- Staat
- TN
- Alter
- 0,6
- Geschlecht
- M
- Eingang
- 04.10.2022
- Impfdatum
- 26.09.2022
- Beginn
- 29.09.2022
- Tage bis Beginn
- 3,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
Baby was found dead of unknown cause on 9/29/22 at 8:30 am. Child sent for autopsy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- pending
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Born at 26 weeks by SVD in a home toilet. In the NICU for 4 months. On vent for 1 mo and on oxygen for 2.5 mo. Large grade 4 IVH on left and grade 1 on right on DOL #1. EEG with cerebral dysfunction on DOL #2. Hemorrhagic hydrocephalus and VP shunt placed at 2 mo age. Retinopathy of prematurity. At 3 mo life, abnormal EEG and started Keppra. Pt was having no clinical seizures for approx 2 months prior to shots.
- Andere Medikamente
- Keppra
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 10.12.2022
- Impfdatum
- 08.12.2022
- Beginn
- 08.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Fatigue
Pyrexia
Respiratory viral panel
Seizure
Skin warm
Symptomtext
Vaccines administered in clinic around 9:15AM on 12/8/22 Parents first noted tactile fever at home around 1PM and gave tylenol Grandmother checked axillary temp at home at 5 PM and was noted to be 100.9, second dose of tylenol was given Mother returned from work after and he felt very hot to touch, so was taken to the local ER due to fever and he had a rectal temperature of 103.4 around 9PM. Received a dose of ibuprofen and within a few minutes began having seizure activity while in the ER and observed by ER staff/RNs. Seizure was brief, whole body. Had a period of fatigue after, but was able to awaken and take a bottle before discharge from the ER at 1AM on 12/9/22
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- 12/8/22 - respiratory viral PCR panel entirely negative
- Aktuelle Erkrankungen
- None He did have a viral respiratory infection with cough/congestion about 40 days prior to vaccine Full RVP run at the time of the event and all negative
- Vorgeschichte
- None
- Andere Medikamente
- Acetaminophen
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 01.08.2023
- Beginn
- 03.08.2023
- Tage bis Beginn
- 2,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pain
Injection site swelling
Injection site warmth
Mobility decreased
Pain
Symptomtext
Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender; Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender, hot to the touch; patient would not crawl; wailed in pain; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667704-1. The original narrative from the sender is the following: "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain" Message was sent to the provider Dr. and they were advised to get seen in urgent care, support care suggested (ibuprofen)" The causal relationship between Vaxelis and the reported events "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain"" was assessed as Related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Diaper rash; Otitis media acute
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.09.2023
- Impfdatum
- 10.05.2023
- Beginn
- 10.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diarrhoea
Pyrexia
Vomiting
Symptomtext
Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since; Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection; Intermittent fever for first 48 hours, TMAX 102F; This spontaneous safety report, with reference number 2307USA002364 (VAERS ID 2632505-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional. Non-significant additional information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632505-1. The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since"," Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection " and " Intermittent fever for first 48 hours, TMAX 102F". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Fever
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 10.11.2022
- Beginn
- 20.11.2022
- Tage bis Beginn
- 10,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal X-ray
Barium enema
Blood culture positive
C-reactive protein
Chest X-ray
Full blood count
Haematocrit
Haemoglobin
Intussusception
Laboratory test
Moraxella test positive
Pallor
Ultrasound abdomen abnormal
Ultrasound abdomen
Unresponsive to stimuli
Urine analysis
Vomiting
X-ray abnormal
Symptomtext
Vomiting; Pallor; Unresponsive to stimuli; Found to have intussusception; Abdominal X-Ray; Barium enema; Blood culture positive; C-reactive protein; Chest X-ray; Full blood count; Hematocrit; Laboratory test; Moraxella test positive; Ultrasound abdomen; Urine analysis; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2519196-1. The original narrative from the sender is the following: Child has history of vomiting, pale appearance and unresponsiveness. Found to have intussusception and subsequent follow up for + blood culture of Moraxella. He was seen after this in ER and given ceftriaxone IM with repeat blood culture with ID consult. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vomiting", "Pallor", "Unresponsive to stimuli", "Found to have intussusception", "Abdominal X-ray", "Barium enema", "Blood culture positive", "C-Reactive protein", "Chest X-Ray", "Full blood count", "Haematocrit", "Haemoglobin", "Laboratory Test", "Moraxella test positive", "Ultrasound abdomen", and "Urine analysis". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vomiting
- Hospital-Tage
- -
- Labordaten
- Test Name: Moraxella test positive
- Aktuelle Erkrankungen
- Pale; Unresponsive to stimuli; Vomiting
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 08.08.2022
- Beginn
- 08.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Allergy test
Urticaria
Symptomtext
Hives; Hives,benedryl resolved over 3-4days; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2441061-1. The original narrative from the sender is the following: Referred for allergy testing before next vaccine, no results yet. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events " urticaria and allergy test" No further information is expected
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 15.12.2022
- Impfdatum
- 28.11.2022
- Beginn
- 28.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Diarrhoea
Irritability
Rash
Sleep disorder
Wrong product administered
Symptomtext
Prevnar 20 was given to a 4-month-old instead of a Prevnar 13 for his second dose. Once error was caught, I contacted the CDC and manufacturing company for recommendations, reactions, and dosing. Mother of the patient was then contacted and informed of all information that was given, stated that the only reactions patient had were similar to any reaction of vaccines as well as a bit fussier, diarrhea and waking up more often at night. Mother then 1 week later reported that patient has had a rash around the mouth and chin and feeding issues.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- None.
- Vorgeschichte
- None.
- Andere Medikamente
- None.
- Allergien
- None.
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 12.09.2022
- Impfdatum
- 08.08.2022
- Beginn
- 08.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Allergy test
Urticaria
Symptomtext
HIVES , BENEDRYL; RESOLVED OVER 3-4 DAYS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- REFERRED FOR ALLERGY TESTING BEFORE NEXT VACCINE, NO RESULTS YET
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 05.08.2022
- Impfdatum
- 04.08.2022
- Beginn
- 05.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site induration
Injection site inflammation
Injection site nodule
Symptomtext
Per Mother the child woke up this morning 8/5 with an red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed. The child was examined by the Doctor and Mom was instructed on how to handle the inflammation and what to do if it worsened.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 15.03.2022
- Beginn
- 15.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Erythema
Peripheral swelling
Injection site erythema
Injection site swelling
Symptomtext
Large amount of redness going from the pts hip to his knee; Large amount of redness going from the pts hip to his knee along with swelling; Crying; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2182077-1. The original narrative from the sender is as below: "Large amount of redness going from the pts hip to his knee along with swelling, and inconsolable. Mom was advised to administer tylenol and gave a warm bath. ""Left leg""" History of Hydronephrosis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Hydronephrosis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 15.03.2022
- Beginn
- 15.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Erythema
Peripheral swelling
Injection site erythema
Injection site swelling
Symptomtext
Large amount of redness going from the pts hip to his knee; Large amount of redness going from the pts hip to his knee along with swelling; Crying; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2182077-1. The original narrative from the sender is as below: "Large amount of redness going from the pts hip to his knee along with swelling, and inconsolable. Mom was advised to administer tylenol and gave a warm bath. ""Left leg""" History of Hydronephrosis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Hydronephrosis
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 03.11.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Product administration error
Symptomtext
VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient; This spontaneous non-serious safety report, with reference number 2023SA341553 (Inquiry# 01833332), was received by the partner on 06-NOV-2023 and forwarded on 07-NOV-2023, from a health professional. Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 10-NOV-2023, with reference number 2023SA341553 (Inquiry# 01836934), was received by the partner on 08-NOV-2023 and forwarded on 10-NOV-2023, from a health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable. Further information is expected. Follow-up information was received on 28-NOV-2023, from a HCP. The case is maintained as non-serious. Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 22.08.2023
- Beginn
- 22.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave; Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2682525-1. The original narrative from the sender is the following: Patient's mother requested to start the covid 10 series for patient. I spoke with and reviewed which vaccine to give with our lead pediatric nurse and covid 19 lead. We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave. Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered. So we did not have the correct supply given to us. Due to the nature of the event, the causal relationship between Vaxelis and the reported events "We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave" and "Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered" was not applicable. 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
- WI
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 22.08.2023
- Beginn
- 22.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave; Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2682525-1. The original narrative from the sender is the following: Patient's mother requested to start the covid 10 series for patient. I spoke with and reviewed which vaccine to give with our lead pediatric nurse and covid 19 lead. We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave. Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered. So we did not have the correct supply given to us. Due to the nature of the event, the causal relationship between Vaxelis and the reported events "We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave" and "Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered" was not applicable. 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
- IA
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 20.11.2023
- Impfdatum
- 03.11.2023
- Beginn
- 03.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Symptomtext
During our count of vaccines after clinic it was noted that the patient received both a vaxelis and polio vaccination. A call was placed to the parents to notify of the inadverent error of giving vaxelis and polio at the same time. The patient has not had any adverse reactions due to this event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.09.2023
- Impfdatum
- 24.08.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs; This spontaneous safety report, with reference number (Case ID #: 02462671) was received by the partner on 30-AUG-2023 and forwarded to company on 31-AUG-2023, from a Physician. 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 "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable. Significant Follow-up information was received by the partner on 14-SEP-2023 and forwarded to company on 14-SEP-2023, from a health care professional. This case is maintained as non-serious. Patient identifiers were received; therefore, the case is considered to be valid. Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable. Further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 20.08.2023
- Impfdatum
- 13.03.2023
- Beginn
- 14.03.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dermatitis atopic
Symptomtext
SEVERE ATOPIC DERMATITIS RESULTED FROM THE VACCINES THE FOLLOWING DAYS AFTER THEY WERE GIVEN. THE CONDITION HAS LASTED EVER SINCE, FLARING UP AGAIN AND GETTING WORSE AFTER HIS 6 MONTH VACCINATIONS FROM THE SAME CARE FACILITY AND THE SAME VACCINES.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dermatitis atopic
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.06.2023
- Impfdatum
- 18.04.2023
- Beginn
- 18.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today; This non-serious spontaneous safety report with reference number 2023SA122541 (and inquiry number 01581087) was received by a partner on 18-APR-2023 and forwarded to agency on 19-APR-2023 from a HCP. Due to the nature of the event, the causality between Vaxelis and the reported event "a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today" was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 22.03.2023
- Beginn
- 22.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB; This non-serious spontaneous Safety Report was received by partner on 19-APR-2023 and forwarded to agency on 21-APR-2023 from other health professional. The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB". 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
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 28.02.2023
- Beginn
- 28.02.2023
- 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 was given a Varivax in addition to a Pro Quad which contained Varicella; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2589271-1. The original narrative from the sender is as follows: Patient was given a Varivax in addition to a Pro Quad which contained Varicella. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient was given a Varivax in addition to a Pro Quad which contained Varicella". No further information is expected. Based on the available information, the events were not related to Vaxelis but to other vaccines. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Asthma; Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 23.02.2023
- Beginn
- 23.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
extra dose of hep b; Patient ordered Pentacel and received Vaxelis; extra dose of hep b; No adverse reaction noted; This case was retrieves during monitoring on 12-APR-2023 with the following Primary ID 2593261-1. The original narrative from the sender is as follows: Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, just extra dose of hep b. Due to the nature of the events, the causal relationship between Vaxelis and the events "Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, and extra dose of hep b" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 31.01.2023
- Beginn
- 31.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2573153-1. The original narrative from the sender is the following: Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib". 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
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 07.12.2022
- Beginn
- 07.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Wrong product administered
Symptomtext
Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine; Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2565932-1. The original narrative from the sender is the following: Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine. No reactions noted at the time of service. No report from parent/guardian of adverse reaction. Parent was notified by provider. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine and Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 07.12.2022
- Beginn
- 07.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Wrong product administered
Symptomtext
Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine; Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2565932-1. The original narrative from the sender is the following: Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine. No reactions noted at the time of service. No report from parent/guardian of adverse reaction. Parent was notified by provider. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine and Combination Vaxelis was administered instead of the ordered DTaP, duplicate HIB vaccine". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- DE
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.06.2023
- Impfdatum
- 31.01.2023
- Beginn
- 01.02.2023
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
C-reactive protein increased
Coagulation test normal
Computerised tomogram limb
Peripheral swelling
Ultrasound Doppler
Ultrasound Doppler normal
X-ray normal
X-ray
Symptomtext
swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2590836-1. The original narrative from the sender is as follows: swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- C-reactive protein increased
- Hospital-Tage
- -
- Labordaten
- Test Name: coagulation studies normal; Test Name: C--reactive protein increased; Test Name: Ultrasound doppler flow left leg; Test Name: X-RAY of tib/fib; Test Name: CT left leg
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- DE
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.06.2023
- Impfdatum
- 31.01.2023
- Beginn
- 01.02.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
C-reactive protein increased
Coagulation test normal
Computerised tomogram limb
Peripheral swelling
Ultrasound Doppler
Ultrasound Doppler normal
X-ray normal
X-ray
Symptomtext
swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2590836-1. The original narrative from the sender is as follows: swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later). Seen in office for problem 2/17/23 and in ER 2/18/23". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- C-reactive protein increased
- Hospital-Tage
- -
- Labordaten
- Test Name: coagulation studies normal; Test Name: C--reactive protein increased; Test Name: Ultrasound doppler flow left leg; Test Name: X-RAY of tib/fib; Test Name: CT left leg
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.04.2023
- Impfdatum
- 06.12.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional. Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable. Further information is expected. For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004410 (same reporter). SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional. 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 "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis (Birth Weight 7lb (pounds) 11 oz (ounces))
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 06.12.2022
- Beginn
- 01.12.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional. Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable. Further information is expected. For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004407 (same reporter). SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional. 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 "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" 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
- ID
- Alter
- -
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 05.12.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional. Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable. Further information is expected. For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004407 and MCM-004410 (same reporter). SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional. 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 "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis (Birth Weight: 7lb (pounds) 10z (ounces))
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 06.12.2022
- Beginn
- 01.12.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional. Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable. Further information is expected. For reference purposes, this case is linked to MCM-004406, MCM-004407, MCM-004409 and MCM-004410 (same reporter). SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional. 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 "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis (Birth Weight: 6 lb (pounds) 14 oz (ounces))
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 05.12.2022
- Beginn
- 01.12.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable. Further information is expected. For reference purposes, this case is linked to MCM-004407, MCM-004408, MCM-004409 and MCM-004410 (same reporter). SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional. 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 "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis (Birth Weight 6 pounds (lb) 4 oz (ounces))
- Vorgeschichte
- Medical History/Concurrent Conditions: Failure to thrive; GERD; Lactose intolerance; Plagiocephaly; Torticollis; Weight gain poor
- Andere Medikamente
- FAMOTIDINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 14.03.2023
- Impfdatum
- 01.03.2023
- Beginn
- 02.03.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Disturbance in attention
Drooling
Feeling abnormal
Hypotonia
Infant irritability
Posture abnormal
Reduced facial expression
Somnolence
Unresponsive to stimuli
Symptomtext
Next day after his vaccines, he was dazed and not focusing well. Low muscle tone. Not holding head up as well. More fussy than usual. Drooling more. Less smiling than prior. Very sleepy. Possibly not opening eyes as far. Seems unresponsive at times. Follow up appointment with Dr on 3/9/23. Referral to neurology.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Disturbance in attention
- Hospital-Tage
- 2,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 08.03.2023
- Impfdatum
- 23.02.2023
- Beginn
- 23.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, just extra dose of hep b.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 2,0
- Geschlecht
- F
- Eingang
- 01.03.2023
- Impfdatum
- 28.02.2023
- Beginn
- 28.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Patient was given a Varivax in addition to a Pro Quad which contained Varicella
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None known
- Vorgeschichte
- Asthma
- Andere Medikamente
- None known
- Allergien
- None known
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 01.02.2023
- Impfdatum
- 31.01.2023
- Beginn
- 31.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 26.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional. Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C" and Vaxelis was not applicable. Further information is expected. For reference purposes this case is linked to MCM-004173, MCM-004202 and MCM-004204.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 24.10.2022
- Beginn
- 24.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
Patient received Vaxelis and Engerix-B on the same date; This non-serious spontaneous safety report, with reference number 2022SA439355/ Inquiry# 01337995 was received by the partner on 25-OCT-2022 and forwarded on 27-OCT-2022 from another health professional. Due to the nature of the event, the causality between the event "Giving an extra dose of HEPTITIS B to a 6-month-old patient. The patient received several other vaccines the same day including VAXELIS." and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by a partner on 28-OCT-2022 and forwarded on 02-NOV-2022, from a HCP. The case is maintained as non-serious. The HCP confirmed that no Adverse Events have been reported. Due to the nature of the event, the causality between the event "Patient received Vaxelis and Engerix-B on the same date" and Vaxelis remained not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 26.09.2022
- 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
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional. Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients" and Vaxelis was not applicable. Further information is expected. For reference purposes this case is linked to MCM-004173, MCM-004202 and MCM-004203.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- 03.10.2022
- Beginn
- 26.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional. Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C" and Vaxelis was not applicable. Further information is expected. For reference purposes this case is linked to MCM-004173, MCM-004203 and MCM-004204.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 06.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- ROTATEQ; PREVENAR 13
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 06.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 29.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 29.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 29.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 27.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 26.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004186, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 29.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004186, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004186, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 21.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 03.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 22.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004186, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 02.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004186, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 26.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004183, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 30.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,7
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 29.09.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004183, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,8
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004183, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 03.10.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 25.08.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022. Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable. No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- 27.09.2022
- Beginn
- 26.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180 / 02268162, was received by the partner on 14-OCT-2022 and forwarded on 17-OCT-2022, from a non-healthcare professional. Due to the nature of the event the causal relationship between Vaxelis and the event "unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown 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
- M
- Eingang
- 28.12.2022
- Impfdatum
- 15.09.2022
- Beginn
- 15.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
ROTATEQ vaccine expired 09-04-2022; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2464591-1. The original narrative from the sender is the following: ROTATEQ VACCINE EXPIRED 09-04-2022. The causal relationship between Vaxelis and the reported event "Expired Product Administered" is assessed as not applicable due to the nature of the event. No further information is expected. Note: Based on the available information, the event was not related to Vaxelis but to Rotateq vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from reporting system and information was kept as reported in the form.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 04.08.2022
- Beginn
- 05.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Vaccination site erythema
Vaccination site induration
Vaccination site inflammation
Vaccination site nodule
Symptomtext
red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2402883. The original narrative from the sender is as follows: Per mother the child woke up this morning 8/5 with an red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed. The child was examined by the Doctor and Mom was instructed on how to handle the inflammation and what to do if it worsened. The reporter did not assess the causal relationship between Vaxelis and "red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed." No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vaccination site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 24.08.2022
- Beginn
- 24.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No known symptoms of adverse effect; Pt was given dose of Rotateq after the age of 8 months; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2427502-1. The original narrative from the sender is the following: Pt was given dose of Rotateq after the age of 8 months, no known symptoms of adverse effect. Due to the nature of the events, the causal relationship between Vaxelis and "Pt was given dose of Rotateq after the age of 8 months" and "No known symptoms of adverse effect" 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
- KS
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 13.09.2022
- Beginn
- 13.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired Product Administered; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2464512-1. The original narrative from the sender is the following: Vaccine expired 09-04-2022. Due to the nature of events the causal relationship between Vaxelis and "Expired product administered" was not applicable. No further information is expected. Notes: Based on the available information, the expired vaccine administered is not sure if Vaxelis, however the case was retrieved from information was kept as reported in the form.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Vaccination error
Symptomtext
5-year-old child; Extra dose administered; Vaccination Error; No Adverse Event; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2456155-1. The original narrative from the sender is the following: Patient presented with caregiver to school health clinic for vaccine update. Immunization record indicated child was due for DTaP, IPV, MMR, Varicella. Child received Vaxelis (DTaP, IPV, Hib, and Hep B), IPV, and ProQuad (MMR, varicella) at 0900 on 9/23/22. No signs or symptoms of local or systemic reaction immediately noted after immunization administration in office. Vaccine error was noted by provider at 1000. Medical director for school clinic was notified of event. Caregiver contacted by phone at 1053 and was notified with vaccine error, potential local/systemic reactions, instructed to monitor and report known adverse reactions, provider contact information, and plan to follow up by phone in 48 hours. No adverse reactions reported by caregiver at time of phone call. Due to the nature of events the causal relationship between Vaxelis and "Extra dose administered, Vaccination error, and No adverse event" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 04.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
Laboratory test
No adverse event
Symptomtext
they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days.; This non-serious spontaneous safety report, with reference number 2022SA410225 (and inquiry number 01308495), was received by a partner on 05-OCT-2022 and forwarded on 06-OCT-2022, from a health care professional. Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable. Further information is expected. SIGNIFICANT FOLLOW UP INFORMATION was received on 19-OCT-2022 from a health care professional. It was reported that there was no adverse reaction following vaccination. Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- Test Date: 20221004; Test Name: Temp; Result Unstructured Data: 36.6; Test Date: 20221004; Test Name: HC; Result Unstructured Data: 41.7
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- 03.10.2022
- Beginn
- 03.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Received a dose of Vaxelis and a dose of Recombivax HB on the same day; This non-serious spontaneous safety report, with case number 02262554 (Interaction number 02262553), was received by a partner, on 06-OCT-2022 and forwarded on 06-OCT-2022 from an other health professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Received a dose of Vaxelis and a dose of Recombivax HB on the same day". 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
- DC
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 28.09.2022
- Beginn
- 28.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Symptomtext
A patient of 5 years old and 2 months received the vaccine VAXELIS; This non-serious spontaneous safety report, with reference number 2022SA404522, was received by the partner on 29-SEP-2022 and forwarded on 30-SEP-2022, from a physician. Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine VAXELIS" was not applicable. Further information is expected. Non-significant follow-up information was received on 14-OCT-2022 from health care professional. Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine 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
- KY
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 16.09.2022
- Beginn
- 16.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Rotateq vaccine expired 09-04-22; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2464571-1. The original narrative from the sender is the following: Rotateq vaccine expired 09-04-22. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Rotateq vaccine expired 09-04-22". No further information is expected. Notes: Based on the available information, the events were not related to Vaxelis but to Rotateq 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 16.09.2022
- Beginn
- 16.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Rotateq vaccine expired 09-04-22; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2464571-1. The original narrative from the sender is the following: Rotateq vaccine expired 09-04-22. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Rotateq vaccine expired 09-04-22". No further information is expected. Notes: Based on the available information, the events were not related to Vaxelis but to Rotateq 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 23.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error). On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported. The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 23.12.2022
- Impfdatum
- 05.12.2022
- Beginn
- 05.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error). On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported. The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 23.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Product storage error
Symptomtext
No additional AEs; temperature excursion; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse and refers to a 19 weeks old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error, product administered to patient of inappropriate age). On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported. The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments: US-009507513-2212USA007828:Same Reporter US-009507513-2212USA007829:Same Reporter US-009507513-2212USA007830:Same Reporter US-009507513-2212USA007831:Same Reporter US-009507513-2212USA007838:Same Reporter US-009507513-2212USA007833:Same Reporter US-009507513-2212USA007834:Same Reporter US-009507513-2212USA007835:Same Reporter US-009507513-2212USA007836:Same Reporter US-009507513-2212USA007837:Same Reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 23.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 9 weeks old (also reported as 10 weeks) male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error). On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported. The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007838: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 23.12.2022
- Impfdatum
- 05.12.2022
- Beginn
- 05.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error). On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported. The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 0,8
- Geschlecht
- F
- Eingang
- 22.12.2022
- Impfdatum
- 19.12.2022
- Beginn
- 19.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
Double dose of HIB was given on 12/19/22 due to using Vaxelis Combo vaccine as well as ActHIB vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none disclosed
- Vorgeschichte
- none
- Andere Medikamente
- Nystatin topical 100,000 u/g ointment
- Allergien
- no known allergies
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 12.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Haematochezia
Symptomtext
had 1st rotavirus vaccine at 2 months of age and had blood in stool x 2 days: no further rotavirus vaccines.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- -
- Beginn
- 04.10.2022
- 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
No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ were administered to multiple patients since they were invloved in a temperature excursion; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided. On 04-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (exact dose and dose number were not reported) and an improperly stored 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) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event). On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- -
- Beginn
- 04.10.2022
- 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
No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ were administered to multiple patients since they were invloved in a temperature excursion; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided. On 04-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (exact dose and dose number were not reported) and an improperly stored 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) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event). On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- -
- Beginn
- 03.10.2022
- 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
No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ were administered to multiple patients since they were invloved in a temperature excursion; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided. On 03-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (exact dose and dose number were not reported) and an improperly stored 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) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event). On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 19.10.2022
- Impfdatum
- 27.09.2022
- Beginn
- 27.09.2022
- 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; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients.; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided. On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (dose and dose number were not reported) and an improperly stored 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) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event). On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.; Sender's Comments: US-009507513-2210USA006289:2210USA006289 US-009507513-2210USA006287:2210USA006287 US-009507513-2210USA006288:2210USA006288
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.10.2022
- Impfdatum
- 06.09.2022
- Beginn
- 06.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Unevaluable event
Symptomtext
No additional AE reported.; an expired dose of ROTATEQ was administered to the patient on 6SEP2022; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown. On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event. The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.10.2022
- Impfdatum
- 15.09.2022
- Beginn
- 15.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 15SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; No additional AE; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1741381, expiration date: 04-SEP-2022, administered orally for prophylaxis (strength was not provided). The reporting nurse stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) has not been involved in a temperature excursion through the date of administration. No additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 11.10.2022
- Impfdatum
- 03.10.2022
- Beginn
- 03.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Overdose
Symptomtext
No additional AE details were provided.; the patient is a 2 month old infant who received a dose of VAXELIS and a dose of RECOMBIVAX HB on the same day on 3OCT2022.; This spontaneous report has been received from a medical assistant concerning to a 2-month-old infant patient of an unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided. On 03-OCT-2022, the patient received a dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were not provided; lot number T032918 that was verified to be valid for vial formulation with an expiration date reported and established as 12-NOV-2022) as prophylaxis; and on the same date, received a 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) injection, at a dose of 0.5 ml (strength, vaccination scheme frequency, route of administration, indication and anatomical site of application were not provided; lot number U7205AA that was verified to be valid with an expiration date reported as 24-OCT-2023 but upon internal validation established as 23-OCT-2024) (overdose). By the reporting time, the patient did not have any adverse reactions. There was no additional adverse event (AE) reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.10.2022
- Impfdatum
- 13.09.2022
- Beginn
- 13.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
No additional AE reported; Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 13SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided. On 13-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) 2 ml, orally, lot # 1741381 with expiration date of 04-SEP-2022, for prophylaxis. It was confirmed that the vaccine did not have a previous temperature excursion. No additional event reporter, no further information provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,8
- Geschlecht
- F
- Eingang
- 28.09.2022
- Impfdatum
- 20.09.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- -
- Allergien
- N.K.D.A
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 23.09.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Vaccination error
Symptomtext
Patient presented with caregiver to school health clinic for vaccine update. Immunization record indicated child was due for DTaP, IPV, MMR, Varicella. Child received Vaxelis (DTaP, IPV, Hib, and Hep B), IPV, and ProQuad (MMR, varicella) at 0900 on 9/23/22. No signs or symptoms of local or systemic reaction immediately noted after immunization administration in office. Vaccine error was noted by provider at 1000. Medical director for school clinic was notified of event. Caregiver contacted by phone at 1053 and was notified with vaccine error, potential local/systemic reactions, instructed to monitor and report known adverse reactions, provider contact information, and plan to follow up by phone in 48 hours. No adverse reactions reported by caregiver at time of phone call.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None at the time of the vaccination, no known illness to provider up to month prior
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 07.09.2022
- Impfdatum
- 31.08.2022
- Beginn
- 02.09.2022
- Tage bis Beginn
- 2,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Barium double contrast
Intestinal obstruction
Intussusception
Ultrasound scan abnormal
Urinary system X-ray
Symptomtext
Intussusception dx at Hospital ED. Air enema x3 to correct on 09/03/2022
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Barium double contrast
- Hospital-Tage
- 1,0
- Labordaten
- KUB showed obstruction. Ultrasound then done that showed intussusception.
- Aktuelle Erkrankungen
- Covid-19 positive on 07/27/2022. Cough and fever with covid
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 02.09.2022
- Impfdatum
- 24.08.2022
- Beginn
- 24.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Pt was given dose of Rotateq after the age of 8 months, no known symptoms of adverse effect
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- -
- Andere Medikamente
- unknown
- Allergien
- NKDA
- Vorherige Impfungen
- -