- Staat
- NC
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 02.12.2023
- Impfdatum
- 07.11.2023
- Beginn
- 14.11.2023
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autopsy
Cardiac arrest
Crying
Death
Fatigue
Poor feeding infant
Sepsis neonatal
Peripheral coldness
Pyrexia
Screaming
Skin discolouration
Symptomtext
We received a phone call reporting to our office on 11/15/2023 that the child had died in his sleep at home on 11/14/2023.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- N/A at this time
- Aktuelle Erkrankungen
- None known
- Vorgeschichte
- Baby was kept in Newborn Nursery from birth being monitored via NAS scoring and was also on Abx for 48 hours due to concerns re: Neonatal Sepsis. -Blood Cx. and labs negative x 48 hours. -Baby with initial hx. of being a poor feeder. -Agency consulted while baby and mom were in the Hospital Newborn Nursery. Baby was discharged home with mom. -Baby's UDS negative in Newborn Nursery as of his first visit to our office on 09/13/2023. Mom with the following medical hx.: -Mom with hx. of drug use and abuse and on Subutex during her pregnancy -Mom with hx. of seizures and was on Topamax med. in the past but discontinued from it during pregnancy. Plans are to restart Topamax per Neurologist, per mom's report -Mom with hx. of ADHD and on Dexroamphetamine med. Note: Mom's UDS +ve for Amphetamines at the time of baby's birth -Mom with hx. of HSV, but no current issues. per report. -Mom's GBS status Negative, RPR Negative.
- Andere Medikamente
- None known or reported by family.
- Allergien
- None known or reported by family.
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 2,0
- Geschlecht
- F
- Eingang
- 12.10.2023
- Impfdatum
- 10.10.2023
- Beginn
- 11.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood culture negative
Computerised tomogram head normal
Electroencephalogram
Full blood count normal
Generalised tonic-clonic seizure
Influenza virus test negative
Intensive care
Laboratory test normal
Mental status changes
Nothing by mouth order
Postictal state
Pyrexia
SARS-CoV-2 test negative
Symptomtext
Patient overdue for multiple immunizations. Above vaccines due per state registry - given 10/10/2023. Patient with witness approximately 10-minute generalized tonic-clonic seizure on 10/11/2023. EMS call and IM Versed was given. Upon arrival to emergency department, patient post-ictal. Repeat generalized tonic-clonic seizure activity approximately 15 minutes after resolution of first seizure. Patient febrile upon arrival to 38.4. In ED, Patient was given a total of 4 mg of Ativan (1mg of which was IM and the rest were 1 mg doses IV), Keppra load with 50 mg/kg, and fosphenytoin load of 20pe/kg which ultimately stopped the seizure activity after about 42 minutes. Patient also received suppository Tylenol and IV Toradol. She was given 2 normal saline boluses. Patient was admitted to ICU for ongoing management and remains admitted at this time. Initially NPO on maintenance IV fluids as patient obtunded following multiple AED's. Supplemental oxygen placed - no advanced airway needed. She was weaned to RA overnight 10/11. Diet was advanced as mental status improved and she is tolerating PO intake. Off of IVF. Remains in ICU for observation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- 2,0
- Labordaten
- Patient was taken to CT approximately 30 minutes after cessation of proloned seizure activity and was noted to have brief intermittent worsening of the upper extremities that lasted 10 seconds. CT head was unremarkable. Labs obtained including CBC, i-STAT Chem-8, and blood culture obtained - unremarkable. Blood culture pending. Flu and COVID negative. Following transfer to ICU, an EEG was ordered to monitor for subclinical seizure activity - results pending.
- Aktuelle Erkrankungen
- None.
- Vorgeschichte
- Severely underweight/Poor weight gain - unclear chronicity as patient lost to follow up. Lab workup pending from 10/23/2023. Last seen 10/10/2022. History of simple febrile seizure 10/10/2022 - single occurrence
- Andere Medikamente
- None.
- Allergien
- None.
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 1,8
- Geschlecht
- F
- Eingang
- 25.10.2023
- Impfdatum
- 17.10.2023
- Beginn
- 19.10.2023
- Tage bis Beginn
- 2,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Rash vesicular
Symptomtext
mild varicella-like rash that developed on her legs, chest and back
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- diagnosed with acute URI on 09/15/2023
- Vorgeschichte
- esotropia
- Andere Medikamente
- Cetirizine 5/5, 2.5 ml once daily
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 02.10.2023
- Impfdatum
- 25.05.2023
- Beginn
- 29.05.2023
- Tage bis Beginn
- 4,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Alanine aminotransferase increased
B-lymphocyte count increased
Coronary artery disease
Cytogenetic analysis normal
Echocardiogram abnormal
Haemophagocytic lymphohistiocytosis
Hypoalbuminaemia
Hypofibrinogenaemia
Immunoglobulin therapy
Inflammatory marker increased
Kawasaki's disease
Natural killer cell activity decreased
Pyrexia
Rash
Serum ferritin increased
Splenomegaly
Sterile pyuria
Thrombocytosis
Symptomtext
Patient developed a rash and fever 4 days after his vaccine and was eventually diagnosed with Kawasaki disease with secondary HLH (hemophagocytic lymphohistiocytosis).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- 9,0
- Labordaten
- o review, patient was hospitalized from 6/20-6/28 for prolonged fever and rash. He did meet criteria for atypical Kawasaki disease (fever, rash, elevated inflammatory markers, hypoalbuminemia, elevated ALT, thrombocytosis, sterile pyuria, and "prominent coronary arteries" on echo. He was treated with IVIG and steroids and fever resolved, but ferritin rose to max 10,410. Was treated with pulse dose steroids with good response, but ferritin rose with weaning to oral steroid, so added anakinra. He was discharged on prednisolone and anakinra. He does meet clinical criteria for HLH: fever, splenomegaly, hypofibrinogenemia, low NK cell activity, high ferritin, and elevated sCD25 (sIL2R). Genetic testing for HLH was negative.
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- None prior to vaccine
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.09.2023
- Impfdatum
- 06.07.2023
- Beginn
- 07.07.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Symptomtext
A baby had a fever of 105 degrees (rectal reading) the day after receiving the first dose of Vaxelis; This serious spontaneous safety report with reference # 02426963 (Interaction # 02426954, Case ID # 5004U00001ATc7aQAD) was received by partner on 13-JUL-2023 from a consumer on behalf of a physician and forwarded on 14-JUL-2023. An infant of unknown age with no relevant medical history reported, had been vaccinated with Vaxelis (dose number unknown) on an unknown date (Batch # unknown) for prophylaxis. No concomitant medication was reported. A consumer reported on behalf of a physician, that a baby had a fever of 105 degrees (rectal reading) the day after receiving the first dose of Vaxelis. It was reported the fever went down within twenty-four hours and no further information was available. At the time of this report, the outcome of the event, "A baby had a fever of 105 degrees (rectal reading) the day after receiving the first dose of Vaxelis" was unknown. The reporter assessed the causal relationship between Vaxelis and the event, "A baby had a fever of 105 degrees (rectal reading) the day after receiving the first dose of Vaxelis" as related. Further information is expected. Significant Follow-up information was received by the partner on 25-JUL-2023 and forwarded on 26-JUL-2022, from a consumer on behalf of a physician. A consumer reported on behalf of a physician that 2-month-old infant with relevant medical history of normal birth weight of 7 pounds 3.3 ounces and umbilical hernia, had been vaccinated with Vaxelis on 06-JUL-2023 (Batch # U7536AA exp. date 30-Sep-2025) for prophylaxis. A baby had a fever of 105 degrees (rectal reading) the day after receiving the first dose of Vaxelis on 07-JUL-2023 and the event resolved the same day. COMPANY COMMENT: Pyrexia is assessed as non-serious. Pyrexia is listed for Vaxelis as per the safety information. In agreement with the reporter and the current knowledge on Vaxelis (Pyrexia is listed as per safety information), no confounding factors (co-suspect vaccine), no prior medical history of fever reported, and that the event occurred within one day of vaccination and despite the lack of information in this case (other medical history), the causal relationship between Vaxelis and the event Pyrexia is assessed as related. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Pyrexia is assessed as non-serious. Pyrexia is listed for Vaxelis as per the safety information. In agreement with the reporter and the current knowledge on Vaxelis (Pyrexia is listed as per safety information), no confounding factors (co-suspect vaccine), no prior medical history of fever reported, and that the event occurred within one day of vaccination and despite the lack of information in this case (other medical history), the causal relationship between Vaxelis and the event Pyrexia is assessed as related. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Umbilical hernia
- Vorgeschichte
- Medical History/Concurrent Conditions: Birth weight normal (7 pounds 3.3 ounces)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.09.2023
- Impfdatum
- 18.05.2023
- Beginn
- 13.07.2023
- Tage bis Beginn
- 56,0
- Dosis
- 1
- Route/Site
- - / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Skin warm
Urticaria
Symptomtext
He had hives and was very warm to the touch; He had hives and was very warm to the touch; This spontaneous safety report, with reference number 2023SA216537 was received by the partner on 14-JUL-2023 and forwarded on 17-JUL-2023, from a health professional. A four-month-old neonate had an immediate reaction to Vaxelis. He experienced hives and was very warm to the touch. Due to the short latency period between time of vaccination and occurrence of the event, the causality between the event "He had hives and was very warm to the touch" and Vaxelis was assessed as related. Further information is expected. Follow-up information was received on 01-AUG-2023, from an HCP. This case is maintained as non-serious. The patient was given Benadryl as treatment for the reported event. The reporter assessed the causal relationship between Vaxelis and the reported event "He had hives and was very warm to the touch" as related. No further information is expected, given that reporter replied to all our queries.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Respiratory distress (NICU for 4 days)
- Andere Medikamente
- ROTAVIRUS VACCINE; PREVNAR 13
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 28.07.2023
- Impfdatum
- 06.07.2023
- Beginn
- 07.07.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Symptomtext
had a fever of 105 degrees (rectal reading); This spontaneous report has been received from a physician via field-based employee (FBE) referring to a 11-week-old (also reported as 2 months, conflict information) male patient. The patient's medical history included umbilical hernia. The patient's concurrent conditions and concomitant therapies were not reported. There was no other vaccine within 4 weeks prior to the suspect vaccines. The patient had no illness at time of vaccination. On 06-JUL-2023, the patient was vaccinated with the first dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7536AA, expiration date: 30-SEP-2025, administered intramuscularly (IM) at left thigh for prophylaxis (strength and dose were not provided); the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X002251, expiration date: 03-JUN-2024, administered orally (PO) for prophylaxis (strength and dose were not provided); the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), batch# GH6086, expiration date reported as 31-MAY-2025, administered intramuscularly at right thigh for prophylaxis (strength, formulation, and dose were not provided). The patient was given the vaccines appropriately at private doctor's office/hospital by a registered nurse (RN) who was trained, and the vaccines were used according to the instruction leaflet. The vaccines were purchased with private funds. There was no temperature excursion occur as a result of a reading from a Data Logger. There was no product quality complaint. On 07-JUL-2023, the baby had fever of 105 degree Fahrenheit (rectal reading). He continued with lower temperatures on the same date. The fever went down and resolved within 24 hours, and the patient did not spike to 105 degree Fahrenheit again. The patient had sought for medical attention. The vaccines were not available for return or evaluation as they were disposed after administration. It was reported the event fever was attributable to the suspect vaccines.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Umbilical hernia
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2023
- Impfdatum
- -
- Beginn
- 12.12.2023
- 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
Nurse called and reported that 1 dose of VAXELIS (pre-filled syringe) had been administered after the product was involved in TE. Caller stated the patient has not had any symptoms. No additional AE/no PQC reported. Temp:48F, Time frame:15min; This spontaneous non-serious safety report, with reference number 02522462, was received by a partner on 14-DEC-2023 and forwarded to Agency on the same day, from a HCP. Due to the nature of the event, the causality between the event "Nurse called and reported that 1 dose of VAXELIS (pre-filled syringe) had been administered after the product was involved in TE. Caller stated the patient has not had any symptoms. No additional AE/no PQC reported. Temp:48F, Time frame:15min" 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
- ME
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2023
- Impfdatum
- -
- Beginn
- 01.12.2023
- 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
HBP calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion. No symptoms or additional details reported; This spontaneous safety report, with reference number 02516459 (Interaction# 02516441), was received by the partner on 04-DEC-2023 and forwarded on 04-DEC-2023, from a non- health professional. Due to the nature of the event, the causality between the event "calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion. No symptoms or additional details reported" 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
- OH
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.12.2023
- Impfdatum
- 03.08.2023
- Beginn
- 03.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Adverse event
Syringe issue
Symptomtext
After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied; Unspecified adverse event; This spontaneous safety report, with reference number 02477799 (VAERS ID # 2676132-1 / interaction # 02477797) was received by the partner on 22-SEP-2023 and forwarded on the same day, from a health professional. Additional information was received on 25-SEP-2023 by the partner and forwarded on 26-SEP-2023. Due to the nature of the event, the causality between the events "After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied and Unspecified adverse event" and Vaxelis was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syringe issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.12.2023
- Impfdatum
- 08.08.2023
- Beginn
- 08.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Needle issue
Off label use
Product use issue
Syringe issue
Symptomtext
As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; Adverse event; Product administered to patient of 0.08 years (1 month); This spontaneous safety report, with reference number 02477067 (VAERS ID # 2668630-1) was received by the partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a health professional. Additional information was received on 22-SEP-2023 by the partner and forwarded to Company on 26-SEP-2023. The case is classified as off-label use due to Product use issue (Product use in unapproved population) Due to the nature of the event, the causality between the events "As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm ", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" and Vaxelis was not applicable. No further information is expected. Non-Significant follow-up information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2668630-1. Case is maintained as non-serious and off label use. The reporter assessed the causal relationship between Vaxelis and the events " As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Needle issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.12.2023
- Impfdatum
- 08.08.2023
- Beginn
- 08.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Needle issue
Off label use
Product use issue
Syringe issue
Symptomtext
As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm; Adverse event; Product administered to patient of 0.08 years (1 month); This spontaneous safety report, with reference number 02477067 (VAERS ID # 2668630-1) was received by the partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a health professional. Additional information was received on 22-SEP-2023 by the partner and forwarded to Company on 26-SEP-2023. The case is classified as off-label use due to Product use issue (Product use in unapproved population) Due to the nature of the event, the causality between the events "As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm ", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" and Vaxelis was not applicable. No further information is expected. Non-Significant follow-up information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2668630-1. Case is maintained as non-serious and off label use. The reporter assessed the causal relationship between Vaxelis and the events " As nurse was administering vaccine Vaxneuvance, vaccine syringe (prefilled) broke at the luer-lock hub leaving the child with a needle inside of the right thigh, needle was removed without complication leaving the child without harm", "Adverse event" and " Product administered to patient of 0.08 years (1 month)" as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Needle issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 1,9
- Geschlecht
- M
- Eingang
- 21.12.2023
- Impfdatum
- 20.12.2023
- Beginn
- 20.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
No adverse event reported, patient tolerated the vaccines. Error recognized and parent informed, as well as escalation up to the chain of command
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- no
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.12.2023
- Impfdatum
- 01.12.2023
- Beginn
- 01.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No other adverse event; HBP calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion.; This spontaneous report was received from a office manager and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided On 01-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965644, expiration date: 02-OCT-2024 (reported as 20-OCT-2024) who had been verified to be a valid number (strength and dose were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7536AA, expiration date: 30-SEP-2025 who had been verified to be a valid number (strength, and route of administration were not provided) administered for prophylaxis. Both vaccines were administered following a temperature excursion (Product storage error). No additional adverse event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 04.12.2023
- Impfdatum
- 22.11.2023
- Beginn
- 22.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- none
- Andere Medikamente
- None
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 3,0
- Geschlecht
- F
- Eingang
- 04.12.2023
- Impfdatum
- 16.11.2023
- Beginn
- 16.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product preparation error
Symptomtext
May have received diluent syringe of vaccine and did not receive vial containing powder vaccine of MMR Priorix, did not have any s/sx of adverse reaction after vaccines on 11/16/23, per mom.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- MMR Priorix given separately, syringe containing diluent given and via containing powder vaccine was found to still be in vaccine box.
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 2,0
- Geschlecht
- F
- Eingang
- 04.12.2023
- Impfdatum
- 16.11.2023
- Beginn
- 16.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product preparation error
Symptomtext
MMR Priorix given separately, syringe diluent given and vial containing powder vaccine found to be left in vaccine box and reconstituted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product preparation error
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 0,7
- Geschlecht
- F
- Eingang
- 07.11.2023
- Impfdatum
- 06.11.2023
- Beginn
- 06.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
Pt came in for 6 month check but, is currently 8 months, pt had already received 2 rotas in the past and was behind on well check up. Pt was normal after Vaccine was given, no side effects reported
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 1,7
- Geschlecht
- F
- Eingang
- 10.10.2023
- Impfdatum
- 10.10.2023
- Beginn
- 10.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Symptomtext
I gave a Vaxelis and a HIB both. I had forgotten that HIB was in the vaxelis. There was no adverse reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 27.06.2023
- Beginn
- 26.06.2023
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Swelling
Symptomtext
mom called and reported redness and localized swelling; mom called and reported redness and localized swelling; 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 2649954-1. The original narrative from the sender is the following: "mom called and reported redness and localized swelling". The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " mom called and reported redness and localized swelling". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 15.06.2023
- Beginn
- 15.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Allergy to vaccine
Infant irritability
Symptomtext
Caller reports after patient received a dose of VAXELIS,she had increased irritability for few days,doctor thinks patient may be allergic to pertussis component of vaxelis.Reports they had patients in past allergic to Pertussis with similar reaction; This non-serious spontaneous safety report, with reference number 2023SA271433, was received by the partner on 05-SEP-2023 and forwarded to company on 06-SEP-2023, from a health professional. The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Caller reports after patient received a dose of VAXELIS, she had increased irritability for few days, doctor thinks patient may be allergic to pertussis component of vaxelis. Reports they had patients in past allergic to Pertussis with similar reaction". Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Allergy to vaccine
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- PREVENAR; ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 20.04.2023
- Beginn
- 20.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine; No known symptoms of adverse reaction; 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 2622372-1. The original narrative from the sender is as follows: Medical history included Eczema on back since an unspecified date but was seen in ER in mid-March. Concomitant medication included Hydrocortisone cream 1% white petroleum ointment for unknown indication. "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine. PT should have received Dtap, Polio, and Hep B vaccines, not the HIB. At this time, no known symptoms of adverse reaction. Will continue to monitor." The causal relationship between Vaxelis and the events "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine" and "No known symptoms of adverse reaction" was assessed as not applicable due to the nature of these reported events. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Eczema
- Vorgeschichte
- Medical History/Concurrent Conditions: Eczema
- Andere Medikamente
- HYDROCORTISONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 20.04.2023
- Beginn
- 20.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine; No known symptoms of adverse reaction; 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 2622372-1. The original narrative from the sender is as follows: Medical history included Eczema on back since an unspecified date but was seen in ER in mid-March. Concomitant medication included Hydrocortisone cream 1% white petroleum ointment for unknown indication. "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine. PT should have received Dtap, Polio, and Hep B vaccines, not the HIB. At this time, no known symptoms of adverse reaction. Will continue to monitor." The causal relationship between Vaxelis and the events "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine" and "No known symptoms of adverse reaction" was assessed as not applicable due to the nature of these reported events. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Eczema
- Vorgeschichte
- Medical History/Concurrent Conditions: Eczema
- Andere Medikamente
- HYDROCORTISONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.06.2023
- Impfdatum
- 15.06.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect route of product administration
Symptomtext
Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023.; This spontaneous safety report, with reference number 02410179 (Interaction #02410170), was received by the partner on 19-JUN-2023 and forwarded to agency on 20-JUN-2023, from a health professional. Due to the nature of the event, the causality between the events "Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023." and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 25.04.2023
- Beginn
- 25.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance; A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance; This non-serious spontaneous safety report, with reference number 2023SA130811/ Inquiry# 01590758 was received by a partner on 25-APR-2023 and forwarded to agency on 26-APR-2023 from a health professional. Due to the nature of the event, the causality between the events "A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance" and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -