- Staat
- IL
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 05.01.2023
- Beginn
- 06.01.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autopsy
Cardiac arrest
Death
Respiratory arrest
Unresponsive to stimuli
Resuscitation
Symptomtext
Patient woke and ate the next morning, then went down for a nap. Father sat next to him on the bed watching a program, and noticed the baby was still. Tried to wake him and he would not respond / was not breathing. Patient was treated for cardiac arrest at the hospital and was never revived. He passed away.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- An autopsy has been performed, and concludes the cause of death is undetermined.
- Aktuelle Erkrankungen
- From birth had difficulty with digesting formula. Would spit up with phlegm. Was put on three different formulas, and once on AR improved, but still had occasional spit ups.
- Vorgeschichte
- See Item 11.
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,9
- Geschlecht
- F
- Eingang
- 26.09.2023
- Impfdatum
- 08.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- -
- Dosis
- 4
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Injection site reaction
Symptomtext
Inadvertently given child Adult Hep A instead of pediatric. Choose wrong dose from refrigerator. No adverse reactions. Contacted patient mother twice and other than slight site reaction, there were no other side effects.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site reaction
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 02.05.2023
- Impfdatum
- 01.05.2023
- Beginn
- 02.05.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pyrexia
Symptomtext
Mom called into the office stating patient had a temp of 101.1 after receiving immunizations. Mom advised to give Tylenol for fever.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- Vitamin D3 drops
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 27.04.2023
- Impfdatum
- 21.04.2023
- Beginn
- 21.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Capillary nail refill test abnormal
Diarrhoea
Pallor
Symptomtext
Diarrhea started the day after rotateq vaccination and had multiple episodes of very watery diarrhea; was pale looking with concerns of dehydration; eval in office 4/24/23 and advised pedialyte and close monitoring; did have reduced capillary refill that day in office; phone FU on 4/26/23 and reported that diarrhea improved 4/25/23.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None ; office and phone follow ups
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None reported
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 24.04.2023
- Impfdatum
- 14.04.2023
- Beginn
- 14.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Diarrhoea
Rotavirus infection
Vomiting
Symptomtext
Related to Rotateq, case of Rotavirus infection. Vomiting 4/14/23 on day of vaccination. Diarrhea since 4/14/23- multiple times a day. Needed office visit and phone call follow ups. Pedialyte recommended and smaller feeds. Symptoms resolved by 4/20/23.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- cow's milk protein
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 20.11.2023
- Impfdatum
- 06.11.2023
- Beginn
- 06.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
received an expired dose of PENTACEL on 06Nov2023 with no adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2023SA352579. This case involves a 15-month-old male patient who had received an expired dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] on 06nov2023 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Nov-2023, the patient received 0.5 mL expired dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (lot: UJ804AA; expiry date: 07-Oct-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency). Treatment: unknown No additional information available at the time of the report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 18.11.2023
- Impfdatum
- 07.11.2023
- Beginn
- 07.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
received an expired dose of PENTACEL with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA350570. This case involves a 1 years old female patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 07-Nov-2023, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ804AA, Expiry date: 07-Oct-2023 with unknown strength) via intramuscular route in the right thigh as immunization with no reported adverse event (expired product administered) (Latency: same day). It was reported "The nurse was asking for guidance on next steps, and she also wanted to know what to tell the patient's parents on what to watch out for in terms of adverse reactions." This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS A; MMR; VARICELLA VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 28.10.2023
- Impfdatum
- 18.10.2023
- Beginn
- 18.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
an expired PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received via consumer. This case involves a 1-year-old male patient and an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation. On 18-Oct-2023, the patient received an 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ804AA, expiry date: 07-Oct-2023) via intramuscular route in left thigh for immunization and an expired pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PREVNAR 20
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,3
- Geschlecht
- F
- Eingang
- 16.10.2023
- Impfdatum
- 10.10.2023
- Beginn
- 10.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
administration of Pentacel that has expired on 07Oct2023 to a patient today with no reported adverse event; Initial information was received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was treated with diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [PENTACEL (VERO)] that has expired on 07oct2023 to a patient today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis a vaccine and influenza vaccine for Immunisation. On 10-Oct-2023, the patient received 0.5 ml, 1X (total) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, suspension for injection (lot UJ804AA, expiry-07-10-23 and strength: unknown) via intramuscular route in left leg on 07oct2023 given to a patient today with no reported adverse event (expired product administered) (latency same day) for prophylactic immunization (immunization). Action taken: not applicable. At time of reporting, the outcome. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS A VACCINE; INFLUENZA VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 11.07.2023
- Impfdatum
- 10.05.2023
- Beginn
- 10.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Underdose
Symptomtext
Given 10 mcg Moderna Bivalent instead of 25 mcg
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Underdose
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Vitamin D 10 mcg
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 31.05.2023
- Impfdatum
- 03.05.2023
- Beginn
- 03.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administration error
Vaccination error
Symptomtext
Vaccine administration error. Dose not valid. No reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Poly-Vi-Sol with Iron 11 mg iron/mL oral drops 1 ml orally Once daily
- Allergien
- No Known Drug Allergies
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 28.04.2023
- Impfdatum
- 28.04.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- N/A
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
At time of wrong injection and while in office for two hours no reaction to patient.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- Azithromycin
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 28.04.2023
- Impfdatum
- 25.04.2023
- Beginn
- 25.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance with no reported AE; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 1 years old male patient who inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Prophylactic vaccination. On 25-Apr-2023, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of 0.5 ml (lot UJ804AA, Expiry date: 07-Oct-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunization). On 25-Apr-2023 the patient inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance (wrong product administered) (same day latency) with no reported adverse event. Action taken was not applicable. At time of reporting, the outcome was unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAXELIS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 27.04.2023
- Impfdatum
- 20.04.2023
- Beginn
- 20.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Unevaluable event
Symptomtext
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 27.04.2023
- Impfdatum
- 21.04.2023
- Beginn
- 21.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Incorrect product formulation administered
Symptomtext
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 27.04.2023
- Impfdatum
- 20.04.2023
- Beginn
- 20.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Incorrect product formulation administered
Symptomtext
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -