chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED TWO SHOTS OF RSV VACCINE MORE THAN TWO YEARS APART. PATIENT GOT FIRST RSV VACCINE MORE THAN TWO YEAR AGO ON 10/08/2023, PATIENT GOT ANOTHER SHOT ON  1/10/2025...PATIENT DID NOT REPORT ANY ADVERSE EVENT
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia with Lewy bodies, Loss of personal independence in daily activities, Neurological symptom
Clinical narrative: Guillain Barre Syndrome symptoms began first, in May. She all of a sudden could no longer do yard and house work. Then neurological symptoms followed and she was diagnosed with Lewy Body Dementia.
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate vaccine. Original vaccine administered 11/17/23. Re-administered 1/10/25.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dementia with Lewy bodies, Fall, Neurological symptom
Clinical narrative: Patient had already been diagnosed with Lewy Body Dementia and she already had Guillain Barre symptoms. However, her condition worsened after each vaccine. Parkinsons/Lewy Body symptoms led to a fall, which led to hospitalization and move to a care facility.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia
Clinical narrative: I had intense nerve pain in the right side of my torso.  I had the shingles vaccine in February and May of 2020, but had shingles without the rash in April 2022 and the pain lasted daily until September 2022 and then fully stopped by December 2022.  This caused pain in the same area of my right torso.  My torso was swollen on that side.  I had nerve pain which was intensified by touch.  I had some muscle pain, but that was bearable.  The pain is still there, but less intense.  At its worst, it was an 8 on the pain scale.  Currently, it's about a 3.  Pain meds helped a very little bit and icing and heat made it worse.  I just have to not wear any tighter bands--bras, etc,--in that area and no touch.  Exercise does not seem to impact it at all, including shoveling, Jazzercise, or aerial, except yoga made it worse and when the silks hit it in aerial, that's bad.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dermatitis contact, Hypoaesthesia, Injection site bruising, Muscular weakness, Pain in extremity
Clinical narrative: Patient complaints that he bleed after injection.   And after 2-3 days, his right arm is swollen and pain, numbs and weak.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Anaphylactoid reaction, Pruritus, Urticaria, Wheezing
Clinical narrative: Patient stated she received vaccinations on Monday, 1/6/25 around 5:30pm. Flu was given on top and Prevnar on bottom, both in right deltoid. She stated on Tuesday she woke up with a dime sized welt and itching. On Wednesday morning she claimed welt was bigger and itching was worse. She took a benadryl and about an hour later she felt she was having "anaphylactic" type symptoms and took her epipen. She went to the ER and spent 4 hours there where they treated her with 60mg of prednisone, 50mg of benadryl, and a "breathing treatment." She improved and they discharged her with minor wheezing.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Brain fog, Chills
Clinical narrative: Within 12 hours after receiving the vaccine, Ive experienced chills, body aches, muscle aches, back pain,  joint pain, headache, fever, brain fog, weakness, fatigue, and loss of appetite. My fever has been between 100.0° and 100.4° even with 400 mg of ibuprofen at a time so I had to add 325mg of Tylenol to bring my fever below 100.0°.  I ve also tried using a heating pad for my back and sleeping a lot during the day, but my symptoms haven t resolved or improved, even after almost 48 hours.  This is the same response I had when I got the second COVID shot, which was also Moderna. Both this instance and the time I received the second COVID shot I was forced to miss work. I still haven?t returned to work after my most recent vaccine 2 days ago. Ive never had any adverse reaction to any vaccine in the past.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: Within 12 hours after receiving the vaccine, Ive experienced chills, body aches, muscle aches, back pain,  joint pain, headache, fever, brain fog, weakness, fatigue, and loss of appetite. My fever has been between 100.0° and 100.4° even with 400 mg of ibuprofen at a time so I had to add 325mg of Tylenol to bring my fever below 100.0°.  I ve also tried using a heating pad for my back and sleeping a lot during the day, but my symptoms haven t resolved or improved, even after almost 48 hours.  This is the same response I had when I got the second COVID shot, which was also Moderna. Both this instance and the time I received the second COVID shot I was forced to miss work. I still haven?t returned to work after my most recent vaccine 2 days ago. Ive never had any adverse reaction to any vaccine in the past.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Within 12 hours after receiving the vaccine, Ive experienced chills, body aches, muscle aches, back pain,  joint pain, headache, fever, brain fog, weakness, fatigue, and loss of appetite. My fever has been between 100.0° and 100.4° even with 400 mg of ibuprofen at a time so I had to add 325mg of Tylenol to bring my fever below 100.0°.  I ve also tried using a heating pad for my back and sleeping a lot during the day, but my symptoms haven t resolved or improved, even after almost 48 hours.  This is the same response I had when I got the second COVID shot, which was also Moderna. Both this instance and the time I received the second COVID shot I was forced to miss work. I still haven?t returned to work after my most recent vaccine 2 days ago. Ive never had any adverse reaction to any vaccine in the past.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given Moderna vaccine for ages 12 and up in error.  I discovered error on way home from clinic and immediately reported to my supervisor at pharmacy.  She called Moderna and received  that no harm is anticipated in the dose other than increased redness at injection site. Moderna stated the CDC considers this a full dose and the child does not need a second dose.  Moderna considers this dose as " acceptable".  I contacted mother within 30 minutes of the vaccination and explained the error. She was very understanding and said her child was fine. I dis follow up calls to mother . The pediatrician never returned my calls .
Age: 7.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given Moderna Vaccine for 12 and up in error. I discovered the error on way home from clinic and immediately reported to my supervisor at pharmacy. She called Moderna and received information from them that no harm is anticipated in the dose given other than increased redness at injection site. moderna  states the CDC considers this a full dose and the child  does not need a second dose. Moderna considers this as "acceptable". I contacted the mother within 30 minutes of the vaccination and explained the error. She was very understanding and said her child was fine. I did follow up calls. The pediatrician never returned my calls.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Blood test, Bone scan, Breast cancer female, Chemotherapy
Clinical narrative: Received vaccine in September, was diagnosed with breast cancer in December, a swollen lymph node in my right armpit confirmed by biopsy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax, Lymphadenectomy, Lymphadenopathy
Clinical narrative: Received vaccine in September, was diagnosed with breast cancer in December, a swollen lymph node in my right armpit confirmed by biopsy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging breast, Mammogram, Radiotherapy
Clinical narrative: Received vaccine in September, was diagnosed with breast cancer in December, a swollen lymph node in my right armpit confirmed by biopsy.
Age: 41.0
Sex: M
Vaccine: HEPAB, IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I called the patient to report the incident and at the time of the call, the patient reported that he was feeling well.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Deafness, Dizziness, Pallor, Syncope, Throat tightness
Clinical narrative: patient  fainted, was pale, dizzy, couldn't see or hear, she said the throat was tight... we did administered an EpiPen and called EMS. Patient left with the paramedics to a local ER.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Visual impairment
Clinical narrative: patient  fainted, was pale, dizzy, couldn't see or hear, she said the throat was tight... we did administered an EpiPen and called EMS. Patient left with the paramedics to a local ER.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Gait disturbance, Impaired driving ability, Nausea
Clinical narrative: The patient received a flu and covid vaccine on 01/09/2025.  She phoned today and said she started feeling nausea on 1/10/25.  she stated she was shopping at the store yesterday and started feeling very dizzy and couldn't walk with out support.  She said several people helped her there and told her she shouldn't drive home.  She told me today she was still having dizziness and wanted to know if it could be from the vaccine.  I told her it was possible but that I wanted her to get checked out by a doctor in case it might be something more serious.  She phoned the nurse line and they advised her to go to the er for examination to make sure she is not having a stroke.  When I phoned her back a few minutes later to follow up she was waiting for her brother to come pick her up.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported on Website. First dose given 383 days prior. Patient experienced NO ADVERSE EVENTS.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received prevnar 20 on 1/10/2024 and was given an additional dose on 1/7/2025. She has no adverse effects to date.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested RSV vaccine; told pharmacist she had not had one yet. Pharmacist failed to see previous RSV vaccine given 01/07/2024. When the pharmacist informed the patient of the error, the patient stated that she did not realize it was a one time dose and miss understood the pharmacist's question regarding having the vaccine before.  The patient was adamant that her provider told her she needed to get a booster despite not being the CDC recommendation for Arexvy. Patient states that she thought she qualified for a second dose due to having COPD.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Rash around injection site, chest, and lower back.  No hives, only slightly itchy.  Feeling better as time goes on
Age: 54.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Patient reports numbness in entire left arm and hand, especially last 3 finger (middle, ring, pinkie) and 3 days of dizziness
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Second dose of Arexvy given in error. No protocol for more than one dose. Previous dose not reported on Website. First dose given 383 days prior. Patient experienced NO ADVERSE EVENTS.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fatigue - unable to keep his eyes open, fever over 103 that would not come down with medication, red hot tender spot on back of left thigh.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Nausea, Rash, Rash erythematous
Clinical narrative: Patient has developed red rash all over the upper arm, & she says  she feels  very nauseous and dizzy .
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Muscular weakness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Received vaccine into L deltoid. I experienced burning sensation while the liquid was being administered. I had arm soreness and pain with arm movement above my head later that day. I could not sleep on my left arm as it caused pain. The next day I had muscle weakness of the left arm and could not carry my grocery bag on my left forearm. I did not work out for several days. I continue to have left arm weakness and can not carry a duffel bag on my left arm.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Laboratory test normal, Pain in extremity, Sleep disorder, Surgery
Clinical narrative: It felt pain within 2 hours of the vaccine, could not sleep on that side, pain enough to wake him up at night. Tried hold/cold compresses, Voltaren and nothing worked. Went to doctor in December and was given antibiotics - not sure of name but thought it was cephalexin. Then had surgery late  December and tornaket was put on same arm and since then has been better. Arm still hurts but not as bad.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial infarction
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: On  the day I received the Covid shot, I developed a very large area on my upper left arm that was sore, ,red and very itchy.  I am on day 5 now and it is still red but the soreness and itchiness is subsiding.  I took Benadryl and Tylenol at bedtime to alleviate the soreness and itchiness.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Patient returned to the clinic 2 hours after receiving the vaccine claiming she had diarrhea and nausea. No other complaints.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received original/first dose of Arexvy on 9/27/23 and received another dose of Arexvy on 11/20/24. Patient reports not experiencing any adverse reaction but is not sure if or what she would have experienced as to what could constitute an adverse reaction.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Confusional state, Fatigue, Gait disturbance
Clinical narrative: 1st event  (11/24/2024)--Extreme fatigue, greatly reduced gait, mental confusion, inability to comprehend or remember things, lack of appetite, refusal to drink.  2nd event (01/06/2025)- Increased fatigue, reduced gait, mental confusion. Improved rapidly over 1 week. No dehydration. (He refused to drink during the first event)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Very sore starting 2 hrs after vaccine.  Developed large 7mm x 7 mm red area, hot and hard on 01/12/2025. Spoke with pharmacist and he suggested going to a doctor.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Chills, Death, Discomfort, Headache
Clinical narrative: ?    Severe headache occurred 24?48 hours after receiving the Moderna COVID-19 vaccine, described by the patient as ?the worst headache since 2015.?     ?    He experienced chills and severe discomfort the day after the vaccination.     ?    The headache persisted despite resting, leading the family to contact his doctor. The doctor prescribed Butalbital/Acetaminophen/Caffeine (for headaches) but did not advise him to go to the emergency room and did not see him in person. The medication was prescribed via phone.     ?    Despite taking the prescribed medication, his headache slightly improved but never fully subsided, and his overall discomfort continued.     ?    On the morning of September 14, 2024, he collapsed in the garage and passed away due to sudden cardiac arrest.     ?    Medical History:     ?    Prior to the vaccination, the patient was healthy and physically active, managing hypertension with medication.     ?    Regular cardiology visits confirmed no history of heart disease or cardiovascular complications.     ?    The coroner indicated hypertension as a contributing factor, but this was well-managed, and the patient had no clinical signs of heart disease prior to vaccination.     ?    Outcome: Death.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: ?    Severe headache occurred 24?48 hours after receiving the Moderna COVID-19 vaccine, described by the patient as ?the worst headache since 2015.?     ?    He experienced chills and severe discomfort the day after the vaccination.     ?    The headache persisted despite resting, leading the family to contact his doctor. The doctor prescribed Butalbital/Acetaminophen/Caffeine (for headaches) but did not advise him to go to the emergency room and did not see him in person. The medication was prescribed via phone.     ?    Despite taking the prescribed medication, his headache slightly improved but never fully subsided, and his overall discomfort continued.     ?    On the morning of September 14, 2024, he collapsed in the garage and passed away due to sudden cardiac arrest.     ?    Medical History:     ?    Prior to the vaccination, the patient was healthy and physically active, managing hypertension with medication.     ?    Regular cardiology visits confirmed no history of heart disease or cardiovascular complications.     ?    The coroner indicated hypertension as a contributing factor, but this was well-managed, and the patient had no clinical signs of heart disease prior to vaccination.     ?    Outcome: Death.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Food allergy
Clinical narrative: Developed a fish and shellfish allergy that is anaphylactic.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of Arexvy on 12/30/2024. Previous dose was administered on 01/31/2024. Unable to reach patient to gather adverse reactions.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash, Rash macular, Skin warm, Swelling face
Clinical narrative: Headache. Temperature 100° Cheeks swollen and red hot blotches also on forehead and temples. Called pharmacy told to use Benadryl. Did so. 2 doses in 24 hours. Less red and swollen today. Head feels better as well
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Computerised tomogram thorax, Iliac artery occlusion, Intraventricular haemorrhage
Clinical narrative: ADMTITED TO HOSPITAL 1/2/25 WITH ACUTE LEFT LEG ISCHEMIA NECESSITATING LEFT ABOVE KNEE AMPUTATION DESPITE HAVING BEEN ON SYSTEMIC ANTICOAGULATION FOR ATRIAL FIBRILLATION. SUFFERED BRAIN HEMORRHAGE 1/10/25 WITH INTRAVENTICULAR HEMORRHAGE, UNCLEAR ETIOLOGY. WAS NOT TAKING HIS ANTICOAGULATION AT THE TIME. COURSE COMPLICATED BY LEFT UPPER AND LOWER LOBE PULMONARY EMBOLI.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Leg amputation, Peripheral ischaemia, Pulmonary embolism, Scan with contrast abnormal, Subarachnoid haemorrhage
Clinical narrative: ADMTITED TO HOSPITAL 1/2/25 WITH ACUTE LEFT LEG ISCHEMIA NECESSITATING LEFT ABOVE KNEE AMPUTATION DESPITE HAVING BEEN ON SYSTEMIC ANTICOAGULATION FOR ATRIAL FIBRILLATION. SUFFERED BRAIN HEMORRHAGE 1/10/25 WITH INTRAVENTICULAR HEMORRHAGE, UNCLEAR ETIOLOGY. WAS NOT TAKING HIS ANTICOAGULATION AT THE TIME. COURSE COMPLICATED BY LEFT UPPER AND LOWER LOBE PULMONARY EMBOLI.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Chest X-ray, Cough, Decreased appetite
Clinical narrative: Emergency room 1-1-2025. Blood in stools. Pain in stomach. Coughing. Aches.  Chills.  Loss of appetite.  Can taste.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Haematochezia, Pain
Clinical narrative: Emergency room 1-1-2025. Blood in stools. Pain in stomach. Coughing. Aches.  Chills.  Loss of appetite.  Can taste.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Muscle atrophy
Clinical narrative: Severe depression, in April 17 2021,  chronic joint pain and mussel degeneration  07/24
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Prevnar 20 on 12/26/23 and again on 1/8/25. Patient did not need the second dose but was given because patient requested it. He experienced no adverse effects per his report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: patient reported redness around the area of injection
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Wound necrosis
Clinical narrative: PATIENT HAS A WOUND APPROXIMATELY AN INCH AND A HALF WIDE THAT APPEARS NECROTIC IN THE MIDDLE AND IS RED AND IRRITATED ON THE EXTERIOR BORDER. Patient REPORTS SEVERE PAIN IN AREA SINCE INJECTION.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient received a second dose of RSV outside of current CDC guidelines.  His first dose was 9/11/23, second dose was 1/7/25.  Patient reports no adverse effects outside of arm soreness.  Pharmacist went over signs and symptoms of Guillain-Barre syndrome due to new labeling.  Patient denied any symptoms, stating he "feels fine."  Reporting due to pharmacy policy to report such an event.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Autoimmune disorder, Blood test abnormal, Fatigue, Impaired work ability
Clinical narrative: Started vomiting in September up to 17 x a day developed multiple autoimmune diseases have no memory of two years of my life have chronic migraines chronic fatigue can not work
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: Started vomiting in September up to 17 x a day developed multiple autoimmune diseases have no memory of two years of my life have chronic migraines chronic fatigue can not work
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: PATIENT HAD MORE BLEEDING THAN TYPICAL
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: Arm redness and warmth with pain, palpable nodule below skin, did not resolve after supportive measures, required antibiotics for improvement
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Oral mucosal erythema, Oral pain, Palatal swelling
Clinical narrative: Swelling and pain in the right posterior palate area, accompanied by erythema
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Patient called 01/12/25 at 2:38pm stating that she is feeling dizzy and trouble walking.  She thinks it is from the flu shot.  She thinks its from mercury in the shot.  I explained that we used a preservative free vaccine.  She asked how often she gets the flus shot and her history shows she has gotten one every year for the at least the past four years.  I told her to get checked out at the urgent care or emergency department.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: patient said she started running a fever the next day and was very tired for 3 to 4 days after receiving vaccine. She stated she would have to rest and take breaks while doing normal daily tasks.
Age: 36.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Patient had a vasovagal reaction following the administration of 3 vaccines (Moderna Covid, Flublok & Adacel). He did not completely pass out, but did feel faint, dizzy, pale. Provided the patient with cold water, a cool cloth and some sugar and he recovered within about 10 minutes. Patient didn't report a history of vasovagal reaction in the past, but said that he hadn't eaten anything that morning.
Age: 76.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Arthritis, Neck pain, Paraesthesia
Clinical narrative: pain and tingling from front of right shoulder to right rear of head. Over a period of several weeks, the pain decreased, and the tingling in the head stopped.  More than two months later, the tingling continues sporadically from the front of right shoulder to back of neck. Doctor felt it was unrelated to the injection, but recommended heat, which occasionally provided temporary relief.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third dose of vaccine administered; recommended vaccine schedule is only for 2 doses
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Vaccination complication
Clinical narrative: suffering a massive stroke; multiple complications; This spontaneous report received from a lawyer concerned a female patient of unspecified age. Documents were received in the form of legal document. No claim, citation, summons or compliant was provided. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: null, and other pre-existing medical conditions included: does the patient have any allergies? : not asked was there drug abuse or illicit drug usage? : not asked does the patient consume alcohol? : not asked does the patient smoke? : not asked. No past medical history was reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on 2021, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering a massive stroke and multiple complications.   Legal document: Inbound call from consumer who reported she had the JNJ Covid 19 vaccine back in 2021. Consumer stated she did report AE from the vaccine back in 2021. Consumer stated following the Covid 19 vaccines, she suffered a massive stroke and has had multiple complications (Dose series 1). Consumer did not elaborate on any additional symptoms or AE she suffered, other than the massive stroke.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of suffering a massive stroke and multiple complications was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0; Medical Assessment comment not required per standard procedure as it is legal case
Sex: F
Vaccine: COVID19, RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: has limited range of motion in her arm and very painful; has limited range of motion in her arm and very painful; This is a spontaneous report received from a Consumer or other non HCP. Regulatory number: 2813077-1 (VAERS ID). Other Case identifier(s): 2025-NVX-US-00020 (Novavax).  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Nov2024 as dose 1, single (Lot number: LN5482) intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 19Nov2024 as dose number unknown, single (Lot number: 6024MF016) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Nov2024, outcome "not recovered" and all described as "has limited range of motion in her arm and very painful". Additional information: suspect drug: Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Mobility decreased and Pain in extremity were reported as non-serious. The reporter assessed the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Mobility decreased and Pain in extremity as possible. No follow-up attempts are possible.
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given immunization that was not storred appropriately, no adverse reaction reported by patient
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given immunization that was not storred appropriately, no adverse reaction reported by patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy given to pregnant patient; Arexvy given to pregnant patient; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy given to pregnant patient) and drug use in unapproved population (Verbatim: Arexvy given to pregnant patient). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter reported that Arexvy given to pregnant patient which led to drug use in unapproved population.
Age: 72.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Ageusia, Dysgeusia
Clinical narrative: sense of taste in his mouth he totally lost a sense of taste; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Oct2024 as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) at the age of 72 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 27Oct2024 as dose number unknown, single (Lot number: UT8473DA) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AGEUSIA (non-serious) with onset Nov2024, outcome "not recovered", described as "sense of taste in his mouth he totally lost a sense of taste". The event "sense of taste in his mouth he totally lost a sense of taste" required physician office visit.  Additional information: patient received Pfizer covid 19 vaccine and after receiving a vaccine 1-2 weeks after that he started getting changes of the sense of taste in his mouth he totally lost a sense of taste wants to know if that was due to Pfizer vaccine or not. As per caller 1-2 weeks after getting the vaccine he started getting a changing in his taste and mouth to the point two weeks after that he ended up with total loss of sense of taste and that was what he still experience now, per caller shortly after he started losing his sense of taste, he followed up with medical doctor she did some tests and told him to check, she send him to the ENT specialist who did some tests and he don't think they found too much grossly abnormal but he further send patient to have MRT of head this Friday to see if anything else was going on, per caller had a breakfast this morning and could not taste it everything taste as a cardboard. Patient received the COVID shot (Clarified as Pfizer COVID-19 Vaccine) at the Redacted on 27October2024, week, one or two weeks after that, he started getting a sensation sense changes, sense of taste in his mouth, to the point where, right now, he has totally lost his sense of taste in his mouth. Went to the medical doctor, and then also recommending an ENT who did a full examination, did not find anything at that point but patient having an MRI on this Friday to see if anything else was going on to see why he have lost his sense of taste. Reported reason why this happened, what he can do to correct it was patient knew personally people have gotten covid have loss their sense of taste, not sure if there was a reason form vaccine also. Patient had No Investigations, No Other Products. Consumer stated, Site of administration as he believed it was left. The injection was at the left arm. Indication stated, he got a vaccine once a year. Consumer stated, On the same day he got the FLU shot.
Age: 72.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Ageusia
Clinical narrative: sense of taste in his mouth he totally lost a sense of taste; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Oct2024 as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) at the age of 72 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 27Oct2024 as dose number unknown, single (Lot number: UT8473DA) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AGEUSIA (non-serious) with onset Nov2024, outcome "not recovered", described as "sense of taste in his mouth he totally lost a sense of taste". The event "sense of taste in his mouth he totally lost a sense of taste" required physician office visit.  Additional information: patient received Pfizer covid 19 vaccine and after receiving a vaccine 1-2 weeks after that he started getting changes of the sense of taste in his mouth he totally lost a sense of taste wants to know if that was due to Pfizer vaccine or not. As per caller 1-2 weeks after getting the vaccine he started getting a changing in his taste and mouth to the point two weeks after that he ended up with total loss of sense of taste and that was what he still experience now, per caller shortly after he started losing his sense of taste, he followed up with medical doctor she did some tests and told him to check, she send him to the ENT specialist who did some tests and he don't think they found too much grossly abnormal but he further send patient to have MRT of head this Friday to see if anything else was going on, per caller had a breakfast this morning and could not taste it everything taste as a cardboard. Patient received the COVID shot (Clarified as Pfizer COVID-19 Vaccine) at the Redacted on 27October2024, week, one or two weeks after that, he started getting a sensation sense changes, sense of taste in his mouth, to the point where, right now, he has totally lost his sense of taste in his mouth. Went to the medical doctor, and then also recommending an ENT who did a full examination, did not find anything at that point but patient having an MRI on this Friday to see if anything else was going on to see why he have lost his sense of taste. Reported reason why this happened, what he can do to correct it was patient knew personally people have gotten covid have loss their sense of taste, not sure if there was a reason form vaccine also. Patient had No Investigations, No Other Products. Consumer stated, Site of administration as he believed it was left. The injection was at the left arm. Indication stated, he got a vaccine once a year. Consumer stated, On the same day he got the FLU shot.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Had the First Dose of Heplisav-B in August of 2024, But Has Not Received the Second Dose Yet; Initial report received on 04-Dec-2024.  A pharmacist reported that a 77-year-old male received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, but he has not received the second dose yet.  No medical history or concomitant medications were reported.  On 12-Aug-2024, the patient received dose 1 of a hepatitis B vaccine (HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient has not received the second dose. The patient had no other side effects.   No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Heplisav-B on Nov 12th, She Came Back For Second Dose on Dec 6th Is it Too Early; Initial report received on 06-Dec-2024.  A nurse reported that a 26-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 12-Nov-2024 and the second dose on 06-Dec-2024.     No medical history or concomitant medications were reported.  On 12-Nov-2024, the patient received dose 1 of a hepatitis B vaccine, HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC number 43528-003-01) intramuscularly (site not reported).    On 06-Dec-2024, 24 days after receiving the first dose, the patient received dose 2 of HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC number 43528-003-01) intramuscularly (site not reported).  The patient received her second injection less than one month after the first. No adverse reactions were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Patient had bitter taste in mouth; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste bitter in a 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 taste bitter (Verbatim: Patient had bitter taste in mouth). The outcome of the taste bitter was not reported.   It was unknown if the reporter considered the taste bitter to be related to Shingrix.     It was unknown if the company considered the taste bitter to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2024 The reporter reported that patient had bitter taste in mouth after administration of Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash over side which itched a lot; This non-serious case was reported by a consumer via patient support programs and described the occurrence of itchy rash in a 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 itchy rash (Verbatim: Rash over side which itched a lot). The outcome of the itchy rash was not reported.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2024 The reporter reported that patient had rash over side which itched a lot after administration of Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: permanently have lost my balance; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of loss of balance in a 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 loss of balance (Verbatim: permanently have lost my balance). The outcome of the loss of balance was not resolved.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.     It was unknown if the company considered the loss of balance to be related to Shingrix.   Additional Information: GSK receipt date: 04-JAN-2025 and 07-JAN-2025 This case was reported by a patient via interactive digital media.  The patient reported that beware the Shingles vaccine (Shingrix), had terrible reaction. He/she had a violent reaction plus permanently had lost balance.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Myalgia, Tenderness
Clinical narrative: stiffness at the injection site; bad muscle ache; sensitive to touch on certain parts of his body which was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles many years ago).   On 20-NOV-2024, the patient received the 1st dose of Shingrix. In NOV-2024, less than 2 weeks after receiving Shingrix, the patient experienced injection site induration (Verbatim: stiffness at the injection site), muscle pain (Verbatim: bad muscle ache) and tenderness (Verbatim: sensitive to touch on certain parts of his body which was painful). The outcome of the injection site induration and muscle pain were resolved and the outcome of the tenderness was not resolved.   It was unknown if the reporter considered the injection site induration, muscle pain and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site induration, muscle pain and tenderness to be related to Shingrix.   Additional Information: GSK receipt date: 12-DEC-2024 The reporter was the spouse of a male patient. The reporter reported that the patient experienced sensitivity in his muscles after the 1st dose of Shingrix Vaccine. It was unknown in which arm the vaccine was administered. The lot and expiry date were unknown.  The reporter stated that the vaccine was provided at a local pharmacy on November 20th, 2024.  The reporter stated that the patient was sensitive to touch on certain parts of his body, and it was painful. Reporter states that the patient initially reported normal stiffness at the injection site, and a bad muscle ache.  The patient reported to the caller that he had shingles many years ago and it feels like the same sensitivity pain. The reporter stated It had been 5 weeks since it started, and the sensitivity pain continued. The reporter stated even the sheets bother him. This case had been link with US2024156990, reported by the same reporter.; Sender's Comments:  US-GSK-US2024156990:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Myalgia
Clinical narrative: stiffness at the injection site; a bad muscle ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-NOV-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 20-NOV-2024, less than a day after receiving Shingrix, the patient experienced injection site induration (Verbatim: stiffness at the injection site) and muscle pain (Verbatim: a bad muscle ache). The outcome of the injection site induration and muscle pain were resolved.   It was unknown if the reporter considered the injection site induration and muscle pain to be related to Shingrix.     It was unknown if the company considered the injection site induration and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2024 The reporter reported that she was a 74 year old female patient.  The patient reported on December 12th, 2024, that she received the 1st dose of Shingrix vaccine at a local pharmacy.  The patient was administered the vaccine in the right arm.  The lot and expiry date were unknown.  Reporter stated that she initially had stiffness at the injection site and a bad muscle ache. Patient reported that her symptoms just lasted a few days and had resolved.  No additional event was reported.; Sender's Comments:  US-GSK-US2024156989:same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He received the first shot 37 days ago/ Twinrix's 2nd late 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 male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received 37 days ago).   On 05-NOV-2024, the patient received the 2nd dose of Twinrix. On 05-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: He received the first shot 37 days ago/ Twinrix's 2nd late 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: 13-DEC-2024 Pharmacist questioned could we mix Havrix and Twinrix if so, what was the schedule. If someone got Twinrix first how long should you wait to get the Havrix. He received the first shot 37 days ago. Out of precaution an AE for Interchange of vaccines was filed but Havrix was not administered. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: product storage error and administration/one patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours; 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 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4799G, expiry date 16-NOV-2026) for prophylaxis.   On 09-DEC-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: product storage error and administration/one patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours). 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: 17-DEC-2024 The patient received Boostrix after it was exposed to 48.3 degree F for 144 hours and also 31.2 degree F for 144 hours, which led to incorrect storage of vaccine.; Reporter's Comments: degree
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix - Late second 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 75-year-old female patient who received HAB (Twinrix) (batch number 344J3, expiry date 12-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 28th May 2024, batch number:344J3 and expiry date:12-SEP-2026).   On 21-DEC-2024, the patient received the 2nd dose of Twinrix. On 21-DEC-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Late second 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: 23-DEC-2024 Pharmacist mentioned that a patient received the first dose of Twinrix on 28th May 2024 and second dose was given on 21st December 2024. The reporter asked how to proceed in this situation. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.