- Staat
- SC
- Alter
- 41,0
- Geschlecht
- M
- Eingang
- 02.11.2023
- Impfdatum
- 02.11.2023
- Beginn
- 02.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Presyncope
Syncope
Symptomtext
Patient after receiving Flublok and Adacel, fainted...appeared to have a vagal reaction after around 5 minutes. EMT's were called came and monitored patient until he had a stable blood pressure and released him under his wife's care who was with him.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Previous history of fainting after getting vaccinations
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- Passed out with a previous vaccination.
- Staat
- WA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 08.09.2023
- Impfdatum
- 08.09.2023
- Beginn
- 08.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
syncope after the shot
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- unknown
- Vorgeschichte
- unknown
- Andere Medikamente
- unknown
- Allergien
- unknown
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 30.12.2023
- Impfdatum
- 30.12.2023
- Beginn
- 30.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cold sweat
Dizziness
Fall
Hyperhidrosis
Mydriasis
Pallor
Posturing
Tremor
Unresponsive to stimuli
Symptomtext
Patient received 3 vaccinations as stated above. Once complete, I urged customer to sit for 15 minutes outside the pharmacy to monitor for side effects. She stated she felt lightheaded at that time, so I placed her feet up in a chair as well and told her to let us know if symptoms persist or worsen. After a few minutes, her friend sitting beside her called to pharmacy personnel for help. The customer was slouched down on the bench, unresponsive, eyes open, pale, and diaphoretic. Her entire body was shaking, though minimally, and she was posturing with her hands drawn inward to her chest. We called a code white at our location. Within a few moments after coming to her side, the customer aroused without additional rescue medication. When asked questions about orientation, she was able to answer all of them. She was provided a cool compress and water. She stated she felt like she had "just gone to sleep". Her friend described her posturing in the same manner and explained her eyes "were dilated and open in a crazy way." The customer quickly returned to "normal" but remained pale and clammy. She refused an ambulance. She was able to walk away from the pharmacy with her friend unassisted about 20 minutes after the event. I gathered pertinent information for reporting and told the customer to please call us with any other concerns. She stated she did not have a history of seizures, nor prior reactions to any vaccinations.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Tremor
- Hospital-Tage
- -
- Labordaten
- BP obtained with automatic machine, 112/64 during patient arousal.
- Aktuelle Erkrankungen
- none stated on patient questionnaire/consent form.
- Vorgeschichte
- none stated on patient questionnaire/consent form.
- Andere Medikamente
- Unknown.
- Allergien
- None stated on patient questionnaire/consent form.
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 12.12.2023
- Impfdatum
- 07.12.2023
- Beginn
- 09.12.2023
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chest discomfort
Chest pain
Fatigue
Pyrexia
Symptomtext
Patient reported feeling soreness to chest on 12/09/23 upon waking up; 5/10 on a numerical scale as per patient. Patient reported that she would feel the pressure upon deep breathing in and out. Patient also developed a fever and felt tired that same day (12/09/23) . As per patient symptoms resolved the following day (12/10/23) upon waking up . Patient has not had any further symptoms up to today.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chest pain
- Hospital-Tage
- -
- Labordaten
- As per patient's mother, patient was not seen by a doctor .
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 60,0
- Geschlecht
- M
- Eingang
- 05.12.2023
- Impfdatum
- 28.09.2023
- Beginn
- 28.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Pain in extremity
Symptomtext
Customer received the 2 vaccines on the left deltoid(Adacel and Flublok) and Shingrix on the right deltoid. He said that his arm was sore from the vaccines but he expected the pain/soreness to go away in a few days but that has not happened. Customer said his arm has been hurting since then. He said he finds it difficult to perform simple activities like putting on seatbelt and raising his hand over his head. He also said that he has gone to see a Doctor and a Chiropractor but the pain is still there. He plans to go for an XRAY to see if there is any damage to his arm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 53,0
- Geschlecht
- F
- Eingang
- 05.11.2023
- Impfdatum
- 01.10.2023
- Beginn
- 02.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Mobility decreased
Pain
Pain in extremity
Tenderness
Symptomtext
patient came in on 11/5/23 and reported that her left arm has been sore and is still tender to touch since she received her immunizations on 10/1/23. She can barely lift up her left arm past 45 degree. Says it is limiting her mobility and is painful
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- unknown
- Vorgeschichte
- unknown
- Andere Medikamente
- unknown
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 11.10.2023
- Impfdatum
- 30.09.2023
- Beginn
- 30.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blister
Malaise
Swelling face
Symptomtext
PATIENT HAD BLISTERS ON FACE; SWOLLEN FACE; SHE STARTED FELLING ILL IN THE SAME EVENING SHE GOT THE VACCINES;
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Malaise
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- NOT KNOWN ILLNESS
- Vorgeschichte
- HYPERTENSION
- Andere Medikamente
- METOPROLOL; LIPITOR; SYNTHROID
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 44,0
- Geschlecht
- M
- Eingang
- 10.10.2023
- Impfdatum
- 06.10.2023
- Beginn
- 06.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Fatigue
Myalgia
Symptomtext
Donor received Tetanus Vaccine. He c/o fatigue, muscle aches and joint pain for 2 days starting on 10/06/2023
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- DEPRESSION, ANXIETY, ACID REFLUX AND FIBROMYALGIA
- Andere Medikamente
- escitalopram, welbutrin and omeprazole
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 38,0
- Geschlecht
- M
- Eingang
- 10.10.2023
- Impfdatum
- 29.09.2023
- Beginn
- 29.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Chills
Fatigue
Myalgia
Symptomtext
Donor sypmtoms on 09/29/2023 were chills, fatigue, muscle and joint pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- ADHD
- Andere Medikamente
- Vyvanse
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 14.09.2023
- Impfdatum
- 12.09.2023
- Beginn
- 13.09.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal discomfort
Erythema
Injection site mass
Injection site pain
Nausea
Rash
Skin warm
Symptomtext
9/13/2023 patient felt sick to his stomach, very nauseous all day. Noticed redness on face and hot to touch beginning last night 9/13/2023 and grandma gave liquid benadryl. This morning 9/14/2023 redness somewhat diminished but rash noticed on upper body. Pill form benadryl given today 9/14/2023. Injection site left upper arm deltoid now has a noticeably raised knot and is very sensitive and tender to touch. No known reactions to any other injections prior to this.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 09.08.2023
- Impfdatum
- 28.07.2023
- Beginn
- 03.08.2023
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Blood immunoglobulin G
Blood immunoglobulin M
Epstein-Barr virus test
Erythema multiforme
Fatigue
Full blood count
Herpes simplex test
Laboratory test
Metabolic function test
Mycoplasma test
Rash
Symptomtext
developed rash 6 days after vaccination. Saw urgent care doctor who thought related to recent vaccine. Came to my office for follwup and rash looked most consistent with erythema multiforme. Labs ordered to see if a possible recent illness could explain the rash or cause the erythema multiforme. Rash is still present.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- labs: cbc, cmp, parvovirus IgM and IgG, EBV titers, HSV IgM and IgG, mycoplasma pneumonia IgM and IgG.
- Aktuelle Erkrankungen
- not identified, felt tired for afew days prior to rash
- Vorgeschichte
- asthma
- Andere Medikamente
- albuterol prn, zyrtec prn
- Allergien
- no
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 23,0
- Geschlecht
- F
- Eingang
- 19.12.2023
- Impfdatum
- 19.12.2023
- Beginn
- 19.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Client received Tdap 12/19/23 after searches under maiden and married name indicated no Tdap given within ten years and following education and discussion with client. Client returned to this clinic on the same day with paper documentation stating received Tdap and flu vaccination 12/13/23 and that she required polio booster. Client advised of duplicate Tdap vaccination, voiced understanding.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- None at this time - client educated to report any adverse effects or reaction to duplicate Tdap in R deltoid with Supervisor's direct number provided - client voiced understanding and agreement, declined any further intervention at this time.
- Aktuelle Erkrankungen
- None known
- Vorgeschichte
- None known
- Andere Medikamente
- None known
- Allergien
- None known
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 05.12.2023
- Impfdatum
- 28.11.2023
- Beginn
- 28.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Unevaluable event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unevaluable event
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- strep infection on 11/14/2023
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none known.
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 25,0
- Geschlecht
- F
- Eingang
- 21.11.2023
- Impfdatum
- 06.11.2023
- Beginn
- 08.11.2023
- Tage bis Beginn
- 2,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Full blood count normal
Laboratory test normal
Neurological examination normal
Slow response to stimuli
Thinking abnormal
Thyroid function test normal
Symptomtext
Patient stated she has clouded thinking, Decreased processing of thoughts and slow responses starting one day after injections.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Full blood count normal
- Hospital-Tage
- -
- Labordaten
- Normal physical and neuro exam. Normal CBC, Chemistry, Thyroid on 11/17/2023
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 20.11.2023
- Impfdatum
- 07.09.2023
- Beginn
- 17.10.2023
- Tage bis Beginn
- 40,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Inappropriate schedule of product administration
Medication error
No adverse event
Symptomtext
reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event; pregnant patient received adacel with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old female pregnant patient where patient inadvertently received 2 doses of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event occurred at 34 weeks of pregnancy and pregnant patient received adacel with no reported adverse event occurred at 34 weeks of pregnancy and the patient was exposed to vaccine at 29 weeks of pregnancy, during third pregnancy trimester for diphtheria-2/tetanus/5 ac pertussis vaccine. The date of last menstrual period was reported as 23-Feb-2023. The estimated due date is 30-Nov-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot U7869AA and expiration date- 18-Aug-2025) via intramuscular route in the right deltoid. On 17-Oct-2023 she also received a dose of the same vaccine lot U7869AA via intramuscular route in the right deltoid (dose, formulation, strength: not provided) for Immunisation (inappropriate schedule of product administration) and (exposure during pregnancy) (latency- same day). Action taken- not applicable. At time of reporting, the outcome was Unknown for the event and Additionally, at time of reporting, the pregnancy is still ongoing. 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
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 52,0
- Geschlecht
- F
- Eingang
- 20.11.2023
- Impfdatum
- 17.11.2023
- Beginn
- 01.11.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product preparation error
Symptomtext
no reported adverse events- vaccine administration error- Shingrix adjuvent only injected, no active antigen
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 13.11.2023
- Impfdatum
- 07.09.2023
- Beginn
- 17.10.2023
- Tage bis Beginn
- 40,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Exposure during pregnancy
Extra dose administered
No adverse event
Symptomtext
Patient was administered TDAP at 28 weeks gestation on 9/7/23 and readministered on 10/17/23 @ 33 weeks gestion. No adverse reaction noted, patient has been seen in the office for 2 appointments since the injections. estimated due date 11/30/23.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Iron 325MG Prenatal Vitamins
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 72,0
- Geschlecht
- F
- Eingang
- 07.11.2023
- Impfdatum
- 07.11.2023
- Beginn
- 07.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Symptomtext
Client was given a high dose flu shot today (11/7/23) after client received a high dose flu shot on 10/18/23.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 09.10.2023
- Impfdatum
- 07.10.2023
- Beginn
- 08.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Swelling
Symptomtext
Swelling, redness
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 05.10.2023
- Impfdatum
- 01.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
QUADRACEL (DTAP/IPV) VACCINE WAS GIVEN IN ERROR.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- 20.09.2023
- Beginn
- 20.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Symptomtext
4-month-old patient was administered with adacel with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient to whom adacekl was given 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 DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)) for Immunisation. On 20-Sep-2023, 4 month old patient received 0.5 ml, once suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE,Suspension for injection lot U7869AA via intramuscular route in the right thigh for prophylactic vaccination (strength and expiry date: unknown) (product administered to patient of inappropriate age) (latency same day). Action taken was not applicable. At time of reporting, the outcome was Unknown for the event 4-month-old patient was administered with adacel 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 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
- PENTACEL; PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 63,0
- Geschlecht
- F
- Eingang
- 24.09.2023
- Impfdatum
- 20.09.2023
- Beginn
- 20.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Erythema
Skin warm
Symptomtext
warm to touch, started day of imz - red and softball size
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 36,0
- Geschlecht
- F
- Eingang
- 15.09.2023
- Impfdatum
- 15.09.2023
- Beginn
- 15.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
Error - Nurse gave MMRV instead of MMR
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 43,0
- Geschlecht
- M
- Eingang
- 31.08.2023
- Impfdatum
- 18.08.2023
- Beginn
- 18.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Product storage error
Symptomtext
The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023; No adverse event; Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. U7869AA) for COVID-19 prophylaxis. It was unknown whether the patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. Previously administered products included for Product used for unknown indication: TdaP (dose 1 U7869AA, right deltoid, intramuscular and sanofi pasteur (PMC)). Past adverse reactions to the above products included No adverse event with TdaP. On 18-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .25 milliliter. On 18-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter considered EXPIRED PRODUCT ADMINISTERED (Clinic Manager stated that a patient received a dose of the Moderna COVID19 vaccine bivalent after the beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jul-2023 and was administered on 18-Aug-2023) and NO ADVERSE EVENT (No adverse event) to be not related. No concomitant medication was reported. Patient received first Moderna vaccine on 07 Apr 2021. Patient received second Moderna vaccine on 05 May 2021.Patient received third Moderna vaccine on 27 Dec 2021. The vial was first punctured on 18-Aug-2023. The dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial size was 2.5 mL. The vial did not undergo any temperature excursions. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2023: Significant Follow-up received contains reporter added, product details added, historical vaccine and causality Updated.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: It was unknown whether the patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine or not.
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 29.08.2023
- Impfdatum
- 26.08.2023
- Beginn
- 26.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administered to patient of inappropriate age
Symptomtext
MMRV given to a 13 year old. Family to be notified.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- Unknown
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 21.08.2023
- Impfdatum
- 16.08.2023
- Beginn
- 16.08.2023
- 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
No adverse event
Symptomtext
Patient previously had a Tdap shot in 2019. The provider advised to give Tdap at 8/16/2023 visit, but after administering the vaccine saw that the patient should not have gotten that vaccine until a later date. No adverse reaction happened and patient and parent were advised it was given early, but that it would not harm the patient.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Exercise-Induced Bronchospasm
- Andere Medikamente
- Levalbuterol Tartrate Inhaler
- Allergien
- Amoxicillin
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 39,0
- Geschlecht
- M
- Eingang
- 15.08.2023
- Impfdatum
- 14.08.2023
- Beginn
- 14.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Planned power outage occurred on Saturday, 8/12 from 12:00p-11:00p. Asked facilities if medications from refrigerators in medication room needed to be removed due to power outages on 8/10/23. Was informed that medication room items should be on backup power so our refrigerator/freezers should be okay. Did not move medications out of these areas. Prior to being notified that refrigerators were out of range over weekend, patient was given adacel vaccine at visit today 8/14/23. Vaccine was given appropriately but should not have been given due to range of medication being inappropriate. Staff was not aware of refrigerator issue at time medication was given to patient. Management informed after of the temperature values in the area and placed signage in area to not use. Met with pharmacy and facilities and was told to discard all medications due to range values.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 14.08.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin laceration
Syringe issue
Symptomtext
tdap (adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves an unknown age female patient, diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date: unknown) (lot: U7869AA) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the patient had event of tdap (adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger (skin laceration) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. It was reported "Yesterday we had a nurse that was given a Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger. We did need to re-administer the vaccine as she was unable to give the medication". Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) was not applicable. It was not reported if the patient received a corrective treatment for the event. Outcome: Unknown.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin laceration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.08.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Accident at work
Skin laceration
Syringe issue
Symptomtext
Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Tdap (Adacel) vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient and reporter reported Tdap [Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7869AA) (with an unknown strength, expiry date) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date, the reporter reported Tdap [Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine while administering the portion of the syringe that you rest your fingers broke off and caused a laceration to the employees finger (skin laceration) (syringe issue) (unknown latency). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the reported events. Outcome: Unknown the reported event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Accident at work
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 37,0
- Geschlecht
- F
- Eingang
- 11.08.2023
- Impfdatum
- 11.08.2023
- Beginn
- 11.08.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Patient given Tdap but needed PCV20.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- None. Provider informed and determined no harm to patient.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Diabetes
- Andere Medikamente
- Zyrtec Singulair Derma-smoothe Lac-Hydrin Econazole Systane Balance
- Allergien
- NKDA No known food allergies
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.08.2023
- Impfdatum
- 31.07.2023
- Beginn
- 31.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Occupational exposure to product
Skin laceration
Syringe issue
Symptomtext
while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger; while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger.; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of an unknown age and gender and while administering diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel], the base of the syringe body broke off and cause a laceration to the rn's finger. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Jul-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date: not reported and lot U7869AA) via intramuscular route in unknown administration site for Prophylactic vaccination (immunization) and the base of the syringe body broke off and cause a laceration to the rn's finger. (occupational exposure to product) (latency: same day). On an unknown date while administering tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the rn's finger (skin laceration) (unknown latency). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Occupational exposure to product
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -