- Staat
- AZ
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 17.04.2022
- Impfdatum
- 13.04.2022
- Beginn
- 13.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Unresponsive to stimuli
Vomiting
Symptomtext
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Medium
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 30.03.2022
- Impfdatum
- 15.03.2022
- Beginn
- 15.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Hypotension
Pallor
Syncope
Symptomtext
Patient became faint and pale after blood was drawn from her arm and the Gardasil injection was given. I put her feet up on a chair and applied cool cloth to her forehead. Her BP was low prior to the injection and went up to a normal range after a few minutes. Pulse ox remained in the high 90's. Patient was given juice and cookies as she hadn't eaten much that day.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- HI
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 08.03.2022
- Impfdatum
- 07.03.2022
- Beginn
- 07.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Loss of consciousness
Syncope
Symptomtext
dizziness, syncope at 02:30pm; regained consciousness after 5minutes. transported to emergency room with full recovery. Discharged from emergency room without further issues.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- N/A
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 22.02.2022
- Impfdatum
- 15.02.2022
- Beginn
- 15.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Dyskinesia
Hyperhidrosis
Loss of consciousness
Pallor
Symptomtext
Client pale, sweaty, and dizzy after vaccination. Loss of consciousness noted for 15-20 seconds with a right arm jerk and pelvic thrust. Client held up/ supported by RN during event. Client came to and moved to floor with legs elevated on chair.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 06.09.2022
- Impfdatum
- 29.08.2022
- Beginn
- 30.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Vaccination site erythema
Vaccination site induration
Vaccination site pain
Symptomtext
large red firm tender area where vaccine was given to L arm - approx 9cm round
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vaccination site pain
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none.
- Andere Medikamente
- Miralax Dly
- Allergien
- Bee stings-nystain-peaches
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 28.07.2022
- Impfdatum
- 14.06.2022
- Beginn
- 20.06.2022
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Arthralgia
Lymphadenopathy
Oedema peripheral
Pain
Pain in extremity
Symptomtext
PT WENT TO THE EMERGENCY ROOM ON 6/20/2022 FOR "PAIN AND ARMPIT SWELLING" PT. C/O PAIN FROM SHOULDER "ALL THE WAY DOWN" MOTRIN 600 Q 6 RXED.DX AXILLARY LYMPHADENOPATHY. SEEN IN CLINIC HERE 7/6/2022 WITH RESOLUTION.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- GERD
- Vorgeschichte
- ANXIETY GERD
- Andere Medikamente
- GABAPENTIN 300 MG FAMOTADINE 20 MG OMEPRAZOLE 20MG HYDROXIZINE 25 MG
- Allergien
- EGG BEE VENOM NORCO
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 07.07.2022
- Impfdatum
- 26.04.2022
- Beginn
- 26.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Pyrexia
Symptomtext
COVID 19 Pfizer dose given beyond use date. Patient developed fever for 3 days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Acne
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 06.07.2022
- Impfdatum
- 06.07.2022
- Beginn
- 06.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood pressure decreased
Dizziness
Nausea
Pallor
Symptomtext
After all 4 vaccines were given pt become dizzy and really pale in the face. He then stated he felt like he was going to vomit. Blood pressure was taken and it was very low 86/46
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- Pt was taken to the ER to receive IV fluids.
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- doxycycline hyclate 100 mg oral capsule, CETIRIZINE 10MG TABLETS Singulair 10 mg oral tablet Neutrogena Acne Wash Oil Free 2% topical soap, use it once a day Flonase 50 mcg/inh nasal spray
- Allergien
- Amoxicillin, glycerin
- Vorherige Impfungen
- -
- Staat
- MP
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 11.04.2022
- Impfdatum
- 07.04.2022
- Beginn
- 07.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Nausea
Symptomtext
Pt came to location for immunization. Verified pt name, DOB, and allergies. Explained to pt what vaccines will be given. Pt verbalized understanding. Vaccines administered. Pt tolerated the injections well. Pt understood aftercare instructions for pain/fever. Pt was observed and started to feel like vomiting. Pt was escorted to the nurse's room by nurse who took over the situation. BP: 109/59 | O2: 99% | P: 80 BP: 110/63 | O2: 99% | P: 80 Pt stated she felt better and was released back to class. School contacted parent and explained the situation. Staff attempted to call the parent, but still awaiting phone call back.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None stated
- Vorgeschichte
- None stated
- Andere Medikamente
- None stated
- Allergien
- None stated
- Vorherige Impfungen
- -
- Staat
- MP
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 11.04.2022
- Impfdatum
- 07.04.2022
- Beginn
- 07.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Nausea
Symptomtext
Pt came to location for immunization. Verified pt name, DOB, and allergies. Explained to pt what vaccines will be given. Pt verbalized understanding. Vaccines administered. Pt tolerated the injections well. Pt understood aftercare instructions for pain/fever. Pt was observed and started to feel like vomiting. Pt escorted to nurse's room by school nurse. BP: 92/62 | O2: 97% | P:94 BP: 93/55 | O2:100 % Pt felt better and was sent back to class in stable condition. School contacted parents about the situation, and nurse also spoke with pt parent about the situation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None stated
- Vorgeschichte
- None stated
- Andere Medikamente
- None stated
- Allergien
- None stated
- Vorherige Impfungen
- -
- Staat
- MP
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 29.03.2022
- Impfdatum
- 29.03.2022
- Beginn
- 29.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cold sweat
Dizziness
Malaise
Nausea
Pallor
Visual impairment
Symptomtext
Verified patient's name/DOB/allergies. nurse administered the vaccines correctly and sent patient to observation because he received the meningitis vaccine which causes some patients to become dizzy, nauseated. When I went to check on the patient 5 mins later, he looked pale and was having cold sweats. The patient said he sees "white" and did not feel well at all. Patient stated that he was not having any difficulty breathing but he did feel like vomiting. I assisted the patient to vomit, but only spit. Patient's vitals were monitored and patient was given water to sip on. Vitals: 09:35a BP @ 89/55 | O2 @ 99% | P @ 81 09:45a BP @ 106/74 | O2 @ 99% | P @ 81 09:55 BP @ 108/73 | O2 @ 99% | P @ 70 Patient was taken to school principal's office to lie down and speak with his father, which made him feel better. Patient pallor returned to normal and patient verbally stated that he felt good. Patient was then sent back to class.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Nothing stated
- Vorgeschichte
- Nothing stated
- Andere Medikamente
- None given
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PR
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 13.10.2021
- Impfdatum
- 08.10.2021
- Beginn
- 08.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Symptomtext
Patient presented with dizziness after the vaccine administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- NO
- Vorgeschichte
- NO
- Andere Medikamente
- NO
- Allergien
- NO
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.06.2023
- Impfdatum
- 07.06.2023
- Beginn
- 07.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
No additional AE; The patient was given an expired dose of GARDASIL 9; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 07-JUN-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U007667 [also reported as "UU007667"] has been verified to be valid, expiration date reported and confirmed as 23-MAY-2023), as prophylaxis (route of administration and anatomical location were not provided) (Expired product administered). A healthcare professional (HCP) was the operator of the device. There were no known temperature excursions. The expiration was supported by Post MEMO Expiry. No adverse events (AEs) nor product quality complaints were reported. This is one of two reports received from the same reporter. ; Sender's Comments: US-009507513-2306USA007857:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.06.2023
- Impfdatum
- 14.06.2023
- Beginn
- 14.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
no additional AE; HCP called to state that the patient was given an expired dose of GARDASIL 9.; This spontaneous report was received from medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided. On 14-JUN-2023, the patient was vaccinated with expired the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (formulation pre-filled syringe, 0.5 mL, lot #U007667, expiration date 23-MAY-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No known temperature excursions. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC). ; Sender's Comments: US-009507513-2306USA008127:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.06.2023
- Impfdatum
- 02.06.2023
- Beginn
- 02.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
No Adverse Event; Caller reported expired dose of GARDASIL 9 was administered. No other information provided. No additional AEs or PQC reported.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JUN-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U007667, expiration date: 23-MAY-2023, 0.5 milliliter, intramuscular (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 06.01.2023
- Impfdatum
- 15.03.2022
- Beginn
- 01.03.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Client received the wrong covid vaccine for his age. He was 11 years old at the time of vaccination, and he received SARS Cov-2 Pfizer(12yr+) for his 2nd dose. No symptoms reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- none
- Allergien
- N.K.D.A
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 18.10.2022
- Impfdatum
- 07.03.2022
- Beginn
- 08.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
SARS-CoV-2 test negative
Symptomtext
Provider prescribed 400 mg Ibuprofen, 1 tablet by oral every 4-6 hours as needed
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- SARS-CoV-2 test negative
- Hospital-Tage
- -
- Labordaten
- Patient was tested for Covid-19 on 03/11/2022 result was negative
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- Paracetamol was given to control headache
- Allergien
- No allergies to any medication or food
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 06.07.2022
- Impfdatum
- 30.06.2022
- Beginn
- 30.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Symptomtext
Tdap vaccine given at this visit. Tdap vaccine also previously placed at another facility on 09/25/2020.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- None needed.
- Aktuelle Erkrankungen
- unk
- Vorgeschichte
- None noted
- Andere Medikamente
- unk
- Allergien
- Amoxicillin, Penicillin
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 29.06.2022
- Impfdatum
- 21.06.2022
- Beginn
- 21.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product preparation issue
Symptomtext
Nurse notified MD day after injection that she realized she only injected patient with diluent and not powder when giving Menveo. Patient's mother was notified. Called GSK and was told since he received CWY strains, no further doses needed to correct error - mother was notified but also told she could choose to have him revaccinated in 6 months to receive the A strain. Our vaccine protocols within the office were rereviewed with all staff.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product preparation issue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- short stature, allergic rhinitis
- Andere Medikamente
- growth hormone
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- NV
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.05.2022
- Impfdatum
- 12.04.2022
- Beginn
- 12.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin laceration
Syringe issue
Symptomtext
provider was cut with the glass from the broken syringe after administration; provider was cut with the glass from the broken syringe after administration; Complaint Description Detail: Merck employee (vaccine rep) calling on behalf of office manager to report AE/PQC. States hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in prefilled syringe (PFS) was administered to a patient that was broken or cracked. Outbound call made to office manager who was able to answer PQC questions but was unable to advise patient information. Stated provider was cut with the glass from the broken syringe after administration. AE for provider filed. See AE case 02148344. Office manager unable to provide NDC number but does state she would like replacement. hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) is not available for collection as it has been discarded. No additional AE details. No additional PQC. Note: QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). Please provide a detailed description of the defect using the questions below: Is there a crack? NO Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) RIM HAD BROKEN AWAY AND THERE WERE SHARP PEICES AROUND THE RIM Provide the exact location of the breakage on the syringe? RIM Does the syringe have a broken component? BROKEN SYRINGE TIP If yes, describe in detail how it is broken. BROKEN AROUND THE RIM A FEW PIECES OF GLASS CRACKED OFF DURING ADMINSTRATION Provide the exact location of the breakage on the syringe? RIM Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, was it supplied by MERCK: UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? UNSPECIFIED Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? NA Is there any broken glass or other separated component in the tray? (if yes specify) NO After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection? YES Was the syringe tip cap attached properly prior to use? YES Was the syringe tray intact and undamaged on receipt? YES If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. UNSPECIFIED Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If complaint sample is not/cannot be returned, please provide reason: CANNOT BE RETURNED AS IT HAS BEEN DISCARDED. NO PICTURES AVAILBALE EITHER 15-APR-2022 13:30 PM: Attachment added to system. 15-APR-2022 Reporter: Requested Agency to r each out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM. 15-APR-2022: Second person review performed by Staff. 15-APR-2022 15:30 PM: Attachment added to system. 15-APR-2022 15:30 PM: Email received in Agency mailbox on 15APR2022 at 2 :23pm from Quality: "Can you please reach out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM. " Forwarded to case owner f or follow up. 15-APR-2022 15:30 PM: Made outbound call to clarify what was meant by broken RIM. Employee was not available at time of call. Will attempt another outbound call on the next business day. 15-APR-2022 18 :30 PM: NDC 58160-0976-20 Finger Flange 15-APR-2022 18:30 PM: Inbound call received from customer. Customer confirms she meant finger flange when referring to the RIM of the syringe. No other part of the syringe was broken. Customer also confirmed NDC number. ; Sender's Comments: US-009507513-2204USA006033:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin laceration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NV
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.05.2022
- Impfdatum
- 12.04.2022
- Beginn
- 12.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Syringe issue
Symptomtext
No additional AE details; GARDASIL 9 in PFS was administered to a patient that was broken or cracked; GARDASIL 9 in PFS was administered to a patient that was broken or cracked; Complaint Description Detail: Merck employee (vaccine rep) calling on behalf of office manager to report AE/PQC. States hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in prefilled syringe (PFS) was administered to a patient that was broken or cracked. Outbound call made to office manager who was able to answer PQC questions but was unable to advise patient information. Stated provider was cut with the glass from the broken syringe after administration. AE for provider filed. See AE case 02148344. Office manager unable to provide NDC number but does state she would like replacement. hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) is not available for collection as it has been discarded. No additional AE details. No additional PQC. Note: QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). Please provide a detailed description of the defect using the questions below: Is there a crack? NO Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) RIM HAD BROKEN AWAY AND THERE WERE SHARP PEICES AROUND THE RIM Provide the exact location of the breakage on the syringe? RIM Does the syringe have a broken component? BROKEN SYRINGE TIP If yes, describe in detail how it is broken. BROKEN AROUND THE RIM A FEW PIECES OF GLASS CRACKED OFF DURING ADMINSTRATION Provide the exact location of the breakage on the syringe? RIM Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, was it supplied by MERCK: UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? UNSPECIFIED Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? NA Is there any broken glass or other separated component in the tray? (if yes specify) NO After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection? YES Was the syringe tip cap attached properly prior to use? YES Was the syringe tray intact and undamaged on receipt? YES If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. UNSPECIFIED Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If complaint sample is not/cannot be returned, please provide reason: CANNOT BE RETURNED AS IT HAS BEEN DISCARDED. NO PICTURES AVAILBALE EITHER 15-APR-2022 13:30 PM: Attachment added. 15-APR-2022: Requested to r each out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM. 15-APR-2022: Second person review. 15-APR-2022 15:30 PM: Attachment added. 15-APR-2022 15:30 PM: Email received on 15APR2022 at 2 :23pm from Quality: "Can you please reach out to the reporter and ask them to clarify what was meant by Broken RIM? Was it the finger flange that was broken and to also confirm if any part of the syringe was broken beside the RIM. " Forwarded to case owner f or follow up. 15-APR-2022 15:30 PM: Made outbound call to clarify what was meant by broken RIM. Employee was not available at time of call. Will attempt another outbound call on the next business day. 15-APR-2022 18 :30 PM: NDC 58160-0976-20 Finger Flange 15-APR-2022 18:30 PM: Inbound call received from customer. Customer confirms she meant finger flange when referring to the RIM of the syringe. No other part of the syringe was broken. Customer also confirmed NDC number. ; Sender's Comments: US-009507513-2204USA008276:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 22.03.2022
- Impfdatum
- 03.12.2018
- Beginn
- 07.01.2020
- Tage bis Beginn
- 400,0
- Dosis
- 4
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
No additional AE; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; 1st dose 03-DEC-2018, 2ND DOSE 05-FEB-2019, 3RD DOSE 07-JAN-2020, 4TH DOSE 03-MAR-2022; This spontaneous report has been received from a physician, concerning to a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies. On 03-DEC-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number validated as R008164, expiration date reported and stablished as 12-NOV-2020), the second dose on 05-FEB-2019 (lot number validated as R011630, expiration date reported and stablished as 12-DEC-2020), and the third dose on 07-JAN-2020 (lot number validated as R030453, expiration date reported and stablished as 23-JUL-2021) (inappropriate schedule of product administration) all three doses as prophylaxis (strength, dose, route of administration and anatomical location were not provided). Moreover, on 03-MAR-2022 inadvertently the patient was administered a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliters (mL) (lot number validated as U007667, expiration date reported and stablished as 23-MAY-2023) instead of a flu vaccine (wrong product administered, extra dose administered) (strength, route of administration and anatomical location were not provided). No additional adverse events (AE) reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 19.03.2022
- Impfdatum
- 12.01.2022
- Beginn
- 12.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No adverse event/ No known pt adverse reactions; Indavertently administered improperly stored GARDASIL 9/ Temps went out of range. Vaccines given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (L.P.N.) regarding a 12-year-old male patient. The patient's medical history included vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (one previous dose) and influenza vaccine (FLUZONE [INFLUENZA VACCINE]) (two previous doses). His concurrent conditions, concomitant therapies, drug reactions, and allergies were not provided. On 12-JAN-2022, the patient was vaccinated with improperly stored: second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number U007667, with an expiration date of 23-MAY-2023, intramuscularly (dose, strength and formulation were not reported) for prophylaxis and with the third dose of influenza vaccine (FLUZONE [INFLUENZA VACCINE]) lot number: UT7317JA, expiry date: 30-JUN-2022, intramuscularly (dose, strength and formulation were not reported) for prophylaxis (product storage error). There were no additional adverse event (no adverse event). Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes, respectively. There were no previous excursions reported. Digital data logger was involved. As of 18-FEB-2022, additional information had been requested. This is one of nine reports received from the same reporter. ; Sender's Comments: US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 18.03.2022
- Impfdatum
- 28.01.2022
- Beginn
- 28.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went out of range - temp. Vaccines given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 15-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided. On 28-JAN-2022, the patient was vaccinated with an improperly stored doses HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number U007667 with an expiration date of 23-MAY-2023 second dose, intramuscularly, in her right deltoid (dose, strength and formulation were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number: U020239, expiry date: reported as 23-JUN-2023, but upon internal validation, established as 28-JUN-2023, second dose, subcutaneously, in her left arm (strength, dose and formulation, were not reported) for prophylaxis (product storage error). There were no known patient's adverse events (no adverse event). Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for varicella virus vaccine live (Oka/Merck) (VARIVAX) were not provided. Digital Data Logger was involved. This is one of nine reports received from the same reporter. ; Sender's Comments: US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA002574: US-009507513-2202USA007813:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 18.03.2022
- Impfdatum
- 02.02.2022
- Beginn
- 02.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event/ 0 known adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccine temps went out of range. Vaccine given; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 12-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, formulation, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On 02-FEB-2022, the patient was vaccinated intramuscularly, in her left deltoid, with an improperly stored (product storage error) second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number U007667 with an expiration date of 23-MAY-2023 (dose was not reported) for prophylaxis. There were no additional adverse event details. Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. The improper storage was recorded by digital data logger. This is one of nine reports received from the same reporter. ; Sender's Comments: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 09.03.2022
- Impfdatum
- 28.02.2022
- Beginn
- 01.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.
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
- OH
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 09.03.2022
- Impfdatum
- 26.01.2022
- Beginn
- 26.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event/ no known pt adverse event; Indavertently administered improperly stored GARDASIL 9/ Temps went out of range - Vaccines were given despite temperature excursions; # of previous doses 3; This spontaneous report was received from a licensed practical nurse (LPN) regarding to an unknown patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number U007667 with an expiration date of 23-MAY-2023 (dose, anatomical location and route of administration were not reported) for prophylaxis. There were no additional adverse event details. Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. The case was considered to be non-valid due the lack of patient identifiers. Follow up information has been received from a Director of Nursing on 18-FEB-2022. It was reported that the caller wanted to know if she needed to send information on every patient that received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) after being improperly stored. Also, it was mentioned that the caller declined to stay on the phone to provide patient information and stated she will have her nurses fax over this information. Additional information has been requested. Follow up information has been received from the licensed practical nurse (LPN) on 23-FEB-2022 and refers to a 13-year-old male patient. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier's were received. On unknown dates, the patient was vaccinated with first, second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (doses, strength, formulations, anatomical location, routes of administration, lot numbers and expiry dates were not reported for all three doses) for prophylaxis. On an unknown date, the patient was vaccinated with first dose of hepatitis B vaccine rhbsag (yeast) (ENGERIX B) (dose, strength, formulation, route of administration, lot number and expiry dates were not reported) for prophylaxis. On 26-JAN-2022, the patient was vaccinated intramuscularly in is left deltoid with improperly stored (product storage error) fourth dose (extra dose administered) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number: U007667 (discrepant information, also reported as J7H4D; upon internal lot validation, lot number J7H4D is not valid for GARDASIL 9), expiry date: 23-MAY-2023 (discrepant information, also reported as 23-MAR-2022) (strength, dose and formulation were not provided) for prophylaxis and second dose of hepatitis B vaccine rhbsag (yeast) (ENGERIX B), intramuscularly in his left deltoid, lot number J7H4D (discrepant information, also reported as U007667), expiry date: 23-MAR-2022 (discrepant information, also reported as 23-MAY-2023) (strength, dose and formulation were not provided) for prophylaxis. This is one of nine reports received from the same reporter. As of 04-MAR-2022, all telephone attempts trying to obtain additional information has been unsuccessful ; Sender's Comments: US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA007813:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 43,0
- Geschlecht
- F
- Eingang
- 26.02.2022
- Impfdatum
- 01.02.2022
- Beginn
- 02.02.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Peripheral swelling
Symptomtext
Both of the patient's hands swelled up; This spontaneous report was received from a physician via company representative concerning to a 43-year-old female patient. The patient's concurrent conditions, pertinent medical history, and concomitant therapies were not provided. She did not have previous history of allergies. On 01-FEB-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (dosage regiment not provided), lot #U007667, expiration date: 23-MAY-2023, administered intramuscularly in left deltoid as prophylaxis. In the night of that day, she also took 1x dose of clonazepam (KLONOPIN) (strength, lot #, expiry date, route of administration, and indication were not provided). On 02-FEB-2022, the patient woke up and both of her hands swelled up. She did not administer any additional clonazepam (KLONOPIN) dose following event time. On an unknown date in February 2022, the patient recovered (also reported as "fine now") from peripheral swelling. The causal relationship between the event of peripheral swelling, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and clonazepam (KLONOPIN) was unknown.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Peripheral swelling
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- KLONOPIN
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.02.2022
- Impfdatum
- 01.02.2022
- Beginn
- 01.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event; Caller reported GARDASIL 9 was involved in this possible excursion, and caller stated the GARDASIL 9 was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-FEB-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, 0.5 milliliter, lot #U007667, expiration date: 23-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) after a potential temperature excursion occurred. The data logger stopped recording for 24 hours, however, there were no specific temperatures to evaluate. The vaccine did not undergo previous temperature excursion. The patient did not experience any adverse event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 22.12.2021
- Impfdatum
- 17.12.2021
- Beginn
- 17.12.2021
- 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
No adverse event
Symptomtext
No other AE; The patient received her first dose of GARDASIL 9 and age 12 and didn't receive the second dose until the age of 25.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, when the patient was 12 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided). On 17-DEC-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, one time, lot # U007667, expiration date: 23-MAY-2023 (route of administration, anatomical location not provided), when she was 25 years old, as prophylaxis (inappropriate schedule of product administration). No other adverse event (AE) was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
