- Staat
- TX
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 12.10.2022
- Impfdatum
- 12.10.2022
- Beginn
- 01.10.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cardio-respiratory arrest
Epistaxis
Face injury
Generalised tonic-clonic seizure
Head injury
Lip injury
Presyncope
Skin abrasion
Syncope
Symptomtext
About 3 - 5 minutes after the vaccination, despite instructions to remain seated, the patient was walking in the clinic and had a presyncopal episode where he hit his face/head on opposite sides of a door jamb , bent over at the waist and collapsed to the floor and then rolled to his back. No LOC. +laceration to upper lip (inside) and mild abrasion around philtrum. Denied any other symptoms. Code called, vitals assessed, patient given fluids and cookies. No neck tenderness to palpation, FROM without pain at neck. Assisted to seating then standing and walked back with assistance to exam room. Asked to sit in chair. About 3 minutes later had a brief tonic clonic seizure (3 - 5 seconds) with LOC - no recollection of event. Noted small nosebleed at this time. Continued to reassess vitals, called EMS and transported to hospital for further management
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardio-respiratory arrest
- Hospital-Tage
- -
- Labordaten
- Pending from ER
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Hyperlipidemia and hypertriglyceridemia Had prior h/o obesity (BMI > 95%ile) but now resolved
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 23.11.2022
- Impfdatum
- 23.11.2022
- Beginn
- 23.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Presyncope
Symptomtext
Vasovagal reaction post administration
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- glucose POC
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- unknown
- Allergien
- none
- Vorherige Impfungen
- vasovagal reaction
- Staat
- OH
- Alter
- -
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 12.10.2022
- Beginn
- 12.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hyperhidrosis
Joint swelling
Mobility decreased
Pain in extremity
Peripheral swelling
Pyrexia
Symptomtext
Joint swelling; Mobility decreased; Peripheral swelling; Pain in extremity; Hyperhidrosis; Pyrexia; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2477955-1. The original narrative from the sender is the following: Mother states that symptoms began that night. Mother reports that child had a fever of 101 and was very sweaty. Mother reports giving child Tylenol, and that it is helping with the fever. Mother reports that child has been saying his legs hurt, hasn't been running around as much, and that the Childs feet/ankles seem swollen. Nurse informed mother that symptoms, aside from swelling of feet/ankles, were normal. Nurse informs mother that a VAERS report will be filled. Nurse instructs mother to call doctor. Nurse instructs mother to bring child to urgent care/hospital if symptoms worsen/continue. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Joint swelling", "Mobility decreased", "Peripheral swelling", "Pain in extremity", "Hyperhidrosis", and "Pyrexia". No further information is expected
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- CETIRIZINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 11.04.2023
- Impfdatum
- 14.03.2023
- Beginn
- 14.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Rash pruritic
Symptomtext
itchy bumps on face, neck and hands approximately 5 hours after getting vaccine, Pt contacted our office spoke with our triage nurse and was instructed to take Benadryl, apply cool compresses and seek emergent eval if resp. sxs developed
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- na
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- -
- Andere Medikamente
- multivitamin
- Allergien
- no known
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 27.02.2023
- Impfdatum
- 21.02.2023
- Beginn
- 22.02.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
Left arm swollen, redness and warmth around injection site patient placed on Bactrim DS 1 tablet BID x7 days. Will recheck on Thursday 3/2/23
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 20.01.2023
- Impfdatum
- 19.01.2023
- Beginn
- 20.01.2023
- Tage bis Beginn
- 1,0
- Dosis
- 5
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Urticaria
Symptomtext
Mother of child reports child woke this morning with a few small hives on his chest. At 1301 she called the Health Department stating school called to report child now has hives on his face, arms, back, and chest. Denies any other symptoms. Advised to monitor and have child evaluated with new or worsening symptoms. Mother spoke with primary care team who advised her to monitor and bring child in if symptoms worsened.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- RSV
- Vorgeschichte
- Spina Bifida
- Andere Medikamente
- n/a
- Allergien
- Prednisone, Dairy
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 19.01.2023
- Impfdatum
- 18.10.2022
- Beginn
- 26.10.2022
- Tage bis Beginn
- 8,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Rash erythematous
Rash maculo-papular
Symptomtext
MMR vaccine given at 12 mon well visit along with other vaccines. Rash maculopapular erythematous all over body 10/26/22 to 10/28/22. Started resolving later rash lasted 5 to 7 days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash erythematous
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 19.11.2022
- Impfdatum
- 14.11.2022
- Beginn
- 15.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site swelling
Local reaction
Symptomtext
LOCALIZED REACTION WITH REDNESS AND SWELLING THE THE UPPER RIGHT ARM. PATIENT DENIED ANY ITCHING OR PAIN TO THE AREA OF CONCERN.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- ADHD, ANXIETY, DEPRESSION
- Andere Medikamente
- GUANFACINE, CONCERTA
- Allergien
- AMOXICILLIN
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- F
- Eingang
- 04.11.2022
- Impfdatum
- 01.11.2022
- Beginn
- 02.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site nodule
Injection site swelling
Symptomtext
mild swelling and redness to upper left thigh with "knot" feeling
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- no
- Andere Medikamente
- -
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 26.10.2022
- Impfdatum
- 24.10.2022
- Beginn
- 24.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Headache
Nausea
Pain
Product preparation error
Pyrexia
Symptomtext
Child was given 0.2 ml of undiluted COVID vaccine. Tolerated vaccine well. Spoke with Step father on 10/25/22 who reports side effects of fever, nausea, body ached and headache within 8 hours of getting vaccine. Symptoms improved by morning.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Unknown
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 25.10.2022
- Impfdatum
- 24.10.2022
- Beginn
- 24.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site discomfort
Product preparation error
Symptomtext
Patient was given 0.2 ml of undiluted Pfizer Monovalent vaccine. Family contacted the next day. Child was experiencing normal side effects - local injection site discomfort. Afebrile. Mother had no concerns.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site discomfort
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- N/A
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 7,0
- Geschlecht
- F
- Eingang
- 21.10.2022
- Impfdatum
- 21.10.2022
- Beginn
- 21.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Nervousness
Symptomtext
Patient was nervous when vaccinated by provider. Once vaccination was complete, the patient stood up and walked over with the clinical coordinator to a sticker table to select a sticker. Patient stated she felt a little dizzy. At which point the clinic coordinator grabbed the patient and lowered her to the floor as her knees began to buckle. Staff were alerted and the patients eggs raised. Patient did not hot her head or lose consciousness during episode. Patient was stayed supine until we were comfortable for her to sit on the floor. Patient was given juice by nurse, and later stood up and walked over to the observation area and was observed for approx 30 minutes. Incident was reported to parent/guardian by school nurse and Onsite medical.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- RI
- Alter
- 47,0
- Geschlecht
- F
- Eingang
- 12.10.2022
- Impfdatum
- 07.10.2022
- Beginn
- 07.10.2022
- 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
Nerve compression
Pain
Pain in extremity
Product administered at inappropriate site
Symptomtext
Patient called on 10/11/2022 at 10:30am. Patient participated at the School public flu event on 10/7/2022 at 8:05am. Patient sat in chair with the nurse at approximately 8:10am and immediately after receiving the influenza vaccine felt shooting pain down arm. Patient iced arm that night but when the pain continued through the weekend went to an urgent care on 10-9-2022. Patient was told the flu vaccine was given in the wrong area - it was injected too high towards the shoulder and caused compression of the nerves. Patient was advised to alternate Ibuprofen and Tylenol and well as ice and to seek an appointment with an orthopedic specialist.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 07.10.2022
- Impfdatum
- 04.10.2022
- Beginn
- 07.10.2022
- Tage bis Beginn
- 3,0
- Dosis
- 7+
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pain in extremity
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
Ten year old female was given Pfizer Bivalent 12 and up vaccine in error. Only adverse effect was a sore arm after injection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- None known.
- Vorgeschichte
- None.
- Andere Medikamente
- None known.
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 8,0
- Geschlecht
- F
- Eingang
- 03.10.2022
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Headache
Product preparation error
Symptomtext
Pfizer vaccine was administered without being diluted. Tried to notify mother on 9/30/2022, no answer, Left message to call me back. Tried to call again 10/3/2022 0800, Left message to call back. 11:30 am Mom called back, states that child was fine all weekend, stated that she had a headache on Friday evening. Mom stated that she was fine rest of weekend.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 27.01.2023
- Beginn
- 27.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Symptomtext
FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2573888-1. The original narrative from the sender is the following: FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV was administered to a patient under 6 months old instead of vaxelis with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination. On 27-JAN-2023 the patient developed a non-serious event of fluzone qiv np (strength, formulation was unknown,dose:0.5ml, batch number: UT7689LA and expiry date:30-Jun-2023 via intramuscular route in Left thigh for prophylactic vaccination) was administered to a patient under 6 months old instead of vaxelis with no reported adverse event (product administered to patient of inappropriate age, wrong product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and VAXELIS. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) was not applicable. Outcome: Unknown 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. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- -
- Geschlecht
- M
- Eingang
- 26.06.2023
- Impfdatum
- 27.01.2023
- Beginn
- 27.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Off label use
Wrong product administered
No adverse event
Product administered to patient of inappropriate age
Symptomtext
Instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with the combo vaccine; therefore they received double dose of IPV.; The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine, instead of just DTaP the patient received the combination vaccine that has DTaP,/ IPV/ HIB/ HepB. Pt was also due & given IPV along with combo vaccine.; 5-year-old child; Mother notified and watched for any adverse reactions. We have not been notified there have been any.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577243-1. The original narrative from the sender is as follows: The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine. The label was not fully read; Instead of just DTaP the patient received the combination vaccine that has DTaP, /IPV/HIB/Hep B. Pt was also due & given IPV along with combo vaccine; therefore, they received double dose of IPV. Mother notified and watched for any adverse reactions. We have not been notified there have been any. Due to the nature of the event the causal relationship between Vaxelis and the events, "no adverse event, extra dose administered, and wrong product administered" is not applicable. The case is considered as "off-label use" (Product use in unapproved population). No further information is not expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 08.11.2022
- Impfdatum
- 04.11.2022
- Beginn
- 04.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Circumstance or information capable of leading to medication error
Scratch
Symptomtext
Patient received a scratch on his arm when he pulled his hand out of his Moms grip and grabbed the vaccine just as I poked his arm. It is unclear if it was the needle or the safety device that scratched him.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Circumstance or information capable of leading to medication error
- Hospital-Tage
- -
- Labordaten
- No
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 6,0
- Geschlecht
- F
- Eingang
- 04.11.2022
- Impfdatum
- 01.11.2022
- Beginn
- 01.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong patient
Symptomtext
This vaccine recipient was not registered to receive the flu vaccine and should not have been vaccinated. The vaccinated child was mistaken for the child who was registered and was supposed to receive the vaccine. The child did not experience an adverse reaction to the vaccine. The school nurse and principal met with the child's parents at the school. The parents preferred to have the child vaccinated at her PCP. The parents completed a vaccination consent form for this vaccine administration and will let this vaccination administration stand for this years flu vaccination. Parents were concerned that medical information be entered into the Vaccine Registry. That has been done. Influenza Incident Report filed with OnSite Medical direction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- Unknow. As there was no adverse reaction to this administration that our staff was made aware of.
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- Unknown
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 28.10.2022
- Impfdatum
- 26.10.2022
- Beginn
- 26.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immunisation reaction
Wrong product administered
Symptomtext
Administered Age appropriate Bivalent instead of Monovalent for correct age to child who didn't receive Monovalent Series. Contacted Family on 10/27/22. Father reports normal side effects and returned to school today.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Immunisation reaction
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- unknown
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 12.10.2022
- Impfdatum
- 12.10.2022
- Beginn
- 12.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Discomfort
Hypoacusis
Visual impairment
Symptomtext
Vaccine Recipient stated that she started to see black, her hearing was squeaky, and her body felt heavy. The vaccine recipient was immediately laid supine on the floor. After three minutes she stated she felt better and wanted to move to a sitting position. After an additional five minutes she was moved to sitting on the bench of the lunch table. At 11:30AM the school nurse released the vaccine recipient to her lunch period.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Discomfort
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Vaccine Recipient denied any pertinent medical history.
- Vorgeschichte
- None disclosed by vaccine recipient.
- Andere Medikamente
- Vaccine Recipient stated no medications taken regularly.
- Allergien
- Vaccine Recipient stated no known allergies.
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Poor quality product administered
Product storage error
Symptomtext
patient received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred, with no reported adverse event; Temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case is linked to cases 2022SA409520(CLUSTER), 2022SA409928(CLUSTER) and 2022SA409694(CLUSTER). This case involves an adult patient (unknown gender) who received Influenza Quadrival A-B Vaccine [Fluzone QIV] np from pre-filled syringes after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, frequency, route: unknown) (lot number: UT7689LA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and patient received fluzone qiv np from pre-filled syringes after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day) and a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) (latency: same day). It was reported, the cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients. This situation is reported as a medication error due to vaccines being administered post-excursion. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable for all events. At time of reporting, the outcome was Unknown for all events. 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
- Poor quality product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- 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
Poor quality product administered
Product storage error
Symptomtext
temperature excursion at low temperature of 29.0F for 45 minutes, with no adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2022SA409526 , 2022SA409520 and 2022SA409694(CLUSTER). This case involves Adult and unknown gender patient to whom Influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post temperature excursion and temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that Influenza quadrival A-B vaccine had temperature excursion at low temperature of 29.0f for 45 minutes, with no adverse event (product storage error) (latency: Unknown) On 23-Sep-2022, the patient received a dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7689LA; formulation, strength, dose and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination post temperature excursion with no adverse event (poor quality product administered) (latency; on same day) Action taken: not applicable. Outcome: Unknown. 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.; Sender's Comments: SAD20220927002156:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- -
- Beginn
- 23.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no reported adverse event; temperature excursion involved a low temperature of 29F with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2022SA408679, 2022SA410140, 2022SA409520, 2022SA409928, 2022SA410163, 2022SA410177, 2022SA410116, 2022SA409707 and 2022SA409694. This case involves an unknown age and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from pre-filled syringes after a temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, temperature excursion occurred and involved a low temperature of 29.0 F (Fahrenheit) and the total excursion time was for 45 minutes with no reported adverse event (product storage error). The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection from pre-filled syringes (dose, strength, expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for prophylactic vaccination after a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) Doctor states that 12 patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred on 23-Sep-2022, including 4 pediatric patients and 8 adults. Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- 01.09.2022
- Beginn
- 01.09.2022
- 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
Poor quality product administered
Product storage error
Symptomtext
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2022SA409520 and 2022SA409694. This case involves an unknown age and unknown gender patient and reporter stated that there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event and vaccine administered post temperature excursion with no adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided. On 23-Sep-2022 , there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error) involving INFLUENZA QUADRIVAL A-B VACCINE. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. In Sep-2022 the patient developed a non-serious event of vaccine administered post temperature excursion with no adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE ( formulation: suspension for injection, strength, route, administration site was unknown, batch number: UT7689LA and expiry date was unknown for prophylactic vaccination). Action taken : not applicable. Outcome: Unknown 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.; Sender's Comments: SAD20220927002156:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- 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
Poor quality product administered
Product storage error
Symptomtext
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no adverse event; patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to 2022SA408679. This case involves Adult and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from pre-filled syringes after a temperature excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE , Suspension for injection (Dose, strength expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for immunization (poor quality product administered) (Latency: same day) after temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no adverse event (product storage error) (unknown latency) . Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- -
- Beginn
- 23.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Vaccine administered post excursion with no reported adverse event; Temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022 the suspect INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event (product storage error). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength and dose not reported; lot UT7689LA) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. 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.; Sender's Comments: US-SANOFI-01296467: SAD20220927002156:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- 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
the temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult (patient-7) and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error). On 23-Sep-22, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization. On 23-Sep-22, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. 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
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- 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
The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional. This case involves adult patient being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA409526, 2022SA409694, 2022SA409707 and 2022SA408679. On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error). On 23-Sep-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot: UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency. Action taken: Not applicable. At time of reporting, the outcome was Unknown for both events. 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- -
- Beginn
- 23.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
vaccine administered post excursion with no reported adverse event; temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2022SA409520(CLUSTER) and 2022SA409694(CLUSTER). This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022 the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization. On an unknown date, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. 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.; Sender's Comments: SAD20220927002156:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.10.2022
- Impfdatum
- 23.09.2022
- Beginn
- 23.09.2022
- 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
The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional. This case involves pediatric patient (Patient-09) being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA409526, 2022SA409520, 2022SA409707 and 2022SA408679. On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error). On 23-SEP-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot: UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) (latency same day). Action taken: Not applicable. At time of reporting, the outcome was Unknown for both events. 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.; Sender's Comments: SAD20220927002156:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 06.10.2022
- Impfdatum
- 04.10.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 1,0
- Dosis
- 5
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Eyelid oedema
Ocular hyperaemia
Swelling of eyelid
Symptomtext
Bilateral swollen eyelids, lower > upper, and eyes mildly red; No discharge, no eye pain, no headache, no fever, no reaction at the injection site. Benadryl was helpful, and 24 hours later eyelids only minimally edematous at 10/05 medical encounter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Eyelid oedema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Developmental Delay with Autism assessment pending
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 10,0
- Geschlecht
- M
- Eingang
- 03.10.2022
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product preparation error
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- Pfizer vaccine was administered without being diluted. Tried to notify mother on 9/30/2022, no answer, Left message to call me back. Tried to call again 10/3/2022 0800, Left message to call back. 11:30 am Mom called back, states that child was fine all weekend, no side effects at all. Did very well with vaccinations.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 6,0
- Geschlecht
- M
- Eingang
- 03.10.2022
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product preparation error
Symptomtext
Pfizer vaccine was administered without being diluted. Tried to notify mother on 9/30/2022, no answer, Left message to call me back. Tried to call again 10/3/2022 0800, Left message to call back. 11:30 am Mom called back, states that child was fine all weekend, no side effects at all. Did very well with vaccinations.
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
- MT
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 26.09.2022
- Impfdatum
- 20.09.2022
- Beginn
- 20.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
Symptomtext
Gave 3rd dose too soon. Was given 4 weeks after 2nd dose instead of 8 weeks.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 0,2
- Geschlecht
- U
- Eingang
- 17.09.2022
- Impfdatum
- 14.09.2022
- Beginn
- 14.09.2022
- 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 administered to patient of inappropriate age
Symptomtext
gave fluzone quadrivalent to a 2-month old,with no reported adverse event; Initial information was received on 14-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old and unknown gender patient who experienced gave fluzone quadrivalent to a 2-month old,with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Sep-2022, the patient received one dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7689LA and expiry-30-06-23) (dose, formulation and strength:unknown) via unknown route in unknown administration site for immunization. On 14-SEP-2022 the patient developed a non-serious gave fluzone quadrivalent to a 2-month old,with no reported adverse event (product administered to patient of inappropriate age) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable. At time of reporting, the outcome was Unknown for the event gave fluzone quadrivalent to a 2-month old,with no reported 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 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -