chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, Myocarditis
Clinical narrative: PFIZER #1 11/30/2021 PFIZER #2 2/28/2022 DEVELOPED VACCINE INDUCED SUBCLINICAL MYOCARDITIS MANIFESTED AS HEART FAILURE AND NONISCHEMIC CARDIOMYOPATHY LVEF 25%.  TREATED WITH CARVEDILOL, ENTRESTO, VERQUVO, FARXIGA, AMIODARONE, COLCHICINE, LIFE-VEST, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 Fluzone HD vaccines by mistake. Prescriber and patient were notified. Proper procedure for reporting events were followed by company guidelines.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: Patient had a sudden onset of "extreme" fatigue after about an hour after the vaccination that lasted a few hours.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dyspnoea
Clinical narrative: within 10 minutes after getting shot patient developed trouble breathing , or swallowing, dizziness, called 911
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient reported that an hour after getting the spikevax she began itching.  No external rash or sign of allergy just a bad internal itch.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Not an adverse reaction. Wrong vaccine, i.e., for 12 yrs and older; pt is 7 yrs old.
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event. Wrong Pfizer Comirnaty covid vaccine for patient age: i.e., for age 12 yrs and up; patient is 5 yrs old.
Age: 0.33
Sex: M
Vaccine: PNC21
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given wrong immunization after confusion with him not needing Hep B yet and combo vaccines, went though 2 verifiers who agreed this was correct , was incorrect vaccine to give as pt was not quite old enough.  PATIENT HAS NOT HAD REACTION
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness after receiving the vaccines.  It happened about 20 to 30 seconds after the administration.  It lasted about 5 seconds.  He was talking immediately after.   He appeared to be okay after the observation period.   He did not feel dizzy and could walk on his own after a couple of minutes.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Diplopia, Disorientation, Fatigue
Clinical narrative: Patient received PFZ Covid vaccine on 10/24/24; she had previously had the Moderna brand.  Patient reports approximately 24 hours after immunization she developed the following symptoms: extreme nausea and vomiting, inability to walk, weakness, double vision, disorientation, fatigue.  Patient indicates these symptoms lasted 2 to 3 hours and resulted in a seizure.  Patient indicates that she has a history of 2 types of seizures: grand mal and complex frontal lobe seizures, and that this seizure was not like seizures she has had in the past.  She informed this RPh that her signs and symptoms begin shortly after she took her dose of Lacosamide.  Emergency services where called and the paramedics cared for her at home.   She reports that she is has recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Nausea, Seizure, Vomiting
Clinical narrative: Patient received PFZ Covid vaccine on 10/24/24; she had previously had the Moderna brand.  Patient reports approximately 24 hours after immunization she developed the following symptoms: extreme nausea and vomiting, inability to walk, weakness, double vision, disorientation, fatigue.  Patient indicates these symptoms lasted 2 to 3 hours and resulted in a seizure.  Patient indicates that she has a history of 2 types of seizures: grand mal and complex frontal lobe seizures, and that this seizure was not like seizures she has had in the past.  She informed this RPh that her signs and symptoms begin shortly after she took her dose of Lacosamide.  Emergency services where called and the paramedics cared for her at home.   She reports that she is has recovered.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colorectal cancer stage IV
Clinical narrative: Stage 4 Colorectal Cancer
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Fall, Head injury, Loss of consciousness, Paraesthesia
Clinical narrative: Patient was given the flu (I?m unsure what type) shot at school by the county health dept.  When she finished she left the classroom and fainted in the hallway falling straight back hitting her head and lying unconscious for close to a minute.  She was transported by ambulance to hospital.  She has a tingling sensation throughout her body.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Syncope, X-ray
Clinical narrative: Patient was given the flu (I?m unsure what type) shot at school by the county health dept.  When she finished she left the classroom and fainted in the hallway falling straight back hitting her head and lying unconscious for close to a minute.  She was transported by ambulance to hospital.  She has a tingling sensation throughout her body.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Malaise, Pyrexia
Clinical narrative: patient report red swollen welp with streaks, fever, malaise. When I viewed the arm it was a large red area around injection site, but not raised or streaks.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: patient report red swollen welp with streaks, fever, malaise. When I viewed the arm it was a large red area around injection site, but not raised or streaks.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe nausea for several hours, painful body aches for several hours, headache for several hours, extreme fatigue
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: RECEIVED 2 FLU SHOTS IN SAME SEASON, 1ST WAS GIVEN ON 08/15/2024.  NO ADVERSE REACTIONS WERE NOTED BY PATIENT
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscle spasms, Nausea, Neck pain
Clinical narrative: Severe right neck pain.  I could not turn my head to the right.  I had very bad muscle spasms and nausea.  Now  18 days later I woke up with absolutely no neck pain and no nausea.   I was taking Aleve, Tylenol, icy hot, biofreeze and Ibuprofen trying to get relief.   It was quite awful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Impaired work ability, Malaise, Migraine, Throat tightness
Clinical narrative: Report "terrible migraine headache, with excessive vomiting. Very ill from the headache and vomiting was sent home for the rest of the day, and could not work the following day." Reports her throat was closing up, denies SOB, Hive, itching, fever, diarrhea, or other symptoms. States has egg allergy but had had regular flu shots for years without problems. Reports has had reactions like this to eggs, corn and vegetable oil. Advised receiving an egg free vaccine next year. Reports will follow up with PCP for dull headache that is remaining on left side today 10/28/24.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Report "terrible migraine headache, with excessive vomiting. Very ill from the headache and vomiting was sent home for the rest of the day, and could not work the following day." Reports her throat was closing up, denies SOB, Hive, itching, fever, diarrhea, or other symptoms. States has egg allergy but had had regular flu shots for years without problems. Reports has had reactions like this to eggs, corn and vegetable oil. Advised receiving an egg free vaccine next year. Reports will follow up with PCP for dull headache that is remaining on left side today 10/28/24.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head, Facial paresis
Clinical narrative: Left sided facial weakness. Bells palsy
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Oral herpes, Pyrexia, Vomiting
Clinical narrative: Fever blisters, fever, chills, vomiting, cold sweats - patient is still recovering today (10/28/24). Was seen by her physician today and received zofran 4 mg q6-8h prn
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Itchy day of, a few hours later. Extreme fatigue and chest pain following day. Over weekend very dizzy felt like I was going to faint, shortness of breathe chest pain, arm/ hand numbness. Went to ER today.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pruritus
Clinical narrative: Itchy day of, a few hours later. Extreme fatigue and chest pain following day. Over weekend very dizzy felt like I was going to faint, shortness of breathe chest pain, arm/ hand numbness. Went to ER today.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Pain in extremity
Clinical narrative: Today patient states her immunization arm started hurting approx. 4 days after vaccination and continues. No redness, no swelling, just pain and joint stiffness. I gave the immunization in her left deltoid. States that ice helps.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Immediate post-injection reaction, Muscle spasms, Product administered at inappropriate site, Pruritus
Clinical narrative: Patient immediately had muscle spasms and cramping along side that she got the vaccine on. Patient states feet itched immediately after the shot. Patient states that the pharmacist gave her the vaccination much too high. Patient has ongoing muscle cramping and spasms, along with lateral headache on affected side.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Atrioventricular block second degree, Bradycardia, Bundle branch block right, Dyspnoea
Clinical narrative: Patient admitted with weakness 10/16/24 and found to have new RBBB with mobitz type 1 heart block on 10/19/24.  She was discharged and returned on 10/28 with weakness and dyspnea.  Now has mobitz type II heart block and bradycardia which she has never had before.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Echocardiogram abnormal, Electrocardiogram, Heart failure with preserved ejection fraction, Human metapneumovirus test positive, Troponin increased
Clinical narrative: Patient admitted with weakness 10/16/24 and found to have new RBBB with mobitz type 1 heart block on 10/19/24.  She was discharged and returned on 10/28 with weakness and dyspnea.  Now has mobitz type II heart block and bradycardia which she has never had before.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: After I received the vaccination,  once or twice a day I would have an episode where my heart would skip about every 10th beat for 30-60 mins.  This went on for about 2 weeks.  This is similar to what happened after I received the original vaccine and the 1st 2  boosters.  With each booster the time before the onset of symptoms grows shorter (5 weeks to 3 weeks to2 days), while the duration of the the episodes also gets shorter (4 months to 1 month to 2 weeks).
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: IM injection appears to have been administer too high on deltoid. Leading to decreased range of motion and pain of left arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC15
Symptoms: Angiogram normal, Blood culture negative, Culture urine negative, Echocardiogram normal, Electroencephalogram abnormal
Clinical narrative: Patient presented on 10/5 with facial twitching. He later developed hypotonia and eye rolling. Previous to administration, the patient met all milestones and had a normal pediatric exam.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC15
Symptoms: Gaze palsy, Hypotonia, Ischaemia, Lumbar puncture normal, Magnetic resonance imaging abnormal
Clinical narrative: Patient presented on 10/5 with facial twitching. He later developed hypotonia and eye rolling. Previous to administration, the patient met all milestones and had a normal pediatric exam.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC15
Symptoms: Muscle twitching, Seizure
Clinical narrative: Patient presented on 10/5 with facial twitching. He later developed hypotonia and eye rolling. Previous to administration, the patient met all milestones and had a normal pediatric exam.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. Patient called to offer re-vaccination after discovery.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigeratory. patient called to offer revaccination after discovery.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: : Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Computerised tomogram, Delusion, Dysgraphia, Fine motor skill dysfunction, Laboratory test
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction/impaired motor skills (inability to write name); Mental Status Changes/altered mental status; Sepsis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00697 (Novavax).  A 79-year-old female patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose number unknown, single (Lot number: HN3801) at the age of 79 years intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Sep2024 as dose number unknown, single (Lot number: 6024MF013) intramuscular for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), on 16Sep2024 as dose number unknown, single (Lot number: X027348) intramuscular for immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 16Sep2024 as dose number unknown, single (Lot number: U8249CA) intramuscular for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 16Sep2024 as dose number unknown, single (Lot number: T4HR9) intramuscular for immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (not ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE; LEFLUNOMIDE. The following information was reported: DELUSION (hospitalization) with onset 16Sep2024, outcome "unknown"; DYSGRAPHIA (hospitalization) with onset 16Sep2024, outcome "unknown"; FINE MOTOR SKILL DYSFUNCTION (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Fine motor skill dysfunction/impaired motor skills (inability to write name)"; MENTAL STATUS CHANGES (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Mental Status Changes/altered mental status"; SEPSIS (hospitalization, medically significant) with onset 16Sep2024, outcome "unknown". The patient was hospitalized for delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (start date: 2024, hospitalization duration: 2 day(s)). The events "delusion", "fine motor skill dysfunction/impaired motor skills (inability to write name)" and "mental status changes/altered mental status" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (16Sep2024) Unknown results; laboratory test: (unspecified date) Unknown results. Clinical course: Per conversation with daughter, patient was admitted to emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a computerised tomogram scan was performed. Based on the spontaneous nature of the report, the causal relationship between the vaccines and the events was considered possible.  No follow-up attempts are possible.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Mental status changes, Sepsis
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction/impaired motor skills (inability to write name); Mental Status Changes/altered mental status; Sepsis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00697 (Novavax).  A 79-year-old female patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose number unknown, single (Lot number: HN3801) at the age of 79 years intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Sep2024 as dose number unknown, single (Lot number: 6024MF013) intramuscular for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), on 16Sep2024 as dose number unknown, single (Lot number: X027348) intramuscular for immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 16Sep2024 as dose number unknown, single (Lot number: U8249CA) intramuscular for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 16Sep2024 as dose number unknown, single (Lot number: T4HR9) intramuscular for immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (not ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE; LEFLUNOMIDE. The following information was reported: DELUSION (hospitalization) with onset 16Sep2024, outcome "unknown"; DYSGRAPHIA (hospitalization) with onset 16Sep2024, outcome "unknown"; FINE MOTOR SKILL DYSFUNCTION (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Fine motor skill dysfunction/impaired motor skills (inability to write name)"; MENTAL STATUS CHANGES (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Mental Status Changes/altered mental status"; SEPSIS (hospitalization, medically significant) with onset 16Sep2024, outcome "unknown". The patient was hospitalized for delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (start date: 2024, hospitalization duration: 2 day(s)). The events "delusion", "fine motor skill dysfunction/impaired motor skills (inability to write name)" and "mental status changes/altered mental status" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (16Sep2024) Unknown results; laboratory test: (unspecified date) Unknown results. Clinical course: Per conversation with daughter, patient was admitted to emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a computerised tomogram scan was performed. Based on the spontaneous nature of the report, the causal relationship between the vaccines and the events was considered possible.  No follow-up attempts are possible.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes, Sepsis
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction/impaired motor skills (inability to write name); Mental Status Changes/altered mental status; Sepsis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00697 (Novavax).  A 79-year-old female patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose number unknown, single (Lot number: HN3801) at the age of 79 years intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Sep2024 as dose number unknown, single (Lot number: 6024MF013) intramuscular for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), on 16Sep2024 as dose number unknown, single (Lot number: X027348) intramuscular for immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 16Sep2024 as dose number unknown, single (Lot number: U8249CA) intramuscular for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 16Sep2024 as dose number unknown, single (Lot number: T4HR9) intramuscular for immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (not ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE; LEFLUNOMIDE. The following information was reported: DELUSION (hospitalization) with onset 16Sep2024, outcome "unknown"; DYSGRAPHIA (hospitalization) with onset 16Sep2024, outcome "unknown"; FINE MOTOR SKILL DYSFUNCTION (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Fine motor skill dysfunction/impaired motor skills (inability to write name)"; MENTAL STATUS CHANGES (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Mental Status Changes/altered mental status"; SEPSIS (hospitalization, medically significant) with onset 16Sep2024, outcome "unknown". The patient was hospitalized for delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (start date: 2024, hospitalization duration: 2 day(s)). The events "delusion", "fine motor skill dysfunction/impaired motor skills (inability to write name)" and "mental status changes/altered mental status" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (16Sep2024) Unknown results; laboratory test: (unspecified date) Unknown results. Clinical course: Per conversation with daughter, patient was admitted to emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a computerised tomogram scan was performed. Based on the spontaneous nature of the report, the causal relationship between the vaccines and the events was considered possible.  No follow-up attempts are possible.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Computerised tomogram, Delusion, Dysgraphia, Fine motor skill dysfunction, Mental status changes
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction/impaired motor skills (inability to write name); Mental Status Changes/altered mental status; Sepsis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00697 (Novavax).  A 79-year-old female patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose number unknown, single (Lot number: HN3801) at the age of 79 years intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Sep2024 as dose number unknown, single (Lot number: 6024MF013) intramuscular for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), on 16Sep2024 as dose number unknown, single (Lot number: X027348) intramuscular for immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 16Sep2024 as dose number unknown, single (Lot number: U8249CA) intramuscular for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 16Sep2024 as dose number unknown, single (Lot number: T4HR9) intramuscular for immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (not ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE; LEFLUNOMIDE. The following information was reported: DELUSION (hospitalization) with onset 16Sep2024, outcome "unknown"; DYSGRAPHIA (hospitalization) with onset 16Sep2024, outcome "unknown"; FINE MOTOR SKILL DYSFUNCTION (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Fine motor skill dysfunction/impaired motor skills (inability to write name)"; MENTAL STATUS CHANGES (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Mental Status Changes/altered mental status"; SEPSIS (hospitalization, medically significant) with onset 16Sep2024, outcome "unknown". The patient was hospitalized for delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (start date: 2024, hospitalization duration: 2 day(s)). The events "delusion", "fine motor skill dysfunction/impaired motor skills (inability to write name)" and "mental status changes/altered mental status" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (16Sep2024) Unknown results; laboratory test: (unspecified date) Unknown results. Clinical course: Per conversation with daughter, patient was admitted to emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a computerised tomogram scan was performed. Based on the spontaneous nature of the report, the causal relationship between the vaccines and the events was considered possible.  No follow-up attempts are possible.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, PPV, RSV, VARZOS, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RVX, UNK, COVID19, FLU4, PPV, RSV, VARZOS
Symptoms: Sepsis
Clinical narrative: Delusion; Dysgraphia; Fine motor skill dysfunction/impaired motor skills (inability to write name); Mental Status Changes/altered mental status; Sepsis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00697 (Novavax).  A 79-year-old female patient received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), on 16Sep2024 as dose number unknown, single (Lot number: HN3801) at the age of 79 years intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 16Sep2024 as dose number unknown, single (Lot number: 6024MF013) intramuscular for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), on 16Sep2024 as dose number unknown, single (Lot number: X027348) intramuscular for immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 16Sep2024 as dose number unknown, single (Lot number: U8249CA) intramuscular for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 16Sep2024 as dose number unknown, single (Lot number: T4HR9) intramuscular for immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (not ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE; LEFLUNOMIDE. The following information was reported: DELUSION (hospitalization) with onset 16Sep2024, outcome "unknown"; DYSGRAPHIA (hospitalization) with onset 16Sep2024, outcome "unknown"; FINE MOTOR SKILL DYSFUNCTION (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Fine motor skill dysfunction/impaired motor skills (inability to write name)"; MENTAL STATUS CHANGES (hospitalization) with onset 16Sep2024, outcome "unknown", described as "Mental Status Changes/altered mental status"; SEPSIS (hospitalization, medically significant) with onset 16Sep2024, outcome "unknown". The patient was hospitalized for delusion, dysgraphia, fine motor skill dysfunction, mental status changes, sepsis (start date: 2024, hospitalization duration: 2 day(s)). The events "delusion", "fine motor skill dysfunction/impaired motor skills (inability to write name)" and "mental status changes/altered mental status" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (16Sep2024) Unknown results; laboratory test: (unspecified date) Unknown results. Clinical course: Per conversation with daughter, patient was admitted to emergency room with altered mental status, delusions and impaired motor skills (inability to write name). Patient was worked up for rule out infection (suspected sepsis) and a computerised tomogram scan was performed. Based on the spontaneous nature of the report, the causal relationship between the vaccines and the events was considered possible.  No follow-up attempts are possible.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MEN
Symptoms: Product storage error
Clinical narrative: given a dose of MENQUADFI post excursion (with no reported adverse event); given a dose of MENQUADFI post excursion (with no reported adverse event); Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 years old male patient who had received a dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] post excursion (with no reported adverse event)  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (lot U7996BB, expiry date: 30-Apr-2026, strength was unknown) via unknown route in unknown administration site for Immunization and given a dose of menquadfi post excursion (with no reported adverse event) (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering MENQUADFI vaccines that are no longer suitable to patients because of a temperature excursion."   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.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of MENQUADFI post excursion (with no reported adverse event); given a dose of MENQUADFI post excursion (with no reported adverse event); Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 years old male patient who had received a dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] post excursion (with no reported adverse event)  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (lot U7996BB, expiry date: 30-Apr-2026, strength was unknown) via unknown route in unknown administration site for Immunization and given a dose of menquadfi post excursion (with no reported adverse event) (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering MENQUADFI vaccines that are no longer suitable to patients because of a temperature excursion."   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.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Angioedema, Headache, Lip swelling, Mouth ulceration, Myalgia
Clinical narrative: Headache; Mouth ulceration; Myalgia; Pyrexia; Rash; Angioedema; Information was obtained on a request by The Company from the agency (# AU-TGA-0000817516) via a Public Case Detail on 22-OCT-2024.  This spontaneous report was received from a consumer or other non health professional referring to a 12-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 23-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered in left arm for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), administered in right arm for prophylaxis (strength, formulation, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced headache, mouth ulceration (lumps and blisters inside mouth), Myalgia (Muscle/body aches), the patient experienced Pyrexia. On an unknown date in 2024, Body temperature showed more than 38, and less than 40 degree Celsius (also reported as 38 degree Celsius). On 23-JUL-2024, the patient experienced angioedema and rash on face, head and neck (not at injection site). Rash symptoms were reported as lip or tongue swelling, started 7 to 72 hours and existed more than 24 hours. On 24-JUL-2024, the patient recovered from the event of angioedema and rash. Self management was performed for rash and Pyrexia. At the time of reporting, the outcome of headache, mouth ulceration, myalgia and pyrexia was not known. The action taken with both suspect  vaccines was not applicable. The reporting institution considered all events to be related to both suspect vaccines.  Upon internal review, the event of angioedema was determined to be medically significant.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Oral mucosal blistering, Pyrexia, Rash, Swollen tongue
Clinical narrative: Headache; Mouth ulceration; Myalgia; Pyrexia; Rash; Angioedema; Information was obtained on a request by The Company from the agency (# AU-TGA-0000817516) via a Public Case Detail on 22-OCT-2024.  This spontaneous report was received from a consumer or other non health professional referring to a 12-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 23-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered in left arm for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), administered in right arm for prophylaxis (strength, formulation, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced headache, mouth ulceration (lumps and blisters inside mouth), Myalgia (Muscle/body aches), the patient experienced Pyrexia. On an unknown date in 2024, Body temperature showed more than 38, and less than 40 degree Celsius (also reported as 38 degree Celsius). On 23-JUL-2024, the patient experienced angioedema and rash on face, head and neck (not at injection site). Rash symptoms were reported as lip or tongue swelling, started 7 to 72 hours and existed more than 24 hours. On 24-JUL-2024, the patient recovered from the event of angioedema and rash. Self management was performed for rash and Pyrexia. At the time of reporting, the outcome of headache, mouth ulceration, myalgia and pyrexia was not known. The action taken with both suspect  vaccines was not applicable. The reporting institution considered all events to be related to both suspect vaccines.  Upon internal review, the event of angioedema was determined to be medically significant.
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report VAQTA was inadvertently administered today, 10/8/2024, after its labeled expiry date of 10/1/2024; This spontaneous report has been received from a medical assistant, regarding a 65-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 08-OCT-2024, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, as prophylaxis (lot number: X006702, which was determined to be valid as syringe formulation, with an expiration date on 01-OCT-2024) (strength, dose, scheme, route and anatomical location of administration were not reported) (Expired product administered).  No side effects, nor previous temperature excursions reported were reported.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP calling to report an AE regarding the MMR II vaccine. HCP reported that a patient had received the MMR II vaccine outside of the MMR II PI schedule.; This spontaneous report was received from a registered nurse and refers to a 21-year-old female.  The patient's medical history included a wrestling accident (over a year and a half ago). The patient's concurrent conditions included cerebrospinal fluid leakage. Concomitant therapies were not reported.  On an unknown date in August 2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) outside of the physician insert schedule (product administered to patient of inappropriate age). The reported stated that the patient had to receive the suspect vaccine because she was an international student and did not have documentation showing that she was immunized with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. No additional adverse event reported (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Posture abnormal, Unresponsive to stimuli, Vision blurred
Clinical narrative: My Son got the Covid Booster shot (COMIRNATY 2024-25(12Y UP) SYRG) lot #Lm2210 just before in his other arm and no reaction, then once the flu shot  (FLUZONE TRIVALENT 2024-25 SYRG) Lot# UT8488NA was administered in the other arm my son started to move what I thought was up and out of the seat he was in during the shots, he just bent his head to knees and then fell to the floor, knocking his glasses off his face and he was unresponsive. When he became aware very quickly once I lifted him back into the chair, he was a bit out of it, said his vision was blurry and he was still not at his full faculties. Luckily there was an EMT waiting to get a shot next and he came over and helped assess the situation. My son was back to normal in just a few minutes and the Pharmacist got him some water to drink. My son had had a good meal in the morning and water for breakfast before these shots. There is no long term impact and he was back to the normal 16 year old teen self within minutes and there was no problems or lasting impact since.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: myalgia, parasthesia -- shooting pain in arm to palm of hand and finger tips, later in the weekend, this progressed to neck pain and inability to sleep with spiking fevers and serious neck pain. I've managed this with Naproxen, Tylenol and Advil with maximum doses for 7 days. I can't continue to manage this pain. It keeps me awake at nite and suffering all day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: myalgia, parasthesia -- shooting pain in arm to palm of hand and finger tips, later in the weekend, this progressed to neck pain and inability to sleep with spiking fevers and serious neck pain. I've managed this with Naproxen, Tylenol and Advil with maximum doses for 7 days. I can't continue to manage this pain. It keeps me awake at nite and suffering all day.
Age: 73.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Arthralgia, Dyspnoea, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: L arm swollen & very red/hot below injection site. Extremely tired, ( no other reason for being wiped out), very painful, stiff joints & can't breathe.  Now, four days later, these things are improving.
Age: 73.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site warmth, Joint stiffness
Clinical narrative: L arm swollen & very red/hot below injection site. Extremely tired, ( no other reason for being wiped out), very painful, stiff joints & can't breathe.  Now, four days later, these things are improving.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cheilitis, Mouth ulceration
Clinical narrative: Got mouth ulcers and lip  imglamation on the left side of the mouth , next day after vaccination, Sunday October 27 2024 .
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter reported that the Bexsero was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes and it was administered to a patient, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128716:same reporter/different patient