- Staat
- UT
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 27.10.2022
- Impfdatum
- 25.10.2022
- Beginn
- 25.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Immediate post-injection reaction
Loss of consciousness
Pallor
Seizure
Tremor
Unresponsive to stimuli
Symptomtext
Patient passed out approximately 3-4 minutes after vaccines were administered. Patient convulsed for approximately 10 seconds while passed out. Was unresponsive for 30 seconds to 1 minute. Patient was pale once she woke up and was shaky. Stated that she was lightheaded. No pain or cognitive deficits noted. Vitals after patient came to were P 70 O2 99 BP 106/72. Patient was given some juice, crackers and sat with her head lowered and her legs propped up. She began to feel better after approximately 10 minutes, stating she no longer felt light headed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 27,0
- Geschlecht
- M
- Eingang
- 26.08.2022
- Impfdatum
- 26.08.2022
- Beginn
- 26.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Syncope
Symptomtext
Dizzy and fainted
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- Fluticasone (FLONASE) 50MCG/ACT Nasal
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 12.08.2022
- Impfdatum
- 01.06.2022
- Beginn
- 01.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- SYR / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal pain upper
Cataplexy
Dyspnoea
Loss of consciousness
Musculoskeletal stiffness
Dizziness
Syncope
Seizure
Symptomtext
Had a syncopal event within a minute after the vaccines were administered. She felt lightheaded, passed out on the exam table and had some stiffening movements of her arms and was unconscious for a reported minute. When she awoke she was shaking, very tearful and felt ill to her stomach. She was kept recumbent for about 15 minutes, given a cool cloth for her head; a drink of water and a popsicle. She reported that she had not eaten anything for breakfast or had anything to drink that morning. She continued to feel tired and exhausted. After about 20 minutes was helped to her car, reclined in the seat. After returning home, she was reported to have slept most of the afternoon and hadn't had much to eat by late afternoon. The following morning, she was reported to be feeling better.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Chronic abdominal pain, on and off
- Andere Medikamente
- None known.
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 29,0
- Geschlecht
- M
- Eingang
- 04.08.2022
- Impfdatum
- 26.07.2022
- Beginn
- 26.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anxiety
Asthenia
Hyperhidrosis
Immediate post-injection reaction
Injection site pain
Memory impairment
Presyncope
Symptomtext
The patient was first given Gardasil 9 (dose #2) in the right deltoid. I then gave Tdap then Typhim Injectable in the left deltoid. Immediately after giving Typhim the patient had a vasovagal episode that listed about 1 minute. Afterwards the student was diaphoretic and briefly could not recall where he was. After 2 minutes the student was no longer diaphoretic and was alert and oriented x3. He was anxious but consolable. He was observed for 20minutes after the vasovagal event when he stated he "felt fine." At depart he was a/o x3 with a steady gait. On August 3rd 2022 the patient reported persistent left shoulder pain and described it as "debilitating."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- No illnesses reported by patient
- Vorgeschichte
- None
- Andere Medikamente
- No medications
- Allergien
- Amoxicillin - rash
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 41,0
- Geschlecht
- M
- Eingang
- 30.08.2022
- Impfdatum
- 11.08.2022
- Beginn
- 14.08.2022
- Tage bis Beginn
- 3,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Injected limb mobility decreased
Sleep disorder
Symptomtext
Left shoulder pain after HPV vaccine. Reports did not have pain immediately after vaccine. Pain started 2-3 days after. Pain makes it hard to sleep and do movement. Pt states did not lift anything or do anything that could have made it worse. Pt denies swelling or feeling hot. Pt states no discoloration. Pt denies headache, fever, or other types of body aches.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- History of COVID-19, recovered
- Andere Medikamente
- None as stated by patient
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 17.06.2022
- Impfdatum
- 14.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Altered state of consciousness
Blood glucose normal
Chills
Depressed level of consciousness
Dizziness
Fatigue
Hyperventilation
Injected limb mobility decreased
Limb discomfort
Nausea
Pain
Pain in extremity
Panic attack
Tremor
Symptomtext
Patient developed dizziness, severe right arm pain and heaviness, hyperventilation, severe shivering, diffuse "pain", nausea, and altered level of consciousness over the course of 20 minutes post-vaccination. Was unable to lift/use right arm and any movement/palpation of right arm caused shivering/tremors and pain. Vital signs including BP, HR, temp, and Oxygen sat remained stable throughout. After 20 minutes pt became very fatigued and was difficult to arouse intermittently therefore 911 was called and paramedics arrived, VS remained stable, blood glucose 95, IV started, pt was given Benadryl IV and transported to ED for ongoing evaluation and observation. Per parent, within 45 minutes of arrival in ED pt had fully recovered, symptoms had resolved completely including pain, and pt was discharged home with diagnosis of "panic attack"
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- Blood glucose 95 (6/14/2022)
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 16.05.2022
- Impfdatum
- 06.05.2022
- Beginn
- 06.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chest pain
Cough
Fatigue
Malaise
Oropharyngeal pain
Respiratory tract congestion
SARS-CoV-2 test negative
Sneezing
Symptomtext
Pt started feeling ill 5 hours after the vaccination. Symptoms included fatigue, sore throat, cough, sneezing, congestion. Coughing became increasingly worse within the week resulting in chest pain. As of today, 5/16/2022, pt is feeling better but still has mild symptoms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chest pain
- Hospital-Tage
- -
- Labordaten
- Pt took two rapid Covid tests at home which were both negative.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Venous hum, migraines, enlarged thyroid gland
- Andere Medikamente
- Melatonin 3 mg nightly, Naprosyn 500 mg as needed for migraine
- Allergien
- NKDA, no other allergies
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 39,0
- Geschlecht
- F
- Eingang
- 12.12.2022
- Impfdatum
- 10.10.2022
- Beginn
- 07.11.2022
- Tage bis Beginn
- 28,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site mass
Symptomtext
Patient developed firm lump at injection site, still present 2 months after injection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 30.08.2022
- Impfdatum
- 17.08.2022
- Beginn
- 18.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Fatigue
Injection site erythema
Injection site rash
Symptomtext
Patient developed a diffuse erythematous rash around injection site of left arm which spread over the course of 2-3 days and remained persistent over the course of 9 days when the pt was evaluated again in the office. There was no sign of infection, area was not indurated or especially painful to touch or warm to touch. Treatment was recommended with topical ice and Benadryl and ibuprofen/Tylenol PRN. Symptoms included fatigue and red rash.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 18.08.2022
- Impfdatum
- 15.08.2022
- Beginn
- 16.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Urticaria
Symptomtext
He developed recurring urticaria the next day. No other signs of anaphylaxis
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None Known
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 07.07.2022
- Impfdatum
- 30.06.2022
- Beginn
- 30.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immediate post-injection reaction
Urticaria
Symptomtext
immediate facial hives. no SOB, no signs of anaphylaxis. gave oral benadryl 25 mg and hives immediately resolved. pt stayed in clinic for 30 min and MD reassessed after that time. pt was doing well so pt cleared to leave.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- Keflex, Latex
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 23.06.2022
- Impfdatum
- 22.06.2022
- Beginn
- 22.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Nausea
Pallor
Vomiting
Symptomtext
Nausea, dizzy, vomited. She was pale and diaphoretic. No loss of consciousness. We had her lay down and applied a cool towel to her forehead. After 5 minutes, she seemed back to her baseline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- BP- 90/58 Pulse Ox- 98%
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 24.05.2022
- Impfdatum
- 09.05.2022
- Beginn
- 19.05.2022
- Tage bis Beginn
- 10,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Symptomtext
Patient developed a rash 10 days after the HPV vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- 10/2012 Immune thrombocytopenic purpura : Hospitalized x2 days, received IVIG
- Andere Medikamente
- NA
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 26.12.2023
- Impfdatum
- 18.12.2023
- Beginn
- 18.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
The patient did not report any side effects or adverse issues from the administration of the expired dose of GARDASIL 9; an expired dose of GARDASIL 9 (Lot: U028825 Expiration: 11/02/2023 with no previous temperature excursions) that was inadvertently administered to a patient on 12/18/2023; This spontaneous report was received from a consumer referring to an 18-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 18-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5mL / once, lot#: U028825, expiration date: 02-NOV-2023; strength) by a certified medical assistance inadvertently for prophylaxis (expired product administered). The vaccine administered did not experience any temperature excursion before. The patient did not report any side effects or adverse issues from the administration of the expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.11.2023
- Impfdatum
- 13.11.2023
- Beginn
- 13.11.2023
- 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 further AE; MGARDASIL 9 u028825 exp 11/02/2023 given to a 19 years old on 11/13/2023; This spontaneous report was received from a pharmacist and referred to a 19-year-old patient with unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported. On 13-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one time, lot #u028825, expiration date: 02-NOV-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (Expired vaccine used). No further adverse event (AE).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 53,0
- Geschlecht
- M
- Eingang
- 28.03.2023
- Impfdatum
- 28.02.2023
- Beginn
- 28.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Symptomtext
Vaccine given to patient outside of accepted age range (9-45)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 09.03.2023
- Impfdatum
- 08.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Alopecia
Symptomtext
complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows.; This spontaneous report was received from a medical assistant concerning a male patient currently 12 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U028825, expiration date: 02-NOV-2023, administered as prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient developed complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows (Alopecia). At the time of reporting, the patient had not recovered from the event of alopecia. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as discontinued. The causal relationship between the event of alopecia 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
- Alopecia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.12.2022
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event; Patient was administered improperly stored GARDASIL 9; This spontaneous report was received from a Certified Medical Assistant, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 30-SEP-2022, the patient was administered an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U028825, expiration date: 02-NOV-2023, for prophylaxis (route and anatomical location were not provided). No additional adverse event was reported. According to the reporter, the excursion occurred on 19-SEP-2022 at 31.8?F for 19 minutes, and there were no previous temperature excursions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 09.11.2022
- Impfdatum
- 18.10.2022
- Beginn
- 18.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Wrong product administered
Symptomtext
N/A - Reporting incorrect vaccine given - COVID booster
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 09.11.2022
- Impfdatum
- 17.10.2022
- Beginn
- 17.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Wrong product administered
Symptomtext
N/A - Reporting incorrect vaccine given - COVID booster
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.08.2022
- Impfdatum
- 29.07.2022
- Beginn
- 29.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no adverse event; Physician calling in to request a vaccine temperature excursion evaluation for GARDASIL 9 (see TE case number 02215650 for details) that had been administered to a patient.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided. On 29-JUL-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection dose 0.5 ml, lot #U028825, expiration date: 02-NOV-2023, administered intramuscularly (strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature excursion information: on 25-JUL-2022 46.5 degree Fahrenheit for 15 min and on 29-JUL-2022 48.2 degree Fahrenheit for 15 minutes. There was no additional adverse event reported (no adverse event). This was one of two cases from the same reporter. ; Sender's Comments: US-009507513-2208USA000140:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.08.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Syringe issue
Symptomtext
Sterile Injectable;N/A;Broken Syringe; No adverse event; Company employee called to report that a nurse informed her HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) arrived broken. She stated that she had pictures and the customer's invoice available and would send photos. No AE reported. Replacement case#02217263. after reviewing photos, it appears that two HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) syringes still in plastic tray have the finger flanges broken. Unable to reach customer at this time, submitting case with limited information and will attempt further contact with nurse to collect/confirm PQC details. 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: 02-Aug-2022 14:30 PM :Email received in the Mailbox on 2-AUG-2022 at 12:50pm with pictures related to this case. The email also contains the facility's invoice for the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). See attached. 02-Aug-2022 14:30 PM :QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: 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 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. 02-Aug-2022 14:30 PM :Outbound call 1 made at 1:39pm. Phone option 1, then left a message on VM for "back office." phone# and case# left for reference. If customer does not call back, 2 additional attempts will be made within the next 7 business days in an attempt to collect PQC details. On callback, please ask all PQC questions from previous note. Determine if PFS with broken finger flanges are available for retrieval. Confirm details from case 02217263 to request a replacement for customer. 02AUG-2022 Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk. 02-AUG-2022 Received & Attached Photos. 02-AUG-2022 Requested to please confirm with the reporter how many of the syringes were received broken. 02-AUG-2022 16:30 PM :Attachment added. 02-AUG-2022 16:30 PM :Email received in the 0Mailbox on 02-AUG-2022 at 3:31pm with the following request from quality: "Can you please reach out to the reporter and ask them how many syringes were broken?" See attached. Forwarded to case owner for follow up. 03-AUG-2022 2022-08-02T16:43:23-04:00 Response to quality email: "Outbound call# 1 made at 1:39pm; left a message on VM; phone# and case# left for reference; 2 additional attempts will be made within the next 7 business days in an attempt to collect PQC details. "
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.07.2022
- Impfdatum
- -
- Beginn
- 27.06.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Syringe issue
Symptomtext
No AE.; Sterile Injectable;N/A;Broken Syringe/Broken syringe; Nurse (also reported as a medical assistant) is calling in to report a PQC for GARDASIL 9. Per caller the finger flange is broken and dangling on the syringe. No AE.. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for Agency: 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 "racked" 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 o If yes, describe the size, shape & depth of the crack: THE FINGER FLANGE IS CRACKED AND DANGLING ON THE SIDE o Provide the exact location of the crack on the syringe: THE FINGER FLANGE IS CRACKED WITH THE PIECE DANGLING ON THE SIDE OF IT o Is the syringe broken into 2 or more pieces? NO o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) NA o Provide the exact location of the breakage on the syringe? NA 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) BROKEN FINGER FLANGE o If yes, describe in detail how it is broken. IT IS BROKEN ON THE SIDES WHERE THE FINGERS GO THERE IS A STRAIGHT BREAK LIKE A PERFECTLY ROUND SNAP o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO o Was there difficulty trying to attach the syringe needle to the syringe? NO o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used? NA o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? NA o Is there any broken glass or other separated component in the tray? (if yes specify) NA o After removing the syringe from the tray? YES o While trying to attach the needle to the syringe? NA o While giving the injection? NA o Immediately after giving the injection? NA o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES 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 o If no, describe damage NA o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe NA o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO o If complaint sample is not/cannot be returned, please provide reason: NA *If photos are available, ask the customer to send them to email. 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. 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: 28-JUN-2022 19:30 PM :Attachment added to System. 28-JUN-2022 19:30 PM :Attachment added to System. 28-JUN-2022 19:30 PM :Email received in Contact Center on 28-JUN-2022 at 5:13pm with pictures for this case. See attached. 29-JUN-2022 Company representative: Received & attached Photos. 29-JUN-2022; Second person reviewed by Company representative 29-JUN-2022 Company representative: Requested company to ask the reporter the following below- Can you please confirm with the reporter if the sample is available for return? If it is , Please send to company. Also if it is not available can you ask them to provide the reason why. 29-JUN-2022 12:30 PM :Attachment added to System. 29-JUN-2022 12:30 PM :Email received on 29-JUN-2022 at 10:33am with the following request from quality: "Can you please confirm with the reporter if the sample is available for return? If it is , Please send to company. Also if it is not available can you ask them to provide the reason why." See attached. Forwarded to case owner for follow up. 29-JUN-2022 15:00 PM :Attachment added to System. 29-JUN-2022 15:00 PM : Labels created 06/29/2022 29-JUN-2022 15:30 PM : Labels created 29-JUN-2022 29-JUN-2022 16:30 PM :Confirmed with caller at time of call that the product is available for return. No AE/no additional PQC details. 29-JUN-2022 16:30 PM :Case closed by mistake. Case reopened and submitted. No AE/additional PQC details. Complaint Description Summary Per caller the finger flange is broken and dangling on the syringe.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 06.06.2022
- Impfdatum
- 01.06.2022
- Beginn
- 01.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product preparation error
Symptomtext
Pt given 0.2ml of undiluted COVID-19 vaccine (orange cap) in right deltoid. Monitored patient in office. No adverse affects noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -