- Staat
- KS
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 31.01.2023
- Impfdatum
- 30.01.2023
- Beginn
- 31.01.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autopsy
Death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Sent for autopsy 01/31/2023
- Aktuelle Erkrankungen
- No known
- Vorgeschichte
- no known
- Andere Medikamente
- D-Vi-Sol (10mcg/mL-400units/mL)
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 25.07.2023
- Impfdatum
- 18.07.2023
- Beginn
- 23.07.2023
- Tage bis Beginn
- 5,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Rash
Symptomtext
Patient came in for a well child check and was due for multiple vaccines. Patients parents agreed with provider to get Varicella, MMR, and Pediarix. Varicella was administered on the right vastus lateralis, MMR and Pediarix was administered on the left vastus lateralis. Patient got vaccinated on 7/18/23 and went to ED on 7/23/23 because of a rash.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 02.03.2023
- Impfdatum
- 01.03.2023
- Beginn
- 01.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Symptomtext
fever (reported by mom as high as 105.2 F). Exam next day 3/2/23 NORMAL
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- tylenol after fever
- Allergien
- no known previous allergies
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 17.11.2022
- Impfdatum
- 10.11.2022
- Beginn
- 11.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Productive cough
Rash
Rhinorrhoea
Symptomtext
10/17/22 HX of Rash that started last Friday at daycare. rash came on suddenly and started on her arms and eventually covered her whole body. daycare called mom and mom took patient to ER. they told mom it was probably a reaction to her vaccines and wrote her prednisone 15mg/5mL take 2.5 mL daily and told mom to give Benadryl as needed per box instructions. prednisone is complete but rash still comes and goes. mom does not think it is a reaction to vaccines. rash not present at this time but mom has pictures. patient has not had any fever, has had ongoing runny nose, new wet cough that started this am, no N/V/D. Mom reports no new foods or laundry detergent.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- Respiratory Panel Pending
- Aktuelle Erkrankungen
- 10/27/22 BOM/COUGH/VIRAL URI
- Vorgeschichte
- NA
- Andere Medikamente
- NA
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 27.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 20.09.2022
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site rash
Injection site swelling
Injection site warmth
Symptomtext
Received vaccines at 6mo wcc on 9/19. Medical Assistant administered Pediarix (Dtap/HepB/IPV) intramuscular on LT, also administered PCV13 IM on LT as well as RotaTeq oral by mouth. Rash/redness on Left thigh, site is warm to touch developed 9/20/22 noted swelling. 9/21 at 845a parents contacted the office to report their concerns and current sx. Patient was scheduled same day for evaluation with provider. The provider documented that Vaccine Adverse Reaction- (pediarix/Prevnar) erythema to left thigh (blanchable). Parent information for supportive care and advise on when to return to clinic or seek care. Advised to f/u as needed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- none
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 2,0
- Geschlecht
- M
- Eingang
- 19.12.2023
- Impfdatum
- 14.02.2023
- Beginn
- 14.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Throat clearing
Tic
Symptomtext
same night started to have facial tics (blinking) and verbal tics (clearing throat) frequently. persistent until now (10 months now)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Throat clearing
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none, delayed vaccination
- Andere Medikamente
- not sure
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 14.11.2023
- Impfdatum
- 10.11.2023
- Beginn
- 10.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Product preparation issue
Symptomtext
Rotarix (do not reconstitute) was mixed as a diluent with the Rotarix powder (reconstitution required) and patient received a double dose.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- None at this time.
- Vorgeschichte
- None at this time.
- Andere Medikamente
- Rotarix, HIB, Pediarix, and Pneumococcal 20 vaccines administered on 11/10/2023.
- Allergien
- NKA.
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,7
- Geschlecht
- M
- Eingang
- 05.09.2023
- Impfdatum
- 30.08.2023
- Beginn
- 01.08.2023
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
Pentacel was in advertently administered. Patient did not have an adverse event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- na
- Aktuelle Erkrankungen
- na
- Vorgeschichte
- na
- Andere Medikamente
- na
- Allergien
- na
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 11.07.2023
- Impfdatum
- 24.04.2023
- Beginn
- 24.04.2023
- 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
Underdose
Symptomtext
Incorrect Moderna COVID vaccine was given - "Pink Cap" rather than "Blue Cap" for 1st dose. Patient had no adverse reactions. Informed parent to bring child in to repeat dose asap.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- none
- Andere Medikamente
- -
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 02.06.2023
- Impfdatum
- 19.05.2023
- Beginn
- 19.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Wrong product administered
Symptomtext
Administered PEDIARIX instead of INFANRIX; Pediarix was a 4th dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15-APR-2024) for prophylaxis. Previously administered products included Pediarix (First dose received in 9 weeks of age.), Pediarix (Second dose received at the age of 18 th week) and Pediarix (Third dose received in 7 months of age.). On 19-MAY-2023, the patient received the 4th dose of Pediarix. On 19-MAY-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Administered PEDIARIX instead of INFANRIX) and extra dose administered (Verbatim: Pediarix was a 4th dose.). The outcome of the wrong vaccine administered and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter reported that the patient received Pediarix instead of Infanrix accidently. The reporter did consent to follow up. The reporter reported that the patient accidently received Pediarix vaccine instead of Infanrix, which lead to wrong vaccine administered. The patient received 4th dose of pediarix which led to extra dose administered.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- M
- Eingang
- 25.05.2023
- Impfdatum
- 16.05.2023
- Beginn
- 16.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Inappropriate schedule of product administration
Overdose
Symptomtext
administered a patient both Kinrix and Pediarix on 16/05/2023; Extra dose administered; patient received kinrix as 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number M7HL3) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) (batch number N7HL3) for prophylaxis. Previously administered products included hepatitis B vaccine (the patient receive at birth), hepatitis B vaccine (received at 25 months of age), IPV (received at 25 months of age) and DTAP (received at 25 months of age). On 16-MAY-2023, the patient received the 2nd dose of Pediarix and the 2nd dose of Kinrix. On 16-MAY-2023, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered a patient both Kinrix and Pediarix on 16/05/2023), extra dose administered (Verbatim: Extra dose administered) and inappropriate schedule of vaccine administered (Verbatim: patient received kinrix as 2nd dose). The outcome of the overdose, extra dose administered and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-MAY-2023 The vaccine, patient and event information was provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter called and stated that a nurse administered a patient both Kinrix and Pediarix at the time of reporting, which led to overdose and inappropriate schedule of vaccine administered. The patient 2nd dose of Kinrix, which led to extra dose administered.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 25.05.2023
- Impfdatum
- 19.05.2023
- Beginn
- 19.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Wrong product administered
Symptomtext
Patient received 4th dose of prediarix instead of 1st dose of infarix
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- no
- Andere Medikamente
- tylenol(prescribed 2022 prn)
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 02.05.2023
- Impfdatum
- 28.11.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
No adverse event
Product administration error
Symptomtext
NO ADVERSE REACTIONS OR EVENTS REPORTED AS OF 11/29/2022. PT (2MONTHS) RECEIVED VACCINES PEDIARIX, PREVNAR, ROTATEQ. PT RECIVED DOUBLE DOSE OF DTAP AND IPV. NO ADVERSE REACTIONS HAVE BEEN REPORTED BY MOTHER AS OF 11/29/22 @9:24AM WHEN NOTIFIED OF ERROR MY MA.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 26.04.2023
- Impfdatum
- 14.04.2023
- Beginn
- 26.04.2023
- Tage bis Beginn
- 12,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Symptomtext
none reported
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- clotrimazole 1% cream
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 15.04.2023
- Impfdatum
- 06.04.2023
- Beginn
- 06.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Symptomtext
Pediarix and Engerix given on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 13-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15-APR-2024) for prophylaxis. Co-suspect products included HBV (Engerix B 10 mcg) (batch number 34G75, expiry date 15-FEB-2024) for prophylaxis. The patient's past medical history included febrile seizure (Febrile seizures as prior medical history). Concomitant products included Pentacel. On 06-APR-2023, the patient received the 1st dose of Pediarix and the 2nd dose of Engerix B 10 mcg. On 06-APR-2023, an unknown time after receiving Pediarix and Engerix B 10 mcg, the patient experienced overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 06-APR-2023 The clinical pharmacist enquired any guidance? Any concern for the patient? The registered pharmacist (RPH) reported a patient received both Pediarix and Engerix doses administered on the day of reporting. The RPH mentioned had concern with too much Hepatitis B for the patient. The patient previously received Pentacel. The reporter did not consent to follow-up. The patient received Pediarix and Engerix-B on the same day, which led to overdose
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Febrile seizure (Febrile seizures as prior medical history)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,6
- Geschlecht
- M
- Eingang
- 20.03.2023
- Impfdatum
- 20.03.2023
- Beginn
- 20.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
Patient was due for a Dtap. A Pediarix vaccine was given which also contained Hep B and IPV. No adverse reactions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 10.03.2023
- Impfdatum
- 01.03.2023
- Beginn
- 01.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Pediarix given instead of Boostrix; Pediarix given to an 11-years-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Kinrix (received 1 dose in 2017), Pediarix (received 1 dose in 2012), Pentacel (received 2 doses in 2012), Pentacel (received 1 dose in 2013), Dtap vaccine (received 4 doses on an unknown date), IPV vaccine (received 3 dose on an unknown date) and hepatitis B vaccine. On 1st March 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments: HCP called in to report that a 11-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix. The healthcare provider gave information about the dose and patient. They accepted to be escalated to second line. Previous vaccination include 1 Kinrix 2017, 1 Pediarix 2012, 2 Pentacel 2012 and 1 Dtap 2013. Other vaccines include 4 doses of IPV and 3 doses of hepatitis B. the reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments: US-GSK-US2023033996:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- F
- Eingang
- 10.03.2023
- Impfdatum
- 01.03.2023
- Beginn
- 01.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Pediarix given instead of Boostrix; Pediarix given to a 14-year-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Kinrix (received dose in 2014), Pediarix (received dose in 2008), Pentacel (received dose in 2009), Dtap vaccine (received dose in 2009), Dtap vaccine (received dose in 2011), Polio vaccine (received 4 doses) and hepatitis B vaccine (received 3 doses). On 1st March 2023, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments: HCP called in to report that a 14-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix. The healthcare provider gave information about the dose and patient. They accepted to be escalated to second line. Previous vaccination mentioned were Kinrix 2014, Pediarix 2008, Pentacel 2009, 2 Dtap in 2009 and 2011, being a total of 5 Dtap. Other vaccines include 4 doses Polio and 3 hepatitis B. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments: US-GSK-US2023034000:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 02.03.2023
- Impfdatum
- 21.02.2023
- Beginn
- 21.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
A 2 month-old given Hiberix, Pediarix, Rotarix on 1/30/2023 and again on 02/21/23; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 3-month-old male patient who received Hib (Hiberix) (batch number 7FZ57, expiry date 30th December 2023) for prophylaxis. Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 959LS, expiry date 17th February 2025) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX) and PEDIARIX. On 21st February 2023, the patient received the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation, Rotarix Oral Applicator Device, the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st February 2023, unknown after receiving Hiberix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date: 21-FEB-2023 Reporter comment: The reporter reported that, the 2 month old patient was given Hiberix, Pediarix, and Rotarix on 30th January 2023 and then again on 21st February 2023. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Hiberix, Pediarix, and Rotarix shorter than the recommended interval, which led to shortening of the vaccine schedule.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 21.02.2023
- Impfdatum
- 21.02.2023
- Beginn
- 21.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- NA
- Andere Medikamente
- NA
- Allergien
- NA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 11.02.2023
- Impfdatum
- 01.02.2023
- Beginn
- 01.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Wrong product administered
Symptomtext
Pediarix instead of Dtap (Infanrix); With Pediarix, now has 4 doses of hep b; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 26th October 2025) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 1st February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 2-Feb-2203 Reporter's comment: Nurse assistant reported by getting Pediarix, the patient now had received 4 doses of Hepatitis B, 4th dose of Dtap and reporter was unaware of where patient was in series for IPV. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Pediarix (extra dose for Hepatitis B), Hiberix (Hib) and Prevenar instead of Infanrix, Hiberix and Prevenar, which led to wrong vaccine administered and extra dose administered.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,6
- Geschlecht
- M
- Eingang
- 05.01.2023
- Impfdatum
- 15.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
No adverse event
Symptomtext
Pediarix and IPV vaccines were given at the same time. Pt didnt have any adverse reaction after. Mother was informed about the situation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical history of non-contributory
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 05.01.2023
- Impfdatum
- 18.10.2022
- Beginn
- 05.01.2023
- Tage bis Beginn
- 79,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Unevaluable event
Symptomtext
There were no adverse events reported and patient's parents were contacted
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 30.12.2022
- Impfdatum
- 20.12.2022
- Beginn
- 20.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
1st Pediarix-Rotarix-Hiberiix 2Dec22, 2nd 20Dec22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received Hib (Hiberix) (batch number yn44n, expiry date 15th December 2023) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15th April 2024) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number z5r33, expiry date 23rd February 2024) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), PEDIARIX and LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX). On 20th December 2022, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 20th December 2022, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:20-DEC-2022 Reporter's Comment: The reporter was practice manager. The reporter reported on 2nd December 2022 that, patient received the first dose of Hiberix , Pediarix and Rotarix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Hiberix , Pediarix and Rotarix below than the recommended schedule, which led to shortening of vaccination schedule.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 29.12.2022
- Impfdatum
- 28.12.2022
- Beginn
- 28.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
Patient was to receive DTaP, Pediarix given causing extra dose of polio and hep b. No adverse reactions noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- anemia
- Vorgeschichte
- none
- Andere Medikamente
- Poly-vi-sol/iron oral soln
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 22.12.2022
- Impfdatum
- 20.12.2022
- Beginn
- 20.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Circumstance or information capable of leading to medication error
Extra dose administered
Wrong product administered
Symptomtext
MA incorrectly placed DTap on the patient. Vaccines for pt. and another patient were pulled at the same time, and MA took the DTap from the other paitent's tray, resulting in pt. receiving another dose. Dr. was made aware, and adivsed no harm to the patient. Dr. informed the mother of the incident. Patient has a follow up appointment in 1 week.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Circumstance or information capable of leading to medication error
- Hospital-Tage
- -
- Labordaten
- Patient has a follow up appointment in 1 week.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Acetaminophen 160mg/5 mL suspension
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- U
- Eingang
- 16.12.2022
- Impfdatum
- 29.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin discolouration
Symptomtext
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis. Previously administered products included Pediarix with an associated reaction of skin discolouration (1st dose received on 05th July 2022, from batch number X9HS4 and refer case US2022AMR171088) and Hiberix with an associated reaction of skin discolouration (1st dose received on 05th July 2022, from batch number FY4E9 and refer case US2022AMR171088). On 29th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. On an unknown date, the outcome of the skin discoloration was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2022AMR171088 Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The reporter reported that the patient after received Hiberix and pediarix experienced gray dot on the right thigh of the leg The reporter was consented to follow up. Additional supportive information: This case had been linked with US2022AMR171088 by same reporter for different patient.; Sender's Comments: US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: US-GSK-US2022AMR149560:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin discolouration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- U
- Eingang
- 28.11.2022
- Impfdatum
- 29.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin discolouration
Vaccine positive rechallenge
Symptomtext
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis. Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047) and Hiberix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047). On 29th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. On an unknown date, the outcome of the skin discoloration was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2022AMR171047 Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The patient experienced gray dots noted on legs (right thigh) after receiving 2nd dose of Pediarix, 2nd dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171047 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: US-GSK-US2022AMR149560:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin discolouration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- U
- Eingang
- 28.11.2022
- Impfdatum
- 11.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin discolouration
Symptomtext
gray dots that have been noted on patient's legs on right thigh after receiving Pediarix, Hiberix and/or Prevnar.; This case was reported by a pharmacist and described the occurrence of skin discoloration in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR) for prophylaxis. Previously administered products included Pediarix (On 8th Jun 2022 1st dose received of Pediarix and Hiberix For tolerance to the 1st dose refer case US2022AMR171034) and Hiberix. On 11th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, the patient received PREVENAR. On an unknown date, less than 3 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2022AMR171034, US2022AMR171042 Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: For tolerance to the 3rd dose refer case US2022AMR171042. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments: US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin discolouration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 28.11.2022
- Impfdatum
- 10.08.2022
- Beginn
- 10.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered at inappropriate site
Skin discolouration
Symptomtext
Grey dots on legs; Vaccine administered at inappropriate site; This case was reported by a pharmacist and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis and pneumococcal vaccine (Prevenar) for prophylaxis. On 10th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, the patient started Prevenar at an unknown dose and frequency. On 10th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2022AMR171028 Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The patient experienced gray dots on skin after receiving Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022AMR171028. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments: US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered at inappropriate site
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 25.11.2022
- Impfdatum
- 19.08.2022
- Beginn
- 21.10.2022
- Tage bis Beginn
- 63,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin discolouration
Symptomtext
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis. On 19th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 21st October 2022, 63 days after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The patient experienced gray dots noted on legs (right thigh) after receiving Pediarix, Hiberix The reporter was consented to follow up. Additional supportive information: The patient received 2nd dose of Pediarix (batch number T5425) and Hiberix ( 5Y9N9) on 21st October 2022 This was 1 of several linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149560: US-GSK-US2022AMR149561:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin discolouration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 11.11.2022
- Impfdatum
- 27.10.2022
- Beginn
- 27.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
MA administered pediarix to a 12 year old pt.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 08.11.2022
- Impfdatum
- 18.10.2022
- Beginn
- 18.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Symptomtext
Vaccine given outside of appropriate age range
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- No medications
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 0,8
- Geschlecht
- M
- Eingang
- 08.11.2022
- Impfdatum
- 07.11.2022
- Beginn
- 07.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administration error
Wrong product administered
Symptomtext
Administration Error was reported to management, the provider and the manufacturer and instructions were given by the provider and manufacturer. Menquadfi was given in place of Hib in error. The mother was contacted and was informed of the mistake. She was scheduled to come back and recieve the Hib vaccine and was advised that the meningococcal series will need to be began as usually because due to the age of the patient he will not be fully protected by the Medquadfi.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administration error
- Hospital-Tage
- -
- Labordaten
- There were no adverse reactions or events to report at this time.
- Aktuelle Erkrankungen
- URI, Viral
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- U
- Eingang
- 22.10.2022
- Impfdatum
- 28.07.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered at inappropriate site
Skin discolouration
Symptomtext
small gray dot on leg; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis. Previously administered products included Pediarix (The patient received Pediarix 1st dose on 27th May 2022. Batch no X9HS4-Refer case US2022AMR148961.). On 28th July 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration and vaccine administered at inappropriate site. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that Prevnar and Acthib were also given in same leg so were not sure which vaccine caused the reaction. The reporter stated that a dose of pediarix in the thigh, patient had a small gray dot on leg that has lasted and not gone away. Additional Supportive Information: It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib. For 3rd dose refer case US2022AMR149561.; Sender's Comments: GSK-US2022AMR148962:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR148961:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148962:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered at inappropriate site
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 0,3
- Geschlecht
- U
- Eingang
- 22.10.2022
- Impfdatum
- 17.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin discolouration
Symptomtext
reaction/faint grey dot; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 3-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis. Previously administered products included Pediarix with an associated reaction of skin discolouration (For tolerance of 1st dose of Pediarix ,refer case US2022AMR148962), Prevnar with an associated reaction of skin discolouration and Actihib with an associated reaction of skin discolouration. On 17th August 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 2 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was unknown. It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient:US2022AMR148962 Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: This case is linked to the case US2022AMR148961, US2022AMR148919, US2022AMR149560 and US2022AMR149561 reported by the same reporter. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib.; Sender's Comments: GSK-US2022AMR148919:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148961:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin discolouration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 27.09.2022
- Impfdatum
- 27.09.2022
- Beginn
- 27.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product preparation issue
Symptomtext
One of the nurses at our office administered the covid vaccine without diluting and mixing it. The vaccine was drawn up front the vial and given with no diluent. So far, patient has not experienced any adverse events. The parent was notified and notified to watch for exaggerated side effects.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product preparation issue
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- Cough
- Vorgeschichte
- -
- Andere Medikamente
- Children's Zyrtec
- Allergien
- No Known Allergies
- Vorherige Impfungen
- -