VAERS Reports U7217AA

VAERS 2699436

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

schwer

Staat: OK
Alter: -
Geschlecht: M
Eingang: 20.10.2023
Impfdatum: 21.08.2023
Beginn: 22.08.2023
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja

Abdominal X-ray Aspartate aminotransferase increased Endoscopy gastrointestinal normal Gastrointestinal pathogen panel Haematemesis International normalised ratio normal Melaena Metabolic function test abnormal Thrombosis Vomiting White blood cell count normal X-ray normal

Symptomtext

Vomiting bright red blood and clots on early AM 8/25; develop melena; Thrombosis; Vomited on day following vaccines (8/22) improved some within 2 days then vomiting bright red blood and clots on early AM 8/25, progressed to coffee ground emesis by 8am 8/25; Aspartate aminotransferase increased; Metabolic function test abnormal; Gastrointestinal pathogen panel; Abdominal X-Ray; Admitted on 8/25, endoscopy done and no source of bleeding; White blood cell count normal; X-Ray normal; International normalised ratio normal; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2683641-1. The original narrative from the sender is as follows: Vomited on day following vaccines (8/22) improved some within 2 days then vomiting bright red blood and clots on early AM 8/25, progressed to coffee ground emesis by 8am 8/25 and then developed melena. Admitted on 8/25, endoscopy done and no source of bleeding. Resolved within 1-2 days, discharged on 8/30. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis. The causal relationship between Vaxelis and the reported events Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-Ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-Ray normal, and International normalised ratio normal was assessed as not applicable, due to the nature of these events. No further information is expected. COMPANY COMMENT: Vomiting, Haematemesis, Melaena, and Thrombosis were assessed as serious due to hospitalization, whereas Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal were assessed as non-serious. Vomiting is listed, whereas Haematemesis, Melaena, Thrombosis, Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal are unlisted for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Vomiting is listed as per Regulatory Authority safety information) and the onset latency (events occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis cannot be excluded and is assessed as related. The causal relationship between Vaxelis and the events Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal was assessed as not applicable, due to the nature of these events. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Vomiting, Haematemesis, Melaena, and Thrombosis were assessed as serious due to hospitalization, whereas Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal were assessed as non-serious. Vomiting is listed, whereas Haematemesis, Melaena, Thrombosis, Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal are unlisted for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Vomiting is listed as per Regulatory Authority safety information) and the onset latency (events occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported events Vomiting, Haematemesis, Melaena, and Thrombosis cannot be excluded and is assessed as related. The causal relationship between Vaxelis and the events Aspartate aminotransferase increased, Metabolic function test abnormal, Gastrointestinal pathogen panel, Abdominal X-ray, Endoscopy gastrointestinal normal, White blood cell count normal, X-ray normal, and International normalised ratio normal was assessed as not applicable, due to the nature of these events. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Thrombosis
Hospital-Tage: 2,0
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: Medical History/Concurrent Conditions: Premature baby 26 to 32 weeks
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2683641

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

schwer

Staat: OK
Alter: 0,3
Geschlecht: M
Eingang: 19.09.2023
Impfdatum: 21.08.2023
Beginn: 22.08.2023
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja

Abdominal X-ray Aspartate aminotransferase increased Endoscopy gastrointestinal normal Gastrointestinal pathogen panel Haematemesis International normalised ratio normal Melaena Metabolic function test abnormal Thrombosis Vomiting White blood cell count normal X-ray normal

Symptomtext

vomited on day following vaccines (8/22) improved some within 2 days then vomiting bright red blood and clots on early AM 8/25, progressed to coffee ground emesis by 8am 8/25 and then developed melena. Admitted on 8/25, endoscopy done and no source of bleeding. Resolved within 1-2 days, discharged on 8/30.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Thrombosis
Hospital-Tage: 2,0
Labordaten: endosccopy-- no source of blood biofire GI panel-- negative CMP nl except AST of 62 WBC nl and INR nl AXR without pneumatosis
Aktuelle Erkrankungen: n/a
Vorgeschichte: ex 30 week infant
Andere Medikamente: n/a
Allergien: n/a
Vorherige Impfungen: -

VAERS 2603433

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

schwer

Staat: WI
Alter: 0,5
Geschlecht: F
Eingang: 24.03.2023
Impfdatum: 20.03.2023
Beginn: 22.03.2023
Tage bis Beginn: 2,0
Dosis: 3
Route/Site: SYR / LG

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Seizure

Symptomtext

Seizure activity noted on 03/22/2023 and 03/24/2023

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure
Hospital-Tage: -
Labordaten: None yet
Aktuelle Erkrankungen: Viral rash and cold
Vorgeschichte: History of parechovirus with encephalitis at 2 weeks old. On Keppra prophylactically for seizure prevention.
Andere Medikamente: Keppra
Allergien: Cows milk protein allergy
Vorherige Impfungen: -

VAERS 2686526

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: OR
Alter: -
Geschlecht: M
Eingang: 28.12.2023
Impfdatum: 20.09.2023
Beginn: 21.09.2023
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Fatigue Urticaria

Symptomtext

patient had developed hives around 24 hours after vaccines were administered. She noted they started on his legs and had started to spread to his arms and torso.; Mother reported patient was slightly more tired than usual, but otherwise had no other symptoms or different behaviors.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2686526-1. The original narrative from the sender is as follows: Patient's mother called clinic >24 hours after vaccines and and notified us that the patient had developed hives around 24 hours after vaccines were administered. She noted they started on his legs and had started to spread to his arms and torso. No other symptoms were reported. Mother took patient to a local urgent care where he was treated with Benadryl and a steroid (according to mother). Within 8-12 hours hives had almost completely resolved. Mother reported patient was slightly more tired than usual, but otherwise had no other symptoms or different behaviors. Mother reported that patient has returned to normal self after all treatment. The reporter assessed the causal relationship between Vaxelis and the event, "Urticaria" as related. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Fatigue". No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Fatigue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Runny nose
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2723121

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: NC
Alter: 1,6
Geschlecht: M
Eingang: 12.12.2023
Impfdatum: 04.12.2023
Beginn: 04.12.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Injection site pain Product administered to patient of inappropriate age

Symptomtext

Patient was given an adult Hep A Vaqta vaccine instead of the pediatric. Per report of mother the only problem he experienced was his legs were sore for a few days.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site pain
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: Amoxicillin caused rash
Vorherige Impfungen: -

VAERS 2712481

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: TX
Alter: 3,0
Geschlecht: M
Eingang: 10.11.2023
Impfdatum: 06.11.2023
Beginn: 07.11.2023
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Erythema Pain in extremity Peripheral swelling Pyrexia

Symptomtext

Pt mom called on 11/8/23 stating her son had vaccines on Monday 11/6/23 woke up Tuesday 11/7/23 with leg hurting little swollen not wanting to walk but mom didn't think much of it at the time and gave him Motrin which got him throughout the day. Then on Wednesday 11/8/23 his leg is more swollen red and painful. Mom was concerned it may be from vaccines. Senn Dr. on 11/9/23 and per note "Swelling of left lower extremity - Fever, leg swelling and redness are most likely due to vaccines (vaxelis, PCV) - Reassured, can use ice/cool packs, tylenol/motrin PRN - Low concern for infectious cause of rash/swelling at this point - Reviewed red flag symptoms and when to seek care - Recommended daily photo documentation in case swelling worsens"

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain in extremity
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: None
Vorherige Impfungen: -

VAERS 2712011

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: TX
Alter: 0,2
Geschlecht: M
Eingang: 09.11.2023
Impfdatum: 24.10.2023
Beginn: 24.10.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / AR

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Asthenia Decreased appetite Rash

Symptomtext

Shortly after Vaxelis, PCV20, Rota AND Beyfortus given for pt.'s 2 month well check (all on the same day) -- he developed poor appetite, decreased energy and a rash on his face (later that day). Symptoms lasted for about 4-5 days. Benadryl used once and seemed to have helped with the rash. No worsening symptoms and managed with supportive care at home.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: Tylenol after vaccines
Allergien: None known of
Vorherige Impfungen: -

VAERS 2692106

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: TX
Alter: 0,5
Geschlecht: M
Eingang: 06.10.2023
Impfdatum: 04.10.2023
Beginn: 04.10.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Chest X-ray normal Culture urine negative Influenza virus test negative Perioral dermatitis Pyrexia Rash SARS-CoV-2 test negative Urine analysis normal

Symptomtext

pt started with rash around mouth then with spread to trunk and back with fever of 101 given motrin taken to ER and temp 104 rectally - given tylenol and monitored

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: UA, urine culture, CXR, COVID/Flu testing - all without concern for infection
Aktuelle Erkrankungen: small amt of congestion day of illness
Vorgeschichte: -
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2610038

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: FL
Alter: -
Geschlecht: M
Eingang: 27.09.2023
Impfdatum: 19.01.2023
Beginn: 20.01.2023
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Diarrhoea Erythema Influenza A virus test Influenza B virus test Irritability Influenza A virus test negative Influenza virus test negative Pyrexia Respiratory syncytial virus test negative Respiratory tract congestion Rhinorrhoea SARS-CoV-2 test negative Respiratory syncytial virus test SARS-CoV-2 test Swelling face Vomiting

Symptomtext

Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows: The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Atopic dermatitis (Current illness and history of allergies); Bronchiolitis (1 week prior bronchiolitis and rash 12/19/2022 atopic dermatitis 01/19/2023); Rash (1 week prior bronchiolitis and rash 12/19/2022 atopic dermatitis 01/19/2023); Wheezing (history of allergies)
Vorgeschichte: -
Andere Medikamente: NUTRAMIGEN; HYDROCORTISONE
Allergien: -
Vorherige Impfungen: -

VAERS 2653104

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: NC
Alter: 0,2
Geschlecht: F
Eingang: 06.07.2023
Impfdatum: 27.06.2023
Beginn: 27.06.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Diarrhoea Infant irritability Vomiting Vomiting projectile

Symptomtext

Vomiting after every feed since vaccines were given. Emesis is NBNB but is projectile at times and is usually at least 1/4 to 1/2 of her feed. Also having loose, watery stools. Fussy. No fevers.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: D-Vi-Sol
Allergien: None
Vorherige Impfungen: -

VAERS 2647087

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: IN
Alter: 0,6
Geschlecht: M
Eingang: 19.06.2023
Impfdatum: 31.05.2023
Beginn: 31.05.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Diarrhoea Vomiting

Symptomtext

Within 24 hours of vaccine admin the infant developed V&D Vomiting resolved w/in 48 hours diarrhea still occuring 7 days later

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: No medications
Allergien: No Known allergies
Vorherige Impfungen: -

VAERS 2608773

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: TX
Alter: -
Geschlecht: M
Eingang: 04.04.2023
Impfdatum: 06.10.2022
Beginn: 10.10.2022
Tage bis Beginn: 4,0
Dosis: 3
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Injection site swelling

Symptomtext

Circular ball like swelling on both thighs underneath fat; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following: Circular ball like swelling on both thighs underneath fat, no redness or pain. The reporter did not provide an assessment of causal relationship between Vaxelis and the event "injection site swelling", No further information is expected

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site swelling
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Viral infection
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2483155

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217aa

mild

Staat: MA
Alter: -
Geschlecht: M
Eingang: 04.04.2023
Impfdatum: 17.10.2022
Beginn: 18.10.2022
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Erythema Feeling abnormal Rash Swelling Irritability Peripheral swelling

Symptomtext

Erythema; Feeling abnormal; Swelling; Rash; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2483155-1. The original narrative from the sender is the following: Swollen red right thigh, rash on torso, fussy. The reporter did not provide an assessment of causal relationship between Vaxelis and the events "erythema, feeling abnormal, rash and swelling", No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2480320

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217aa

mild

Staat: WI
Alter: -
Geschlecht: M
Eingang: 04.04.2023
Impfdatum: 13.10.2022
Beginn: 14.10.2022
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Exposure to communicable disease Extra dose administered Loss of personal independence in daily activities Pain in extremity Pyrexia

Symptomtext

Loss of personal independence in daily activities; Exposure to communicable disease; Pain in extremity; Extra dose administered; Pyrexia; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2480320-1. The original narrative from the sender is the following: Child got varicella vaccine 2 days in a row. On 11-OCT-2022 exposed to varicella at school. On 12-OCT-2022 vaccinated at school with Varivax with father's consent (name spelled different and 2nd last name omitted on consent) present during education and consent completion. On 13-OCT-2022 mother brings child to vaccine clinic and screening had occurred on 11-OCT-2022. Mother consented through which indicated child needed varicella vaccination. Error was not noted until entry after clinic. Call to mother 14-OCT-2022, child had mild fever treated with acetaminophen on 13-OCT-2022 and mother kept him home from school next day due to arm pain, but states child is eating and paying normally 24 hours after vaccination. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Loss of personal independence in daily activities", "Pyrexia" and "Pain in extremity". The causal relationship between Vaxelis and the reported events "Exposure to communicable disease (Child exposed at school)" and "Extra dose administered" were assessed as not related and not applicable respectively, due to the nature of these events. No further information is expected

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain in extremity
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2475707

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: TX
Alter: 0,5
Geschlecht: M
Eingang: 11.10.2022
Impfdatum: 06.10.2022
Beginn: 10.10.2022
Tage bis Beginn: 4,0
Dosis: 3
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Injection site swelling

Symptomtext

circular ball like swelling on both thighs underneath fat, no redness or pain

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site swelling
Hospital-Tage: -
Labordaten: BA
Aktuelle Erkrankungen: Viral illness
Vorgeschichte: -
Andere Medikamente: NA
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2464124

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: NY
Alter: -
Geschlecht: M
Eingang: 29.09.2022
Impfdatum: 23.05.2022
Beginn: 23.05.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Irritability Pyrexia

Symptomtext

irritability; Fever Tmax 104; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2307092-1. The original narrative from the sender is the following: Fever Tmax 104 and irritability.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: Medical History/Concurrent Conditions: Fever (with fever); Upper respiratory infection (Viral URI)
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2429002

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: PA
Alter: 0,3
Geschlecht: M
Eingang: 05.09.2022
Impfdatum: 31.05.2022
Beginn: 25.06.2022
Tage bis Beginn: 25,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja

Diarrhoea Haematochezia Intussusception Pain Ultrasound abdomen abnormal Vomiting

Symptomtext

He developed a small bowel to small bowel intussusception on June 25, 2022 which spontaneously reduced. This occurred in the midst of persistent diarrhea which started the week of his 2nd dose of Rotateq. The diarrhea continued to increase. By June 14, was having diarrhea every 10-15 minutes and vomiting. Seen in ER, no change in plan. Then within a few days developed blood in stool which became more intense and associated with pain and sent to ER where the US showed a small bowel to small bowel intussusception which reduced. Admitted overnight. Mom had been dairy free for months. Subsequenttly bloody stools resolved after elimination of soy from maternal diet as well

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: 1,0
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: healthy infant but hx of premature at 33 3/7 weeks gestation. Stat c/s due to fetal heart rate abnormality. Apgars 3 and 8. Brief resp support but on RA by 1-29-22. Hyperbili and phototherapy. Apnea of prematurity. Was exposed to parents who had COVID19 at the time of his birth. Infant COVID19 negative. Received amp and gent briefly but sepsis ruled out. All issues resolved prior to NICU discharge. Mild left pelvocaliectasis on left with a renal calculus/calculi
Andere Medikamente: poly-vitamin with iron 1 ml daily breastmilk fortified with neosure
Allergien: subsequent diagnosis of allergic procto-colitis to cow milk protein and soy (clinical diagnosis and dietary elimination). Mom had eliminated dairy prior to possible vaccine reaction
Vorherige Impfungen: -

VAERS 2370467

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7217AA

mild

Staat: PA
Alter: 0,3
Geschlecht: F
Eingang: 15.07.2022
Impfdatum: 12.07.2022
Beginn: 13.07.2022
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Injection site erythema Injection site reaction Rash macular Vomiting

Symptomtext

5 x 3 cm splotchy erythema at right lateral proximal thigh with ~ 1.5 cm area of erythema. Vomiting after each breast feeding 7/13/2022 and 7/14/2022.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: No medications
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2307092

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

mild

Staat: NY
Alter: 0,3
Geschlecht: M
Eingang: 02.06.2022
Impfdatum: 23.05.2022
Beginn: 23.05.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Infant irritability Pyrexia

Symptomtext

Fever Tmax 104 and irritability

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: 5/4/22 viral URI with fever
Vorgeschichte: none
Andere Medikamente: none
Allergien: NKA
Vorherige Impfungen: -

VAERS 2664212

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MO
Alter: -
Geschlecht: M
Eingang: 28.12.2023
Impfdatum: 13.06.2023
Beginn: 13.06.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Inappropriate schedule of product administration No adverse event Product administered to patient of inappropriate age

Symptomtext

Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2664212-1. The original narrative from the sender is the following: "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early." Due to the nature of the event, the causal relationship between Vaxelis and "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early." 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: -

VAERS 2700586

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MO
Alter: 0,4
Geschlecht: M
Eingang: 23.10.2023
Impfdatum: 18.10.2023
Beginn: -
Tage bis Beginn: -
Dosis: 1
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Product administered to patient of inappropriate age Wrong product administered

Symptomtext

none noted - no obvious signs/symptoms Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none known
Vorgeschichte: none known
Andere Medikamente: none known
Allergien: none known
Vorherige Impfungen: -

VAERS 2689311

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217aa

gering

Staat: PA
Alter: -
Geschlecht: F
Eingang: 02.10.2023
Impfdatum: 01.04.2023
Beginn: 01.04.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Underdose

Symptomtext

Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated.; No known symptoms; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID. The original narrative from the sender is the following: "Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary case provider called and advised parents of the incident". The causal relationship between Vaxelis and the events "Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated" and "No known symptoms" was assessed as not applicable due to the nature of these reported events. Of note, these events do not concern Vaxelis, but rather COVID19 vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS. No further information is expected. is not working, added State under vaccine facility information and Reporter State.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2638482

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217aa

gering

Staat: PA
Alter: -
Geschlecht: F
Eingang: 02.10.2023
Impfdatum: 01.04.2023
Beginn: 01.04.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Underdose

Symptomtext

UNDERDOSE; No Adverse Event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2638482-1. The original narrative from the sender is the following: Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident. The causal relationship between Vaxelis and the events " Underdose and no adverse event" was assessed as not applicable due to the nature of the reported event. No further information is expected. Is not working, added State under vaccine facility information and Reporter State.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2687469

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: OK
Alter: -
Geschlecht: F
Eingang: 27.09.2023
Impfdatum: 05.06.2023
Beginn: 01.05.2023
Tage bis Beginn: -
Dosis: 1
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product storage error

Symptomtext

Inadvertent administration of Vaxelis and Rotateq after temperature excursion; This non-serious spontaneous safety report, with reference number 02430542, was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023, from a non-HCP. The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after temperature excursions" was assessed as not applicable due to the nature of the event. Further information is expected. Significant Follow-up information was received by the partner on 03-APR-2023 and forwarded on the same day, from a physician. This case is maintained as non-serious. The causal relationship between VAXELIS and the reported event of "Inadvertent administration of Vaxelis and Rotateq after temperature excursion" was assessed as not applicable due to the nature of the event. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2687467

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: OK
Alter: -
Geschlecht: U
Eingang: 27.09.2023
Impfdatum: -
Beginn: 01.05.2023
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product storage error

Symptomtext

Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes;; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day, from a non-HCP. Additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023 by a HCP. The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes" was assessed as not applicable due to the nature of the event. Further information is expected

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2687466

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: OK
Alter: -
Geschlecht: U
Eingang: 27.09.2023
Impfdatum: -
Beginn: 01.05.2023
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day and significant additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023, from a HCP The causal relationship between Vaxelis and the reported event "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms. No additional AE. Time frame:65.2F for 9 hrs 45 mins,32.4F for 42 hrs 45 mins." was assessed as not applicable due to the nature of the event. Further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2660697

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7217AA

gering

Staat: OK
Alter: 0,3
Geschlecht: M
Eingang: 25.07.2023
Impfdatum: 05.06.2023
Beginn: 10.06.2023
Tage bis Beginn: 5,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Blood alkaline phosphatase C-reactive protein normal Differential white blood cell count Eosinophil count normal Erythema Full blood count Haemoglobin Irritability Joint swelling Lymphocyte percentage increased Metabolic function test Monocyte percentage Neutrophil percentage decreased Oedema peripheral Platelet count increased Screaming Ultrasound joint abnormal

Symptomtext

vaccines received on 6/5, on 6/10 patient awoke from nap screaming. Mom noted Rt knee was red swollen and appeared to be tender. An hour later mom noticed B elbows were red and swollen , patient was fussy. Parents took him to the ED-- upon arrival B ankles, knees, and elbows were red, swollen and appeared to be painful. No fevers during that time. Patient was discharged home with tylenol/motrin following blood work and joint u/s. Symptoms resolved by noon on 6/11.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Blood alkaline phosphatase
Hospital-Tage: -
Labordaten: CRP 2.4mg/dl CBC with wbc 12.7, hgb 10.7, hct 32.4, platelets 653; 28% neutrophils, 1% bands, 59% lymphs, 7% atypical lymphs, 4% monos, 1: eos cmp wnl except alk phos of 604 and co2 16 Rt knee u/s with mild edema overlying the right knee
Aktuelle Erkrankungen: none
Vorgeschichte: torticollis
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2659570

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7217AA

gering

Staat: OK
Alter: 0,1
Geschlecht: U
Eingang: 21.07.2023
Impfdatum: 01.05.2023
Beginn: 01.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

No adverse event; HCP reported following excursion 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes; This spontaneous report was received from a health care professional (HCP) and refers to a 7-week-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported. On 01-MAY-2023, the patient was vaccinated with inappropriate storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W020326, (expiration date: 17-OCT-2023), administered orally; and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (anatomical site injection and route of administration were not provided), lot #U7217AA, (expiration date: 12-NOV-2024), both vaccines administered for prophylaxis (strengths, doses were not provided) (product storage error) The HCP reported following temperature excursion 65.2 Fahrenheit for 9 hours 45 minutes; and 32.4F Fahrenheit for 42 hours 45 minutes for both vaccines. No adverse event was reported. This is one of several reports from the same reporter.

Weitere VAERSDATA-Felder

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

VAERS 2659569

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7217AA

gering

Staat: -
Alter: 0,1
Geschlecht: U
Eingang: 21.07.2023
Impfdatum: 01.05.2023
Beginn: 01.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

No additional AE/PQC.; Caller reported AE for inadvertent administration of VAXELIS and ROTATEQ after TE`; This spontaneous report has been received from a consumer referring to a 1-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided. On unspecified date rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), experienced 2 temperature excursions, one at 65.2 F for 9 hours and 45 minutes and another one at 32.4 F for 42 hours and 45 minutes. On 01-MAY-2023, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number: W020326, expiration date: 17-OCT-2023) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot number: U7217AA, expiration date: 12-NOV-2024) via unspecified route for prophylaxis (strengths, exact doses and dose numbers, were not known) after the aforementioned temperature excursions (TE) (product storage error). No symptoms were reported. At the time, no additional adverse event (AE) or product quality complaint (PQC) was reported.

Weitere VAERSDATA-Felder

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

VAERS 2638726

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217aa

gering

Staat: -
Alter: 0,5
Geschlecht: F
Eingang: 30.05.2023
Impfdatum: 01.04.2023
Beginn: 01.04.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt

No adverse event Underdose

Symptomtext

Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.

Weitere VAERSDATA-Felder

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

VAERS 2608769

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MI
Alter: -
Geschlecht: M
Eingang: 04.04.2023
Impfdatum: 21.10.2022
Beginn: 21.10.2022
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 Off label use Product administered to patient of inappropriate age Product use issue

Symptomtext

Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following: Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported. The case is classified as Off-Label Use (Product use in unapproved population). Due to the nature of the event, the causality between the events, "Product storage error", "Product use in unapproved population" and "no adverse event" and Vaxelis is not applicable. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: ADHD
Vorgeschichte: -
Andere Medikamente: VYVANSE; WELLBUTRIN XL; LAMICTAL; FLUORITAB
Allergien: -
Vorherige Impfungen: -

VAERS 2526877

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MD
Alter: -
Geschlecht: M
Eingang: 04.04.2023
Impfdatum: 01.12.2022
Beginn: 01.12.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

After administration of COVID vaccine, it was discovered that the vaccine had expired.; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2526877-1. The original narrative from the sender is the following: After administration of COVID vaccine, it was discovered that the vaccine had expired. Vaccine diluted 11/30/22 at 11:35AM, expired 11/30/22 at 11:35PM. Vaccine administered 12/1/22 at 8:50PM, approximately 9 hours and 20 min after expiration. Pfizer contacted for stability report. No further information available. Pfizer recommending communicating with their supply chain department as they may have further stability report. Dr. called and informed mom of event. Pt doing well, no adverse symptoms. Received word from supply chain department that they do not have stability reports to support effectiveness of vaccine. Called and spoke with mom. Pt is doing well and does not appear to have any adverse symptoms from vaccine. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "After administration of COVID vaccine, it was discovered that the vaccine had expired". No further information is expected

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2544244

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: GA
Alter: 0,2
Geschlecht: F
Eingang: 28.12.2022
Impfdatum: 01.11.2022
Beginn: 20.10.2022
Tage bis Beginn: -
Dosis: 1
Route/Site: - / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product storage error

Symptomtext

Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician. The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233) It was reported that the patient did not experience any adverse event (Temperature excursion only). Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable. For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004325. Further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2544243

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: GA
Alter: 0,3
Geschlecht: F
Eingang: 28.12.2022
Impfdatum: 01.11.2022
Beginn: 20.10.2022
Tage bis Beginn: -
Dosis: 2
Route/Site: - / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician. The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233) (Temperature excursion case) Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable. For reference purposes, the case is linked to MCM-004233, MCM-004325 and MCM-004327. Further information is expected. FOLLOW-UP INFORMATION was received on 12-DEC-2022, from a HCP. The case is maintained as non-serious. The HCP confirmed that there were no adverse events following Vaxelis administration.. Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA" and Vaxelis remained not applicable. Further information is expected..

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2544242

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: GA
Alter: 0,2
Geschlecht: M
Eingang: 28.12.2022
Impfdatum: 01.11.2022
Beginn: 20.10.2022
Tage bis Beginn: -
Dosis: 1
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product storage error

Symptomtext

Vaccines administered after temperature excursion (46.2 F). Vaccines involved :VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician. The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233) It was reported that the patient did not experience any adverse event (Temperature excursion only). Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable. For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004327. Further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2544236

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: ME
Alter: -
Geschlecht: U
Eingang: 28.12.2022
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

VAXELIS was administered to a patient after a non-supported temp excursion. No additional AE details or PQC.; This non-serious spontaneous report with reference numbers 02271074 / 02271042 was received by partner on 19-OCT-2022 and forwarded on 20-OCT-2022 from a health care professional. The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event. Further information is expected. Non-Significant follow up information was received on 17-NOV-2022 from the other health care professional. No adverse event was reported. The causal relationship between Vaxelis and the reported event "non-supported temp excursion, Temperature 28.2F, 50.7F, Time frame 72 hours 45 minutes and 0 seconds, 19 hours 0 minutes and 0 seconds (RESPECTIVELY)" was assessed as not applicable due to the nature of the event. 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: -

VAERS 2544202

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217AA

gering

Staat: MN
Alter: -
Geschlecht: U
Eingang: 28.12.2022
Impfdatum: 12.10.2022
Beginn: 12.10.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product storage error

Symptomtext

1st dose at 7-years old; A nurse reported that a 7 year old patient was administered Vaxelis; This non-serious spontaneous safety report with reference# 02268150 and interaction# 02268145 was received by a partner on 14-OCT-2022 from a Nurse and forwarded on 14-OCT-2022. Due to the nature of the event, the causality between Vaxelis and the reported events of "A nurse reported that a 7 year old patient was administered Vaxelis", was not applicable. Off label use classification added as 1st dose at 7-years old. Further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2544180

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: WI
Alter: -
Geschlecht: M
Eingang: 28.12.2022
Impfdatum: 26.09.2022
Beginn: 26.09.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Device connection issue Syringe issue Underdose

Symptomtext

Syringe Use; Underdose; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2463118-1. The original narrative from the sender is the following: Patient received half of the dose as about half of the dose squirted out the syringe around where the needle is screwed onto the syringe. Consulted with MD and patient did not receive additional dose. Due to the nature of events the causal relationship between Vaxelis and "Syringe use and Underdose" was not applicable. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Device connection issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2452297

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MO
Alter: -
Geschlecht: M
Eingang: 28.12.2022
Impfdatum: 25.07.2022
Beginn: 25.07.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Extra dose administered No adverse event

Symptomtext

patient was given Vaxelis and Hib on the same day.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2452297-1. The original narrative from the sender is the following: Patient was given Vaxelis and Hib on the same day. Patient had no adverse reaction or side effects. Dr. did speak with patient's mother regarding the event. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given Vaxelis and Hib on the same day". No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: LACTULOSE
Allergien: -
Vorherige Impfungen: -

VAERS 2523025

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7217AA

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Staat: MA
Alter: 11,0
Geschlecht: F
Eingang: 05.12.2022
Impfdatum: 05.12.2022
Beginn: 05.12.2022
Tage bis Beginn: 0,0
Dosis: N/A
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

No adverse event Product administered to patient of inappropriate age

Symptomtext

Patient has no symptoms to the vaccine given. Parent was advised to advise our office if any symptoms occur so she can be evaluated.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: N/A
Allergien: N/A
Vorherige Impfungen: -

VAERS 2497636

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: MI
Alter: 11,0
Geschlecht: M
Eingang: 03.11.2022
Impfdatum: 21.10.2022
Beginn: 21.10.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

No adverse event Product storage error

Symptomtext

Patient is outside of the age range, but was overdue to complete vaccination series. No other adverse reactions reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: ADHD
Andere Medikamente: Vyvanse, Wellbutrin XL, Lamictal, fluoritab
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2487340

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: PA
Alter: 0,4
Geschlecht: F
Eingang: 24.10.2022
Impfdatum: 26.09.2022
Beginn: 26.09.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Incorrect product formulation administered No adverse event

Symptomtext

Pneumo Conjugate (Prevnar 20) given in error. (Should have received Prevnar13). No known events.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: N/A
Allergien: NKA
Vorherige Impfungen: -

VAERS 2325512

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7217AA

gering

Staat: KY
Alter: -
Geschlecht: F
Eingang: 29.09.2022
Impfdatum: 21.06.2022
Beginn: 21.06.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Extra dose administered

Symptomtext

Upon charting, RN noticed an extra dose in Hepatitis B present in Vaxelis vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2325512-1. The original narrative from the sender is the following: RN administered vaccine. Upon charting, RN noticed an extra dose in Hepatitis B present in Vaxelis vaccine. This was the first time RN had administered Vaxelis vaccine.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: VITAMIN D [VITAMIN D NOS]
Allergien: -
Vorherige Impfungen: -

VAERS 2463118

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7217AA

gering

Staat: WI
Alter: 0,8
Geschlecht: M
Eingang: 28.09.2022
Impfdatum: 26.09.2022
Beginn: 26.09.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue Underdose

Symptomtext

Patient received half of the dose as about half of the dose squirted out the syringe around where the needle is screwed onto the syringe. Consulted with MD and patient did not receive additional dose.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: None
Allergien: No know drug or food allergies.
Vorherige Impfungen: -