- Staat
- AR
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 10.10.2023
- Beginn
- 10.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Peripheral swelling
Rash
Urticaria
Symptomtext
swelling of the hands and feet at around 9pm; hives were still noted on face, arms, and legs as well and swelling to hands and feet; rash; This serious spontaneous safety report was retrieved from the Vaccines Adverse Event Reporting System (VAERS), VAERS Primary ID# 2694046-1, by a partner on 11-DEC-2023 and forwarded to Company on 14-DEC-2023 from a HCP. The original narrative from the sender is the following: "Mom started to notice hives on the patients body and swelling of the hands and feet at around 9pm on 10/10/2023. Mom took patient to the nearest emergency department where they were given Benadryl and told to follow up with PCP. Patient was seen today 10/11/2023 and hives were still noted on face, arms, and legs as well and swelling to hands and feet. Patient advised to continue Benadryl every 8 hours and to go back to the emergency department if the rash becomes worse or patient develops any trouble breathing." Due to the nature of the event, the causality between the events: "swelling of the hands and feet at around 9pm", "hives were still noted on face, arms, and legs as well and swelling to hands and feet", and "rash" and Vaxelis was assessed as related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 10.10.2023
- Beginn
- 10.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Peripheral swelling
Rash
Urticaria
Symptomtext
swelling of the hands and feet at around 9pm; hives were still noted on face, arms, and legs as well and swelling to hands and feet; rash; This serious spontaneous safety report was retrieved from the Vaccines Adverse Event Reporting System (VAERS), VAERS Primary ID# 2694046-1, by a partner on 11-DEC-2023 and forwarded to Company on 14-DEC-2023 from a HCP. The original narrative from the sender is the following: "Mom started to notice hives on the patients body and swelling of the hands and feet at around 9pm on 10/10/2023. Mom took patient to the nearest emergency department where they were given Benadryl and told to follow up with PCP. Patient was seen today 10/11/2023 and hives were still noted on face, arms, and legs as well and swelling to hands and feet. Patient advised to continue Benadryl every 8 hours and to go back to the emergency department if the rash becomes worse or patient develops any trouble breathing." Due to the nature of the event, the causality between the events: "swelling of the hands and feet at around 9pm", "hives were still noted on face, arms, and legs as well and swelling to hands and feet", and "rash" and Vaxelis was assessed as related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 03.08.2023
- Beginn
- 04.08.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immunisation reaction
Pyrexia
Rash
Symptomtext
Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body; child had a fever and rash all over her body; child had a fever and rash all over her body; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2687989-1. The original narrative from the sender is as follows: Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body and family took her to the ER around 8-4-2023. Mom says the ER doctor said it was from the vaccines. Child was not admitted to hospital, was sent home. Have not been able to get records from the hospital, have called mom to get ROI sighned but mom has not returned phone call. The causal relationship between Vaxelis and the reported events of "Immunisation reaction, pyrexia and rash" was assessed as related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 08.09.2023
- Beginn
- 08.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site mass
Injection site nodule
Symptomtext
Right thigh nodule/ Lump; Right thigh nodule/ Lump; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2686980-1. The original narrative from the sender is as follows: Right thigh nodule/lump The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "injection site nodule and injection site mass". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 25.07.2023
- Beginn
- 25.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Eye swelling
Rash
Symptomtext
Rash and eye swelling; Rash and eye swelling; 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 2660591-1. The original narrative from the sender is the following: "Rash and eye swelling" The reporter did not provide an assessment of causal relationship between Vaxelis and the event " Rash and eye swelling" No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 18.07.2023
- Beginn
- 18.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Dysstasia
Fatigue
Gait inability
Symptomtext
Mom said she wouldn't walk or stand yesterday and it is the same today; continues to not be able to stand or walk; Mom took her outside she couldn't stay standing due to weakness.; few hours later she was showing signs of increased fatigue; 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 2658364-1. The original narrative from the sender is the following: "Patient received Vaxelis and PCV yesterday morning. A few hours later she was showing signs of increased fatigue but still wanted to go outside. When Mom took her outside, she couldn't stay standing due to weakness. Mom gave her Tylenol twice yesterday. Mom said she wouldn't walk or stand yesterday, and it is the same today. Today Mom gave her some Motrin but that did not help with symptoms and continues to not be able to stand or walk. Recommendation: Triaged per protocol. After more discussion about severity of symptoms with the inability to walk or stand advised Mom to take her to the Emergency Department". The reporter assessed the causal relationship between Vaxelis and the reported events "Mom said she wouldn't walk or stand yesterday, and it is the same today"," continues to not be able to stand or walk", "Mom took her outside she couldn't stay standing due to weakness" and "few hours later she was showing signs of increased fatigue" as related No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Heart murmur
- Andere Medikamente
- VITAMIN D 3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 18.07.2023
- Beginn
- 18.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Dysstasia
Fatigue
Gait inability
Symptomtext
Mom said she wouldn't walk or stand yesterday and it is the same today; continues to not be able to stand or walk; Mom took her outside she couldn't stay standing due to weakness.; few hours later she was showing signs of increased fatigue; 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 2658364-1. The original narrative from the sender is the following: "Patient received Vaxelis and PCV yesterday morning. A few hours later she was showing signs of increased fatigue but still wanted to go outside. When Mom took her outside, she couldn't stay standing due to weakness. Mom gave her Tylenol twice yesterday. Mom said she wouldn't walk or stand yesterday, and it is the same today. Today Mom gave her some Motrin but that did not help with symptoms and continues to not be able to stand or walk. Recommendation: Triaged per protocol. After more discussion about severity of symptoms with the inability to walk or stand advised Mom to take her to the Emergency Department". The reporter assessed the causal relationship between Vaxelis and the reported events "Mom said she wouldn't walk or stand yesterday, and it is the same today"," continues to not be able to stand or walk", "Mom took her outside she couldn't stay standing due to weakness" and "few hours later she was showing signs of increased fatigue" as related No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Heart murmur
- Andere Medikamente
- VITAMIN D 3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 21.12.2023
- Impfdatum
- 21.12.2023
- Beginn
- 21.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Injection site rash
Rash
Rash papular
Urticaria
Symptomtext
Urticarial rash surrounding injection site. Ice pack applied. Papular rash on abdomen, back, chest, upper extremities, and lower extremities approximately 10 minutes after vaccines given. Attempted to use Benadryl however patient vomited right after. 8mg methylprednisolone IM injection. Rapid improvement in rash.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Vitamin D
- Allergien
- No known
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 13.06.2023
- Beginn
- 13.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Crying
Hypophagia
Incorrect product formulation administered
Injection site induration
Miliaria
Pyrexia
Rash
Rash erythematous
Rash macular
Underdose
Symptomtext
Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; She states that her food intake has been minimal for 24-hours; It appears to be like heat rash and it not raised or bumpy; It appears to be like heat rash and it not raised or bumpy; Childs left leg is hard to the touch but does not appear read or swollen; It appears to be like heat rash and it not raised or bumpy; She thinks she was febrile but did not take her temperature; She cried and was inconsolable for the entire night; This spontaneous safety report, with reference number 2645370-1, was received by the partner on 25-JUL-2023 and forwarded to UBC on 24-AUG-2023, from a consumer. Due to the nature of the event, the causality between the events "She states that her food intake has been minimal for 24-hours, it appears to be like heat rash and it not raised or bumpy, Childs left leg is hard to the touch but does not appear read or swollen, she thinks she was febrile but did not take her temperature and she cried and was inconsolable for the entire night" and Vaxelis was related. The event "Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation" and Vaxelis was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site induration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Cow's milk allergy
- Vorgeschichte
- Medical History/Concurrent Conditions: Baby premature; Constipation; Low birth weight baby
- Andere Medikamente
- COVID-19 VACCINE; FLULAVAL; VAXNEUVANCE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 08.05.2023
- Beginn
- 08.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site rash
Symptomtext
patient developed a rash on the thigh at the site where she was given Vaxelis; 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 2644045-1. The original narrative from the sender is the following: "Mom reported that patient developed a rash on the thigh at the site where she was given Vaxelis". The reporter did not provide an assessment of causal relationship between Vaxelis and the event "patient developed a rash on the thigh at the site where she was given Vaxelis". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 08.05.2023
- Beginn
- 08.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site rash
Symptomtext
patient developed a rash on the thigh at the site where she was given Vaxelis; 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 2644045-1. The original narrative from the sender is the following: "Mom reported that patient developed a rash on the thigh at the site where she was given Vaxelis". The reporter did not provide an assessment of causal relationship between Vaxelis and the event "patient developed a rash on the thigh at the site where she was given Vaxelis". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2023
- Impfdatum
- 08.09.2023
- Beginn
- 08.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient. Temperature 12.1 C FOR 13 MINUTES, 13.1 C FOR 13 MINUTES, previous TE; This non-serious spontaneous safety report, with MSD Case ID number:02478849, was received by a partner on 25-SEP-2023 and forwarded to Company on 26-SEP-2023, from a HCP. Due to the nature of the event, the causality between the event "patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient. Temperature 12.1 C FOR 13 MINUTES, 13.1 C FOR 13 MINUTES, previous TE" and Vaxelis was assessed as not applicable. Companion case: MCM-005302. Same reporter, same event, different patient. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 31.08.2023
- Beginn
- 06.09.2023
- Tage bis Beginn
- 6,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Immunisation reaction
Symptomtext
Adverse effect of vaccines and biological substances, init on 2023-09-06.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2687916-1. The original narrative from the sender is as follows: Adverse effect of vaccines and biological substances, init on 2023-09-06. Concomitant medication included Nystatin 100000 unit/gm ex crea. Medical history included current illnesses atresia of bile ducts; diaper dermatitis; atresia of bile ducts, encntr for routine child health exam w/o abnormal findings; Encounter for immunization. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Immunisation reaction". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Immunisation reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Biliary atresia; Dermatitis diaper
- Vorgeschichte
- -
- Andere Medikamente
- NYSTATIN
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 12.09.2023
- Beginn
- 12.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Product storage error
Product use issue
Symptomtext
Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; product storage error; Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2681331-1. The original narrative from the sender is as follows: "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions". Due to the nature of the events, the causal relationship between Vaxelis and "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 12.09.2023
- Beginn
- 12.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Product storage error
Product use issue
Symptomtext
Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; product storage error; Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2681331-1. The original narrative from the sender is as follows: "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions". Due to the nature of the events, the causal relationship between Vaxelis and "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- 10.03.2023
- Beginn
- 11.03.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Haematochezia
Symptomtext
Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2670324-1. The original narrative from the sender is the following: Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well. The reporter assessed the causal relationship between Vaxelis and the event, "Haematochezia" as related. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Haematochezia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Oral candidiasis (possible thrush (oral candidiasis) on 2/17/23)
- Andere Medikamente
- VITAMIN D3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.12.2023
- Impfdatum
- 02.08.2023
- Beginn
- 02.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). No harm noted.; No adverse event; This spontaneous safety report, with reference number 2667673 (VAERS ID# 2667673-1), was received by the partner on 21-SEP-2023 and forwarded to UBC on 25-SEP-2023, from a health professional in the United States. Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event" and Vaxelis was not applicable. No further information is expected as the safety report was retrieved from VAERS-FDA. FOLLOW-UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667673-1. The case is maintained as non-serious. The original narrative from the sender is the following: "Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). Merck notified for alternative vaccine schedule recommendations. No harm noted." Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event", "No adverse event" and Vaxelis was Not Applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.12.2023
- Impfdatum
- 02.08.2023
- Beginn
- 02.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / OT
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). No harm noted.; No adverse event; This spontaneous safety report, with reference number 2667673 (VAERS ID# 2667673-1), was received by the partner on 21-SEP-2023 and forwarded to UBC on 25-SEP-2023, from a health professional in the United States. Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event" and Vaxelis was not applicable. No further information is expected as the safety report was retrieved from VAERS-FDA. FOLLOW-UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667673-1. The case is maintained as non-serious. The original narrative from the sender is the following: "Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). Merck notified for alternative vaccine schedule recommendations. No harm noted." Due to the nature of the event, the causality between the events "Product administered to patient of inappropriate age and no adverse event", "No adverse event" and Vaxelis was Not Applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,8
- Geschlecht
- F
- Eingang
- 02.11.2023
- Impfdatum
- 02.10.2023
- Beginn
- 03.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Granuloma
Symptomtext
Presumed granuloma in left thigh, developed within 24 hours of administration, still present 1 month after administration
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Granuloma
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 06.10.2023
- Impfdatum
- 29.09.2023
- Beginn
- 29.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
inappropriate vaccine given, no adverse events
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 11.07.2023
- Beginn
- 11.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Symptomtext
Caller states a 6 year old patient was administered Vaxelis in order to get the patient caught up on vaccinations.; This non-serious spontaneous safety report, with Case Number: 2023SA223339 (Inquiry Number: 01699146), was received by partner, on 20-JUL-2023 and forwarded on 21-JUL-2023 from other health professional. The causal relationship between Vaxelis and the reported event "Caller states a 6-year-old patient was administered Vaxelis in order to get the patient caught up on vaccinations" was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.09.2023
- Impfdatum
- 08.09.2023
- Beginn
- 08.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
no adverse event; HCP calling to report AE for patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient on 08SEP2023. No side effects reported. Operator of Device was a Health Professional. No other medical information; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-SEP-2023, the patient started therapy with diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, (strength, and route of administration were not provided); lot #U7392AA, expiration date: 31-MAY-2025, administered for prophylaxis and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (strength, and route of administration were not provided), lot #X011332, expiration date: 01-JAN-2025, administered for prophylaxis. The vaccines were improperly stored (Temperature 12.1 Celsius degrees for 13 minutes and 13.1 Celsius degrees for 13 minutes). There was also previous temperature excursion reported. No side effects reported. ; Sender's Comments: US-009507513-2309USA008760:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 12.04.2023
- Beginn
- 12.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Oedema peripheral
Symptomtext
After administration of vaccines, patient turned extremely red, leg edema; After administration of vaccines, patient turned extremely red, leg edema; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2613851-1. The original narrative from the sender is as follows: After administration of vaccines, a four-month-old neonate turned extremely red, leg edema. Due to the nature of the event the causal relationship between Vaxelis and the events, "After administration of vaccines, patient turned extremely red, leg edema" is related. No further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 1,3
- Geschlecht
- U
- Eingang
- 27.06.2023
- Impfdatum
- 26.05.2023
- Beginn
- 26.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
Patient was given both Vaxelis and ActHIB in the same injection site; Patient was given both Vaxelis and ActHIB; This non-serious spontaneous safety report, with MSD Case ID: 02397640 (Interaction Number 02397630), was received by partner on 30-MAY-2023 and forwarded on the same day from other health professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient was given both Vaxelis and ActHIB in the same injection site and Patient was given both Vaxelis and ActHIB". Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 06.01.2023
- Beginn
- 06.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Discomfort
Muscle spasms
Symptomtext
Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2591780-1. The original narrative from the sender is as follows: Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no color change or weakness Could not breastfeed due to spasms Parents called on call Nurse and spoke with on Call Doctor, given option to monitor at home or go to ER. Parents chose to monitor at home over night. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Discomfort
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.04.2023
- Impfdatum
- -
- Beginn
- 03.03.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes; This spontaneous safety report, with reference number 02355015 (Interaction # 02354956) was received by the partner on 16-MAR-2023 and forwarded on 17-MAR-2023, from a health professional. Due to the nature of the event, the causality between the event "Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes" and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.04.2023
- Impfdatum
- 21.02.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Medical assistant reported VAXELIS was administered after a temperature excursion (8.8?C); This non-serious spontaneous safety report with reference number 02354967 was received by a partner on 16-MAR-2023 and forwarded on 17-MAR-2023 from a HCP. Due to the nature of the event, the causality between Vaxelis and the reported event "Medical assistant reported VAXELIS was administered after a temperature excursion (8.8?C)" was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 06.03.2023
- Impfdatum
- 06.01.2023
- Beginn
- 06.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Discomfort
Muscle spasms
Poor feeding infant
Sleep disorder
Symptomtext
Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no color change or weakness Could not breastfeed due to spasms Parents called on call Nurse and spoke with on Call Doctor, given option to monitor at home or go to ER. Parents chose to monitor at home over night
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Discomfort
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- Vitamin D drops
- Allergien
- N/A
- Vorherige Impfungen
- -