- Staat
- NC
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 14.07.2021
- Impfdatum
- 08.07.2021
- Beginn
- 08.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Full blood count
Syncope
Symptomtext
Syncope 1 hour after receiving vaccine, occurred at home. No other symptoms
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none, recommended CBC and Chem 14 but did not go to lab
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 25.06.2021
- Impfdatum
- 23.06.2021
- Beginn
- 23.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Syncope
Symptomtext
After finishing his visit and receiving vaccinations, the individual accompanied by his mother at the reception told his mother that he felt a little dizzy, the mother expressed that it was probably because he had not eaten and suddenly the child began to get dizzy. The individual fainted without answering his mother's questions. Immediately without waiting, the receptionist and the staff called the doctors, and the child was transferred to the exam room. Vital signs were taken, alcohol was used to awaken from fainting, the individual had normal vital signs, and his reaction to fainting was momentary without consequences. The individual was evaluated and sent home in good health by Dr, MD (pediatrician).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 07.06.2021
- Impfdatum
- 07.06.2021
- Beginn
- 07.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Dizziness
Pallor
Seizure
Symptomtext
Patient felt dizzy after vaccines were given. Patient sat down , noticed his eyes and face looked pale. Patient then started to convulse for less than 5 seconds. Vitals were taken and 911 was called.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- none
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 28.04.2021
- Impfdatum
- 27.04.2021
- Beginn
- 27.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Eye movement disorder
Fall
Seizure
Tonic clonic movements
Unresponsive to stimuli
Symptomtext
After administration of all three vaccines, patient's feel to floor from chair, body still and appeared to have seizure like activity with body tensing. At this point she was none responsive with eyes rolling back. After about 30 seconds, patient regained consciousness. She was alert and oriented. EMS and parents called. EMS evaluated calling episode a vasovagal response. Patient and family refused transport to ED.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None reported
- Vorgeschichte
- None reported
- Andere Medikamente
- None reported
- Allergien
- None reported
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 24.08.2021
- Impfdatum
- 04.08.2021
- Beginn
- 04.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Pallor
Tremor
Symptomtext
After vaccination administration, patient became lightheaded, and pale. I laid him down and held him under my arm, he began to shake his head slightly. I elevated his legs, and he then immediately got up and said he felt fine. Face turned back to original color, I asked him to stay for observation. After 20 minutes he left. Followed up with a call to parents and he has been doing well with no adverse reactions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Tremor
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- Myopia
- Andere Medikamente
- Vitamin D
- Allergien
- Cashews
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 13.08.2021
- Impfdatum
- 09.08.2021
- Beginn
- 10.08.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Axillary pain
Dyspnoea
Fatigue
Pain
Pain in extremity
Pyrexia
Symptomtext
low grade fever 100.2, body aches more specifically the left side under his arm pit, and fatigue. Pt states he had a hard time breathing morning of 8/10 but it resolved by the afternoon. Mother instructed to continue giving Tylenol 500mg 1-2 tab tid prn, if SOB or swelling of face/mouth develop call 911 go to ER. On 8/11/21 followed up with mother and she reported fever broke and body aches resolved but arm still sore and left axilla lump still there and sore. They were instructed to continue Tylenol prn and to try warm compress on the axilla to help with pain. They were informed to follow up on Friday 8/13/21 if symptoms persisted but they did not call to come in for an appointment.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- Acne no other illnesses reported at time of vaccine
- Vorgeschichte
- Acne, generalized anxiety
- Andere Medikamente
- minocycline 50 mg capsule. Unknown of any over the counter meds/supplements
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 21.05.2021
- Impfdatum
- 17.05.2021
- Beginn
- 17.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Crying
Fear
Headache
Palpitations
Tearfulness
Symptomtext
1315-approx. 10 minutes after administration patient c/o headache, states she feels like her heart racing with palpitations. Pt is awake and alert, oriented, conversational and able to follow commands. Resp even and unlabored, rate 16. Skin warm and dry with slight pallor. Pt assisted from chair where she was seated to gurney and encouraged to lay down, and breath deeply; pt complied. Blood pressure obtained and recorded; results wnl for age and situation. Pt became tearful, stated she was crying due to h/a 5/10 and states she is scared. Patient reassured and cool moist compress applied to forehead. Continued monitoring in observation area for additional 15 minutes, during this time Patient able to sit up, at a banana, drink water, talk with parent and siblings, no longer tearful. At reassessment pt awake and alert, oriented, respiratations even/unlabored, 18/min; Skin warm and dry, normal color, no pallor noted; states she feels better, denies pain. Parent states she has episodes of anxiety, during which she has similar complaints. VS again obtained and WNL. Pt able to stand and walk, denies lightheaded, no s/s of syncope; no s/s discomfort or distress. No further complaints from pt at this time. Family instructed on post-vaccine comfort measures before departing. Medical Director notified
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Palpitations
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- DENIES
- Vorgeschichte
- Denies
- Andere Medikamente
- Denies
- Allergien
- EGG, PORK-DERIVED
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 12.08.2021
- Impfdatum
- 10.08.2021
- Beginn
- 10.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bone pain
Headache
Hyperhidrosis
Impaired work ability
Lethargy
Malaise
Pain in extremity
Pruritus
Rash
Swelling face
Symptomtext
8/10/21 1700-arm hurt, didn't feel well while at work 8/10/21 Late Evening and into the night, did not recall exact time-diaphoretic, Facial swelling, headache Morning 8/11/21-facial swelling still present, but had gone down, feet and hands itching, lethargic. Pt made mother aware of symptoms, she called clinic at approx. 0930 we had him come into clinic for 1000 appt. Patient was examined and administered a dose of Depo Medrol. 8/12/21 spoke with patients mother 1115. Pt woke mother up early complaining that his "bones hurt". His arm is still swollen, but he had noted a rash starting in different areas all over his body, still complains of hands itching. Mother gave him Tylenol and antihistamine around 0630. Patient did go into work. His mother said he is suppose to check in with her during his lunch.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bone pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 11.08.2021
- Impfdatum
- 10.08.2021
- Beginn
- 10.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Nausea
Vomiting
Symptomtext
Immediately after receiving both vaccines, the Patient became nauseated and about 15-20 seconds later he vomited x2. Pt did not lose consciousness nor did he have any difficulty with breathing. After vomiting, the Patient stated that he immediately began to feel better
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None Known
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 05.08.2021
- Impfdatum
- 03.08.2021
- Beginn
- 03.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Symptomtext
Sore arm at injection site
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Adhd
- Andere Medikamente
- Vyvanse 10mg
- Allergien
- Penicillin
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 03.08.2021
- Impfdatum
- 16.07.2021
- Beginn
- 20.07.2021
- Tage bis Beginn
- 4,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Rash
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- ELEVATED BLOOD PRESSURE READING W/O A DIAGNOSIS OF HYPERTENSION R03.0 SEVERE OBESITY DUE TO EXCESS CALORIES E66.01, Z68.54
- Vorgeschichte
- NONE
- Andere Medikamente
- CHOLECALCIFEROL, VIT D3, 25 MCG CHEWABLE TAB
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 02.07.2021
- Impfdatum
- 02.07.2021
- Beginn
- 02.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pruritus
Injection site rash
Injection site swelling
Injection site warmth
Symptomtext
Menactra Red, Swollen, hot to touch, itching rash encompassing a dinner plate size on the right thigh which started the night of vaccine administration. TDAP Red rash encompassing a small dinner size plate with itching which started the night of vaccine administration. Ice packs were used the night of administration. Visit to office on 7/1/2021 and given PRID to apply to sites. Was told to return if reaction worsens.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- No medications or supplements
- Allergien
- No medications and food allergies
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 17.06.2021
- Impfdatum
- 16.06.2021
- Beginn
- 16.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Vomiting
Symptomtext
PT WAITING IN WAITING ROOM FOR 15 MIN, PATIENT STARTED TO FEEL DIZZY AND VOMITTING
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 14.06.2021
- Impfdatum
- 10.06.2021
- Beginn
- 10.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Nausea
Pallor
Symptomtext
Vaccines given at 1344 BP at this time 123/80, HR 82, Temp. 98.8. Patient verbalized feeling dizzy and nausea at 1348. Patient was asked to lay down on exam table. B/P 89/46 left arm, HR 74, RESP 22, Temp. 98.8. PT was oriented x3, visibly pale and sweating, @ 1351 BP 102/64, HR 76 laying down left arm. Pt sat up drank water, at 1355 BP 116/82 left arm sitting, HR 88, SPO2 99%. PT was evaluated by the Nurse Practitioner and cleared to go home.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- otc allergy medication
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 27.05.2021
- Impfdatum
- 24.05.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site induration
Injection site pain
Injection site swelling
Injection site warmth
Local reaction
Symptomtext
Right arm at the shot site was mild tender, warmth + indurated, and swollen. local reaction to vaccination advised to take ibuprofen every 8 hours after food for next 2-3 days as needed for pain. ICE the affected area if any worsening or fever return for follow up in the office
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site induration
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none known
- Vorgeschichte
- major depressive disorder generalized anxiety disorder
- Andere Medikamente
- none known
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 14.05.2022
- Impfdatum
- 04.05.2022
- Beginn
- 04.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
administered MENACTRA yesterday and after the event, they found out that it expired on 13APR2022 with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old female patient who experienced administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event while receiving vaccine Meningococcal a-c-y-w135 (d conj) vaccine [menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-May-2022, the patient received suspect Meningococcal a-c-y-w135 (d conj) vaccine at a dose of 0.5 ml once (strength, formulation :unknown) lot U6919AA expiry date :13-apr-2022 via unknown route in unknown administration site for immunization. On 04-MAY-2022 the patient developed a non-serious administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event (expired product administered) (latency :same day) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 05.04.2022
- Impfdatum
- 10.03.2022
- Beginn
- 10.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Swelling face
Symptomtext
Swelling to right side of face within 1 hour of receiving vaccinations. Treated with over the counter benadryl. Symptom subsided by morning per client's mother.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Swelling face
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Benadryl allergy as needed
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 10.11.2021
- Impfdatum
- 28.07.2021
- Beginn
- 28.07.2021
- 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
Symptomtext
no symptoms at time of vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- Constipation
- Vorgeschichte
- None
- Andere Medikamente
- Flonase, Singulair, Allegra and fexofenadine
- Allergien
- Seasonal Allergies
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 01.09.2021
- Impfdatum
- 02.08.2021
- Beginn
- 03.08.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Peripheral swelling
Symptomtext
We could not get in touch with the patient mother via phone . letter mailed out to the home. Pt c mild swelling to her R arm. Mom thought Regular reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Peripheral swelling
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- RAD, constipation
- Andere Medikamente
- Albuterol, Epi pen
- Allergien
- Peanut containing Products , Cat hair
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 18.08.2021
- Impfdatum
- 16.08.2021
- Beginn
- 16.08.2021
- 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
Wrong product administered
Symptomtext
I gave Kinrix (Dtap-polio) instead of intended Tdap to an 11 year old. I noticed my error right away and told the mother immediately while still in the room. The child had no adverse symptoms when the mother called back a few hours later.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- ADHD
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 29.07.2021
- Impfdatum
- 15.07.2021
- Beginn
- 16.07.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Lip swelling
Swelling of eyelid
Symptomtext
Swelling of lower lip and swelling of bilateral lower eyelids. This was noted the morning following vaccination. Resolved spontaneously over several hours without treatment. No other symptoms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Lip swelling
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- No known allergies to drugs, food, other products
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
lowest temperature reached was 1.6 dregrees Celsius / total time out of range was 2 hours and 30 minutes / wasn't a consecutive time frame / patients received the vaccines involved in the excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number J7H4D, expiry date unknown) for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) (batch number 1659422, expiry date unknown) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DR7158, expiry date unknown) for prophylaxis and MENACTRA (batch number U6919AA, expiry date unknown) for prophylaxis. On an unknown date, the patient received Engerix B, HPV vaccine, PREVNAR 13 and MENACTRA. On an unknown date, unknown after receiving Engerix B and HPV vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient received Engerix B,HPV Vaccine,Prevnar 13 and Menactra. Caller stated about temperature excursion with a vaccine. Also stated that it dropped bellows 2 degrees for 2 hours and 30 minutes and that it wasn't consecutive. The agend said the only number that showed up when the caller stated was the caller confirmed the details provided by the transfer agent. Caller confirmed she was calling to obtain stability details. The caller clarified the lowest temperature reached was 1.6 degrees Celsius. She confirmed that the total time out of range was 2 hours and 30 minutes. It wasn't a consecutive time frame. She said patients received the vaccines involved in excursion. The caller does not have any patients information with her to provide. Nurse clarified that patient received 4 different vaccines that given that day so just provided lot or batch numbers.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 18.07.2021
- Impfdatum
- 18.06.2021
- Beginn
- 18.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
Menactra exposed to - 51 Fahrenheit for about 14 hours, with no adverse event; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from a physician. This case involves an 11 years old male patient for whom reported MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] exposed to - 51 fahrenheit for about 14 hours. The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS PERTUSSIS VACCINE); and HPV VACCINE. On 18-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6919AA and expiry date: 13-Apr-2022] via an intramuscular route at left deltoid for prophylactic vaccination. It was case of actual medication error due to product storage error [Latency: on the same day]. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- DIPHTHERIA TETANUS PERTUSSIS VACCINE; HPV VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 18.07.2021
- Impfdatum
- 11.06.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Menactra was exposed to negetive 46 degree Celsius for about 14 hours with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Physician via Global Medical Information (GMI) (Reference number- 00672178) and transmitted to Sanofi on 07-Jul-2021. This case involves an 18 years old male patient who received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to negative 46 degree Celsius for about 14 hours (product storage error). The patient's medical history, past medical treatment, past vaccinations and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. On 11-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA and expiry date: 13-Apr-2021) via intramuscular route in the left deltoid for prophylactic vaccination that was exposed to negative 46 degree Celsius for about 14 hours (product storage error). The reported called for guidance and confirm if revaccination is needed. It was a potential medication error case due to product storage error temperature too low (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- MENINGOCOCCAL VACCINE B; HEPATITIS A VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 18.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
The patient received Menactra that was exposed to negative 51 Fahrenheit for about 14 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00672249) and transmitted to Sanofi on 07-Jul-2021. This case involves a 16 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], which was exposed to negative 51 F (Fahrenheit) for about 14 hours (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA, expiry date: 13-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to Product storage error temperature too low (latency: same day). It was reported "The physician mentioned that the temperature excursion was discovered after 3 people had already received the Menactra and she called to confirm if revaccination was needed" At time of reporting, no adverse event was reported. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 17.06.2021
- Impfdatum
- 08.06.2021
- Beginn
- 08.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Wrong product administered
Symptomtext
given Menactra and not the prescribed Polio vaccine due to the Menactra was placed in the Polio vaccine storage box with no ae; Initial information was received on 08-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00632999). It was reported that 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6919AA, expiry date: 13-Apr-2022) was administered to a four year old female patient and not the prescribed polio vaccine due to the menactra was placed in the polio vaccine storage box, on 08-Jun-2021 via intramuscular route in right deltoid for prophylactic vaccination (wrong product administered). It was a case of actual medication error due to wrong vaccine administered. The consumer did not get the Polio vaccine at the time of this report. At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 06.05.2021
- Impfdatum
- 05.05.2021
- Beginn
- 05.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Inappropriate schedule of product administration
Symptomtext
medication given too early in series
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
