- Staat
- FL
- Alter
- 31,0
- Geschlecht
- M
- Eingang
- 05.03.2023
- Impfdatum
- 01.03.2023
- Beginn
- 01.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Unresponsive to stimuli
Symptomtext
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 14.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
patient had syncope 10 minutes; This spontaneous report was received from a physician via a company representative, referring to a 12-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown. 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) injection (lot #U031056, expiration date was not reported, but upon internal validation established as 16-JUN-2024) for prophylaxis (dose, strength and route of administration were not provided). On an unknown date, the patient had syncope 10 minutes after vaccination. At the time of reporting, the outcome of the event syncope was unknown. It was unknown whether lab diagnostics/ studies were performed, whether the patient sought medical attention or whether the patient was given treatment for the event syncope. The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event syncope was determined to be medically significant. ; Sender's Comments: US-009507513-2212USA002944:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 18.11.2022
- Impfdatum
- 17.11.2022
- Beginn
- 17.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cold sweat
Dizziness
Dyskinesia
Immediate post-injection reaction
Loss of consciousness
Pallor
Tremor
Vomiting
Symptomtext
Immediately after vaccine patient started to feel clammy and dizzy. Patient then passed out while sitting upright. Mom and RN supported patient's upper body so he did not fall. While passed out the patient's legs extended straight and head/arms made jerking motion. Pt quickly woke up within one minute of passing out. The patient asked where he was but quickly became aware of his surroundings. The patient still appeared pale. He then vomited and his legs were shaking mildly. Once the patient was stable the RN alerted doctor of the incident and asked for her to evaluate the patient. Mom stayed with patient while RN out of room. Vitals were done and the patient rested in room. Ice pack, snack and water were given to help him recover. Doctor evaluated the patient. Per doctor's judgement the patient was able to leave the office once he felt able to safely leave. The patient was able to walk out of office after about 30 minutes. His color had returned to normal in his face and he was no longer clammy when he left the office. Mom was to stay with patient to monitor him throughout the day.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none known
- Vorgeschichte
- stuttering adjustment disorder with mixed emotional features
- Andere Medikamente
- bupropion hydrochloride ER, tretinoin
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 10,0
- Geschlecht
- M
- Eingang
- 15.11.2022
- Impfdatum
- 08.11.2022
- Beginn
- 08.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Syncope
Symptomtext
Pt passed out when leaving facility. Was assisted back to exam room, given water and sugar source. MD discussed with mom vasovagal syncope process. Pt left facility walking with mom and sibling.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- DX Pharyngitis thought to be caused by seasonal allergies 10/28/22
- Vorgeschichte
- unknown
- Andere Medikamente
- unknown
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 07.10.2022
- Impfdatum
- 05.10.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyskinesia
Immediate post-injection reaction
Syncope
Symptomtext
I administer Flu Vaccine first and then HPV. Patient was very nervous before vaccines. Right after administration she fainted. She was sitting on exam table and mom was next to her. When she fainted, she had some movements they look like a seizure. I went and got a doctor and when we got back, she was feeling better. I did two sets of vitals and after 15 min her vitals were in normal range, and she was ok to leave.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- Reaction to vaccine.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 38,0
- Geschlecht
- F
- Eingang
- 20.02.2023
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Mobility decreased
Symptomtext
Patient reports she had shoulder pain for several weeks and had difficulty using and raising her arm, patient did not report this event until Feb 14, 2023
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 23,0
- Geschlecht
- F
- Eingang
- 09.03.2023
- Impfdatum
- 12.09.2022
- Beginn
- 13.09.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / OT
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site discolouration
Injection site pain
Injection site reaction
Injection site swelling
Skin lesion
Symptomtext
Pt developed a 2cm x 1cm purple, raised, tender lesion over the injection site that has not gone away since the injection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site discolouration
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Nexplanon implant
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 10.01.2023
- Impfdatum
- 10.01.2023
- Beginn
- 10.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Urticaria
Symptomtext
Immunization administered at 1421 and patient left facility shortly after with grandfather and brother who accompanied her to appointment. Mom called at 1446 reporting that her child was experiencing hives on her face. Nurse told mom to administer Benadryl and to monitor for trouble breathing or worsening hives and at that point to call EMS or go to the nearest emergency room.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- Only HPV immunization was administered.
- Aktuelle Erkrankungen
- None that we are aware of
- Vorgeschichte
- None that we are aware of
- Andere Medikamente
- None that we are aware of
- Allergien
- Sulfa
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 15.11.2022
- Impfdatum
- 04.11.2022
- Beginn
- 05.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Back pain
Chills
Eye swelling
Immunisation reaction
Lacrimation increased
Ocular discomfort
Ocular hyperaemia
Pain
Swelling of eyelid
Symptomtext
The night he received his vaccines (Bivalent, HPV, MCV4, Flu) - he had the chills and back pain. No temperature was taken He was given ibuprofen to help with the pain The next day, his left eye started to become swollen, he noticed it when he woke - both lids were swollen Possible erythema, white part of the eye was red, no pain but a little uncomfortable, there was some tearing, no other discharge He went to the UC that day - was told that it was from the vaccines - given benadryl and antibiotics Family did not start the otic antibiotics The swelling improved by the time he was seen at the UC and completely resolved in 2 days. The benadryl helped. No swelling at the site of injection of any of the vaccines Minimal pain that resolved in 2 days and did not need treatment No erythema at the site of injections on either arm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Back pain
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Respiratory : Exercise induced bronchospasm--Medium Genitourinary: Tight foreskin---Medium Other : Child in welfare custody---Medium Allergic rhinitis---Medium Delayed immunizations
- Andere Medikamente
- ? albuterol 108 (90 Base) MCG/ACT inhaler, Inhale 2 puffs every 6 (six) hours if needed for wheezing or shortness of breath (night cough, 10-15 min before exercise). Use with spacer, Disp: 18 g, Rfl: 3 ? betamethasone, augmented, (Diprole
- Allergien
- ? Watermelon [Citrullus Vulgaris] Itching and Swelling Pt states throat closed and he needed his inhaler the last time he ate watermelon. ? Pineapple Itching
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 41,0
- Geschlecht
- F
- Eingang
- 09.09.2022
- Impfdatum
- 07.09.2022
- Beginn
- 07.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site rash
Rash
Somnolence
Symptomtext
She received vaccinations-HPV first dose and influenza. She came back into the office shortly after stating she has a rash around the site where she received the HPV vaccine-right arm. Also a rash on her right upper part of her thumb. Vitals were checked and normal. PCP evaluated her. She is going to receive Benadryl 0.3 ML via dorsogluteal. Safety alert was put in. She was informed to wait about 15 minutes after receiving the Benadryl injection but she decided to leave as her ride was waiting on her. Followed up with patient to see how she was doing. She is doing good. Just sleepy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site rash
- Hospital-Tage
- -
- Labordaten
- Evaluated by PCP before leaving office.
- Aktuelle Erkrankungen
- Leukocytosis, unspecified and kidney function decreased. Urinary retention.
- Vorgeschichte
- Attention deficit hyperactivity disorder ICD-9-CM: 314.01 ICD-10-CM: F90.9 6/16/2010 - Present 7/23/2020 Posttraumatic stress disorder ICD-9-CM: 309.81 ICD-10-CM: F43.10 6/16/2010 - Present 7/23/2020 Panic disorder with agoraphobia ICD-9-CM: 300.21 ICD-10-CM: F40.01 4/7/2011 - Present 7/23/2020 Sprain of ankle ICD-9-CM: 845.00 ICD-10-CM: S93.409A 6/10/2013 - Present 1/4/2021 Tear of talofibular ligament ICD-9-CM: 845.09 ICD-10-CM: S93.499A 5/19/2014 - Present 7/23/2020 Cobalamin deficiency ICD-9-CM: 266.2 ICD-10-CM: E53.8 10/15/2015 - Present 7/23/2020 Migraine with aura and without status migrainosus, not intractable ICD-9-CM: 346.00 ICD-10-CM: G43.109 11/5/2015 - Present 5/12/2022 Cervical high risk human papillomavirus (HPV) DNA test positive ICD-9-CM: 795.05 ICD-10-CM: R87.810 4/14/2016 - Present 7/23/2020 Sleep disturbance ICD-9-CM: 780.50 ICD-10-CM: G47.9 6/13/2016 - Present 9/21/2017 Uncontrolled type 2 diabetes mellitus ICD-9-CM: 250.02 ICD-10-CM: IMO0002 4/25/2019 - Present 7/23/2020 BMI 40.0-44.9, adult ICD-9-CM: V85.41 ICD-10-CM: Z68.41 6/20/2019 - Present 6/20/2019 Balance problems ICD-9-CM: 781.99 ICD-10-CM: R26.89 6/20/2019 - Present 6/20/2019 Type 2 diabetes mellitus with diabetic polyneuropathy, with long-term current use of insulin ICD-9-CM: 250.60, 357.2, V58.67 ICD-10-CM: E11.42, Z79.4 Unknown - Present 3/10/2022 Vitamin D deficiency ICD-9-CM: 268.9 ICD-10-CM: E55.9 7/23/2020 - Present 7/23/2020 Unruptured synovial cyst of popliteal space, unspecified laterality ICD-9-CM: 727.51 ICD-10-CM: M71.20 7/23/2020 - Present 7/23/2020 Tobacco use disorder ICD-9-CM: 305.1 ICD-10-CM: F17.200 7/23/2020 - Present 7/23/2020 Schizoaffective disorder ICD-9-CM: 295.70 ICD-10-CM: F25.9 7/23/2020 - Present 7/23/2020 Pure hypertriglyceridemia ICD-9-CM: 272.1 ICD-10-CM: E78.1 7/23/2020 - Present 7/23/2020 Other personal history presenting hazards to health ICD-9-CM: V15.89 ICD-10-CM: Z91.89 7/23/2020 - Present 7/23/2020 Other depressive disorder ICD-9-CM: 311 ICD-10-CM: F32.89 7/23/2020 - Present 7/23/2020 Other chronic pain ICD-9-CM: 338.29 ICD-10-CM: G89.29 7/23/2020 - Present 7/23/2020 Other and unspecified noninfectious gastroenteritis and colitis ICD-9-CM: 558.9 ICD-10-CM: K52.9 7/23/2020 - Present 7/23/2020 CRNP Class 3 severe obesity due to excess calories with serious comorbidity and body mass index (BMI) of 40.0 to 44.9 in adult ICD-9-CM: 278.01, V85.41 ICD-10-CM: E66.01, Z68.41 7/23/2020 - Present 5/12/2022 Mixed hyperlipidemia ICD-9-CM: 272.2 ICD-10-CM: E78.2 7/23/2020 - Present 7/23/2020 Lumbar radiculopathy ICD-9-CM: 724.4 ICD-10-CM: M54.16 7/23/2020 - Present 3/10/2022 Chronic insomnia ICD-9-CM: 780.52 ICD-10-CM: F51.04 7/23/2020 - Present 8/25/2021 GERD without esophagitis ICD-9-CM: 530.81 ICD-10-CM: K21.9 7/23/2020 - Present 7/23/2020 Fatty liver ICD-9-CM: 571.8 ICD-10-CM: K76.0 7/23/2020 - Present 7/23/2020 Depressed bipolar I disorder in full remission ICD-9-CM: 296.56 ICD-10-CM: F31.76 7/23/2020 - Present 7/23/2020 Circadian rhythm disorder ICD-9-CM: 327.30 ICD-10-CM: G47.20 7/23/2020 - Present 7/23/2020 Disorder of teeth and supporting structures ICD-9-CM: 525.9 ICD-10-CM: K08.9 7/23/2020 - Present 7/23/2020 Intermittent asthma, unspecified asthma severity, unspecified whether complicated ICD-9-CM: 493.90 ICD-10-CM: J45.20 7/23/2020 - Present 7/23/2020 Seasonal allergic rhinitis due to other allergic trigger ICD-9-CM: 477.8 ICD-10-CM: J30.89 7/23/2020 - Present 1/4/2021 Bilateral sciatica ICD-9-CM: 724.3 ICD-10-CM: M54.31, M54.32 11/5/2020 - Present 11/5/2020 Overview Signed 11/5/2020 10:20 AM Added automatically from request for surgery Spondylosis ICD-9-CM: 721.90 ICD-10-CM: M47.9 11/5/2020 - Present 11/5/2020 Overview Signed 11/5/2020 10:20 AM for surgery Obesity (BMI 30-39.9) ICD-9-CM: 278.00 ICD-10-CM: E66.9 1/25/2021 - Present 1/25/2021 Sensory ataxic gait ICD-9-CM: 781.2 ICD-10-CM: R26.0 3/22/2021 - Present 3/22/2021 Neuropathic pain ICD-9-CM: 729.2 ICD-10-CM: M79.2 3/22/2021 - Present 3/22/2021 Essential hypertension ICD-9-CM: 401.9 ICD-10-CM: I10 5/21/2021 - Present 5/21/2021 Chronic bilateral low back pain without sciatica ICD-9-CM: 724.2, 338.29 ICD-10-CM: M54.50, G89.29 5/21/2021 - Present 5/21/2021 Encounter for long-term (current) use of medications ICD-9-CM: V58.69 ICD-10-CM: Z79.899 6/9/2021 - Present 6/9/2021 Open wound of right foot, initial encounter ICD-9-CM: 892.0 ICD-10-CM: S91.301A 8/17/2021 - Present 8/17/2021 Leg weakness, bilateral ICD-9-CM: 729.89 ICD-10-CM: R29.898 3/10/2022 - Present 3/10/2022 Intellectual disability ICD-9-CM: 319
- Andere Medikamente
- albuterol sulfate (HFA aerosol inhaler) PROVENTIL;VENTOLIN 90 mcg/actuation Inhale 2 puffs every 6 (six) hours as needed for wheezing atorvastatin calcium (tablet) LIPITOR 40 mg Take 1 tablet (40 mg total) by mouth every evening blood su
- Allergien
- No known allergies.
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 50,0
- Geschlecht
- M
- Eingang
- 22.11.2023
- Impfdatum
- 28.04.2023
- Beginn
- 22.11.2023
- Tage bis Beginn
- 208,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Symptomtext
patient was 50 years old when he got this shot and its only allowed to be given to people age 45 or less
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 50,0
- Geschlecht
- M
- Eingang
- 22.11.2023
- Impfdatum
- 22.11.2023
- Beginn
- 01.11.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
no adverse event. just reporting because patient was 50 and only allowed to get this vaccine if youre less than 45 years old
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 03.07.2023
- Impfdatum
- 05.06.2023
- Beginn
- 01.06.2023
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Product preparation error
Product preparation issue
Symptomtext
INDIVIDUAL THAT GAVE VACCINE DID NOT MIX IT ACCORDING TO THE MANUFACTURERS GUIDELINES. MENA (ORANGE CAP) WAS NOT MIXED WITH THE MENCYW (GREY CAP) INSTEAD IT WAS MIXED WITH THE LIVE VIRUS DILUENT SO PATIENT DID NOT RECEIVE THE ENTIRE MENVEO DOSE. MOTHER WAS INFORMED THAT THE DOSE IS INVALID AND PATIENT WILL NEED DOSE REPEATED.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- UNKNOWN
- Vorgeschichte
- UNKNOWN
- Andere Medikamente
- UNKNOWN
- Allergien
- UNKNOWN
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 03.07.2023
- Impfdatum
- 05.06.2023
- Beginn
- 05.06.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Product preparation error
Symptomtext
INDIVIDUAL THAT ADMINISTERED VACCINE DID NOT MIX IT PER MANUFACTURER INSTRUCTIONS. THE MEN A (ORANGE CAP) WAS NOT MIXED WITH MENCYW(GREY CAP) BUT RATHER WITH THE DILUENT FOR THE LIVE VACCINE SOLUTION. PATIENT DID NOT GET THE COMPLETE DOSE OF MENVEO. MOTHER INFORMED PATIENT WILL NEED DOSE REPEATED .
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- UNKNOWN
- Vorgeschichte
- UNKNOWN
- Andere Medikamente
- UNKNOWN
- Allergien
- UNKNOWN
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.05.2023
- Impfdatum
- 30.03.2023
- Beginn
- 30.03.2023
- 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 other adverse events reported; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 30-MAR-2023, the patient was vaccinated with the first dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection (lot number U031056 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Expiration date has been established as 16-JUN-2024), administered for prophylaxis (strength, and route of administration were not provided). No other adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.05.2023
- Impfdatum
- 01.05.2023
- Beginn
- 01.05.2023
- 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 AEs; Nurse reported that GARDASIL 9 was administered to 1 patient following temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-MAY-2023, the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection that suffered a temperature excursion; lot # U031056, expiration date on 16-JUN-2024, for prophylaxis (route of administration and anatomical location were not provided). The temperature excursion ranged from a temperature of 33.5?C for 7 hours and 31 minutes to a temperature of 16.3?C for 7 hours and 53 minutes. No previous temperature excursion occurred and no additional adverse events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.05.2023
- Impfdatum
- 02.03.2023
- Beginn
- 02.03.2023
- 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 reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information. ? Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAR-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2305USA008276
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.05.2023
- Impfdatum
- 30.03.2023
- Beginn
- 30.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received form an administrator, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not reported. On 30-MAR-2023, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 time dose, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). The administered dose underwent a temperature excursion of -40 degrees Fahrenheit (F), for 70 hours and 5 minutes. No previous temperature excursion was reported. 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
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.05.2023
- Impfdatum
- 09.03.2023
- Beginn
- 09.03.2023
- 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 other adverse events reported; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information. ? Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report has been received from an administrator, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. On 09-MAR-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U031056, which was determined to be valid as syringe, with an expiration date on 16-JUN-2024) (strength, dose, scheme, route and anatomical location of administration were not reported). The administered dose underwent a temperature excursion of -40 degrees Fahrenheit (F), for 70 hours and 5 minutes. No previous temperature excursion was reported. 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
- NY
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.05.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- 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 reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information. ? Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-JAN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2305USA008279
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 44,0
- Geschlecht
- M
- Eingang
- 27.04.2023
- Impfdatum
- 24.04.2023
- Beginn
- 24.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Patient has had no adverse effects. He is older than the recommended age for vaccination
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- MS
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.03.2023
- Impfdatum
- 20.02.2023
- Beginn
- 20.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; Customer reported 1 dose of GARDASIL 9 that was administered after experiencing temperature excursion which started on estimated date of 14Dec2022, ended on 20Feb2023. Temperature: 63F for 1641 hours 0 minutes 0 seconds Date of administration: 20Fe; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided. On 20-FEB-2023, 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) after experiencing temperature excursion which started on estimated date of 14-DEC-2022, ended on 20-FEB-2023, lot # U031056 expiration date of 16-JUN-2024, for prophylaxis (product storage error) (route of administration and frequency were not reported). Temperature: 63F (Fahrenheit) for 1641 hours 0 minutes 0 seconds. Prior excursion: No-one continuous excursion of 1641 hours. No additional event reported. This is a non-valid report due to lack of patient's identifiers. Follow-up information has been received from the nurse 02-MAR-2023. The reporter confirmed that the spontaneous report referred to an 11-years-old male patient who on 20-FEB-2023, was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as previously reported, with a dose of 0.5 ml by intramuscular route. It was confirmed that no side effects were reported by the patient or his parents. No more medical information had been reported. This report was prior considered to be non-valid due to lack of patient's identifiers; on 02-MAR-2023 the nurse confirmed the patient's demographics and the case became to be valid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 10.03.2023
- Impfdatum
- 01.01.2023
- Beginn
- 25.02.2023
- Tage bis Beginn
- 55,0
- Dosis
- 2
- 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 AE's were reported; that the patient was given her second dose of GARDSIL 9 one month after her first dose instead of two months after the first dose; This spontaneous report was received from a medical assistant and refers to a female of unknown age. The pertinent medical history, concomitant medications or drug reactions and allergies were not reported. On an unknown date in January 2023, 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) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 25-FEB-2023, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, injection, 0.5 milliliter, lot #U031056, expiration date 16-JUN-2024, administered intramuscularly (injection site was not provided)f or prophylaxis. The patient was given her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one month after her first dose instead of two months after the first dose (inappropriate schedule of product administration). No additional adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 31,0
- Geschlecht
- M
- Eingang
- 17.01.2023
- Impfdatum
- 07.10.2022
- Beginn
- 07.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Inappropriate schedule of product administration
No adverse event
Symptomtext
HPV vaccine dose 2 was administered 3 weeks and 3 days after the HPV vaccine dose 1, 5 days before the minimum recommendation of 4 weeks. No adverse reaction was noted. Patient was given HPV vaccine dose 2 on 01/17/2023 and HPV vaccine dose 3 is scheduled 12 weeks apart on April 11th 2023
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 21.12.2022
- Impfdatum
- 06.12.2022
- Beginn
- 06.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product storage error
Symptomtext
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 19.12.2022
- Impfdatum
- 30.11.2022
- Beginn
- 30.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Feeling hot
Immediate post-injection reaction
Posture abnormal
Staring
Unresponsive to stimuli
Symptomtext
Patient was to receive HPV, Flu, Menningitis & TDAP. He was given HPV & Menningitis in Lt Deltoid then flu in Rt Deltoid. Immediately after 3rd injection he had blank stare, became unresponsive & went limp into Mothers arms as she was standing behind him. I called for help & as Dr. and PA came into room patient was coming to. Vitals were taken and were within acceptable limits. Patient complained of being hot so I placed fan in room which he stated helped. Within 10 minutes patient's color had improved, he was talking and responding appropriately. He remained in room sitting in chair talking & laughing with mother & sister as she was waiting her post vaccine shot time. Patient was then discharged in care of mother with normal vital signs and no appearnt distress.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Feeling hot
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 16.12.2022
- Impfdatum
- 08.12.2022
- Beginn
- 08.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Wrong product administered
Symptomtext
MMR vaccine was given instead of Varicella vaccine. No adverse reaction has been reported to date.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 15.12.2022
- Impfdatum
- 10.08.2016
- Beginn
- 02.08.2021
- Tage bis Beginn
- 1.818,0
- Dosis
- 4
- 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 additional AE reported; Customer reported that a patient got an extra dose (4th dose) of GARDASIL 9. Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022. No additional; Patient received 1st dose of GARDASIL 9 on 8/10/2016, patient received the 2nd dose on 8/2/2021, 3rd dose on 8/3/2022 and an additional 4th dose on 11/21/2022.; This spontaneous report was received from a nurse (also reported as customer) and refers to a 20-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-AUG-2016, 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, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). The patient received the second dose on 02-AUG-2021 (Inappropriate schedule of vaccine administered) and the third dose on 03-AUG-2022. On 21-NOV-2022, the patient received an additional fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No additional adverse event reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 16.11.2022
- Impfdatum
- 16.11.2022
- Beginn
- 16.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Immediate post-injection reaction
Unresponsive to stimuli
Symptomtext
Right after the last vaccine was administered, the patient layed her head down on the desk. At first, she was replying to the father and the nurse talking to her, then became unresponsive. The initial vital signs were taken. The patient was lowered to the ground, and her feet were elevated. The vital signs were taken again, and then every 2-3 minutes until the ambulance arrived. Last set of vitals were taken at 9:18 am: BP 86/65, RR 22, HR 84, O2 99%.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Immediate post-injection reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 15.11.2022
- Impfdatum
- 14.11.2022
- Beginn
- 14.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product use issue
Symptomtext
Moderna bivalent booster was given after beyond use date. Administered on 11/14/2022. No signs or symptoms of adverse reaction with the patient
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- -
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 15.11.2022
- Impfdatum
- 14.11.2022
- Beginn
- 14.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product use issue
Symptomtext
Patient was given Moderna bivalent booster past the beyond use date of 11/11/2022. Vaccine was administered on 11/14/2022. No signs or symptoms of adverse reactions
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product use issue
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- -
- Andere Medikamente
- Focalin XR, risperidone, guanfacine, celexa
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 10.11.2022
- Impfdatum
- 01.11.2022
- Beginn
- 01.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
No adverse event
Symptomtext
no adverse event - just given too soon -
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 7,0
- Geschlecht
- M
- Eingang
- 28.10.2022
- Impfdatum
- 13.10.2022
- Beginn
- 13.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong patient received product
Wrong product administered
Symptomtext
Medical Assistant drew up the vaccines mixing up with another patient and gave vaccines to wrong patient.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong patient received product
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Needle issue
Symptomtext
Full AE filed due to them using the GARDSIL 9 and it breaking while they were using on a patient caller did not report any other issues; when they open a new package of GARDASIL9 and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place; GARDASIL 9 syringe flange broke into 3 different pieces; no adverse event; Complaint Description Detail Per caller he thinks this PQC was called in already but caller did not have case to reference. Caller reported he can send a picture from this issues where the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. Patient did not miss dose. It happened while in us and being given to patient. Caller mentioned that they have this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking. This case is being filed due to not being able to fine original case. AE & PQC 02268087. Product no able to be sent back. LOT: Unknown by reporter EXP: Unknown by reporter "Per caller when they open a new package of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break." Full AE filed due to them using the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it breaking while they were using on a patient caller did not report any other issues or concerns with the patient. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for RA: 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? YES/NO/NA/UNSPECIFIED If yes, describe the size, shape & depth of the crack: Provide the exact location of the crack on the syringe: Is the syringe broken into 2 or more pieces? YES/NO/NA/UNSPECIFIED If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Provide the exact location of the breakage on the syringe? Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. Provide the exact location of the breakage on the syringe? Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED If yes, describe If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? Under what situation was this defect noticed: (select one) While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify) After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED While giving the injection? YES/NO/NA/UNSPECIFIED Immediately after giving the injection? YES/NO/NA/UNSPECIFIED Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES/NO/NA/UNSPECIFIED If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED If complaint sample is not/cannot be returned, please provide reason: If photos are available, ask the customer to send them to email. 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: 14-OCT-2022 16:30: Attachment added to Service Cloud. 14-OCT-2022 16:30: Email received in the Service Center Mailbox on 14-OCT-2022 at 12:16 with photos from the customer of this case. See attached. 14-OCT-2022: Company Employee - Requested obtain the complete lot number from the photo. 14-OCT-2022 18:30: Attachment added to Service Cloud. 14-OCT-2022 18:30: Email received in the PQC Mailbox on 14-OCT-2022 16:57 from QUALITY"Pls. obtain the complete lot number from the photo provided." See attached. Forwarded to case owner for follow up. 17-OCT-2022: Company Employee - PHOTO received & attached 17-OCT-2022: Company Employee - Based on attached photo received stating "I was giving a HPV vaccine today and the bottom glass part broke and cut my finger. I was able to give the full dose. The lot number is U031056." 17-OCT-2022: Company Employee NOTE: Unknown lots for reported issues where "Caller mentioned that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking" logged under PR 372903. 17-OCT-2022: Second person reviewed by Reviewer 1 18-OCT-2022 17:30: Attachment added to Service Cloud. 18-OCT-2022 17:30: Attachment added to Service Cloud. 18-OCT-2022 17:30: Email received in the PQC Mailbox on 18-OCT-2022 at 15:53 with the following message from Specialist, Quality Assurance with the following message from quality: "The Investigator has a few clarifying questions surrounding the two complaint PQC's entered on 14-OCT-2022. Please review and follow-up with customer. 1. Why does PQC 372903 have complaint category of "Cracked Syringe" selected? 2. Why do PQCs 372897 and 372903 have complaint categories of "Disassembled Upon Opening"? 3. For PQC 372903, can the batch number be confirmed? Was the batch number U031056 which was reported PQC 372897? 4. Can you confirm the number of broken syringes for PQC 372903?" See attachment. Replied to specialist, quality assurance asking for SC case numbers. No additional information. 18-OCT-2022 17:30: Email received in the PQC mailbox on 18-OCT-2022 at 16:18 with a reply from quality stating: "I retrieved information from the records in question and added below in yellow/green." Her responses are included: Why does PQC 372903 have complaint category of "Cracked Syringe" selected? 17-OCT-2022: Company Employee Additional Complaint Category added to Reported & Investigated PQC Categories based on follow up received in case 02268045 (PR 372905) stating "Caller reported he can send a picture from this issue where the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. Caller mentioned that they have this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking". 1. Why do PQCs 372897 and 372903 have complaint categories of "Disassembled Upon Opening"? Per caller when they open a new package of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break." 2. For PQC 372903, can the batch number be confirmed? Was the batch number U031056 which was reported PQC 372897? PR 372903 was specifically logged for the unknown broken/cracked syringes 3. Can you confirm the number of broken syringes for PQC 372903? This was logged due to the mention of having so many syringes that are broken so 2 is logged for more than one unknown lot, the reported lot they had on hand was reported in 372897 "Per caller when they open a new package of GARDASIL9 and it always seems that the actually syringes in the packaging are always loose. Caller reported it always seems like the syringes are out of place like the holder itself is not holding them in place. Caller thinks that maybe why they are having so many syringes break."' See attachment. Complaint Description Summary HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. It happened while in use and being given to patient. ; Sender's Comments: US-009507513-2210USA005617:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Needle issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 21.10.2022
- Impfdatum
- 12.10.2022
- Beginn
- 12.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Symptomtext
Minor pregnant at the time of vaccine administration. Estimated delivery date 06/29/2023.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- Chlamydia
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- Peanuts
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 21.10.2022
- Impfdatum
- 21.09.2022
- Beginn
- 21.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Symptomtext
Minor was pregnant at the time of vaccination. Estimated delivery date is 05/21/2023.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- Chlamydia
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- Penicillin
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.10.2022
- Impfdatum
- -
- Beginn
- 14.10.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Limb injury
Syringe issue
Symptomtext
always seems like the syringes are out of place like the holder itself is not holding them in place; cut my finger; syringe flange broke into 3 different pieces/bottom glass part broke and cut my finger; broken syringe; This spontaneous report as received from a nurse and refers to a female patient (medical assistante) of unknown age. The patient concurrent condition and concomitant medicaitons were not reported. On 14-OCT-2022 (reported as" today"), the medical assistent was given to the patient (MARRS # 2210USA005747) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U031056, expiration date 16-JUN-2024 (dose and route of administration were not reported) and the bottom glass part broke and cut her finger. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe flange broke into 3 different pieces. She was able to give the full dose and had gloves. It was also reported that when open a new package of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) "it always seems that the actually syringes in the packaging are always loose" and "seems like the syringes are out of place like the holder itself is not holding them in place". The causality assessment was not provided. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2210USA005747:MSD
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Limb injury
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syringe issue
Symptomtext
Sterile Injectable;N/A;Broken Syringe; No adverse event; Complaint Description Detail Email received in the PQC mailbox on 03-OCT-2022 at 3:42 pm with PQC: Report verbatim: "This provider received several hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) doses with broken vials. The vaccine was shipped from the warehouse to the provider, but it was initially shipped from warehouse." See attachment. Within the attachment the customer mentions on 30-SEP-2022 "We discovered that 2 syringes of HPV vaccine (lot U031056, exp 6/16/24) were broken in the packaging. I called and notified manufacturer about this, and they said to let you all know. I will plan to waste these two doses in our reconciliation when I order vaccines next week." I am unable to locate original case, company awareness date reflects the date the email was received in the mailbox. No AE reported on attachment. Will follow up. Attachment added. 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: 03-OCT-2022 17:30 PM: QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: o 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. o 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). o Please provide a detailed description of the defect using the questions below: o Is there a crack? YES/NO/NA/UNSPECIFIED o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: o Is the syringe broken into 2 or more pieces? YES/NO/NA/UNSPECIFIED o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) o Provide the exact location of the breakage on the syringe? o Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. o Provide the exact location of the breakage on the syringe? o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) o Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED o If yes, describe o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED o If not supplied by MERCK, what type & brand, needle size & gauge was used?' o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED o Is there any broken glass or other separated component in the tray? (if yes specify) o After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED o While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED o While giving the injection? YES/NO/NA/UNSPECIFIED o Immediately after giving the injection? YES/NO/NA/UNSPECIFIED o Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED o If no, describe damage. o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES/NO/NA/UNSPECIFIED o If no, describe damage o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED o If complaint sample is not/cannot be returned, please provide reason: *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) o 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. 03-OCT-2022 17:30 PM: Outbound call made in attempts to contact customer. Front desk reported that she is not in the office until Wednesday, 05-OCT-2022 but that she might be working remotely on 04-OCT-2022. Case number and phone number left with office staff and a request to contact. I also sent an email to the customer requesting her to contact. Upon call back please have customer answer all PQC questions related to the broken finger flange. Customer also noted that she "called and notified Merck about this" on 30-SEP-2022, however there are no cases located. Please have customer clarify who she spoke with at manufacturer. Will follow up. 04-OCT-2022: Received & attached photos 04-OCT-2022: Requested to please confirm with the reporter, how many syringes were broke, based on the photos provided it only appears to be one. 04-OCT-2022: Second person reviewed 04-OCT-2022 12:30 PM: Attachment added. 04-OCT-2022 12:30 PM: Email received on 04-OCT-2022 at 8:50AM from Quality: "Can you please confirm with the reporter, how many syringes were broken based on the photos provided it only appears to be one?" See attached. Forwarded to case owner for follow up. 05-OCT-2022, Registered Nurse (also reported as Nurse) confirmed that 2 syringes were broken although it was hard to see in photos provided. Broken syringes have been disposed in sharps container and were not available for return.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syringe issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 28.09.2022
- Impfdatum
- 28.09.2022
- Beginn
- 28.09.2022
- Tage bis Beginn
- 0,0
- 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
Symptomtext
Pt received Pfizer Bivalent (12+) vaccine booster when Pfizer 5-11 vaccine booster was indicated due to age being 11 y 6 m old.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- No known illnesses
- Vorgeschichte
- No known chronic health condition
- Andere Medikamente
- Focalin XR
- Allergien
- N.K.D.A.
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 28,0
- Geschlecht
- M
- Eingang
- 22.09.2022
- Impfdatum
- 22.09.2022
- Beginn
- 22.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect product formulation administered
Symptomtext
Patient was give 0. 5 mL of Moderna Bivalent vaccine for a first primary dose instead of the monovalent moderna vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 16.09.2022
- Impfdatum
- 13.09.2022
- Beginn
- 13.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Patient was indicated to receive and father consented to provision of HiB vaccine. HPV was accidentally administered in its place by the Medical Assistant. Upon realization of the error, Dr (myself) called the family to report the error, explain what to expect, and to answer any questions or concerns. I called again the next day, about 18 hours after the error occurred. At that time, patient's mother reported no change in behavior or symptoms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- N/A
- Allergien
- None
- Vorherige Impfungen
- -