chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site swelling
Clinical narrative: Patient experienced a local reaction immediately after receiving vaccine. Symptoms included bleeding, bruising, and swelling at the injection site. Within minutes, pharmacist cleaned area of injection site and applied a cold compress to injection site. Patient remained in immunization room until 03:30pm for monitoring. Swelling and bruising both decreased during monitoring period, so pharmacist advised patient to continue monitoring at home and notify her primary care physician of the reaction she had.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient received a TDAP vaccine on 11/30/2024 from Staff and the vaccine was given too high in the shoulder. 2 days after vaccine administration the patient had significant arm pain. The patient was diagnosed with bursitis after a visit with her provider on Friday 12/06/24
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discomfort, Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient received a TDAP vaccine on 11/30/2024 from Staff and the vaccine was given too high in the shoulder. 2 days after vaccine administration the patient had significant arm pain. The patient was diagnosed with bursitis after a visit with her provider on Friday 12/06/24
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Deafness unilateral, Ear discomfort, Nausea, Vertigo
Clinical narrative: Two weeks after the first Covid vaccine I had a fullness feeling in my left ear. Thought they was fluid or wax build up, nothing was seen on exam. Two weeks following my second Covid Vaccine (Pfizer-BioNtech Lot number EK9231) on February 24, 2021 I had severe Vertigo with Nausea and vomiting that required a EMS call and ER visit. At that time there was no diagnoses, and I had follow up care with my primary care provider. At the visit she suspected Vertigo and over the next several weeks I had head CT and ENT visits. The left ear had moderate hearing loss and have continued to have severe vertigo issues that can last hours to days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Two weeks after the first Covid vaccine I had a fullness feeling in my left ear. Thought they was fluid or wax build up, nothing was seen on exam. Two weeks following my second Covid Vaccine (Pfizer-BioNtech Lot number EK9231) on February 24, 2021 I had severe Vertigo with Nausea and vomiting that required a EMS call and ER visit. At that time there was no diagnoses, and I had follow up care with my primary care provider. At the visit she suspected Vertigo and over the next several weeks I had head CT and ENT visits. The left ear had moderate hearing loss and have continued to have severe vertigo issues that can last hours to days.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram
Clinical narrative: This isn't Friends seem to almost immediately notice chest heaviness and tightness, tried it eliminating caffeine, and scheduled with my cardiologist for 12/3/24
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Seizure, Syncope
Clinical narrative: The patient received a flu shot in the left deltoid. Afterward, the pt stood up, proceeded to check out of the immunization area, and handed his paperwork to RN. At this point, RN noticed the pt fainting and falling backward. RN immediately jumped up, and I ran over to assist. She positioned the pt on his side, as it appeared he was experiencing a seizure. I requested a blood pressure cuff and measured the pts blood pressure at 120/100. I called for administrative assistance to summon a provider. Two providers, arrived promptly, evaluated the pt, and determined that he was stable. The pt stated that this type of episode has occurred before and mentioned that he had not eaten all day. After receiving snacks, the pt reported feeling better. Both a UIR (Unusual Incident Report) and a VAERS (Vaccine Adverse Event Reporting System) report were completed.
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Donor has redness, swelling, and hardness around site. Site is also warm. Donor reports being lightheaded and nausea in the morning of 12/8/24.
Sex: U
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Donor has redness, swelling, and hardness around site. Site is also warm. Donor reports being lightheaded and nausea in the morning of 12/8/24.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Aphasia, Computerised tomogram head normal, Condition aggravated, Eye pruritus
Clinical narrative: Per Son's report:  2 hours post vaccine, sick to stomach. Next morning she reports "worst migraine I have ever had" though out the day was incoherently speaking, couldn't reason or speak - in and out with this though out the day. Saturday (12/7/24), went to Emergency Room - CT was taken no blood clots found., stayed over night. Sunday (12/8/24), MRI given, MRI did not reveal evidence of stroke. This is all reported by her son, when he came to pick up a new "seizure/migraine" medication.   Per Patient report: Pt reported, within 3 hours post vaccine Thursday (12/5/24) - itchy red eyes, extreme fatigue, nausea, stomach pain, intestinal pain. Friday (12/6/24) morning woke up with migraine headache - hurt all day. Hadn't had a migraine in years. Migraine got better by night. Eyes problems persisted all day long.  Slept pretty good Friday night into Saturday (12/7/24).  Saturday at about 10-11am Migraine/Nausea restarted, by afternoon couldn't speak or explain - certain words wouldn't come out. Went to ER. CT scan done, Saturday afternoon - no signs of blood clot. Kept overnight at hospital - MRI done Sunday (12/8/24) morning, no signs of stroke. Released from hospital Sunday afternoon - started on Keppra 500mg 1 twice daily. Referred to neurologist. Red itchy eyes persisted all day Saturday, eyes improving today.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Gastrointestinal pain, Impaired reasoning, Incoherent, Magnetic resonance imaging head normal
Clinical narrative: Per Son's report:  2 hours post vaccine, sick to stomach. Next morning she reports "worst migraine I have ever had" though out the day was incoherently speaking, couldn't reason or speak - in and out with this though out the day. Saturday (12/7/24), went to Emergency Room - CT was taken no blood clots found., stayed over night. Sunday (12/8/24), MRI given, MRI did not reveal evidence of stroke. This is all reported by her son, when he came to pick up a new "seizure/migraine" medication.   Per Patient report: Pt reported, within 3 hours post vaccine Thursday (12/5/24) - itchy red eyes, extreme fatigue, nausea, stomach pain, intestinal pain. Friday (12/6/24) morning woke up with migraine headache - hurt all day. Hadn't had a migraine in years. Migraine got better by night. Eyes problems persisted all day long.  Slept pretty good Friday night into Saturday (12/7/24).  Saturday at about 10-11am Migraine/Nausea restarted, by afternoon couldn't speak or explain - certain words wouldn't come out. Went to ER. CT scan done, Saturday afternoon - no signs of blood clot. Kept overnight at hospital - MRI done Sunday (12/8/24) morning, no signs of stroke. Released from hospital Sunday afternoon - started on Keppra 500mg 1 twice daily. Referred to neurologist. Red itchy eyes persisted all day Saturday, eyes improving today.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Nausea, Ocular hyperaemia
Clinical narrative: Per Son's report:  2 hours post vaccine, sick to stomach. Next morning she reports "worst migraine I have ever had" though out the day was incoherently speaking, couldn't reason or speak - in and out with this though out the day. Saturday (12/7/24), went to Emergency Room - CT was taken no blood clots found., stayed over night. Sunday (12/8/24), MRI given, MRI did not reveal evidence of stroke. This is all reported by her son, when he came to pick up a new "seizure/migraine" medication.   Per Patient report: Pt reported, within 3 hours post vaccine Thursday (12/5/24) - itchy red eyes, extreme fatigue, nausea, stomach pain, intestinal pain. Friday (12/6/24) morning woke up with migraine headache - hurt all day. Hadn't had a migraine in years. Migraine got better by night. Eyes problems persisted all day long.  Slept pretty good Friday night into Saturday (12/7/24).  Saturday at about 10-11am Migraine/Nausea restarted, by afternoon couldn't speak or explain - certain words wouldn't come out. Went to ER. CT scan done, Saturday afternoon - no signs of blood clot. Kept overnight at hospital - MRI done Sunday (12/8/24) morning, no signs of stroke. Released from hospital Sunday afternoon - started on Keppra 500mg 1 twice daily. Referred to neurologist. Red itchy eyes persisted all day Saturday, eyes improving today.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had already received the yearly Flu Vaccine. This was given to them by mistake.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Donor has redness, swelling, and hardness around site. Site is also warm to touch. Donor reports lightheadedness and nausea on 12/8/2024.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Donor has redness, swelling, and hardness around site. Site is also warm to touch. Donor reports lightheadedness and nausea on 12/8/2024.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two high dose flu shots. She recieved one in September and a second one in december.  She forgot she had already received the first one.  She reported no adverse effects from getting a second flu shot.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Headache, Fever, Pulsating Headache, Restlessness, Fatigue, Chills, Sore Muscles, Sore Joints, Soreness at Injection Sites, High Heart Rate, Numbness in Fingers, Nausea
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Fever, Pulsating Headache, Restlessness, Fatigue, Chills, Sore Muscles, Sore Joints, Soreness at Injection Sites, High Heart Rate, Numbness in Fingers, Nausea
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Restlessness
Clinical narrative: Headache, Fever, Pulsating Headache, Restlessness, Fatigue, Chills, Sore Muscles, Sore Joints, Soreness at Injection Sites, High Heart Rate, Numbness in Fingers, Nausea
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT MISTAKENLY RECEIVED THIS SHOT TWICE WHEN IT SHOULD ONLY BE A ONE TIME SHOT. HIS FIRST SHOT WAS 10/03/2023.  I HAVE TRIED REACHING OUT TO THE PATIENT TO CHECK ON THEM AND PROVIDE ANY COUNSELING FOR POTENTIAL ADVERSE EVENTS BUT HAVE BEEN UNSUCCESSFUL SO FAR.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Contusion, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient started to experience a small bruise that worsened to a larger bruise that spread throughout half of her left arm. She stated her arm was in a lot of pain and she could not use arm after. Patient's arm is currently still have bruised.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain around the injection site
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood magnesium, Chest X-ray, Computerised tomogram head
Clinical narrative: I received the vaccine on Friday, 10/24/2024.  On Saturday my arm was very sore, then on Sunday I didn't feel good, low grade fever and weakness.  Monday morning about 1:00 AM I got up to visit the bathroom, but didn't make it.  I had a seizure.  I have no memory of this.  When I came to, I was lying on the floor, very weak and could not move much.  I had lost control of my bladder and had several cuts to my face where I had hit the bed and floor.  I had to call for an ambulance to go to the ER.  In my 83 years of life, I have never had this happen to me.  I feel strongly that the covid vaccine was the cause.  I was admitted to the hospital for observation the next day.  There was no reoccurance of this event.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Computerised tomogram spine, Electrocardiogram, Full blood count, Malaise
Clinical narrative: I received the vaccine on Friday, 10/24/2024.  On Saturday my arm was very sore, then on Sunday I didn't feel good, low grade fever and weakness.  Monday morning about 1:00 AM I got up to visit the bathroom, but didn't make it.  I had a seizure.  I have no memory of this.  When I came to, I was lying on the floor, very weak and could not move much.  I had lost control of my bladder and had several cuts to my face where I had hit the bed and floor.  I had to call for an ambulance to go to the ER.  In my 83 years of life, I have never had this happen to me.  I feel strongly that the covid vaccine was the cause.  I was admitted to the hospital for observation the next day.  There was no reoccurance of this event.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Mobility decreased, Pain in extremity, Pyrexia, Seizure
Clinical narrative: I received the vaccine on Friday, 10/24/2024.  On Saturday my arm was very sore, then on Sunday I didn't feel good, low grade fever and weakness.  Monday morning about 1:00 AM I got up to visit the bathroom, but didn't make it.  I had a seizure.  I have no memory of this.  When I came to, I was lying on the floor, very weak and could not move much.  I had lost control of my bladder and had several cuts to my face where I had hit the bed and floor.  I had to call for an ambulance to go to the ER.  In my 83 years of life, I have never had this happen to me.  I feel strongly that the covid vaccine was the cause.  I was admitted to the hospital for observation the next day.  There was no reoccurance of this event.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Skin laceration, Troponin, Urinary incontinence
Clinical narrative: I received the vaccine on Friday, 10/24/2024.  On Saturday my arm was very sore, then on Sunday I didn't feel good, low grade fever and weakness.  Monday morning about 1:00 AM I got up to visit the bathroom, but didn't make it.  I had a seizure.  I have no memory of this.  When I came to, I was lying on the floor, very weak and could not move much.  I had lost control of my bladder and had several cuts to my face where I had hit the bed and floor.  I had to call for an ambulance to go to the ER.  In my 83 years of life, I have never had this happen to me.  I feel strongly that the covid vaccine was the cause.  I was admitted to the hospital for observation the next day.  There was no reoccurance of this event.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: FEVER MORE THAN 101F, BODY ACHES, FATIGUE, MYALGIA, HEADACHE, HEADACHE
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient daughter came in and requested RSV vaccine for mother. signed consent form. rsv vaccine was billed, insurance paid,  and vaccine was administered.  we received an email from our corporate clinical department stating that the patient already received the vaccine last year
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient reports that around the injection site is red, and the red rash is spreading down to her forearm. It itches and feels warm to the touch.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Insomnia
Clinical narrative: patient couldn't sleep at night
Age: 36.0
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient became nauseated and dizzy. Her face color turned grey. symptoms occurred from 3:13pm to 3:25pm. Patient was sitting and was was given water to drink.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Exposure during pregnancy, No adverse event, Ultrasound scan normal
Clinical narrative: This vaccine was administered to a 23 year old patient that is 12 weeks pregnant. This is considered a contraindication to receiving the vaccine. The patient had no adverse reaction, but was sent to the ER to be assessed
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Fatigue, Hyperaesthesia teeth, Oral discomfort
Clinical narrative: Periods of pain and fatigue started the next day.  These became progressively worse over time, more frequent and with more intensity over the last few years.  I started having chronic pain daily starting around February 2024.  The pain varies, sometimes in the joints like arthritis, sometimes, stinging in my hands and feet.  There is often a burning sensation in my mouth.  My teeth became sensitive for a while and couldn't tolerate eating or drinking anything hot or cold.  I experienced trigeminal neuralgia for a while - the worst pain I've experienced in my life.  The pain intensity and location varies but it is always constant.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Trigeminal neuralgia
Clinical narrative: Periods of pain and fatigue started the next day.  These became progressively worse over time, more frequent and with more intensity over the last few years.  I started having chronic pain daily starting around February 2024.  The pain varies, sometimes in the joints like arthritis, sometimes, stinging in my hands and feet.  There is often a burning sensation in my mouth.  My teeth became sensitive for a while and couldn't tolerate eating or drinking anything hot or cold.  I experienced trigeminal neuralgia for a while - the worst pain I've experienced in my life.  The pain intensity and location varies but it is always constant.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLUA4
Symptoms: Computerised tomogram head abnormal, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: Systemic: Heart Attack-Medium
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLUA4
Symptoms: Myocardial infarction
Clinical narrative: Systemic: Heart Attack-Medium
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Back pain, Blood test normal, Contusion, Cyanosis, Dizziness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Lymph Node Swelling-Medium
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Lymph Node Swelling-Medium
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Respiratory tract congestion, Swelling, Swelling face, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Lymph Node Swelling-Medium
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dysphagia, Dyspnoea, Lymphadenopathy, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Lymph Node Swelling-Medium
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Bradycardia, Cardiovascular disorder, Echocardiogram
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: low pulse and fluctuations in pulse-Medium, Systemic: Hypotension-Medium, Additional Details: patient stated that his pulse dropped to 30 and then would fluctuate between 30 and 70
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram QRS complex, Heart rate, Heart rate decreased, Hypotension
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: low pulse and fluctuations in pulse-Medium, Systemic: Hypotension-Medium, Additional Details: patient stated that his pulse dropped to 30 and then would fluctuate between 30 and 70
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus bradycardia, Vaccination site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: low pulse and fluctuations in pulse-Medium, Systemic: Hypotension-Medium, Additional Details: patient stated that his pulse dropped to 30 and then would fluctuate between 30 and 70
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate decreased, Hypotension, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: low pulse and fluctuations in pulse-Medium, Systemic: Hypotension-Medium, Additional Details: patient stated that his pulse dropped to 30 and then would fluctuate between 30 and 70
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Dizziness, Headache, Impaired driving ability, Impaired work ability, Laboratory test
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Mild, Additional Details: Patient got the flu shot together with Tdap, not sure which one caused her severe vertigo.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Nausea, Vertigo, Vision blurred
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Mild, Additional Details: Patient got the flu shot together with Tdap, not sure which one caused her severe vertigo.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP, FLU4
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Mild, Additional Details: Patient got the flu shot together with Tdap, not sure which one caused her severe vertigo.
Sex: U
Vaccine: MMR, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; Nurse calling to report inadvertently administering a third dose of MMRII to a patient on 11/20/2024. Caller stated patient has reported no symptoms. Caller provided lot and expiration for 3rd dose of MMRII. Permission to contact HCP was granted. No; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 20-NOV-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 3rd dose, lot #Y004117, expiration date: 12-FEB-2026 (albumin status: recombinant human albumin (rHa)) administered for prophylaxis (strength, and route of administration were not provided). No adverse events reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Nurse calling to report inadvertently administering a third dose of MMRII to a patient on 11/20/2024. Caller stated patient has reported no symptoms. Caller provided lot and expiration for 3rd dose of MMRII. Permission to contact HCP was granted. No; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 20-NOV-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 3rd dose, lot #Y004117, expiration date: 12-FEB-2026 (albumin status: recombinant human albumin (rHa)) administered for prophylaxis (strength, and route of administration were not provided). No adverse events reported.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Mother called office on 12/6/24 and reported patient had been vomiting all night.  Mother denies any other symptoms.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; HCP called to report a TE with VARIVAX.  Administered after being improperly stored.  No adverse effects were reported.  Consent to contact is yes. No additional AE/No PQC.; This spontaneous report as received from a medical assistant referring to a 4-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 02-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y005919, expiration date 13-MAR-2026, 0.5 milliliter (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix serum was not refrigerated properly; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix serum was not refrigerated properly). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2024 The reporter reported that the Shingrix vaccine serum was not refrigerated properly. Letter did not specify if the serum was previously frozen which led to incorrect storage of drug. Wondering if she needs to re-do that vaccine or how to proceed to ensure. She was properly protected with the Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: She did report arm soreness for a couple of days following administration of Shingrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (She has had Shingles in the past.). Concurrent medical conditions included rheumatoid arthritis (She also has rheumatoid arthritis.).   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 pain in arm (Verbatim: She did report arm soreness for a couple of days following administration of Shingrix). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 08-NOV-2024 Patient took Shingrix dose 1 at age 48.  She has had Shingles in the past and wanted to get vaccinate.  She also had rheumatoid arthritis and wanted to get vaccinated with Shingles due to her underlying medical condition She did report arm soreness for a couple of days followed by administration of Shingrix. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation reaction
Clinical narrative: extreme reactogenicity; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of reactogenicity event in a male 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 reactogenicity event (Verbatim: extreme reactogenicity). The outcome of the reactogenicity event was not resolved.   It was unknown if the reporter considered the reactogenicity event to be related to Shingrix.     It was unknown if the company considered the reactogenicity event to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-NOV-2024 The reporter reported that cohost admits he only received the first dose of the vaccine because he experienced extreme reactogenicity after the first dose. He also said he would have received his second dose, but when he was planning to receive it, he had a major medical problem and was not able to go back to get it.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pain, Pain in extremity
Clinical narrative: sore arm; chills; body aches; upset stomach; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 06-NOV-2024, the patient received the 2nd dose of Shingles vaccine. In NOV-2024, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm), chills (Verbatim: chills), general body pain (Verbatim: body aches) and upset stomach (Verbatim: upset stomach). The outcome of the pain in arm, chills, general body pain and upset stomach were not reported.   It was unknown if the reporter considered the pain in arm, chills, general body pain and upset stomach to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, chills, general body pain and upset stomach to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUL-2024 This case was reported by a patient via interactive digital media. The patient had 2nd shingles vaccine day before reporting and besides had a sore arm, chills, body aches, and upset stomach. The patient hoped not to get shingles, this was bad enough. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles down her back and leg; did not receive the 2nd dose of shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles down her back and leg) and incomplete course of vaccination (Verbatim: did not receive the 2nd dose of shingrix). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 22-NOV-2024 The patient reported that her therapist had a patient that did not receive the second dose of Shingrix and ended up getting shingles down her back and leg. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been link with US2024AMR146306, reported by the same reporter; Sender's Comments:  US-GSK-US2024AMR146306:same reporter
Age: 24.0
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: patient received Twinrix first dose and she received monovalent hep B vaccine Heplisav; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 02-OCT-2024, the patient received the 1st dose of Twinrix. On 04-NOV-2024, the patient received Heplisav b. On an unknown date, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: patient received Twinrix first dose and she received monovalent hep B vaccine Heplisav). The outcome of the interchange of vaccine products 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: 06-NOV-2024 The reporter reported that the patient received Twinrix first dose and was under nursing program and she received monovalent hep B vaccine Heplisav which led to interchange of vaccine products. The vaccine administration facility was the same as primary reporter.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: received a dose of Infanrix instead of the requested Boostrix; patient 11 years of age received a dose of Infanrix; patient 11 years of age received a dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 06-AUG-2024, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 06-AUG-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Infanrix instead of the requested Boostrix), adult use of a child product (Verbatim: patient 11 years of age received a dose of Infanrix) and underdose (Verbatim: patient 11 years of age received a dose of Infanrix). The outcome of the wrong vaccine administered, adult use of a child product and underdose were 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: 07-NOV-2024 and 20-NOV-2024 Licensed practical nurse reported on November 7th 2024 that they recently discovered that a female patient 11 years of age received a dose of Infanrix instead of the requested Boostrix for school (Administration date was on August 6th 2024) which led to wrong vaccine administered, adult use of a child product and underdose.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose before 6 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX).   On 06-NOV-2024, the patient received the 2nd dose of Havrix. On 06-NOV-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Second dose before 6 months). The outcome of the drug dose administration interval too short 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: 07-NOV-2024 A medical assistant asked for recommendations. The patient received second dose of Havrix earlier than the recommended interval (two weeks after first dose), which led to which led to shortening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: accidentally administered a second dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose of Arexvy vaccine on 04-JAN-2024 with 295DF batch number and 06-JUL-2025 expiry date).   On 07-NOV-2024, the patient received the 2nd dose of Arexvy. On 07-NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: accidentally administered a second dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2024 A pharmacist reported that a patient accidentally administered a 2nd dose of Arexvy, which led to extra dose administered.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: came back in August 27th of this year for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (Patient received first dose in August 2021).   On 27-AUG-2024, the patient received the 2nd dose of Engerix B. On 27-AUG-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: came back in August 27th of this year for the 2nd dose). The outcome of the drug dose administration interval too long 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: 07-NOV-2024 Pharmacist stated a patient received dose 1 and came back in August 27th of this year for the 2nd dose. The patient was back on the day of reporting for the 3rd dose but it was not administered. Pharmacist Consented to follow up.  The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to get a Havrix, Hep A vaccine but was given Hep B, Engerix B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 64-year-old male patient who received HBV (Engerix B) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis.   On 19-SEP-2024, the patient received the 1st dose of Engerix B. On 19-SEP-2024, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: Patient was supposed to get a Havrix, Hep A vaccine but was given Hep B, Engerix B vaccine). The outcome of the wrong vaccine administered 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: 07-NOV-2024 Registered Nurse reported that, patient was supposed to get a Havrix, Hep A vaccine but was given Hep B, Engerix B vaccine, which led to Wrong vaccine administered. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: while administering Havrix to a patient a very small portion of the dose got into her eye; while administering Havrix to a patient a very small portion of the dose got into her eye; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via eye contact in a 23-year-old female patient who received HAV (Havrix) (batch number C24B9, expiry date 06-MAY-2026) for prophylaxis.   On 07-NOV-2024, the patient received Havrix. On 07-NOV-2024, an unknown time after receiving Havrix, the patient experienced exposure via eye contact (Verbatim: while administering Havrix to a patient a very small portion of the dose got into her eye) and inadvertent exposure to vaccine (Verbatim: while administering Havrix to a patient a very small portion of the dose got into her eye). The outcome of the exposure via eye contact and inadvertent exposure to vaccine were 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: 07-NOV-2024 A medical assistant reported that 15 minutes ago while administering Havrix to a patient a very small portion of the dose got into her eye which led to exposure via eye contact, inadvertent exposure to vaccine.  She already had rinsed her eye with water and asked for recommendations on this situation.
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: nurse accidentally only gave the adjuvant, the liquid part; nurse accidentally only gave the adjuvant, the liquid part; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a infant female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: nurse accidentally only gave the adjuvant, the liquid part) and inappropriate dose of vaccine administered (Verbatim: nurse accidentally only gave the adjuvant, the liquid part). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2024 The nurse reported that she accidentally only gave the adjuvant, the liquid part, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not know the lot number of this dose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix in Jan 21st 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix in 21st January 2020) and Zostavax (Patient received Zostavax in 2011).   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: received the first dose of Shingrix in Jan 21st 2020 ). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2024 Pharmacist called to asked if a patient who received the first dose of Shingrix in January 21st 2020 should re started the series.  Patient received Zostavax in 2011. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: second dose was administered after the maximum interval; patient accidentally received only the diluent portion of Shingrix; patient accidentally received only the diluent portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number B79K5, expiry date 11-APR-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On 08-NOV-2024, the patient received the 2nd dose of Shingrix. On 08-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was administered after the maximum interval), inappropriate preparation of medication (Verbatim: patient accidentally received only the diluent portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient accidentally received only the diluent portion of Shingrix). The outcome of the drug dose administration interval too long, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-NOV-2024 The pharmacist reported that how to proceed a patient accidentally received only the diluent portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They also stated that the first dose was administered approximately 5 years ago, which led to drug dose administration interval too long. Data about the vaccine, event and patient was provided. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; 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 15-year-old female patient who received HBV (Engerix B) (batch number 4VN3H) for prophylaxis.   On 10-AUG-2024, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). 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-NOV-2024 and 11-NOV-2024 Healthcare Professional called us to request stability data for Engerix-B and Infanrix, this due to a below temperature excursion, they provided it and then she asked that what if the vaccines were given to the patients.  The patient received only Engerix-B, one of the vaccines exposed to the excursion.  The reporter reported the following excursions for this vaccine: For May:1) 15 May 2024: a temperature of 32.2 degree F, for 2 hours and 30 minutes. 2) 16 May 2024: a temperature of 30.6 degree F, for 7 hours and 2 minutes. 3) 21 May 2024: a temperature of 34.7 degree F, for 32 minutes. 4) 31May 2024: a temperature of 35.2 degree F, for 18 minutes. For June,1) 13 Jun 2024: a temperature of 32.9 degree F, for 58 minutes. For July: 1) 26 Jul 2024: a temperature of 32.2 degree F, for 43 minutes. For September: 1) 04 Sep2024: a temp. of 34.3 degree F, for 2 hours and 14 minutes. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 5 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024139710:Same reporter US-GSK-US2024139708:Same reporter US-GSK-US2024139715:Same reporter US-GSK-US2024139716:Same reporter