chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient didn't have any symptoms or reactions , Patient received private supply flu vaccine.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were NO adverse events or reactions. Reporting due to administration of expired vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration
Clinical narrative: 90X80MM INDURATION AND REDNESS
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness/vertigo starting the day after vaccine and lasting 5 days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain, Pyrexia
Clinical narrative: Dizziness, muscle aches, pain, fever for 36 hours
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, HIV test negative, Hepatitis B test negative, Injury associated with device
Clinical narrative: Employee administered a flu vaccine and accidentally stuck herself with the needle while trying to engage and discard it.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pain
Clinical narrative: Fever, body aches, headache, nausea, weakness, vomiting (all extreme), lasting 3 days, then continuing dizziness, weakness, and nausea lasting for 4 more days, and nausea and weakness continuing to today.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, body aches, headache, nausea, weakness, vomiting (all extreme), lasting 3 days, then continuing dizziness, weakness, and nausea lasting for 4 more days, and nausea and weakness continuing to today.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Bed bug infestation, Brain tumour operation, CSF culture, CSF protein, CSF white blood cell count
Clinical narrative: Patient was admitted to Hospital on 3/17 (four days after vaccination with MMRV and Hep A), where medulloblastoma was diagnosed. Patient began a course of corticosteroids (high dose decadron), as treating physicians were unaware of recent vaccination at unaffiliated health facility. On 3/20, brain tumor was surgically removed; sometime after surgery, patient became encephalopathic with focal seizure activity. Decadron was discontinued on 3/31. On 4/15, MRI showed blood flow deficits in the patient's brain, and lumbar puncture showed protein and white blood cells unexplained by medulloblastoma. On 4/16, patient began treatment for bacterial meningitis while CSF test was pending (test was called culture and PCR in different places). On 4/17, patient was diagnosed with varicella zoster virus (VZV) encephalitis. By time of discharge, patient had significant neurologic impairment with slow improvement, and was at that point tracheostomy dependent, ventilator dependent and G tube dependent.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Dependence on respirator, Encephalopathy, Gastrostomy, Herpes zoster meningoencephalitis, Magnetic resonance imaging head abnormal
Clinical narrative: Patient was admitted to Hospital on 3/17 (four days after vaccination with MMRV and Hep A), where medulloblastoma was diagnosed. Patient began a course of corticosteroids (high dose decadron), as treating physicians were unaware of recent vaccination at unaffiliated health facility. On 3/20, brain tumor was surgically removed; sometime after surgery, patient became encephalopathic with focal seizure activity. Decadron was discontinued on 3/31. On 4/15, MRI showed blood flow deficits in the patient's brain, and lumbar puncture showed protein and white blood cells unexplained by medulloblastoma. On 4/16, patient began treatment for bacterial meningitis while CSF test was pending (test was called culture and PCR in different places). On 4/17, patient was diagnosed with varicella zoster virus (VZV) encephalitis. By time of discharge, patient had significant neurologic impairment with slow improvement, and was at that point tracheostomy dependent, ventilator dependent and G tube dependent.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Medulloblastoma, Meningitis bacterial, Nervous system disorder, Partial seizures, Polymerase chain reaction
Clinical narrative: Patient was admitted to Hospital on 3/17 (four days after vaccination with MMRV and Hep A), where medulloblastoma was diagnosed. Patient began a course of corticosteroids (high dose decadron), as treating physicians were unaware of recent vaccination at unaffiliated health facility. On 3/20, brain tumor was surgically removed; sometime after surgery, patient became encephalopathic with focal seizure activity. Decadron was discontinued on 3/31. On 4/15, MRI showed blood flow deficits in the patient's brain, and lumbar puncture showed protein and white blood cells unexplained by medulloblastoma. On 4/16, patient began treatment for bacterial meningitis while CSF test was pending (test was called culture and PCR in different places). On 4/17, patient was diagnosed with varicella zoster virus (VZV) encephalitis. By time of discharge, patient had significant neurologic impairment with slow improvement, and was at that point tracheostomy dependent, ventilator dependent and G tube dependent.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Scab, Tracheostomy
Clinical narrative: Patient was admitted to Hospital on 3/17 (four days after vaccination with MMRV and Hep A), where medulloblastoma was diagnosed. Patient began a course of corticosteroids (high dose decadron), as treating physicians were unaware of recent vaccination at unaffiliated health facility. On 3/20, brain tumor was surgically removed; sometime after surgery, patient became encephalopathic with focal seizure activity. Decadron was discontinued on 3/31. On 4/15, MRI showed blood flow deficits in the patient's brain, and lumbar puncture showed protein and white blood cells unexplained by medulloblastoma. On 4/16, patient began treatment for bacterial meningitis while CSF test was pending (test was called culture and PCR in different places). On 4/17, patient was diagnosed with varicella zoster virus (VZV) encephalitis. By time of discharge, patient had significant neurologic impairment with slow improvement, and was at that point tracheostomy dependent, ventilator dependent and G tube dependent.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF ARM STILL BEING SORE AFTER 13 DAYS.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Fatigue, Pain, Pyrexia
Clinical narrative: Febrile, severe body aches, fatigue 9/13-9/20, ongoing.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Crepitations, Fatigue, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Day O (9/16/2024) - general discomfort at injection sites.  Day 1 (AM - redness just below injection sites, halfway down arm / PM sharp pain started below lower left ribs).  Day 2 Sharp pain increasing, hard to take a deep breath if standing, redness on arm now down to elbow with slight swelling (itchy, too). Started taking Diphenhydramine for arm. Felt tired all day. PM - pain under ribs felt like broken ribs. Discovered that if I slept on my left side, all pain went away with a rush of relief.  Day 3 - Pain still present, but now it seems to be "braking up" and crackling as if it were congestion. Day 4 (today) Pain has subsided immensely. Breathing exercises, still painful to take a deep breath but a lot better.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site swelling, Musculoskeletal chest pain, Painful respiration
Clinical narrative: Day O (9/16/2024) - general discomfort at injection sites.  Day 1 (AM - redness just below injection sites, halfway down arm / PM sharp pain started below lower left ribs).  Day 2 Sharp pain increasing, hard to take a deep breath if standing, redness on arm now down to elbow with slight swelling (itchy, too). Started taking Diphenhydramine for arm. Felt tired all day. PM - pain under ribs felt like broken ribs. Discovered that if I slept on my left side, all pain went away with a rush of relief.  Day 3 - Pain still present, but now it seems to be "braking up" and crackling as if it were congestion. Day 4 (today) Pain has subsided immensely. Breathing exercises, still painful to take a deep breath but a lot better.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Nausea
Clinical narrative: About 12 hours after vaccine, I experienced teeth chattering, chills, extreme fatigue, slight nausea, giddiness
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Posture abnormal, Tension
Clinical narrative: after giving the patient shingrex, flu and covid vaccines, the patient said he was dizzy and then sort of had a lack of consciousness, eyes sort of closed, body tensed up lasted maybe 40 seconds, I had to put my hand on his shoulder to keep him from sliding out of the chair, then he  would come back, got clammy, never had any breathing problems, this happened maybe 4 times, someone called EMS, he checked out ok, refused to go in ambulance and later left.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient had an onset of itching and rash about 38 hours after receiving the flu shot (approximately 11;30 pm 9/14/24).  Itching started on her left chest, saw red bump on her upper left breast area.  Patient took Zyrtec at that time which helped a little.  The next morning the patient had large red bumps on her arm, abdomen and back which were itchy.  No history of a similar rash.  Patient was advised to continue Zyrtec daily and was prescribed Desonide 0.05% cream.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: PATIENT STATED HE HAD NO SYMPTOMS INITIALLY. HOWEVER, AS HE WAS TALKING WITH HIS PROFESSOR ON 09/19/2024 HIS LIPS BEGAN TO SWELL. HIS PROFESSOR SENT HIM TO URGENT CARE WHERE THEY TOLD HIM HE WAS HAVING A DELAYED ALLERGIC REACTION.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: patient was diagnosed with bell's palsy after symptoms started two-three days post vaccine
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood pressure increased, Muscle swelling, Pruritus, Rash
Clinical narrative: Severe itching, muscle swelling, rash, and increased blood pressure (very high).  Itching for 1 week, muscle swelling 1 week, rash 2 weeks, increase in blood pressure on-going.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3, YF
Symptoms: Confusional state, Dizziness, Erythema, Foaming at mouth, Loss of consciousness
Clinical narrative: On 9/19/24, patient came in to receive travel vaccinations (YF-Vax, Afluria, and Comirnaty). She was charged for the vaccines at the register at 3:31 pm and then received the immunizations by the staff pharmacist. At the end of the immunizations, she stated that she felt dizzy. At that point, she became non-responsive and her body became stiff. The staff pharmacist called the pharmacy manager to come into the vaccination room to help. Manager noticed that she was having a seizure while seated in the chair. Her face turned bright red and her mouth started to foam. Manager instructed the staff pharmacist to grab the emergency kit, the pharmacy clerk to call emergency services, and the pharmacy tech to call management for additional assistance. Manager and the staff pharmacist got her out of the chair and onto the floor positioning her on her side. The Epi-Pen from the emergency kit was administered at 3:40 pm. She immediately got color back in her face and regained consciousness within a one to two minutes. She was confused as to where she was and what had happened in the beginning. After a few minutes she was able to sit on the floor against a wall. The EMTs arrived around 3:55 pm and took over.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3, YF
Symptoms: Musculoskeletal stiffness, Seizure, Unresponsive to stimuli
Clinical narrative: On 9/19/24, patient came in to receive travel vaccinations (YF-Vax, Afluria, and Comirnaty). She was charged for the vaccines at the register at 3:31 pm and then received the immunizations by the staff pharmacist. At the end of the immunizations, she stated that she felt dizzy. At that point, she became non-responsive and her body became stiff. The staff pharmacist called the pharmacy manager to come into the vaccination room to help. Manager noticed that she was having a seizure while seated in the chair. Her face turned bright red and her mouth started to foam. Manager instructed the staff pharmacist to grab the emergency kit, the pharmacy clerk to call emergency services, and the pharmacy tech to call management for additional assistance. Manager and the staff pharmacist got her out of the chair and onto the floor positioning her on her side. The Epi-Pen from the emergency kit was administered at 3:40 pm. She immediately got color back in her face and regained consciousness within a one to two minutes. She was confused as to where she was and what had happened in the beginning. After a few minutes she was able to sit on the floor against a wall. The EMTs arrived around 3:55 pm and took over.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT INJECTION SITE. MOM STATES TODAY (2 DAYS POST IMMUNIZATION) REDNESS AND SWELLING HAS GONE DOWN,
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Patient reports pinching sensation throughout her entire back that started 1 day after the administration.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Wrong dose of COVID vaccine given, non-diluted. 3x dose was given. As of 9/20/2024 denies any symptoms
Age: 1.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was given 3x the dose for COVID pfizer vaccine because the vial was not diluted. No adverse reaction as of 9/20/2024
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, HEP, VARZOS
Symptoms: Urticaria
Clinical narrative: Generalized Hives, vaccines given approx 9:50am, reported to pharmacy at 1:08 pm same day
Age: 2.0
Sex: M
Vaccine: COVID19, FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: COVID vaccine was given at 3x the dose as it was not diluted. Diarrhea noted on 9/20/2024. So far no other side effects
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: vasovagal syncope
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pruritus, Throat irritation
Clinical narrative: After the vaccine was administered, the patient stated that her arms felt itchy and throat felt irritated. Patient was immediately given a dose of famotidine 20 mg (tablet) and diphenhydramine 50 mg (liquid). After 20-30 minutes, symptoms began to resolve.  Followed up with patient on 09/20/2024, she reports that she had taken an additional famotidine 20mg, diphenhydramine 50 mg and loratadine 10 mg due to throat irritation/itching and coughing the evening after receiving the vaccine. She also reports taking loratadine 10 mg and famotidine 20 mg the following morning due to throat irritation. She stated that symptoms had resolved after 24 hours from receiving the vaccine.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No Adverse Event. Patient tolerated well. Vaccine administered incorrectly with 5/8" needle. Administration likely not deep enough for intramuscular dose.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness ,pain , swelling.  T80.29XA
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Full body hives within 15 minutes of injection.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Fatigue, Lymphadenopathy, Neck pain
Clinical narrative: Got extreme shaking, body felt like it was on fire, neck hurt and glands swelled up, trouble breathing, kidneys both hurt  and body ached. I have had all the recommended Covid vaccines and while I have always had more side effects than my husband, I have never had anything near what I went through with this one. Those effects lasted about 18 hours. I continue to have tiredness and sore arm but the worst past in the first 24 hours. It hit the hardest about 10 hours after the shot but started about 5 to 6 hours afterwards. I realize I have autoimmune issues but I truly felt like this one could have killed me. I was very close to calling an ambulance. This was not safe for me. I will risk Covid over a vaccine in the future.  There is no doubt in my mind that this was caused by the Covid vaccine!  There should be more research on Covid vaccines with autoimmune illnesses before you recommend it for people like me.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Renal pain, Tremor
Clinical narrative: Got extreme shaking, body felt like it was on fire, neck hurt and glands swelled up, trouble breathing, kidneys both hurt  and body ached. I have had all the recommended Covid vaccines and while I have always had more side effects than my husband, I have never had anything near what I went through with this one. Those effects lasted about 18 hours. I continue to have tiredness and sore arm but the worst past in the first 24 hours. It hit the hardest about 10 hours after the shot but started about 5 to 6 hours afterwards. I realize I have autoimmune issues but I truly felt like this one could have killed me. I was very close to calling an ambulance. This was not safe for me. I will risk Covid over a vaccine in the future.  There is no doubt in my mind that this was caused by the Covid vaccine!  There should be more research on Covid vaccines with autoimmune illnesses before you recommend it for people like me.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported foot swelling (same side of administration) a few minutes after her vaccination. She noticed because her shoe began getting tight at the top of her left foot.  Throughout the night, the aching gradually increased more and more in both the top and bottom of her foot. In the middle of the night, her left calf cramped up. Today, the swelling has gone down but it still feels like a bruise on the outer top part of her foot. She reports that it is difficult to walk due to the pain.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: PHARMACY INTERN ADMINISTRED VACCINE TO PATIENT THEN HAD A NEEDLESTICK CONTIMINATION INCIDENT THEREAFTER (SHE RETRACTED NEEDLE AND THE NEEDLE STUCK THE PALM OF HER RIGHT HAND)
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Rash
Clinical narrative: Skin rash on both legs, from knees to feet
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Back pain, Cough, Diarrhoea, Ear pain, Eating disorder
Clinical narrative: AE were coughing, ears hurt, neck sore, sneezing, diarrhea, pains up and down back, could not eat, fatigued
Age: 86.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Fatigue, Neck pain, Sneezing
Clinical narrative: AE were coughing, ears hurt, neck sore, sneezing, diarrhea, pains up and down back, could not eat, fatigued
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: Patient states he didn't feel well. He felt sick and his left hand felt numb
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: PATIENT REPORTS PAIN RADIATING FROM INJECTION SITE ON RIGHT SHOULDER
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Joint swelling
Clinical narrative: Pt presented to to the pharmacy stating that 1 day after getting the vaccine she had both of her arms at the elbows swell up and has become hard since then.  She wanted to let us know about this but it was not sever enough for her to seek medical attention.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No actual adverse reaction is known. Pt was given the 6mo-11yr old version, instead of the 12month and up
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Pt got a total of 2 RSV shots, the first one was 11/03/2023 and the second was 09/20/24. Pt reported he had never received an RSV shot before which is why this second one was given. Pt
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: right deltoid redness and soreness where injection was administered, bilateral eye pressure, headache, vertigo, body chills, fever, fatigue, body/muscle aches
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia, Ocular discomfort, Pain, Pyrexia, Vertigo
Clinical narrative: right deltoid redness and soreness where injection was administered, bilateral eye pressure, headache, vertigo, body chills, fever, fatigue, body/muscle aches
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received two doses of HD influenza vaccine.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu doses in the 2024 calendar year. 1 dose was given on 8/28/24. The patient requested to receive her flu shot again on 9/17/24 and it was not caught that this was a duplicate. The patient reported she "felt great."
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient has a warm, red rash forming at the bottom of her right deltoid. It is forming approximately 3-4 inches below the injection site. This formed approximately 24 hours after administration. Patient was referred to primary care doctor.
Age: 55.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: Yellow fever vaccination inadvertently administered IM instead of SQ. 5/8" needle used.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Haematochezia, Infant irritability, Mucous stools
Clinical narrative: developed mucous and streaks of blood in stools within 3 days of receiving immunization. lasted about 10 days, had some increased fussiness as well. No changes in formula, did not develop intussusception
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: HSV2 outbreak, very unusual, do not get them often & they are usually less symptomatic
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Incontinence, Muscle spasms, Myalgia
Clinical narrative: Muscle pain, weakness, incontinence and muscle spasms.  Muscle pain and spasms still affecting me on the 20th
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: pt came in the next day after vaccine administration complaining of dizziness
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, HEP, HEPA, MMRV
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Patient's father called our department on 9/19/2024 stating his son first had a rash close to his injection site later in the day after vaccination. Over the course of a week, the rash spread across the full body with itching. Nurse advised client to be seen by a primary care provider to determine if this was the bodies allergic reaction or an immune response to the vaccinations received.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient given 2 doses of Afluria. Patient wanted flu and covid shot. She received both shots but was given extra dose of flu.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chromaturia, Constipation, Decreased appetite, Fatigue, Somnolence
Clinical narrative: excessive sleepiness and decreased appetite following a flu vaccination received last week. Within an hour of receiving the flu shot, patient reports feeling extremely tired and has been sleeping most of the time since then. She also notes a significant decrease in appetite, consuming only crackers, water, toast, and an egg since the onset of symptoms. Patient mentions that her urine was dark initially, prompting her to increase water intake, which has since resolved. She has not had a bowel movement since Thursday morning but denies any abdominal pain. Patient denies any numbness or tingling. She has a history of a localized reaction to the RSV vaccine, which involved swelling and pain at the injection site for a few days.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth, Mobility decreased, Neck pain
Clinical narrative: left arm swelled at injection site a couple of hours after, warm to the touch.  trouble lifting arms above shoulder and pain in neck
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Product prescribing error
Clinical narrative: MD sent us prescription for Arexvy 9/21/2023 and it was administered by our pharmacy. Same MD office sent us a prescription for Arexvy 9/17/2024. (pharmacy computer system) did not flag and neither did insurance. Patient was administered another dose of Arexvy 9/18/2024. This vaccine is indicated as a one time dose, not yearly. This error was caught when submitting vaccine record to database.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Pharyngeal swelling, Pruritus
Clinical narrative: flu shot given. developed symptoms about 40 minutes later. went to ER with dizziness, nausea, itching, tongue numbness, throat swelling
Age: 13.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: At approximately 3:40 patient walked out of the vaccine clinic into 90+ degree heat.  She vomitted and fainted.  The school nurse came to her aid and she quickly regained consciousness.  She then went home with her mother.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Dizziness, Dysstasia, Erythema, Feeling hot
Clinical narrative: Following a 6pm vaccine injection, symptoms began at 2am and included severe dizziness while laying prone, nausea,  inability to stand due to dizziness & nausea, full-body tingling, full-body inflammation/heat, full-body sweating (to the point of removing blankets & clothes), intense heart palpitations despite slow pulse (checked in neck & w/ ring next morning), followed by intense full-body chills & shivering. Difficult to estimate how long reaction lasted, but estimate around 60 minutes. Upon waking on 9/19/24, my skin (full-body) was red & inflamed to touch.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Heart rate decreased, Hyperhidrosis, Inflammation, Nausea, Palpitations
Clinical narrative: Following a 6pm vaccine injection, symptoms began at 2am and included severe dizziness while laying prone, nausea,  inability to stand due to dizziness & nausea, full-body tingling, full-body inflammation/heat, full-body sweating (to the point of removing blankets & clothes), intense heart palpitations despite slow pulse (checked in neck & w/ ring next morning), followed by intense full-body chills & shivering. Difficult to estimate how long reaction lasted, but estimate around 60 minutes. Upon waking on 9/19/24, my skin (full-body) was red & inflamed to touch.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Paraesthesia
Clinical narrative: Following a 6pm vaccine injection, symptoms began at 2am and included severe dizziness while laying prone, nausea,  inability to stand due to dizziness & nausea, full-body tingling, full-body inflammation/heat, full-body sweating (to the point of removing blankets & clothes), intense heart palpitations despite slow pulse (checked in neck & w/ ring next morning), followed by intense full-body chills & shivering. Difficult to estimate how long reaction lasted, but estimate around 60 minutes. Upon waking on 9/19/24, my skin (full-body) was red & inflamed to touch.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The employee did not have any adverse event with this vaccination, but I wanted to report this because I found out that when I gave the vaccine on 8/14/24, it was expired. The vaccine is listed as having expired on 7/13/24. I found this out on 9/20/24 when checking  the employee's Varicella titer and Varicella immunization records after a potential Varicella exposure in her department.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cardiac stress test, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Recieved 1st Covid-19 vaccine 9/22/2021; Symptoms began 9/26/2021; Heart palpitations. Tachycardia, Chest pain/heaviness, Shortness of Breath, Dizziness and Fatigue, Loss of consciousness.  Swollen toe (potential blood clot). Symptoms continued for 2 weeks and worsened. On 10/8/2021 visited ER due to symptoms;  12 lead performed; Diagnosed with Vaccine Induced Myocarditis; Referred to Cardiologists for follow-up.  Visited Cardiologist; Stress test, Echocardiogram, and heart monitor worn x2 weeks. Diagnosed with Premature atrial contractions, premature ventricular contractions, leaky mitral valve; the doctor suggested symptom management with medication (Beta Blocker).  Later visited an electrophysiologist due to continued symptoms; and increased Heart rate; Doctor also suggested a Beta blocker for symptom relief, but is unable to provide any other tx at this time. Symptoms continue now almost 3 years later.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: Recieved 1st Covid-19 vaccine 9/22/2021; Symptoms began 9/26/2021; Heart palpitations. Tachycardia, Chest pain/heaviness, Shortness of Breath, Dizziness and Fatigue, Loss of consciousness.  Swollen toe (potential blood clot). Symptoms continued for 2 weeks and worsened. On 10/8/2021 visited ER due to symptoms;  12 lead performed; Diagnosed with Vaccine Induced Myocarditis; Referred to Cardiologists for follow-up.  Visited Cardiologist; Stress test, Echocardiogram, and heart monitor worn x2 weeks. Diagnosed with Premature atrial contractions, premature ventricular contractions, leaky mitral valve; the doctor suggested symptom management with medication (Beta Blocker).  Later visited an electrophysiologist due to continued symptoms; and increased Heart rate; Doctor also suggested a Beta blocker for symptom relief, but is unable to provide any other tx at this time. Symptoms continue now almost 3 years later.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart valve incompetence, Immunisation reaction, Laboratory test, Loss of consciousness, Myocarditis
Clinical narrative: Recieved 1st Covid-19 vaccine 9/22/2021; Symptoms began 9/26/2021; Heart palpitations. Tachycardia, Chest pain/heaviness, Shortness of Breath, Dizziness and Fatigue, Loss of consciousness.  Swollen toe (potential blood clot). Symptoms continued for 2 weeks and worsened. On 10/8/2021 visited ER due to symptoms;  12 lead performed; Diagnosed with Vaccine Induced Myocarditis; Referred to Cardiologists for follow-up.  Visited Cardiologist; Stress test, Echocardiogram, and heart monitor worn x2 weeks. Diagnosed with Premature atrial contractions, premature ventricular contractions, leaky mitral valve; the doctor suggested symptom management with medication (Beta Blocker).  Later visited an electrophysiologist due to continued symptoms; and increased Heart rate; Doctor also suggested a Beta blocker for symptom relief, but is unable to provide any other tx at this time. Symptoms continue now almost 3 years later.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling, Supraventricular extrasystoles, Tachycardia, Ventricular extrasystoles
Clinical narrative: Recieved 1st Covid-19 vaccine 9/22/2021; Symptoms began 9/26/2021; Heart palpitations. Tachycardia, Chest pain/heaviness, Shortness of Breath, Dizziness and Fatigue, Loss of consciousness.  Swollen toe (potential blood clot). Symptoms continued for 2 weeks and worsened. On 10/8/2021 visited ER due to symptoms;  12 lead performed; Diagnosed with Vaccine Induced Myocarditis; Referred to Cardiologists for follow-up.  Visited Cardiologist; Stress test, Echocardiogram, and heart monitor worn x2 weeks. Diagnosed with Premature atrial contractions, premature ventricular contractions, leaky mitral valve; the doctor suggested symptom management with medication (Beta Blocker).  Later visited an electrophysiologist due to continued symptoms; and increased Heart rate; Doctor also suggested a Beta blocker for symptom relief, but is unable to provide any other tx at this time. Symptoms continue now almost 3 years later.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient is complaining about sore right arm and shoulder.  Patient is unable to raise her arm above her head.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Bright red circle 2 inches or more, at Covid vaccine injection site so far lasting 2 days. Sometimes itchy.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: un-noticed temperature excursion occured; No adverse event; This spontaneous report has been received from a registered nurse, regarding to a currently 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with the second dose of an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously (SC) in the left arm (LA) for prophylaxis (lot number Y004547 which has been verified to be valid, expiration date: 19-AUG-2025) (exact dose was not provided). The vaccine was administered after un-noticed temperature excursions occurred (temperature: -12 degrees Celsius (C), during a time frame of 37 minutes) (product storage error). There was a previous temperature excursion. It was stated that vaccine was administered before vaccine was cleared by manufacturer. Vaccine had been cleared for use. No other information was provided. No additional adverse effects (AEs) or product quality complaint (PQC) was reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA005168:
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Un-noticed temperature excursion occured; This spontaneous report has been received from a registered nurse, regarding to a 13-month-old male patient.   The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical vaccines 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 20V. Concomitant medications included hepatitis B vaccine (HEPATITIS B VACCINE).  On 08-AUG-2024, the patient was vaccinated with the first dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) subcutaneous injection, administered subcutaneously (SC) in the right thigh (RT) for prophylaxis (lot number Y004547 which has been verified to be valid, expiration date: 19-AUG-2025) (exact dose was not provided). The vaccine was administered after un-noticed temperature excursions occurred (temperature: -12 degrees Celsius (C), during a time frame of 37 minutes) (product storage error). There was a previous temperature excursion. It was stated that vaccine was administered before vaccine was cleared by manufacturer. Vaccine had been cleared for use. No other information was provided. No additional adverse effects (AEs) or product quality complaint (PQC) was reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA005168:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient who was administered an expired dose of MMR-II on 9/16/2024; No symptoms reported. No additional AE; This spontaneous report was received from a licensed vocational nurse concerning to a patient of unspecified age and gender. The patient's medical history, historical drug, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 16-SEP-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) injection, 0.5 ml/dose, lot #W029540, expiration date: 15-SEP-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (Expired product administered) (no temperature excursions [TE]), by a health professional. No additional adverse events or product quality complaints were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failue; I had both vaccines and still got a mild case; poison ivy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failue) (serious criteria GSK medically significant), herpes zoster (Verbatim: I had both vaccines and still got a mild case) and poison ivy rash (Verbatim: poison ivy). The outcome of the vaccination failure, herpes zoster and poison ivy rash were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster and poison ivy rash to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the herpes zoster and poison ivy rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported that a patient had both vaccines and still got a mild case. Initially he/she thought it was poison ivy. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(dose 1 and 2).
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pts that may have received two Arexvy vaccinations; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received their first dose on an unknown date).   On an unknown date, the patients received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: pts that may have received two Arexvy vaccinations ). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-SEP-2024 The physician asked if before he knew the correct prescribing information for Arexvy, he told appropriate patients that received their first Arexvy vaccine and he recommended that they receive an Arexvy vaccine each year thereafter. The physician asked were their any concerns or detrimental effects to the patients that may had received two Arexvy vaccinations that he needed to call and inform these patients, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: she said that it got red from the injection side to above the elbow; patient had redness around injection site/ a localized reaction where the side get red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: patient had redness around injection site/ a localized reaction where the side get red) and erythema of extremities (Verbatim: she said that it got red from the injection side to above the elbow). The outcome of the injection site erythema was resolved (duration 2 days) and the outcome of the erythema of extremities was not reported.   It was unknown if the reporter considered the injection site erythema and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the injection site erythema and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-SEP-2024 The pharmacist reported that a patient who received one in 2019 and had a localized reaction where the side get red and her doctor said. The pharmacist reported wow you should not get any more and the patient wanted to have the second one but it was 5 years after that, 2019.  The pharmacist asked was that considered, the redness, you know, in that area, was that considered a contraindication to get the second shot or she could restart the series because it was 5 years. The pharmacist reported that injectable side was very red did go down the arm, but the patient said that, well she never showed to anybody so, the pharmacist had no record of this got nothing.  The patient told the pharmacist 5 years later, she said that it got red from the injection side to above the elbow, nothing beyond that, you know like anaphylaxis or nothing like that. The patient was over 50 years old not immunocompromised. After shingrix first dose, patient had redness around injection site.  The patient was fine after 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than six months have elapsed since the first shot. No second shot is administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: More than six months have elapsed since the first shot. No second shot is administered.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-SEP-2024 The other health professional reported that the patient received one dose of Shingrix.  The other health professional reported more than six months had elapsed since the first shot.  No second shot was administered.  The other health professional reported asked after receiving the second dose, was the same efficacy achieved as would be if the patient had received the two doses at the appropriate intervals. The other health professional asked after what interval should the patient re-start the two-dose Shingrix series, should the patient re-start.  No other information was provided. Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received a dose of Shingrix, the patient was supposed to receive the varicella vaccine.; A 41 years old male patient received a dose of Shingrix,; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number 45N4Z, expiry date 19-JUN-2026) for prophylaxis.   On 10-SEP-2024, the patient received Shingrix. On 10-SEP-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Shingrix, the patient was supposed to receive the varicella vaccine.) and inappropriate age at vaccine administration (Verbatim: A 41 years old male patient received a dose of Shingrix,). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 10-SEP-2024 A nurse called to report  that they administered Shingrix today (on the day of reporting) to a patient who was supposed to get the varicella vaccine instead, which led to wrong vaccine used. The patient was 41 years old, which led to inappropriate age at vaccine administration. Consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: another nurse did not realize it and also give a Hep B vaccine so, the child actually received 2 doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 1-day-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b pediatric).   On 10-SEP-2024, the patient received the 2nd dose of Engerix B pediatric. On 10-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental overdose (Verbatim: another nurse did not realize it and also give a Hep B vaccine so, the child actually received 2 doses). The outcome of the accidental overdose 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: 10-SEP-2024 The pharmacist reported that they had an incident there where one of their newborns was given the Hepatitis B vaccine (Engerix B pediatric) and another nurse did not realized it and also gave a Hepatitis B vaccine so the child (patient) actually received 2 doses, which led to accidental overdose. Pharmacist said that both doses were pediatric.