- Staat
- MD
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 17.06.2022
- Impfdatum
- 17.06.2022
- Beginn
- 17.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood glucose normal
Pallor
Syncope
Unresponsive to stimuli
Symptomtext
5 minutes after vaccines were administered, pt appearing to faint. found in older sister's arms. Initially non responsive.. EMS called. Pt responded about 1 minute later. Assessed to be oriented x 3. HR 86, BP was 90/60. RR 16. Pt was pale . EMS responded to the scene about 5 minutes later. EMT assessed pt. obtained and found to have BP on 106/64, Pulse ox was 99%. bld glucose was 115. Pt was oriented x3. Pallor resolved. Pt was cleared by EMT but offered to take to ER , pt and family declined. Pt reports that she is afraid of needles.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- accu check by EMT VS by clinic staff VS with pulse check by EMT
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 20.05.2022
- Impfdatum
- 18.05.2022
- Beginn
- 18.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Hyperhidrosis
Pallor
Syncope
Symptomtext
Shortly after patient received all 3 vaccines she fainted for approximately 5-10 seconds. After she regained consciousness she was talking and laughing. She was pale and sweaty. She recovered and felt back to normal within 10 minutes, no further issues.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Childrens multivitamin
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 11.05.2022
- Impfdatum
- 11.05.2022
- Beginn
- 11.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Dyspnoea
Supine position
Syncope
Throat irritation
Throat tightness
Symptomtext
On May 11, 2022, the patient listed above came in for childhood vaccines. Child was given Hepatitis A 1st dose, Hepatitis B 2nd dose, HPV9 - 1st dose, MMR - 1st dose, TDAP - 2nd dose, and IPV - 1st dose. After patient was given her sixth vaccine, which was the IPV nurse was applying Band-Aids to the patient when patient experienced a syncopal episode. Patient easily aroused within a few seconds. Patient was immediately placed in supine position. Vitals obtained at 09:38 a.m. which where 119/63 HR 64. Patient complained of dizziness and scratchy throat. No difficulty breathing. Remained in clinic for 15 minutes and walked to waiting area on her own accord. Patient was reassessed at 10:00 a.m. in the waiting room and was still complaining of scratchy throat and some dizziness. Patient returned to the clinic area and placed in supine position and vitals reassessed at 10:05 a.m., which were 118/80 HR 65. Patient continued to complain of scratchy tightening throat but no SOB. Decision was made to call EMS for further evaluation at 10:12 a.m. EMS arrived and evaluated patient and recommended transport to the ED for further evaluation and mother declined. Patient left clinic on her own accord accompanied by mother.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None listed on registration
- Vorgeschichte
- None listed on registration
- Andere Medikamente
- None listed on registration
- Allergien
- Pineapple
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 12.07.2023
- Impfdatum
- 05.07.2023
- Beginn
- 05.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Arthralgia
Chest X-ray
Dyspnoea
Muscular weakness
Symptomtext
migratory arthralgias Intermittent muscle weakness in bilateral lower extremities shortness of breath
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- CXR 7/10/23
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- asthma anxiety depression
- Andere Medikamente
- Albuterol PRN Melatonin
- Allergien
- Amoxicillin, Azithromycin, Cefdinir, hazelnut, raspberries, strawberries
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 37,0
- Geschlecht
- F
- Eingang
- 20.04.2023
- Impfdatum
- 14.03.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Paraesthesia
Symptomtext
pins and needles of toes and feet bilaterally; This spontaneous report was received from a registered nurse referring to a 37-year-old female patient. The patient's medical history and concurrent conditions were not reported. There was no known drug allergy. Concomitant therapies were not reported. On 14-MAR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, administered intramuscularly for prophylaxis (lot #U019413, expiration date: 01-NOV-2023; strength was not provided). On an unknown date in 2023, the patient experienced pins and needles of toes and feet bilaterally. It happened more so when she was sitting and standing. She did not have any weakness, dizziness, discoloration, warmth or issues with hands and arms. It had been happening frequently throughout the day since a few days after vaccination. The patient was unable to provide an exact date of onset. The patient had sought medical attention. She called the nurse on 04-APR-2023 (reported as today). No treatment was given for the event. She was not hospitalized. The outcome of the event was not recovered. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was discontinued, the patient refused additional doses, she would not receive any additional hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccines. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paraesthesia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 43,0
- Geschlecht
- F
- Eingang
- 08.06.2023
- Impfdatum
- 18.05.2023
- Beginn
- 06.06.2023
- Tage bis Beginn
- 19,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Vaccination site erythema
Vaccination site nodule
Vaccination site pain
Vaccination site warmth
Symptomtext
Swollen knot on arm and red area underneath vaccination site. Warm to touch, and patient reports it as painful.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vaccination site pain
- Hospital-Tage
- -
- Labordaten
- unknown-recommended patient to call primary care provider
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 12.01.2023
- Impfdatum
- 11.01.2023
- Beginn
- 11.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Face injury
Fall
Hyperhidrosis
Pallor
Skin laceration
Symptomtext
About 2 minutes after shot was given she felt light headed and tried to get up from exam table and fell on the carpeted floor,provider responded in less than 5 seconds,she looked pale and sweaty but responsive to vocal command ,was laid down on the floor,checked BP,Heart rate(normal range) and she was breathing by herself with good color,was given a glass of water to drink and when she started feeling much better,was transfered to exam table and was monitored for some time,was given candy to eat .she fell on her face down and got small superficial laceration on chin that was cleaned with antiseptic and applied bandage,and transfered to ER VIA AMBULANCE.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- NONE.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- HYPOTHYROIDISM ON SYNTHROID
- Andere Medikamente
- LORATADINE REGULAR tab 10 mg 1 tab daily
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 11.01.2023
- Impfdatum
- 27.12.2022
- Beginn
- 11.01.2023
- Tage bis Beginn
- 15,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Injection site swelling
Peripheral swelling
Symptomtext
Arm swelling 15 days after injection. Swelling and pain at site.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- ADD, ODD, Austism, Asthma
- Andere Medikamente
- Zyrtec, Singulair, Omeprazole, Concerta, guanfacine, Abilify
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 04.10.2022
- Impfdatum
- 29.09.2022
- Beginn
- 29.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Symptomtext
Client become sweaty and light headed approx. 15 mins after receiving HPV9, flu and Pfizer covid vaccines. Client was lowered to the floor by mom. Client was provided with cold washcloth for forehead by nurse and nurse stayed with client and mom in the lobby. Client started feeling better within approx. 3 mins and was able to sit up. Client was provided water, an apple and granola bar, per mom's consent. Client was able to consume all 3 and reported feeling better, at baseline, before leaving clinic with mom. Mom reported that client was seeing his PCP for a well child check later that day and would inform them of the event as well.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- none known
- Vorgeschichte
- none known
- Andere Medikamente
- None known
- Allergien
- none reported
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 16.07.2022
- Impfdatum
- 05.07.2022
- Beginn
- 05.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Nausea
Symptomtext
Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; Caller is physician reporting that a patient received first dose of GARDASIL 9 yesterday 05JUL2022. Within 10 minutes of vaccine administration, patient was nauseated, diaphoretic and dizzy.; This spontaneous report was received from a physician and refers to a 15-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient was not receiving concomitant medications. On 05-JUL-2022 (reported also as yesterday), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe, lot #: U019413, expiration date: 01-NOV-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Within 10 minutes of vaccine administration, the patient was nauseated, diaphoretic and dizzy. No intervention was necessary other than additional monitoring. The patient recovered from the events on the same day. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 9,0
- Geschlecht
- F
- Eingang
- 06.06.2022
- Impfdatum
- 06.06.2022
- Beginn
- 06.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Nausea
Pallor
Vomiting
Symptomtext
Patient given shot. ~5min later patient became pale and nauseated. Went to bathroom and vomited x1. Came back still light headed but better. BP 85/50. Had patient lie down with feet up. Gave a piece of candy and water. Checked about 10 minutes later. Color improved and patient no longer light headed and left office with mom without additional assistance
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- mild intermittent asthma seasonal allergies
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 28.04.2022
- Impfdatum
- 20.04.2022
- Beginn
- 26.04.2022
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Headache
Laboratory test abnormal
Occipital neuralgia
Pain
Torticollis
Symptomtext
Started with headache, pain in the back of head and hurt his head to move it around. Went to ED. Was diagnosed with Occipital Neuralgia of right side and Torticollis. Was given ibuprofen 450mg and Diazepam 10 mg.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- C-Spine 2 or 3V Findings- Limited evaluation due to roation of the neck of the left. No fracture is seen at C1-C3. Limited evaluation of C4-C7
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Celiac Disease
- Andere Medikamente
- ibuprofen
- Allergien
- Gluten, Peanuts, tree nuts
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 27.11.2023
- Impfdatum
- 17.11.2023
- Beginn
- 17.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
No additional AEs; Caller reported expired dose of GARDASIL 9 was administered.; This spontaneous report as received from a pharmacist, referring to 12-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided. On 17-NOV-2023, the patient was vaccinated with expired second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 mL, intramuscularly, lot #U019413 was valid for formulation pre-filled syringe, expiration date 01-NOV-2023, anatomical location was not provided) for prophylaxis (Expired vaccine used). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported (No adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 24.11.2023
- 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
No additional AEs; Caller reported expired 1st dose of GARDASIL 9 was administered. Caller asked what side effects would be expected. No other information provided. No additional AEs or PQC reported. See related AE cases 02510121 and 02510150.; Information has been received from a pharmacist, referring to a 11 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-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 #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 36,0
- Geschlecht
- U
- Eingang
- 24.11.2023
- Impfdatum
- 17.11.2023
- Beginn
- 17.11.2023
- 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 additional AEs; Caller reported expired dose of GARDASIL 9 was administered. Caller asked what side effects would be expected. No other information provided. No additional AEs or PQC reported.; Information has been received from a pharmacist, referring to a 36 years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2023, the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.03.2023
- Impfdatum
- 01.11.2017
- Beginn
- 09.03.2022
- Tage bis Beginn
- 1.589,0
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Inappropriate schedule of product administration
No adverse event
Symptomtext
No symptomatic AE reported; then a year later a fourth one was given; first two doses were given too close together, so the state flagged him as being due for another dose. A third dose was given; This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-NOV-2017, 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) vial (dose description, and route of administration were not provided), lot #N009801, expiration date: 20-NOV-2019, administered as prophylaxis. On 16-MAR-2018, he was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial (dose description, and route of administration were not provided), lot #N021572, expiration date: 01-MAY-2020, administered as prophylaxis. The reported stated that as the first 2 doses were given too close, he was flagged to being due for another dose; therefore, a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given on 09-MAR-2022, (dose description, and route of administration were not provided), lot #U019413, expiration date: 01-NOV-2023, administered as prophylaxis (Inappropriate schedule of product administration). Then, a year later, on 08-MAR-2023, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given (dose description, and route of administration were not provided), lot #W013165, expiration date: 14-DEC-2024, administered as prophylaxis (extra dose administered). No symptomatic adverse events (AE) were reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 19.01.2023
- Impfdatum
- 19.12.2022
- Beginn
- 19.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Device connection issue
Incorrect dose administered
No adverse event
Poor quality device used
Syringe issue
Symptomtext
no adverse reactions; it started leaking out around the hub and did not come out of the needle; none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub.; From where did the leaking occur? Between the syringe hub/Luer lock and syringe needle? YES; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter. On an unknown date in 2022, the nurse received 1 box containing 2 cartons of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with 5 pre-filled syringes per carton; 10 pre-filled syringes total. Nurse stated they used the first 5 pack with no problems. On 19-DEC-2022, the patient was vaccinated with 1 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml), lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly (IM) as prophylactic vaccine for Human Papillomavirus (HPV) (strength 0.5 mL). On 19-DEC-2022, the nurse opened the second carton of 5 syringes and took one out and attached the needle to the hub/luer lock part of the syringe. It seemed to be securely attached and then she felt a click and it kept turning. As she pushed the vaccine through the syringe and tip of needle to get the air out, it started leaking out around the hub and did not come out of the needle so she disposed of it and got another pre-filled syringe from the carton. She stated this one seemed to be fine and the needle securely attached to the syringe without issues but while administering to the patient, the liquid came out all around the hub where the needle connects (syringe issue; poor quality device used; device connection issue). She said she knows none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub. The patient had no adverse reactions and did not need treatment (no adverse event). The outcome of all the events was unknown (also reported as recovered). The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all the events was not applicable (also reported as therapy discontinued). The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Device connection issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 19.01.2023
- Impfdatum
- 19.12.2022
- Beginn
- 19.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Device connection issue
Incorrect dose administered
No adverse event
Poor quality device used
Syringe issue
Symptomtext
no adverse reactions; it started leaking out around the hub and did not come out of the needle; none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub.; From where did the leaking occur? Between the syringe hub/Luer lock and syringe needle? YES; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter. On an unknown date in 2022, the nurse received 1 box containing 2 cartons of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with 5 pre-filled syringes per carton; 10 pre-filled syringes total. Nurse stated they used the first 5 pack with no problems. On 19-DEC-2022, the patient was vaccinated with 1 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml), lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly (IM) as prophylactic vaccine for Human Papillomavirus (HPV) (strength 0.5 mL). On 19-DEC-2022, the nurse opened the second carton of 5 syringes and took one out and attached the needle to the hub/luer lock part of the syringe. It seemed to be securely attached and then she felt a click and it kept turning. As she pushed the vaccine through the syringe and tip of needle to get the air out, it started leaking out around the hub and did not come out of the needle so she disposed of it and got another pre-filled syringe from the carton. She stated this one seemed to be fine and the needle securely attached to the syringe without issues but while administering to the patient, the liquid came out all around the hub where the needle connects (syringe issue; poor quality device used; device connection issue). She said she knows none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub. The patient had no adverse reactions and did not need treatment (no adverse event). The outcome of all the events was unknown (also reported as recovered). The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all the events was not applicable (also reported as therapy discontinued). The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Device connection issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.12.2022
- Impfdatum
- 07.12.2022
- Beginn
- 07.12.2022
- 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; GARDASIL 9 was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported. On 07-DEC-2022, the patient administered with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot# U019413, expiration date 01-NOV-2023, once, strength, anatomical location and route of administration were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 55 degree Fahrenheit (F) for 15 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 9,0
- Geschlecht
- M
- Eingang
- 05.10.2022
- Impfdatum
- 12.08.2022
- Beginn
- 12.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Symptomtext
There was no adverse event that took place at the time of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Rash on toes
- Vorgeschichte
- Respiratory symptoms
- Andere Medikamente
- Flovent, Proventil
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 9,0
- Geschlecht
- M
- Eingang
- 17.09.2022
- Impfdatum
- 11.08.2022
- Beginn
- 23.08.2022
- Tage bis Beginn
- 12,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthma
Influenza virus test
Respiratory syncytial virus test
SARS-CoV-2 test
Symptomtext
Dates when patient was in hospital for Asthma exacerbation: 23 Aug 2022 to 25 Aug 2022; This spontaneous report has been received from a nurse via Pfizer (manufacturer control number: 202201151170) concerning a 9-year-old male patient. Since an unspecified date in 2015, the patient was allergic to peanuts; and also presented asthma. The patient's concomitant medications, drug reactions or allergies were not provided. On 11-AUG-2022, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe injection, 0.5 milliliter (ml) administered intramuscularly on the left deltoid as prophylaxis (lot number U019413 has been verified to be a valid lot number with expiration date on 01-NOV-2023) (vaccination scheme was not reported). ;and also with the first dose of COVID-19 vaccine injection 0.2 milliliter administered intramuscularly (IM) in the right deltoid, lot number: FL8094 (vaccination scheme, indication, and expiration date was not provided). On 23-AUG-2022, the patient experienced asthma exacerbation (asthma aggravated) that required him to visited the emergency room; therefore, the patient was hospitalized from 23-AUG-2022. That day, laboratories were performed such as: RSV test, influenza test, COVID-19 test, which all came negative. The patient received treatment for the event such as steroids; thus, he was going to be seen by a pulmonologist and was doing much better; therefore, on 25-AUG-2022, the patient was discharged from the hospital. On 07-SEP-2022, the second dose of COVID-19 vaccine injection 0.2 milliliter administered IM in the right deltoid, lot number: FL2757 (vaccination scheme, indication and expiration date was not provided). By the reporting time, he was recovering from the event. Causality assessment between the suspect therapy and the events was not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Asthma
- Hospital-Tage
- 3,0
- Labordaten
- Test Date: 20220823; Test Name: Influenza virus test; Test Result: Negative ; Test Date: 20220823; Test Name: RSV test; Test Result: Negative ; Test Date: 20220823; Test Name: COVID Test; Test Result: Negative
- Aktuelle Erkrankungen
- Asthma; Peanut allergy
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 02.09.2022
- Impfdatum
- 02.09.2022
- Beginn
- 02.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Product administered to patient of inappropriate age
Symptomtext
Minor received third dose of Pfizer Vaccine on 8/29/2022 Then received a fourth dose of Pfizer Vaccine on 9/2/2022
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- Penicillin
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 23.08.2022
- Impfdatum
- 19.08.2022
- Beginn
- 19.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product preparation issue
Symptomtext
Clinical staff mixed the powder portion of the menveo vaccine with a sterile diluent instead of the liquid portion of the menveo vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product preparation issue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 19.08.2022
- Impfdatum
- 19.08.2022
- Beginn
- 19.08.2022
- 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
Product administered to patient of inappropriate age
Symptomtext
5-11year orange top vaccine given to 13 year old. Also was beyond use. Drawn up on 8/18 at 8 am and given on 8/19 at 9:30am. Patient family notified of invalid dose and error. Will return for repeat vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 01.08.2022
- Impfdatum
- 27.07.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No reaction. Patient has no adverse reaction.
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
- M
- Eingang
- 21.07.2022
- Impfdatum
- 13.07.2022
- Beginn
- 13.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administration error
Symptomtext
Vaccine Administration Error, Non Viable Vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administration error
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- NA
- Andere Medikamente
- NA
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 25,0
- Geschlecht
- F
- Eingang
- 11.05.2022
- Impfdatum
- 13.04.2022
- Beginn
- 13.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
No adverse event
Symptomtext
Pt did not have an adverse reaction or outcome however she was dosed with Gardasil 4 on 2/9/2012, 4/17/2012, 9/10/2012 and then dosed with Gardasil 9 on 2/6/2020, 4/6/2020, 4/13/2022
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- , Hypertension
- Vorgeschichte
- Beta Thalasemmia Minor, Hypertension, Fibroids
- Andere Medikamente
- Labetolol 100 mg
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 03.05.2022
- Impfdatum
- 02.05.2022
- Beginn
- 02.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 05.04.2022
- Impfdatum
- 05.04.2022
- Beginn
- 05.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Unevaluable event
Symptomtext
Pt received first HPV 07/26/18. Seen 04/05/22 for 15yo Well Child Visit. HPV #2 vaccine was standing order for this age if 1st HPV is given. Vaccine was given by MA prior to MD speaking with parent, who at that time said she didn't want patient to receive HPV #2. Advised of indication for 2nd HPV, risks and benefits. Patient had no adverse event from HPV #1.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
