORMATION was received by partner on 06-DEC-2021 and forwarded on the same date. A 2-month-old female patient was vaccinated with Vaxelis (batch# U7124AA) and PEDVAXHIB (batch# T042015) in error. The reporter stated that Prevnar 13 was intended to be given instead of PEDVAXHIB. Therefore, the patient accidentally received 2 doses of HIB. No adverse event was experienced by the patient. Due to the nature of the event, the causality between "received 2 doses of HIB (Vaxelis and PEDVAXHIB)" and Vaxelis is not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Prophylaxis; Weight abnormal
- Andere Medikamente
- SIMETHICONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.12.2021
- Impfdatum
- 16.11.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
First dose received at 1 year and 2 months; Temperature excursion; This spontaneous safety report was received by the partner on 29-Oct-2021 and forwarded on 1-Nov-2021 from a consumer. This case was considered non-valid due to no patient identifiers (temperature excursion only). Due to the nature of the event, the causality between the event and Vaxelis was not applicable. No further information is expected. FOLLOW-UP INFORMATION was forwarded on 03-Dec-2021 from a nurse. Case became valid since patient identifiers were provided. Reporter was not contacted by the patient's parent regarding any adverse event experienced. No treatment was provided to the patient. Due to the nature of the event, the causality between the event of First dose received at 1 year and 2 months and Vaxelis was not applicable. No 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
- 0,2
- Geschlecht
- M
- Eingang
- 31.12.2021
- Impfdatum
- 13.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Gait disturbance
Lethargy
Symptomtext
Extremities limp; Lethargic; This spontaneous safety report was received by the Regulatory Authority on 25-OCT-2021 and forwarded to Agency on 27-OCT-2021 from a nurse. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events lethargy and gait disturbance. No further information is expected since the reporter denied consent to be contacted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Gait disturbance
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 31.12.2021
- Impfdatum
- 13.10.2021
- Beginn
- 13.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Lethargy
Symptomtext
Lethargic for few minutes; This non-serious spontaneous safety report was received by a partner on 25-OCT-2021 and forwarded on 26-OCT-2021 from a nurse. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of two month old baby received a dose of Vaxelis and had a reaction. Further information is expected. FOLLOW-UP INFORMATION was forwarded on 12-NOV-2021 from a nurse. The case is maintained as non-serious. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of Lethargic for few minutes. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Lethargy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D NOS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 03.12.2021
- Impfdatum
- 22.11.2021
- Beginn
- 22.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Accidental overdose
No adverse event
Wrong product administered
Symptomtext
no additional adverse events reported; patient received V AXELIS plus PEDV AXHIB today in error; received VAXELIS plus PEDVAXHIB today in error / PREVNAR was intended to be given instead of PEDVAXHIB / this was a general human error; This spontaneous report was received from a certified medical assistant and refers to a 2-month-old patient of an unknow gender. No information regarding the patient's medical history or concurrent condition was provided. Her concomitant medications included Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). On 22-NOV-2021, the patient received diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) lot # U7124AA was confirmed to be valid, expiration date 13-JUL-2024, 1 dose (exact dose, route and site of administration were not reported) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # T042015 was confirmed to be valid, expiration date 23-JUL-2023, 1 dose (exact dose, route and site of administration were not reported) both for prophylaxis, reported as in error. Pneumococcal vaccine conj 7v (crm197) (PREVNAR) was intended to be given instead of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and there was nothing regarding packaging that caused this error. It was reported as a general human error (wrong product administered, accidental overdose). No further information was provided. No additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Accidental overdose
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,1
- Geschlecht
- M
- Eingang
- 20.10.2021
- Impfdatum
- 20.10.2021
- Beginn
- 20.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
Patient came in for a well child check today and the provider ordered the administration of Vaxelis, PCV-13, and Rotavirus vaccine. While I was taking these out of the fridge, I got distracted and pulled out Hep B by mistake instead of rotavirus. I administered Vaxelis, Hep B, and PCV. Within one minute of administration, I realized that I gave Hep B by mistake and forgot to administer the rotavirus vaccine. I immediately informed the provider, and she spoke with the patient's mother. Patient did not experience any symptoms or signs while in the office, and the provider advised mother to monitor for any concerning signs or symptoms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- M
- Eingang
- 09.10.2021
- Impfdatum
- 08.09.2021
- Beginn
- 08.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
A 16 year old patient received a VAXELIS vaccination in the office on 08SEP2021; This non-serious spontaneous safety report was received by a partner on 15-SEP-2021 and forwarded to Agency on 16-SEP-2021 from a nurse. The causal relationship between Vaxelis and the reported event: A 16-year-old patient received a VAXELIS vaccination in the office on 08-SEP-2021 is assessed as not applicable due to the nature of the event. 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
- MMRVAXPRO
- Allergien
- -
- Vorherige Impfungen
- -
