- Staat
- MD
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 08.06.2022
- Impfdatum
- 08.06.2022
- Beginn
- 08.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immediate post-injection reaction
Nausea
Vomiting
Symptomtext
Patient developed nausea immediately after the administration of the IPV vaccine. He ran to the adjoining restroom and vomited once in the toilet. He returned to the exam room table and laid down on the table. He returned to baseline in 5 minutes. He was observed for 15 minutes and remained stable without any new symptoms. He declined offer of pretzels and juice.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 05.05.2022
- Impfdatum
- 03.05.2022
- Beginn
- 03.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Diarrhoea
Irritability
Symptomtext
The patient did not have any reaction to the vaccine in the office, the patient has loose stool and is fussy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 11.04.2022
- Impfdatum
- 07.04.2022
- Beginn
- 07.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Injection site erythema
Symptomtext
Patient was given an extra dose of IPOL. CMA giving vaccine was busy at time before getting vaccines ready and forgot that there is Polio in the Pediarix vaccine already. She did not realize it until after vaccines were given. Patient's mother was contacted regarding the mishap and stated patient was doing fine. He only had a small localized reaction at injection site of redness.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- no
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 1,1
- Geschlecht
- F
- Eingang
- 03.02.2022
- Impfdatum
- 25.01.2022
- Beginn
- 26.01.2022
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Asthenia
Body temperature increased
Pain in extremity
X-ray normal
Symptomtext
child rec'd dose on 1/25/22. On 1/27 child temp went up to 101F and unable to weight bare. Child taken to ER xray done-negative results. Saw PCP on 1/31 as follow up, temp 99. Child's temp did not exceed 101 and other than sore leg, no other symptom, no redness at all
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- 1/27/22 xray of right leg was done..........negative
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 05.11.2021
- Impfdatum
- 05.11.2021
- Beginn
- 05.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Asthenia
Gait disturbance
Hyperhidrosis
Nausea
Vomiting
Symptomtext
Patient stood up after receiving vaccinations, stated he felt weak and tripped. Caught by father, guided back to examination chair. Patient reported feeling nauseated and was visibly diaphoretic. RN called for assistance, instructed patient to lie down on his side. Emergency kit brought to patient. Cool compress given. Patient did not lose consciousness at anytime. One episode of emesis. Reported not eating breakfast or drinking anything prior to coming into clinic. Rested for 10 minutes in exam room, stated improvement in symptoms. Able to stand and walk out with no assistance needed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- Vital signs taken at time of adverse reaction. Blood pressure 110/60, heart rate 70, respirations 18.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 12.05.2023
- Impfdatum
- 29.03.2023
- Beginn
- 29.03.2023
- 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
No adverse event
Symptomtext
administered expired doses of IPOL with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient and was administered expired doses of IPV (VERO) [IPOL] 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 Varicella Zoster Vaccine (Varicella Vacc.); measles vaccine, mumps vaccine, rubella vaccine (MMR); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic Vaccination (Immunisation). On 29-Mar-2023, the patient received a dose of suspect IPV (VERO) Suspension for injection strength: not reported lot U1A601M expiry date: 27-Feb-2023 via intramuscular route in the left thigh for prophylactic vaccination (immunization). On 29-MAR-2023 the patient developed a non-serious administered expired doses of ipol with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO). Action taken was not applicable. At time of reporting, the outcome was Unknown for the event administered expired doses of ipol with no reported adverse event. 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 guidelines. 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
- IA
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 12.05.2023
- Impfdatum
- 24.04.2023
- Beginn
- 24.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 5
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
inadvertently administered expired doses of IPOL with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who had inadvertently administered expired doses of ipol with no reported adverse event after receiving vaccine IPV (VERO) [ipol]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included varicella zoster vaccine (varicella vaccine) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunisation; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation. On 24-Apr-2023, the patient received a dose 5, 0.5 ml once of suspect IPV (VERO) Suspension for injection, lot U1A601M, 27-FEB-2023 via intramuscular route in the right thigh for Immunization. On 24-Apr-2023 the patient developed a non-serious inadvertently administered expired doses of ipol with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. Outcome: 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 guidelines. 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
- IA
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 11.05.2023
- Impfdatum
- 23.03.2023
- Beginn
- 23.03.2023
- 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
inadvertently administered expired doses, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient for whom inadvertently expired dose of IPV (Vero) [IPOL] was administered, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Mar-2023, the patient received a dose of suspect IPV (VERO) at dose 0.5 ml (1x) suspension for injection of standard strength (lot: U1A601M, expiry date: 27-Feb-2023) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered) (latency: same day). Action taken: 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 guidelines. 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
- -
- Alter
- 27,0
- Geschlecht
- F
- Eingang
- 04.03.2023
- Impfdatum
- 04.03.2023
- Beginn
- 04.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Patient received expired vaccine. Was administered 3/4/2023, IPV expired /272/2023. Patient was notified and instructed to notify medial facility if they experience any adverse reactions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 13.01.2023
- Impfdatum
- 13.01.2023
- Beginn
- 13.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 5
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.01.2023
- Impfdatum
- 06.01.2023
- Beginn
- 06.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Medication error
No adverse event
Wrong product administered
Symptomtext
an extra dose of IPOL was administered to a patient instead of the intended GARDASIL vaccine with no reported AE; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 years old male patient who was administered an extra dose of ipol instead of the intended gardasil vaccine with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 06-Jan-2023, the patient received a dose of suspect poliomyelitis vaccine (inactivated) (Ipol) Suspension for injection at a dose of 0.5 ml with lot U1A601M and expiry date- 27-Feb-2023 via intramuscular route in the left deltoid for Immunization (strength unknown). On 06-Jan-2023 the patient was administred an extra dose of ipol instead of the intended gardasil vaccine with no reported AE(wrong product administered) (latency same day). Action taken: not applicable Outcome: 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 guidelines. 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
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 01.08.2022
- Impfdatum
- 30.07.2022
- Beginn
- 30.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cyanosis
Opisthotonus
Unresponsive to stimuli
Symptomtext
0940 7/30/22 Patient was unresponsive, blue across bilateral upper eyes with back slightly arched. A cool compression was applied across the patient's forehead and chest. After applying cool compression patient became responsive to name and touch stimuli. administrated EpiPen 0.3mg in upper right thigh at 0942. Vital signs obtained patient legs elevated and more cool compression was applied as transport arrived. Report was given to ER Provider . Patient was taken to the ER via wheelchair with his mother holding him in her lap patient was alert and orited x3.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cyanosis
- Hospital-Tage
- -
- Labordaten
- none started patient was transported to ER for higher level of care.
- Aktuelle Erkrankungen
- No known illnesses.
- Vorgeschichte
- None reported.
- Andere Medikamente
- Unknown
- Allergien
- No known allergies to medication.
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 16.07.2022
- Impfdatum
- 29.04.2022
- Beginn
- 29.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
refrigerator door was left open; low temperature reached: 8.56 Celsius (C) /duration out of labelled range: 45 minutes (punctured Ipol) with no reported adverse event; administered with vaccines that was exposed to excursion with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a nurse This case involves a 4 years old female patient who was administered with vaccines that was exposed to excursion with no reported adverse event and reported Product storage error (refrigerator door was left open; low temperature reached: 8.56 Celsius (C) /duration out of labelled range: 45 minutes (punctured Ipol) with no reported adverse event ) while receiving vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS A VACCINE INACT (HAVRIX); HIB VACCINE (HIB); INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) all for immunization. On 29-Apr-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot U1A601M, expiry date: 27-Feb-2023, strength, form: not reported) via subcutaneous route in the left arm for immunisation.. On an unknown date the patient refrigerator door was left open; low temperature reached: 8.56 C; duration out of labelled range: 45 minutes (punctured Ipol) with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO). On 29-Apr-2022 the patient developed a non-serious was administered with vaccines that was exposed to excursion with no reported adverse event (poor quality product administered) (latency: same day). Nurse also inquired if they need to revaccinate patient that was administered with vaccines that was exposed to excursion. Action taken : not applicable for both the events. Outcome: Unknown for both the events 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 guidelines. 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.; Sender's Comments: 01176068:other 01176155:other
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 16.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
Max/Low Temperature reached: 8.56 C, Duration out of labelled range: 45 minutes, with no reported adverse event; patient was administered with vaccines that was exposed to excursion, with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 mL dose of suspect IPV (vero) (lot: U1A601M, expiry date: 27-Feb-2023; formulation not reported) via subcutaneous route in the left thigh for immunization. On an unknown date, the patient was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event (product storage error) and (circumstance or information capable of leading to medication error). Action taken was not applicable. Outcome: 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 12.07.2022
- Impfdatum
- 29.04.2022
- Beginn
- 29.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
refrigerator door was left open; low Temperature reached: 8.56 C; Duration out of labelled range: 45 minutes (punctured IPOL) with no reported adverse event; was administered with vaccines that was exposed to excursion with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from nurse. This case involves a 18 years old female patient who was administered with vaccines that was exposed to excursion with no reported adverse event and reported Product storage error (refrigerator door was left open; low temperature reached: 8.56 c; duration out of labelled range: 45 minutes (punctured ipol) with no reported adverse event) while receiving vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO); and HEPATITIS A VACCINE INACT (HAVRIX) all for Immunisation. On 29-Apr-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot U1A601M, expiry date: 27-Feb-2023, strength, form: not reported) via subcutaneous route in the left arm for immunisation. On an unknown date the patient refrigerator door was left open; low temperature reached: 8.56 c; duration out of labelled range: 45 minutes (punctured ipol) with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO). On 29-Apr-2022 the patient developed a non-serious was administered with vaccines that was exposed to excursion with no reported adverse event (poor quality product administered) latency same day following the administration of IPV (VERO). Nurse also inquired if they need to revaccinate patients that was administered with vaccines that was exposed to excursion. Action taken: Not applicable. Outcome: Unknown for both the events. 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 guidelines. 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.; Sender's Comments: 01176068: 01176149:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event; IPOL was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of an unknown age and gender and it involved temperature excursion, low temperature 32.82 Fahrenheit (F) for 25 minutes total time with no reported adverse event and ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event , for punctured vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), ( lot: U1A601M ; expiry date: 2-Feb-2023) in unknown administration site for prophylactic vaccination (immunization). On an unknown date there was temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event (product temperature excursion issue) (onset and unknown latency) On an unknown date , Ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event (poor quality product administered) (onset and unknown latency) Action taken : not applicable for both the events. Outcome: unknown for both the events 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.; Sender's Comments: 01160269: 01160330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 30.06.2022
- Impfdatum
- 27.06.2022
- Beginn
- 27.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SC / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
The MMRV vaccine was given and it was expired as of 06/16/22. The assistant did not scan the vaccine before administering and this is how the mistake happened.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- non
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
use of IPOL that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event; Initial information received on 03-Jun-2022 from other Health Care Professional regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves 6 patients who used ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event while receiving vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patients received a dose of suspect IPV (VERO) (batch lot U1A601M) (Unknown dosage, strength, formulation and expiry date ) via unknown route in unknown administration site for immunization. On an unknown date the patients developed a non-serious event of use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event (product storage error) (unknown latency) following the administration of IPV (VERO). Action taken : not applicable. At time of reporting, the outcome was Unknown for the event use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 03.05.2022
- Impfdatum
- 26.04.2022
- Beginn
- 29.04.2022
- Tage bis Beginn
- 3,0
- Dosis
- 5
- Route/Site
- SC / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product storage error
Symptomtext
Vaccine given to patient after a temperature excursion and the dose needs to be repeated.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- not known
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 29.04.2022
- Impfdatum
- 29.04.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 4
- Route/Site
- SC / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Symptomtext
pt was inadvertently given and extra IPV . no reaction at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
temperature excursion was 47.5F; total time of excursion was 1 day and 13 hours with no reported adverse event; Initial information received on 28-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a patient with unknown demographics who had temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event while receiving vaccines IPV (VERO) [IPOL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HIB (PRP/T) VACCINE [ACT-HIB] and while treated with TUBERCULIN TEST [TUBERSOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (lot - C5762CA) for Product used for unknown indication for immunization. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE with unknown dose lot 9977H via unknown route in unknown administration site for immunization. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot C5923AA for immunization. On an unknown date, the patient received a dose of suspect IPV (VERO) with unknown dose lot U1A601M via unknown route in unknown administration site for immunization. On an unknown date the patient had temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of IPV (VERO). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (temperature excursion was 47.5F; total time of excursion was 1 day and 13 hours with no reported adverse event). At time of reporting, the outcome was Unknown for the event temperature excursion was 47.5f; total time of excursion was 1 day and 13 hours with no reported adverse event. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -