- Staat
- MA
- Alter
- 36,0
- Geschlecht
- M
- Eingang
- 13.07.2023
- Impfdatum
- 11.07.2023
- Beginn
- 11.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Computerised tomogram head
Electrocardiogram
Generalised tonic-clonic seizure
Laboratory test
Symptomtext
tonic/clonic seizure
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- labs, CT head - EKG
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Intestinal disaccharidase deficiency Penile cellulitis Vitamin D deficiency Pure hypercholesterolemia Obesity On pre-exposure prophylaxis for HIV Anxiety disorder Vertigo High risk sexual behavior Hx of cold sores History of gonorrhea
- Andere Medikamente
- acetaminophen DESCOVY ibuprofen lidocaine viscous ATIVAN ANTIVERT ELOCON mupirocin VIAGRA
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 15.12.2022
- Impfdatum
- 11.08.2022
- Beginn
- 11.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Atrial fibrillation
Blood magnesium
Cardioversion
Cold sweat
Differential white blood cell count
Electrocardiogram abnormal
Fall
Full blood count
Head injury
Heart rate increased
Heart rate irregular
Metabolic function test
Muscular weakness
Pallor
Presyncope
Vomiting
Symptomtext
At apx 10:15 vaccines were given at apx 10:20 am pt hit head on floor, RN was documenting and is not sure if pt stood up or fell from chair. This RN stayed with pt while another engaged CNP. Pt came to in apx 30 sec and was alarmed he was on the floor. Awaited presents of other staff to return pt to chair. Used wet wash cloth to back of neck and forehead. Pt was given water and sucker. CNP arrived in clinic and assessed pt. Pt was held for observation. Pt seem to start to feel better and then would get pale and cold and clammy again. Also upon attempting to get pt to his feet, pt stated his legs felt weak his heart rate greatly increased to 112-116 Engaged provider again as pt was not recovering as expected and mother had arrived and given information that father had an event triggered by and immunization; a vaso vagal reaction turned into a fib that had to be cardioverted. Pt pulse did vary over the hour he was observed. Initial pulse after fall was 57 highest reading right before EMS arrived was 122 during 2nd standing trial. Vitals taken, mother arrived to clinic and road with pt to ED EMS was called at 11:10am which is when pt had his first of 3 episodes of emesis. Vitals were 118/75 p 96 O2 100% At 11:10 11:20am vitals 119/73 p 80, 94,77 Upon standing right when EMS walked in was 122 as we were attempting to stand pt for the second time. Pt stated he did feel better than the last standing attempt. Pt didn't ambulate out of office he was rolled out on a gurney and mom left with EMS at 11:50am
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- EKG, CBC/Diff, CMP, Mag level (done at ED)
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- No Known Allergies
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 15.08.2022
- Impfdatum
- 15.08.2022
- Beginn
- 15.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyskinesia
Presyncope
Symptomtext
Pt in for immunizations. Due today for Tdap, Men Quad, and HPV. VIS given to mother before administration. Tdap and Men Quad given in LD, Gardasil given in RD. After completion of administration of vaccines, pt had a near syncopal episode with singular body jerk. No loss of consciousness, no head injury. Pt A&O x 4 immediately following incident and no evidence of post-ictal state. No loss of bowel/bladder control and VS WNL. Pt follows commands and answers questions appropriately. Patient's mother called for assistance and patient was assessed by 3 clinic RNs and clinic supervisor discussed follow up care with mother of patient. Pt's mother verbalized understanding and ambulated with patient to lobby. Patient ambulatory with steady gait, no s/s of distress noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 28.07.2022
- Impfdatum
- 27.07.2022
- Beginn
- 27.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Nausea
Pallor
Syncope
Vomiting
Symptomtext
Client fainted within 5 minutes of receiving vaccination. Client pale, nauseous and vomited X3 during next 15 minutes post vaccination. Client sat quietly with damp paper towels on neck and face, water available for rinsing mouth. No more fainting episodes. After 20 minutes observation, was able to walk unassisted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 07.06.2022
- Impfdatum
- 07.06.2022
- Beginn
- 07.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Loss of consciousness
Symptomtext
Patient passed out after receiving the vaccine. Vital signs was obtained and was within normal limits. She was giving water and cracker and was told to lay down. She laid down for 20 min and then giving juice and Vital signs was repeated. She was reexamined by Provider. Mom was giving instruction and the patient was able to go home.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- Pt was given Garasil 9 Merck Lot # U019412 Dose: 0.5ml Intramuscular Left Arm NDC: 00006-4119-03
- Allergien
- Environmental and Seasonal Allergies
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 01.03.2023
- Impfdatum
- 15.08.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Amnesia
Anxiety
Cognitive disorder
Dissociation
Disturbance in attention
Emotional poverty
Fatigue
Feeling abnormal
Headache
Hyperhidrosis
Hypoaesthesia
Insomnia
Malaise
Mydriasis
Ocular hyperaemia
Palpitations
Panic attack
Tachyphrenia
Symptomtext
Dr office gave my son the 3rd dose of the vaccine 4 months too soon. Gave last does in August 14, 2022 and this should have been administered 12/2022. My son started showing signs of disassociation, felt like he was in a dream, lack of feelings/emotion, fatigue/tired, severe loss of thirst, blood shot/red eyes, chronic head numbness and headaches, panic attacks/heart palpitations, couldn't sleep through the night, sudden onset of extreme anxiety/worry, profusely sweating, racing thoughts, feeling blah, couldn't concentrate, memory loss, pupils would dilate several times in minutes, couldn't retain comprehend what he was reading, could put a thought together, felt like he had a brain tumor and was going to die because his head wouldn't stop racing, brain wouldn't shut down etc.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Palpitations
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- no
- Andere Medikamente
- no
- Allergien
- no
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 20.09.2022
- Impfdatum
- 31.08.2022
- Beginn
- 31.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Mobility decreased
Pain
Pain in extremity
Symptomtext
Patient reports that since date of injection, her arm has been significantly sore and has become worse since 9/12/22. Pain stops her from doing normal activities, although she can move her arm and shoulder, pain is exacerbated when moving arm/shoulder upwards. Has tried ice/heat x 3 weeks with no improvement. No visible marks or redness, lumps, swelling.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Fluticasone nasla spray 50mcg/spray PRN
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 08.12.2022
- Impfdatum
- 08.11.2022
- Beginn
- 15.11.2022
- Tage bis Beginn
- 7,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Symptomtext
PT STATED THAT HER ARM IS IN SEVERE PAIN. " AS THOUGH SOMEONE WITH A KNIFE IS STABBING HER" AND THAT THIS PAIN HAS BEEN OCCURING FO RTHE LAST 2-3 WEEKS NOW. AFTER SHE HAD RECEIVED THE VACCINE SHE SAT FOR 5 MINTUES BECUASE THE INJECTION SITE HURT HER SO MUCH SHE WANTED TO CRY. SHE HAD A SORE ARM FOR A DAY OR TWO BUT AND WAS FINE AFTER THAT BUT A WEEK LATER THE PAIN CAME BACK AND HAS BEEN THERE SINCE. SHE HAS NOT TAKEN ANY MEDICATIONS OR SEEK MEDICAL ATTENTION FOR THIS.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- NOT APPLICABLE AT THE TIME.
- Vorgeschichte
- NOT APPLICABLE AT THE TIME.
- Andere Medikamente
- UNKNOWN TO PHARMACY
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 23.08.2022
- Impfdatum
- 18.08.2022
- Beginn
- 18.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abnormal sensation in eye
Fatigue
Headache
Hyperhidrosis
Pallor
Visual impairment
Symptomtext
After getting vaccines patient was sitting in chair and said his eyes felt funny. When asked what he met by his eyes felt funny he stated he couldn't see things were looking black. This nurse assisted patient to exam table to lay down. Upon getting on exam table patient stated his stomach hurt and he became diaphoretic and pale. Nurse gave patient a juice. After taking a few sips of juice patient was able to sit on the exam table and color had returned. Patient complaining of headache and being tired, but other wise doing better. Snack given to patient and blood pressure obtained and WNL.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Claratin
- Allergien
- No know Allergies
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 12.08.2022
- Impfdatum
- 25.07.2022
- Beginn
- 25.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Myalgia
Swelling
Symptomtext
PATIENT WAS TO RECEIVE HPV DOSE #2 & HEP A DOSE #1. HOWEVER, WHILE GETTING THE VACCINES OUT APPARENTLY 2 HPV VACCINES WERE TAKEN OUT & GIVEN TO THE PATIENT IN SEPARATE SITES. THIS WAS NOTED WHEN THE OFFICE DID THE VACCINE COUNT AT THE END OF THE MONTH (7/29/22) & IT WAS OFF. AFTER FURTHER INVESTIGATION IT WAS CONCLUDED THAT THE PATIENT ABOVE RECEIVED 2 HPV VACCINES INSTEAD OF ONE HPV & ONE HEP A. A PHONE CALL WAS PLACED TO THE LOCAL HEALTH DEPARTMENT (8/1/22) TO SEE IF THERE WAS ANYTHING SPECIFICALLY THAT NEEDED TO BE LOOKED FOR & PER THE STATE NURSE THE MOST LIKELY ISSUE WOULD BE AN INCREASED RISK OF A LOCALIZED SYSTEMIC REACTION. THERE WAS NO PHONE CALL FROM MOM REGARDING ANY IMMEDIATE REACTIONS BY THE PATIENT. WHEN THE SITUATION WAS DISCUSSED WITH THE MOM (8/5/22), SHE STATED THAT THE PATIENT ONLY HAD MILD SWELLING & MUSCLE SORENESS BUT WAS OTHERWISE FINE.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myalgia
- Hospital-Tage
- -
- Labordaten
- NONE NEEDED
- Aktuelle Erkrankungen
- NONE NOTED
- Vorgeschichte
- SENSORNEURAL BILATERAL HEARING LOSS & ECZEMA
- Andere Medikamente
- CLARITIN
- Allergien
- NO KNOWN ALLERGIES
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 01.08.2022
- Impfdatum
- 27.07.2022
- Beginn
- 29.07.2022
- Tage bis Beginn
- 2,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Hypersensitivity
Pruritus
Urticaria
Symptomtext
Ptpresented to immunizations clinic for third HPV vaccination on 27 Jul 2022. Vaccine was administered 27 Jul 2022 @ 1003 am. Member waited at the clinic for 15 Minutes after the vaccination. No reactions observed at that time. Pt reports he had allergic reactions starting 29 Jul 2022. Pt has larger than a quarter size hives all over his body. Pt complaints of itchiness and redness. No know allergies at this time. Pt has had 2 HPV vaccines in the past with no allergic reactions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pruritus
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 29.07.2022
- Impfdatum
- 28.07.2022
- Beginn
- 28.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Oropharyngeal discomfort
Urticaria
Symptomtext
Pt developed hives on bilateral armpits and trunk about 90 minutes post vaccine. Pt returned to clinic and was evaluated by Provider, DNP, and given 4mg Decadron IM and a script for oral Prednisone. Pt left clinic but then returned an hour later with worsening hives and "fullness" in the throat. Pt was escorted to Emergency Department where pt was given 3mg Epi subq and 50mg Benadryl im.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 22.07.2022
- Impfdatum
- 18.07.2022
- Beginn
- 18.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pain
Pain in extremity
Peripheral swelling
Rash
Symptomtext
Patient reports pain and swelling to right arm where vaccine was given. Pain was present on the first and second day after administration. Rash is reported as well on right arm. Patient was advice to apply cold compress and take Benadryl.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- N/a
- Aktuelle Erkrankungen
- Allergic conjunctivitis of both eyes, Multiple atypical skin moles.
- Vorgeschichte
- Generalized anxiety disorder
- Andere Medikamente
- Adderall XR 20 mg and Buspar 5 mg.
- Allergien
- Bactrim and sulfa only ( sulfonamide antibiotics)
- Vorherige Impfungen
- -
- Staat
- PR
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 11.07.2022
- Impfdatum
- 07.07.2022
- Beginn
- 07.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Malaise
Nausea
Pain in extremity
Pallor
Symptomtext
Patient reports feeling ill, nausea, pain in left arm and pale, 5 minutes after receiving vaccination. Remained under observation until 12:27, patient reports feeling better, doesn't report nausea or pale skin. Patient stable, walking and leaving the facility with legal guardian.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Malaise
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 30.06.2022
- Impfdatum
- 10.06.2022
- Beginn
- 17.06.2022
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Erythema
Injection site nodule
Lymphadenopathy
Ultrasound scan abnormal
Symptomtext
injection site nodule, first noted approx 1 week after immunization. Associated with left axillary adenopathy and erythema. Given course of cephalexin with resolution of axillary LAD and erythema, no improvement in injection-site nodule. Soft tissue ultrasound obtained approx 18 days after immunization notable for: Ill-defined area in the subcutaneous fat overlying the left deltoid, possibly reflecting an injection granuloma or focal inflammation. No discrete fluid collection or abscess visualized. Measured size: 1.7x0.6x3.0 cm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site nodule
- Hospital-Tage
- -
- Labordaten
- Soft tissue ultrasound (6/28/22), see above
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- chronic granulomatous disease migraines adhd general anxiety disorder mild intermittent asthma
- Andere Medikamente
- interferon-gamma, bactrim, itraconazole, adderol, zoloft, zyrtec, flovent, probiotics
- Allergien
- fentanyl, propofol
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.12.2023
- Impfdatum
- 20.12.2023
- Beginn
- 20.12.2023
- 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 reported; expired GARDASIL 9 was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported. On 20-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: U019412, expiration date: 30-OCT-2023; strength, dose, and route of administration were not reported) for prophylaxis (expired product administered). The administered vaccine did not have any temperature excursions before. No additional adverse events (AE) were reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.11.2023
- Impfdatum
- 17.11.2023
- Beginn
- 17.11.2023
- 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
Pharmacist confirmed that the patient has reported no additional AEs.; Pharmacist reported that an expired dose of GARDASIL 9 (expiration date 30OCT2023) was administered to a patient at their pharmacy on 17NOV2023. Pharmacist confirmed that the patient has reported no additional AEs. No PQC/additional AE reported.; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided. On 17-NOV-2023, the patient was vaccinated an expired vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot number U019412 [expiration date 30-OCT-2023]) (dose, dose number, frequency, route of administration, anatomical location, and vaccination scheme were not provided) for prophylaxis (expired product administered). The reporter confirmed that the patient had reported no additional adverse events (AEs).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 24,0
- Geschlecht
- F
- Eingang
- 13.04.2023
- Impfdatum
- 10.04.2023
- Beginn
- 10.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Pregnancy test positive
Product use in unapproved indication
Symptomtext
no additional adverse event reported; Product use in unapproved indication; Nurse practitioner reported patient received a dose of GARDASIL 9 on Apr 10, 2023 and then later on the same day patient found out that she was pregnant. Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has; This spontaneous report was received from nurse practicioner and refers to a 24-year-old female. The patient's medical history included papanicolaou smear abnormal. The patient's concurrent conditions included mildasthma. Concomitant therapies were not reported. On 10-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, lot #U019412, expiration date: 30-OCT-2023, administered intramuscularly for smear cervix abnormal and papilloma viral infection (strength was not provided) (product use in unapproved indication). On an unknown date (also reported as: last week), pregnancy test was negative. On unknown date, nurse practitioner reported that on 10-APR-2023, patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, patient found out that she was pregnant (maternal exposure druring pregnancy). Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has irregular periods and did not think it was possible to get pregnant. No further information provided. No additional AE reported. No PQC reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- Test Date: 20230410; Test Name: pregnancy test; Test Result: Positive
- Aktuelle Erkrankungen
- Human papillomavirus infection
- Vorgeschichte
- Medical History/Concurrent Conditions: Asthma; Papanicolaou smear abnormal
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- 28,0
- Geschlecht
- M
- Eingang
- 06.03.2023
- Impfdatum
- 06.03.2023
- Beginn
- 06.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect product formulation administered
Symptomtext
Client seen for routine visit and public health department 03/06/2023. Requested covid bivalent booster. Client incorrectly received covid primary booster 0.3ml IM right deltoid at 02:10pm instead. Client made aware of error immediately upon discovery on 03/06/2023 at 04:00pm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- adderall, ritalin, montelukast
- Allergien
- tree nuts
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.11.2022
- Impfdatum
- 15.10.2022
- Beginn
- 15.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
no additional AEs reported; Caller reported 30 year old female received 1st GARDASIL 9 in 2007 and received 2nd GARDASIL 9 vaccine on 10/15/2022. Lot number and expiration date documented for 2nd dose. Information for 1st dose is unknown. No other information provided. No; This spontaneous report was received from a pharmacist and refers to a 30-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On an unknown date in 2007, 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) injection (exact dose, route of administration, anatomical location, lot #, and expiration date were not reported) and on 15-OCT-2022, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered intramuscularly, lot # U019412 confirmed to be valid for formulation syringe, expiration date 30-OCT-2023 (anatomical location was not reported), both for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- M
- Eingang
- 17.09.2022
- Impfdatum
- 30.08.2022
- Beginn
- 30.08.2022
- 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 reported.; the finger flanges broke off the syringe during administration.; the patient did received the full dose of GARDASIL 9; Complaint Description Detail: Caller is a medical assistant calling to report an adverse event and product quality complaint for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Caller reports that another medical assistant in the office was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and stated that the finger flanges broke off the syringe during administration. Caller reports that the patient did received the full dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and there was no injury to the patient at all. Caller reports that the broken barrel of the syringe injured the medical assistant during administration and stated that the syringe "sliced the medical assistants fingers". Caller reports that the broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe was discarded, and would not be able to obtained to send back to Merck. No additional information provided. Additional AE/PQC filed in 02236404 for the medical assistant that sustained injury from the broken syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) reported in this case. No additional AE reported. No additional PQC reported. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for agencies: 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 If yes, describe the size, shape & depth of the crack: N/A Provide the exact location of the crack on the syringe: N/A 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.) The syringe barrel broke in half Provide the exact location of the breakage on the syringe? The portion of the barrel where the finger flange is attached broke off the syringe. Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) f yes, describe in detail how it is broken. The finger flanges broke off the syringe barrel Provide the exact location of the breakage on the syringe? Toward the end of the syringe where the finger flanges are located. 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, describe N/A If yes, was it supplied by MERCK: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A 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? NIA Is there any broken glass or other separated component in the tray? NIA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? YES Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? YES If no, describe issue: NIA Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. NIA If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES If no, describe damage NIA Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe N/A 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: The syringe was discarded, and not able to be retrieved. If photos are available, ask the customer to send them. Retrieval Information: Obtain product (& tray if possible) Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 30-AUG-2022 17:30 : Attachment added. 30-AUG-2022 17:30 : HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) retrieval will not occur as the customer stated that the product has been discarded. 31-AUG-2022 Company employee: Requested to please confirm 02236367/ 02236404? 31-AUG-2022 10:30 :Attachment added. 31-AUG-2022 10:30 : Email received in the PQC Mailbox on 31-AUG-2022 at 8: 42am from quality stating: "Can you please confirm if: 02236367/ 02236369 is a duplicate of: 02236367/ 02236404?" See attached. Email forwarded to case owner for further handling. 31-AUG-2022 12:30 : Clarification received from quality to confirm if this case is a duplicate of 02236404. This agent can confirm that the PQC information reported for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in case 02236404 is a duplicate of this case (02236369). This agent filed a AE/PQC case to reflect the adverse event for 2 different patient's with the same HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) involved in PQC. No additional information. No new AE or PQC reported. 31-AUG-2022 Company Employee: Requested to please confirm how many syringes were broken and if the reporter has photos, since an AE was filed because of 2 different patients 31-AUG-2022; Second person reviewed 31-AUG-2022 14:30 :Attachment added. 31-AUG-2022 14:30 :Email received in the PQC Mailbox on 31Aug2022 at 13:47 pm with the following message from quality: "02236367/ 02236404 Hi, This record will be closed as a duplicate of; 02236367/ 02236369. Thanks, Company Emplyee: See attachment. Forward to case owner. 31-AUG-2022 14:30 :Attachment added. 31-AUG-2022 14: 30 : Email 1 received in the PQC Mailbox on 31Aug2022 at 13:43 pm with the following message from quality: "Urgent request: 02236367/ 02236404 and 02236367/ 02236369 Hi, Can you please confirm how many syringes were broken and if the reporter has photos, since an AE was filed because of 2 different patients? Thanks, Company Employee See attachment. \ forward to case owner. 31-AUG-2022 15:30 :Clarification received from quality. There was only 1 syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) affected for this PQC. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe that was being administered to the patient broke during administration and injured the medical assistant that was administering it to the patient. The customer was not able to provide this agent with photographs of the broken syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), as she stated that it had been discarded in the biohazard container at the time of the initial call. No additional information provided. No new AE or PQC. 31-AUG-2022 17:30 :Attachment added. 31-AUG-2022 17:30 :Attachment added. 01-SEP-2022 10:30 : Per Agent, product does not need to be retrieved. Mail team task has been cancelled 01-SEP-2022 Company Employee: Received & Attached failure- No Missing info added 02-SEP-2022 Company Employee: Received & Attach email. Complaint Description Summary Reporter stated that the finger flanges broke off the syringe during administration. ; Sender's Comments: US-009507513-2208USA011721:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 15.09.2022
- Impfdatum
- 15.09.2022
- Beginn
- 15.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect product formulation administered
No adverse event
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Incorrect vaccine given. Given Bivalent booster 0.3ml (patient 11years of age) No symptoms noted waited 15 min in waiting room.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 14.09.2022
- Impfdatum
- 13.09.2022
- Beginn
- 13.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Incorrect product formulation administered
Symptomtext
Gave Covid Moderna 6m to 5 year to a 10 year old
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- F
- Eingang
- 10.09.2022
- Impfdatum
- -
- Beginn
- 30.08.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin laceration
Syringe issue
Symptomtext
sliced the medical assistants fingers; finger flanges broke off the syringe during administration; This spontaneous report was received from a medical assistant concerning a 42-year-old non-pregnant female patient who was also a medical assistant. The patient's medical history, concurrent conditions, and concomitant medication were not provided. On 30-AUG-2022, the patient was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot #U019412, expiration date 30-OCT-2023 for prophylaxis (route of administration, and injection anatomical location was not provided), and the finger flanges broke off the syringe barrel in half towards the end of the syringe, during administration and sliced the patient's fingers (Syringe issue) (Skin laceration). The patient wrapped her fingers with a medical gauze wrap and contacted her worker's compensation per facility protocol. It was reported that the syringe tray and carton were intact and undamaged on receipt, and syringe tip cap was attached properly prior to use. Also, the broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe was discarded, and retrieval would not be possible. At the time of the report, the patient was not recovered from the adverse event. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the adverse event was not provided. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2208USA011450:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin laceration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.07.2022
- Impfdatum
- 15.07.2022
- Beginn
- 15.07.2022
- 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 additional AE reported.; Patient was administered improperly stored, separate GARDASIL 9 on 07/15/2022; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided. On an unspecified date (reported as "within this past year") there was a temperature excursion registered for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) of 46.8 Fahrenheit degrees for 40 minutes; and on 24-JUN-2022, there was another temperature excursion registered below 36 Fahrenheit degrees (34.7 Fahrenheit degrees) for 20 minutes. On an unknown date, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #U019412, expiration date: 30-OCT-2023 (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). No additional adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 19.07.2022
- Impfdatum
- 18.07.2022
- Beginn
- 18.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Flushing
Pallor
Visual impairment
Symptomtext
Patient received vaccines per protocol. Youth was accompanied without incident to waiting room, reseated and instructed to wait per vaccination protocol. He then stated he was having trouble seeing, and became visibly pale. He was supported by two healthcare personnel and complied with instruction to lie on exam table. Alert and oriented to person, place and time. Upon questioning, he stated that he had "a bowl of ramen" around noon and appeared flushed. Patient was given a snack size bag of candy and consumed this in sitting position. He stated he felt better and was helped to his feet and ambulated without assistance in the care of his father.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Flushing
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None reported
- Vorgeschichte
- None reported
- Andere Medikamente
- None reported
- Allergien
- None reported
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 07.07.2022
- Impfdatum
- 29.06.2022
- Beginn
- 29.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
No adverse event
Product preparation error
Symptomtext
0.2ml of undiluted Pfizer COVID 5-11yr vaccine administered - should have been a 10mcg dose and was given 28mcg patient had no adverse reaction, mom was advised to give tylenol/ibu and apply ice mom also advised to monitor for local and systemic reactions as patient was a higher risk for these with the increased dose in contact with mom 8 days after incident and patient remains free of any ill effect
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none known
- Vorgeschichte
- allergic rhinitis, asthma, adhd
- Andere Medikamente
- Dexmethylphenidate 20mg, Sodium Fluoride 1mg, Montelukast 5mg, Claritin 5mg, MTV, Omega3 500mg, Melatonin 5mg
- Allergien
- NKA
- Vorherige Impfungen
- -