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Reporte zur Charge U7151AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

72Reporte angezeigt
1Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 16 OK 10 GA 7 AR 4 KY 4 OH 4 RI 3 NC 3 TN 3 MS 3 ME 2 IN 2

VAERS 2410190

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

kritisch
Staat
RI
Alter
0,2
Geschlecht
F
Eingang
12.08.2022
Impfdatum
11.08.2022
Beginn
12.08.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Death Respiratory arrest Resuscitation

Symptomtext

Pt seen for well visit in the AM on 8/11. Brought to ER on 8/12 at about 2AM. Not breathing - CPR performed - pt died.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
ex 35 week premie
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2477955

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

moderat
Staat
OH
Alter
-
Geschlecht
M
Eingang
04.04.2023
Impfdatum
12.10.2022
Beginn
12.10.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Hyperhidrosis Joint swelling Mobility decreased Pain in extremity Peripheral swelling Pyrexia

Symptomtext

Joint swelling; Mobility decreased; Peripheral swelling; Pain in extremity; Hyperhidrosis; Pyrexia; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2477955-1. The original narrative from the sender is the following: Mother states that symptoms began that night. Mother reports that child had a fever of 101 and was very sweaty. Mother reports giving child Tylenol, and that it is helping with the fever. Mother reports that child has been saying his legs hurt, hasn't been running around as much, and that the Childs feet/ankles seem swollen. Nurse informed mother that symptoms, aside from swelling of feet/ankles, were normal. Nurse informs mother that a VAERS report will be filled. Nurse instructs mother to call doctor. Nurse instructs mother to bring child to urgent care/hospital if symptoms worsen/continue. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Joint swelling", "Mobility decreased", "Peripheral swelling", "Pain in extremity", "Hyperhidrosis", and "Pyrexia". No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Mobility decreased
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
CETIRIZINE
Allergien
-
Vorherige Impfungen
-

VAERS 2580309

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

moderat
Staat
MN
Alter
0,5
Geschlecht
M
Eingang
13.02.2023
Impfdatum
07.02.2023
Beginn
08.02.2023
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
C-reactive protein Chest X-ray Electrocardiogram Full blood count Influenza virus test Metabolic function test Protein C Pyrexia Respiratory syncytial virus test SARS-CoV-2 test Sepsis Sinus tachycardia Tachypnoea Troponin

Symptomtext

Sepsis, fever, sinus tachycardia, tachypnea

Weitere VAERSDATA-Felder
Praegender Schweregrund
Sinus tachycardia
Hospital-Tage
1,0
Labordaten
Influenza testing, RSV testing, Covid testing, Chest xray, Troponin, CBC, BMP, C protein, EKG
Aktuelle Erkrankungen
None
Vorgeschichte
Maternal substance abuse affecting newborn. Maternal hypo thyroidism.
Andere Medikamente
Tylenol, Ibuprofen, Gerber Sooth Probiotic Colic
Allergien
NKA
Vorherige Impfungen
-

VAERS 2396334

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

moderat
Staat
MO
Alter
3,0
Geschlecht
F
Eingang
29.07.2022
Impfdatum
21.07.2022
Beginn
21.07.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Affective disorder Hypophagia Lethargy Mobility decreased Pyrexia

Symptomtext

07/20/2022-mom stated patient had a fever but didn't check the degree 07/21/2022-vaccinations give that morning-that evening temp 104, lethargic, not eating and no ambulation 07/22/2022-monotone mood, 103 temp, still ambulation altering Ibuprofen and Tylenol 07/23/2022-playing, no walking till that evening, no fever 07/24/20022-fever free 07/25/2022- fever free, acts normal per mom

Weitere VAERSDATA-Felder
Praegender Schweregrund
Mobility decreased
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
When asked if child felt okay, no fever-guardian said yes. When the family called back with reaction, the child had been fevering the day before.
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2674304

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
OR
Alter
-
Geschlecht
M
Eingang
28.12.2023
Impfdatum
11.08.2023
Beginn
12.08.2023
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Disorientation Irritability Musculoskeletal stiffness Pyrexia Unresponsive to stimuli

Symptomtext

The next day he was fussy and somewhat disorented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; The next day he was fussy and somewhat disoriented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; That evening ,around 8pm,patient developed a fever of 101.9F; The next day he was fussy and somewhat disoriented; 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 2674304-1. The original narrative from the sender is the following: ?patient's mother reported that patient had received second dose of Vaxelis on 08/11/2023. That evening, around 8pm, patient developed a fever of 101.9F. His parents put him to bed and co-slept with him to monitor him. Patient's mom went to check on him at 0100 and found he was "stiff as a board" and was not responding. She started screaming for help and had her phone ready to call 911 when he finally came to Per father, patient was not responding for about 1-2 minutes, and they were unsure if he was breathing or not. They did not call 911 or bring him to the hospital. The next day he was fussy and somewhat disoriented. Patient's mom spoke with an MD online provider who thought he may have been in REM sleep during the episode. The patient's mother disagrees with that assessment and states after the first dose of Vaxelis he has been very lethargic. Patient's primary care provider is unsure this event was related to the vaccination." The reporter assessed the casual relationship between Vaxelis and the events "That evening, around 8pm, patient developed a fever of 101.9F, the next day he was fussy and somewhat disoriented, Patient's mom went to check on him at 0100 and found he was "stiff as a board, not responding, the next day he was fussy and somewhat disoriented" as related. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
Medical History/Concurrent Conditions: Drug allergy (Augmentin(reaction-diarrhea)); Iron deficiency anemia; Reactive airways disease
Andere Medikamente
FERROUS SULFATE; CETRIZINE; LACTOBACILLUS [LACTOBACILLUS NOS]; AZELASTINE; NASAL SPRAY II; VITAMIN D [COLECALCIFEROL]
Allergien
-
Vorherige Impfungen
-

VAERS 2674304

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
OR
Alter
-
Geschlecht
M
Eingang
28.12.2023
Impfdatum
11.08.2023
Beginn
12.08.2023
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Disorientation Irritability Musculoskeletal stiffness Pyrexia Unresponsive to stimuli

Symptomtext

The next day he was fussy and somewhat disorented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; The next day he was fussy and somewhat disoriented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; That evening ,around 8pm,patient developed a fever of 101.9F; The next day he was fussy and somewhat disoriented; 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 2674304-1. The original narrative from the sender is the following: ?patient's mother reported that patient had received second dose of Vaxelis on 08/11/2023. That evening, around 8pm, patient developed a fever of 101.9F. His parents put him to bed and co-slept with him to monitor him. Patient's mom went to check on him at 0100 and found he was "stiff as a board" and was not responding. She started screaming for help and had her phone ready to call 911 when he finally came to Per father, patient was not responding for about 1-2 minutes, and they were unsure if he was breathing or not. They did not call 911 or bring him to the hospital. The next day he was fussy and somewhat disoriented. Patient's mom spoke with an MD online provider who thought he may have been in REM sleep during the episode. The patient's mother disagrees with that assessment and states after the first dose of Vaxelis he has been very lethargic. Patient's primary care provider is unsure this event was related to the vaccination." The reporter assessed the casual relationship between Vaxelis and the events "That evening, around 8pm, patient developed a fever of 101.9F, the next day he was fussy and somewhat disoriented, Patient's mom went to check on him at 0100 and found he was "stiff as a board, not responding, the next day he was fussy and somewhat disoriented" as related. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
Medical History/Concurrent Conditions: Drug allergy (Augmentin(reaction-diarrhea)); Iron deficiency anemia; Reactive airways disease
Andere Medikamente
FERROUS SULFATE; CETRIZINE; LACTOBACILLUS [LACTOBACILLUS NOS]; AZELASTINE; NASAL SPRAY II; VITAMIN D [COLECALCIFEROL]
Allergien
-
Vorherige Impfungen
-

VAERS 2662655

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7151aa

mild
Staat
KY
Alter
-
Geschlecht
F
Eingang
28.12.2023
Impfdatum
24.07.2023
Beginn
25.07.2023
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site rash Injection site reaction Irritability Urticaria Injection site swelling

Symptomtext

Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; including fussiness; 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 2662655-1. The original narrative from the sender is the following: "Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site the next morning after the vaccine was given, including fussiness. Mother was asked if any, difficulty breathing, fever or any other symptoms. No other symptoms. Mother gave fever reducing oral liquid drops for any discomfort. Mother claimed she (mother) also has adverse reaction in her medical history to Dtap" The causal relationship between Vaxelis and the reported events" Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site"; " including fussiness" was assessed as related. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2614536

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7151aa

mild
Staat
TX
Alter
-
Geschlecht
M
Eingang
27.09.2023
Impfdatum
12.04.2023
Beginn
01.04.2023
Tage bis Beginn
-
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site swelling Injection site warmth

Symptomtext

Swelling, redness, warmth at the injection site; Swelling, redness, warmth at the injection site; Swelling, redness, warmth at the injection site; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2614536-1. The original narrative from the sender is as follows: The patient experienced swelling, redness, warmth at the injection site. The reporter did not provide and assessment of the causal relationship between Vaxelis and the events, "The patient experienced swelling, redness, warmth at the injection site". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Food allergy (Soy bean); Underweight
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649634

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
-
Geschlecht
F
Eingang
27.06.2023
Impfdatum
16.03.2023
Beginn
01.03.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Contusion Urticaria

Symptomtext

It was bruised badly and had welts; It was bruised badly and had welts; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2602428-1. The original narrative from the sender is as follows: Notes per provider during follow-up office visit as follows: "Pt was seen by another provider one week ago & received shots (Vaxelis, MMR, Varicella). Dad reports that it was bruised badly and had welts. It had spread but now it is better according to dad. She was given an allergy med. At home." cephALEXin (Keflex) 250 MG/5ML suspension prescription sent to pharmacy with for patient to take 2.4 mLs (120 mg total) by mouth 3 (three) times daily for 10 days. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "It was bruised badly and had welts". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649626

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
-
Geschlecht
M
Eingang
27.06.2023
Impfdatum
02.02.2023
Beginn
02.02.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site swelling

Symptomtext

Localized site reaction with swelling and redness; a nodule present at 4 month well child (2 months later); Localized site reaction with swelling and redness; Localized site reaction with swelling and redness; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2598701-1. The original narrative from the sender is as follows: Localized site reaction with swelling and redness, improved over time but still has a nodule present at 4 month well child (2 months later). The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Localized site reaction with swelling and redness, and a nodule present at 4 months well child (2 months later)". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649623

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
0,4
Geschlecht
M
Eingang
27.06.2023
Impfdatum
02.02.2023
Beginn
02.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration Injection site nodule Off label use Vaccination site erythema Vaccination site swelling

Symptomtext

Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; HCP reported that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/ nodule was still present at follow up 17/03/2023; This spontaneous safety report, with reference number 02366699 (Interaction# 02366693), was received by the partner on 05-APR-2023 and forwarded to agency on 06-APR-2023, from a non- health professional. The case was considered off-label due to Incorrect route of product administration. The reporter did not assess the causal relationship between Vaxelis and the reported events of "Agency calling on behalf of HCP to report AE for VAXELIS. Agency received information verbally from HCP during meeting on 4/5/23. HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose." Due to the nature of the event, the causality between the event "Route of administration reported as IV for Vaxelis" and Vaxelis was not applicable. Further information is expected. For reference purposes the case is linked to MCM-004673 (same reporter). SIGNIFICANT FOLLOW-UP INFORMATION was received on 19-APR-2023 by partner from the physician and forwarded to agency on 20-APR-2023. Off-label classification was removed as route of administration was reported as intra-muscular. The reporter assessed the causal relationship between Vaxelis and the event, "HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/ nodule was still present at follow up 17/03/2023" as related. The reporter did not assess the relationship between Vaxelis and the event, "Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site nodule
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2597650

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
-
Geschlecht
M
Eingang
27.06.2023
Impfdatum
07.03.2023
Beginn
07.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site nodule Nodule

Symptomtext

Nodule on L thigh; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2597650-1. The original narrative from the sender is as follows: Nodule on L thigh. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Nodule on L thigh". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site nodule
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2597650

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
-
Geschlecht
M
Eingang
27.06.2023
Impfdatum
07.03.2023
Beginn
07.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site nodule Nodule

Symptomtext

Nodule on L thigh; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2597650-1. The original narrative from the sender is as follows: Nodule on L thigh. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Nodule on L thigh". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site nodule
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2598701

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
0,4
Geschlecht
M
Eingang
24.04.2023
Impfdatum
02.02.2023
Beginn
02.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inflammation Injection site erythema Injection site nodule Injection site swelling Injection site reaction

Symptomtext

nodule/bump still present at injection; redness at the vaccination site; swelling at the vaccination site; inflammation; This spontaneous report was received from a physician and refers to a 5-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-FEB-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot# FL4125, expiration date: 30-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (dose, strength was not provided); and pneumococcal vaccine conj (PNEUMOCOCCAL CONJUGATE VACCINE), administered intramuscularly (dose, strength, formulation, lot #, expiry date, and indication were not provided). The vaccination was performed by a health care professional at private doctor's office/hospital. The vaccines were purchased with private funds. There was not temperature excursion. On an unknown date in 2023, the patient recovered from the event of inflammation. On 02-FEB-2023, the patient experienced nodule/bump present at the injection site. On an unknown date in 2023, the patient experienced redness at the vaccination site, swelling at the vaccination site, and inflammation. On an unknown date in 2023, the patient recovered from the event of inflammation. At the time of the report, the patient had not recovered from the event of nodule/bump still present at injection. The outcome of the rest of the events was unknown. The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown. The reporter considered events to be related to diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS).

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2608772

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TN
Alter
-
Geschlecht
F
Eingang
04.04.2023
Impfdatum
14.10.2022
Beginn
14.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Urticaria

Symptomtext

Urticaria; Injection site erythema; This case was retrieve during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following: Mother reports that approximately 3 hours after vaccination she noticed severe redness on entire right thigh and several hives on infant's abdomen. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Urticaria", and "Injection site erythema". No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
VITAMIN D SUPPORT
Allergien
-
Vorherige Impfungen
-

VAERS 2602428

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TX
Alter
4,0
Geschlecht
F
Eingang
23.03.2023
Impfdatum
16.03.2023
Beginn
01.03.2023
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Contusion Urticaria

Symptomtext

Notes per provider during follow-up office visit as follows: "Pt was seen by another provider one week ago & received shots (Vaxelis, MMR, Varicella). Dad reports that it was bruised badly and had welts. It had spread but now it is better according to dad. She was given an allergy med. At home. " cephALEXin (Keflex) 250 MG/5ML suspension prescription sent to pharmacy with for patient to take 2.4 mLs (120 mg total) by mouth 3 (three) times daily for 10 days.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2583458

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7151AA

mild
Staat
TX
Alter
0,5
Geschlecht
F
Eingang
17.02.2023
Impfdatum
16.02.2023
Beginn
16.02.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Body temperature increased Diarrhoea Rash Vomiting

Symptomtext

Pt with tmax to 103.8 tympanic temperature at 1830 about 8 hours after a dose of Motrin given. She also broke out in full body rash, diarrhea, and had vomiting x 1.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
COVID-19 1/30/23
Vorgeschichte
None
Andere Medikamente
Probiotic Vitamin D
Allergien
None
Vorherige Impfungen
High fevers and diarrhea at 2 months old with Vaxelis also

VAERS 2544201

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
NH
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
17.08.2022
Beginn
18.08.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Crying Diarrhoea Vomiting

Symptomtext

loose watery stools; Inconsolable crying; Emesis; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2417741-1. The original narrative from the sender is the following: The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis. Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home. Baby was seen in the office today and appeared happy with a normal abdominal exam. Passed a normal BM today. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Diarrhoea" "Crying" and "Vomiting". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
COVID-19 ((Baby tested positive on 30-Jul-2022))
Vorgeschichte
-
Andere Medikamente
VITAMIN D NOS
Allergien
-
Vorherige Impfungen
-

VAERS 2544187

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
IN
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
19.08.2022
Beginn
16.08.2022
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia

Symptomtext

Fever 103; First dose of Vaxelis scheduled at 1.5 years.; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2422612-1. The original narrative from the sender is the following: Fever 103, given Tylenol & Advil at Hospital. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Fever 103". Due to the nature of the event the causal relationship between Vaxelis and First dose of Vaxelis scheduled at 1.5 years was not applicable. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544178

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
MO
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
21.07.2022
Beginn
21.07.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Decreased appetite Gait disturbance Lethargy Mood altered Pyrexia

Symptomtext

Monotone mood; not eating; No ambulation/ still ambulation altering; Lethargic; Patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2396334-1. The original narrative from the sender is as follows: 07/20/2022-mom stated patient had a fever but didn't check the degree 07/21/2022-vaccinations give that morning-that evening temp 104, lethargic, not eating and no ambulation 07/22/2022-monotone mood, 103 temp, still ambulation altering Ibuprofen and Tylenol 07/23/2022-playing, no walking till that evening, no fever 07/24/2022-fever free, acts normal per mom. When asked if child felt okay, no fever-guardian said yes. When the family called back with reaction, the child had been fevering the day before. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Monotone mood, not eating, no ambulation/ still ambulation altering, lethargic and patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544175

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
MS
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
07.07.2022
Beginn
07.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Feeling abnormal Pyrexia

Symptomtext

Fever 103.8 4-6 hours past shot fussiness; Fever 103.8 4-6 hours past shot fussiness; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2365961-1. The original narrative from the sender is the following: Fever 103.8 4-6 hours past shot fussiness. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Fever 103.8 4-6 hours past shot fussiness". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2527062

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
MS
Alter
2,0
Geschlecht
F
Eingang
08.12.2022
Impfdatum
-
Beginn
01.12.2022
Tage bis Beginn
-
Dosis
N/A
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site pain Wrong product administered

Symptomtext

PATIENT INADVERTENTLY RECEIVED THE VAXELIS VACCINE. The patient was examined the following day with soreness to injection site noted, but no other signs of reaction. The vaccine was given on 12/01/2022 at approximately 1600. The child was examined on 12/02/2022 around 0815.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
-

VAERS 2481783

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
TN
Alter
0,2
Geschlecht
F
Eingang
18.10.2022
Impfdatum
14.10.2022
Beginn
14.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Urticaria

Symptomtext

Mother reports that approximately 3 hours after vaccination she noticed severe redness on entire right thigh and several hives on infant's abdomen.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
Vitamin D supplement
Allergien
no know allergies
Vorherige Impfungen
-

VAERS 2313407

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
OH
Alter
-
Geschlecht
M
Eingang
29.09.2022
Impfdatum
01.06.2022
Beginn
01.06.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site swelling Ultrasound scan

Symptomtext

Swelling at injection site; Ultrasound scan; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2313407-1. The original narrative from the sender is as below: Swelling at injection site, left thigh. Non-tender. No fluid collection.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2313407

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
OH
Alter
-
Geschlecht
M
Eingang
29.09.2022
Impfdatum
01.06.2022
Beginn
01.06.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site swelling Ultrasound scan

Symptomtext

Swelling at injection site; Ultrasound scan; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2313407-1. The original narrative from the sender is as below: Swelling at injection site, left thigh. Non-tender. No fluid collection.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2298737

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
NC
Alter
-
Geschlecht
F
Eingang
29.09.2022
Impfdatum
16.05.2022
Beginn
17.05.2022
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Muscle spasms Pyrexia

Symptomtext

Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines; Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2298737-1. The original narrative from the sender is as below: Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines. No current illness was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Medical History/Concurrent Conditions: Foramen ovale patent
Andere Medikamente
VITAMIN D NOS
Allergien
-
Vorherige Impfungen
-

VAERS 2422612

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
IN
Alter
1,5
Geschlecht
F
Eingang
29.08.2022
Impfdatum
19.08.2022
Beginn
16.08.2022
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Pyrexia

Symptomtext

fever 103, given Tylenol & Advil at Hospital

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2417741

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
NH
Alter
0,3
Geschlecht
F
Eingang
22.08.2022
Impfdatum
17.08.2022
Beginn
18.08.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Crying Diarrhoea Vomiting

Symptomtext

The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis. Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home. Baby was seen in the office today and appeared happy with a normal abdominal exam. Passed a normal BM today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Covid (baby tested positive on 7/30/2022)
Vorgeschichte
None
Andere Medikamente
Vitamin D 400 IU PO daily
Allergien
None
Vorherige Impfungen
-

VAERS 2365961

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

mild
Staat
MS
Alter
0,2
Geschlecht
F
Eingang
09.07.2022
Impfdatum
07.07.2022
Beginn
07.07.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Infant irritability Pyrexia

Symptomtext

Fever 103.8 4-6 hours past shot fussiness

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2727903

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
IA
Alter
-
Geschlecht
M
Eingang
28.12.2023
Impfdatum
23.10.2023
Beginn
23.10.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

VAXELIS was administered to a 28-year old patient instead of Tdap; VAXELIS was administered to a 28-year old patient instead of Tdap; This non-serious spontaneous safety report, with reference number 2023SA325943/ Inquiry# 01815498 was received by a partner on 23-OCT-2023 and forwarded on 24-OCT-2023 from a health care professional. The case is classified as off label due to Product use in unapproved population. Due to the nature of the event, the causality between the event "VAXELIS was administered to a 28-year-old patient instead of Tdap" and Vaxelis is not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received on 08-NOV-2023 from a health care professional. The case is maintained as non-serious. The case is classified as off label due to Product use in unapproved population. Due to the nature of the event, the causality between the event "VAXELIS was administered to a 28-year-old patient instead of Tdap" and Vaxelis is not applicable. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2686989

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7151AA

gering
Staat
GA
Alter
80,0
Geschlecht
F
Eingang
27.09.2023
Impfdatum
18.09.2023
Beginn
18.09.2023
Tage bis Beginn
0,0
Dosis
1
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 Wrong product administered

Symptomtext

80 year old patient was given Vaxelis vaccine but should have been given Tdap. Patient had no reaction or adverse outcome to vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Htn, Hypothyroidism, Hyperlipidemia, Vitamin D deficiency, GERD, A-Fib
Andere Medikamente
Eliquis, Dofetilide, Duloxetine, Ergocalciferol, Fluticasone nasal spray, Furosemide, Levocetirizine, Levothyroxine, Metoprolol, Multivitamin, Omeprazole, Potassium Chloride, Simvastatin
Allergien
ASA, Codeine, Lisinopril, Naproxen, Ultram
Vorherige Impfungen
-

VAERS 2639746

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
ME
Alter
-
Geschlecht
M
Eingang
27.09.2023
Impfdatum
30.05.2023
Beginn
30.05.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / GM
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error Wrong product administered

Symptomtext

Only diluent was given to patient; 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 2639746-1. The original narrative from the sender is the following: "only diluent was given to patient". The causal relationship between Vaxelis and the event "only diluent was given to patient" was assessed as not applicable due to the nature of this reported event. It should be noted that it is unclear to which vaccines this event is associated. However, the case was databased to mirror what was reported in VAERS. No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
VITAMIN D [COLECALCIFEROL]
Allergien
-
Vorherige Impfungen
-

VAERS 2639746

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
ME
Alter
-
Geschlecht
M
Eingang
27.09.2023
Impfdatum
30.05.2023
Beginn
30.05.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LG
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error Wrong product administered

Symptomtext

Only diluent was given to patient; 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 2639746-1. The original narrative from the sender is the following: "only diluent was given to patient". The causal relationship between Vaxelis and the event "only diluent was given to patient" was assessed as not applicable due to the nature of this reported event. It should be noted that it is unclear to which vaccines this event is associated. However, the case was databased to mirror what was reported in VAERS. No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
VITAMIN D [COLECALCIFEROL]
Allergien
-
Vorherige Impfungen
-

VAERS 2620134

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
27.09.2023
Impfdatum
24.04.2023
Beginn
24.04.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Medication error No adverse event Product administered to patient of inappropriate age Product administration error

Symptomtext

Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well; 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 2620134-1. The original narrative from the sender is the following: " Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing". The causal relationship between Vaxelis and the events, "Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made" and "Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well" was assessed as not applicable due to the nature of the reported events. No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649660

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
KS
Alter
-
Geschlecht
M
Eingang
27.06.2023
Impfdatum
15.06.2023
Beginn
15.06.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Physician states that a 25 year old patient was given Vaxelis by accident; This non-serious spontaneous safety report, with Case Number: 2023SA184651 (Inquiry Number: 01655266), was received by partner, on 15Jun2023 and forwarded to agency on 16Jun2023 from a physician. Due to the nature of the event, the causal relationship between Vaxelis and the reported event "Physician states that a 25 year old patient was given Vaxelis by accident" was assessed as not applicable. Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2583520

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
TN
Alter
-
Geschlecht
M
Eingang
27.06.2023
Impfdatum
02.12.2022
Beginn
02.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Off label use Product administered to patient of inappropriate age

Symptomtext

Vaxelis inadvertantly given as 12 month dose; No patient harm or reaction to this vaccine; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2583520-1. The original narrative from the sender is as follows: Vaxelis inadvertently given as 12 month dose. No patient harm or reaction to this vaccine. Due to the nature of the event, the causal relationship between Vaxelis and the reported events of "no adverse event and product administered to patient of inappropriate age" is not applicable. The case is considered "off label use". 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 2578050

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
-
Geschlecht
M
Eingang
26.06.2023
Impfdatum
06.02.2023
Beginn
06.02.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Breath holding Crying Posture abnormal Respiration abnormal Skin discolouration Somnolence

Symptomtext

He seemed to hold his breath for 30-45 seconds; He threw his head back and then got very quiet; Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal.; Mom said he looked gray.; he started crying really loudly; Somnolence; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2578050-1. The original narrative from the sender is as follows: Grandma gave him a hot bath in the evening, put lotion on, and he started crying really loudly, he threw his head back and then got very quiet. He seemed to hold his breath for 30-45 seconds. Mom said he looked gray. His color returned pretty quickly when the brought him back. Called emergency services, paramedics checked him out, did not transport. He seemed to be more sleepy after that. Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal. His temperature has been around 99.9 - 100. His temperature got up to 100.1. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "breath holding, crying, posture abnormal, respiration abnormal, skin discolouration and somnolence." No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Breath holding
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Medical History/Concurrent Conditions: Prematurity
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2608782

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
TX
Alter
-
Geschlecht
M
Eingang
04.04.2023
Impfdatum
08.02.2023
Beginn
08.02.2023
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

Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV; Wrong vaccine administered; This non-serious spontaneous safety report, with reference number 2023SA057617/ Inquiry# 01495467 was received by a partner on 16-FEB-2023 and forwarded on 20-FEB-2023 from a physician. Due to the nature of the event, the causality between the events "Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV" and Vaxelis was not applicable. Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; MMR; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2608768

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7151aa

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
04.04.2023
Impfdatum
20.10.2022
Beginn
20.10.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Device power source issue No adverse event Product storage error

Symptomtext

Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following: Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No acute adverse reactions have been reported by the patient or guardian. Due to the nature of the event, the causality between the events, "Expired product administered" and "Product storage error" and Vaxelis is not applicable. The reporter did not provide an assessment of causal relationship between Vaxelis and the event "No adverse event". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Device power source issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
HYDROCORTISONE; NYSTATIN; OFLOXACIN
Allergien
-
Vorherige Impfungen
-

VAERS 2605009

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
NC
Alter
1,3
Geschlecht
M
Eingang
28.03.2023
Impfdatum
28.03.2023
Beginn
28.03.2023
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 Wrong product administered

Symptomtext

Child was ordered to receive an MMR & Varicella separately. Child received Proquad (MMR + VARICELLA) and Varicella.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Ear infection
Vorgeschichte
-
Andere Medikamente
Amoxicillin 600mg, Amoxicillin 400mg, Simethicone 40mg,
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2563266

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7151AA

gering
Staat
TX
Alter
0,8
Geschlecht
M
Eingang
19.01.2023
Impfdatum
12.01.2023
Beginn
17.01.2023
Tage bis Beginn
5,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Nodule

Symptomtext

KNOT ON THIGH

Weitere VAERSDATA-Felder
Praegender Schweregrund
Nodule
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544241

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
GA
Alter
73,0
Geschlecht
M
Eingang
28.12.2022
Impfdatum
07.11.2022
Beginn
07.11.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

inadvertently received a dose of VAXELIS instead of the ordered FLUZONE HIGH DOSE QIV; Vaccine administered to a 73yr old; This non serious spontaneous safety report with reference #2022SA461540 was received by the partner on 08-NOV-2022 and forwarded on 09-NOV-2022 from a health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. Further information is expected. Case is linked to MCM-004263 (same reporter link) SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional. The reporter confirmed that the patient did not experience any adverse event. Patient history, dose, batch number and expiration date of Vaxelis dose were provided. The causal relationship between Vaxelis and the reported events were not applicable. The case is maintained as non-serious. No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Aneurysm aortic; Chronic pain; Congenital heart disease NOS; Hyperlipidemia; Hypertension; Obesity; Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544240

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
GA
Alter
76,0
Geschlecht
M
Eingang
28.12.2022
Impfdatum
07.11.2022
Beginn
07.11.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Inadvertently received a dose of Vaxelis instead of the ordered Fluzone high Dose Q/V; Vaccine administered to a 76years old; This non serious spontaneous safety report was received by the partner on 08-Nov-2022 and forwarded on 09-Nov-2022 with the following reference number 2022SA460825 from other health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional. The reporter confirmed that the patient did not experience any adverse event. Dose, batch number and expiration date of Vaxelis dose were provided. The causal relationship between Vaxelis and the reported events were not applicable. The case is maintained as non-serious. No further information is expected

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Chronic kidney disease stage 3; Chronic obstructive pulmonary disease; Hyperlipidemia; Hypertension; Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544238

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
RI
Alter
4,0
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
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

a 4 year old patient received the product VAXELIS instead of KINRIX; This non-serious spontaneous safety report, with reference number 2022SA439239/ Inquiry# 01335763 was received by a partner on 24-OCT-2022 and forwarded on 27-OCT-2022 from another health professional. Due to the nature of the event, the causality between the event "a 4-year-old patient received the product VAXELIS instead of KINRIXS." and Vaxelis was not applicable. Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544235

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
GA
Alter
-
Geschlecht
U
Eingang
28.12.2022
Impfdatum
-
Beginn
13.10.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Crying

Symptomtext

Had excessive crying at the time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying". Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Crying
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544234

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
GA
Alter
-
Geschlecht
U
Eingang
28.12.2022
Impfdatum
-
Beginn
13.10.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Crying

Symptomtext

Had excessive crying at time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying". Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Crying
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544212

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
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 non-serious 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. 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-004181, MCM-004183, 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
-

VAERS 2544211

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,2
Geschlecht
M
Eingang
28.12.2022
Impfdatum
25.08.2022
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 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. 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-004183, 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
-

VAERS 2544210

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,2
Geschlecht
F
Eingang
28.12.2022
Impfdatum
30.08.2022
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
-

VAERS 2544209

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,2
Geschlecht
M
Eingang
28.12.2022
Impfdatum
31.08.2022
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
-

VAERS 2544208

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,3
Geschlecht
M
Eingang
28.12.2022
Impfdatum
01.09.2022
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 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
-

VAERS 2544207

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,3
Geschlecht
F
Eingang
28.12.2022
Impfdatum
01.09.2022
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 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
-

VAERS 2544205

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,4
Geschlecht
M
Eingang
28.12.2022
Impfdatum
07.09.2022
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 in 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
-

VAERS 2544204

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
0,5
Geschlecht
M
Eingang
28.12.2022
Impfdatum
25.08.2022
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 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
-

VAERS 2544191

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
AR
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
18.07.2022
Beginn
20.07.2022
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Swelling face

Symptomtext

Had swelling on the facial area; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374944-1. The original narrative from the sender is the following: Patients mother called clinic this morning, 07/20/2022 and stated that patient had swelling on the facial area. Patients mother stated that it just began when she woke this morning. Mother stated that patient was acting normal and had no signs of dyspnea. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had swelling on the facial area". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Swelling face
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Allergic rhinitis; Otitis externa (Right ear); Plagiocephaly (Congenital deformity of head)
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544189

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
AR
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
18.07.2022
Beginn
20.07.2022
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Swelling face

Symptomtext

Woke this morning with swelling of the face; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374938-1. The original narrative from the sender is the following: Patients mother called clinic and notified us that patient woke this morning, 7/20/2022, with swelling of the face, mother stated that she was acting fine and had no signs of dyspnea. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "woke this morning with swelling of the face". No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Swelling face
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Acute conjunctivitis; Candidiasis of skin NOS
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2544172

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
MA
Alter
-
Geschlecht
M
Eingang
28.12.2022
Impfdatum
06.07.2022
Beginn
06.07.2022
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

Symptomtext

Had given Vaxelis and had also given a dose on HIB that did not need to be given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2359757-1. The original narrative from the sender is the following: When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had given Vaxelis and had also given a dose on HIB that did not need to be given". 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
-

VAERS 2544170

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
TX
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
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Was given Vaxelis in error instead of the ordered TDAP; 11-year old patient; This non-serious spontaneous safety report, was received by partner, on 07OCT2022 and forwarded on 11OCT2022 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Was given Vaxelis in error instead of the ordered TDAP" and "11 year old patient". 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 2544163

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
21.09.2022
Beginn
21.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

Patient received Vaxelis and ACTHIB during the same visit; This non-serious spontaneous safety report, with case number 02251468/02251464, was received by a partner, on 21SEP2022 and forwarded on 22SEP2022 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient received Vaxelis and ACTHIB during the same visit". Further information is expected. SIGNIFICANT FOLLOW UP INFORMATION was received on 17-OCT-2022 from the other health professional. The causal relationship between Vaxelis and the event, "Patient received Vaxelis and ACTHIB during the same visit" is not applicable, due to the nature of the event. No adverse event was reported. Further information is not expected.

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

VAERS 2544162

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OK
Alter
1,0
Geschlecht
M
Eingang
28.12.2022
Impfdatum
25.08.2022
Beginn
01.08.2022
Tage bis Beginn
-
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event 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 by a partner on 12-SEP-2022 and forwarded on 13-SEP-2022, from a Health Professional. This case was considered non-valid since no patient identifiers were provided (temperature excursion only). 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. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 / 02244285 was received by partner on 21-SEP-2022 and forwarded to Regulatory Agency on 22-SEP-2022 from a Health Professional. Twenty-nine (29) administration dates and temperature excursion durations were reported for Vaxelis with batch # U7151AA (expiration date: 17-JUL-2024): 255 HRS 02 MIN 9/7/2022 60 HRS 24 MINS 8/19/2022 60 HRS 24 MINS 8/16/2022 19 HRS 2 MINS 8/4/2022 193 HRS 42 MINS 9/1/2022 193 HRS 42 MINS 8/30/2022 255 HRS 02 MIN 9/1/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/17/2022 60 HRS 24 MINS 8/15/2022 60 HRS 24 MINS 8/22/2022 255 HRS 02 MIN 8/31/2022 62 HRS 20 MINS 8/23/2022 60 HRS 24 MINS 8/15/2022 26 HRS 47 MINS 8/12/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/8/2022 62 HRS 20 MINS 8/25/2024 22 HRS 3 MINS 8/8/2022 19 HRS 2 MINS 8/5/2022 22 HRS 3 MINS 8/8/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/9/2022 5 HRS 32 MINS 8/2/2022 22 HRS 3 MINS 8/9/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022 The case is maintained as non-valid. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 was received on 17-Oct-2022 from a Health Professional. ID, DOB, Vaxelis administration date, gender, age, dose number, concomitant vaccines and confirmation of no adverse event were provided for 29 patients. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
PNEUMOCOCCAL CONJUGATE VACCINE; MMRVAXPRO; HEPATITIS A VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2528960

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
NC
Alter
16,0
Geschlecht
F
Eingang
12.12.2022
Impfdatum
12.12.2022
Beginn
12.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Pregnancy Wrong product administered

Symptomtext

Pregnant, EDD 01/11/2023 GA35weeks and 5 days. DTP/aP was given instead of Tdap No adverse reactions to report

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
Prenatal Vitamins
Allergien
No Known Allergies
Vorherige Impfungen
-

VAERS 2501774

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7151AA

gering
Staat
GA
Alter
73,0
Geschlecht
M
Eingang
08.11.2022
Impfdatum
07.11.2022
Beginn
01.11.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Wrong product administered

Symptomtext

MD ordered High Dose Fluzone to be given and the nurse administered Vaxelis

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
hypertension, chronic pain, congenital heart dx, hyperlipidemia, aneurysm of thoracic aorta, chronic pain syndrome, obesity
Andere Medikamente
n/a
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2501767

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U7151AA

gering
Staat
GA
Alter
76,0
Geschlecht
M
Eingang
08.11.2022
Impfdatum
07.11.2022
Beginn
01.11.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Wrong product administered

Symptomtext

MD ordered HD Fluzone to be given to patient. Vaxelis was given instead.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
n/a
Vorgeschichte
Chronic Kidney Dx stage III, DM II, hyperlipidemia, Hypertension, COPD
Andere Medikamente
n/a
Allergien
carvelidlol
Vorherige Impfungen
-

VAERS 2492637

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge u7151aa

gering
Staat
TX
Alter
0,6
Geschlecht
F
Eingang
28.10.2022
Impfdatum
20.10.2022
Beginn
20.10.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event Product storage error

Symptomtext

Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No acute adverse reactions have been reported by the patient or guardian.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Hydrocortisone 1% cream- PRN, Nystatin 100000 unit/gm crea-PRN, Ofloxacin 0.3% solution-PRN
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2490025

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
RI
Alter
4,0
Geschlecht
M
Eingang
26.10.2022
Impfdatum
24.10.2022
Beginn
24.10.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product administered to patient of inappropriate age

Symptomtext

N/A

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None known
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2464088

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
KY
Alter
-
Geschlecht
U
Eingang
29.09.2022
Impfdatum
-
Beginn
11.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A vaccine that experienced a supported temp excursion was administered to patients; This non-serious spontaneous safety report was received with reference numbers 02202410 / 02202359 on 11-JUL-2022 and forwarded on 12-JUL-2022 from another health care professional. The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event. Further information is expected.

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

VAERS 2464087

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
KY
Alter
-
Geschlecht
U
Eingang
29.09.2022
Impfdatum
-
Beginn
11.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A vaccine that experienced a supported temp excursion was administered to patients; This non-serious spontaneous safety report was received with reference numbers 02202377/02202359 on 11-JUL-2022 and forwarded. on 12-JUL-2022 from another health care professional. The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event. Further information is expected.

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

VAERS 2464086

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
KY
Alter
-
Geschlecht
U
Eingang
29.09.2022
Impfdatum
-
Beginn
11.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F; This non-serious spontaneous safety report was received with reference numbers 02202409 / 02202359 on 11-JUL-2022 and forwarded on 12-JUL-2022 from another health care professional. The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event. Further information is expected.

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

VAERS 2452255

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
OH
Alter
5,0
Geschlecht
M
Eingang
20.09.2022
Impfdatum
04.08.2022
Beginn
20.09.2022
Tage bis Beginn
47,0
Dosis
1
Route/Site
SYR / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Off label use Product administered to patient of inappropriate age

Symptomtext

No adverse event occurred.. Vaxelis was given "off-label" to child > 4 years in order to get caught up due to delayed vaccines. The one and only Dtap/HIB was given on 4/8/22, and the one and only IPV was given on 5/11/22. No Hep. B ever given

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

VAERS 2374944

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
AR
Alter
0,8
Geschlecht
F
Eingang
20.07.2022
Impfdatum
18.07.2022
Beginn
20.07.2022
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Swelling face

Symptomtext

Patients mother called clinic this morning, 07/20/2022 and stated that patient had swelling on the facial area. Patients mother stated that it just began when she woke this morning. Mother stated that patient was acting normal and had no signs of dyspnea.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Swelling face
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Allergic Rhinitis Unspecified otitis externa, right ear
Vorgeschichte
Congenital Deformity of Head Plagiocephaly
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2374938

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
AR
Alter
0,8
Geschlecht
F
Eingang
20.07.2022
Impfdatum
18.07.2022
Beginn
20.07.2022
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Swelling face

Symptomtext

Patients mother called clinic and notified us that patient woke this morning, 7/20/2022, with swelling of the face, mother stated that she was acting fine and had no signs of dyspnea

Weitere VAERSDATA-Felder
Praegender Schweregrund
Swelling face
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
06/22/2022- Bilateral acute conjunctivitis, Candidiasis of skin and nails
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2359757

MSP VACCINE COMPANY · DTAP+IPV+HIB+HEPB (VAXELIS) · Charge U7151AA

gering
Staat
MA
Alter
0,5
Geschlecht
M
Eingang
06.07.2022
Impfdatum
06.07.2022
Beginn
06.07.2022
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

Symptomtext

When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-