chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Tearfulness
Clinical narrative: Immediately following administration of vaccines, Patient collapsed and began to seize. Episode lasted appx 30 seconds. Post -ictal period patient was confused and tearful. At this time mom disclosed HX of prior similar episodes. May not be related to vaccine administration, however due to timing,  we are reporting.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is under the prescribed age range for vaccination.  Vaccine is for age 12yr >,  Patient's age at the time of vaccine is 4yrs
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is under the required age rage for the vaccine.  The vaccine is for 12yr >.  The patient was 6yrs at the time of vaccine
Age: 52.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently gave MMRV vaccine to a 52yr old female. MMRV has age restrictions for up to 12yrs old. No treatment at this time.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Exposure during pregnancy, Fungal infection, Genital herpes, Genital lesion
Clinical narrative: On 8/29/21 I received a Covid vaccine in my third trimester while pregnant at a pharmacy.  A few days later I had some tingling and irritation that I assumed was due to pregnancy. On 09/14/2021 I called my provider in pain and concerned. On 09/17/2021 I saw my doctor and she believed it was a yeast infection and prescribed a tolical antifungal. Now I have leisons completely sobering my genitalia area. 30+ sores all touching eachother and oozing pus. Absolutely horrific pain urinating. I couldn?t walk or sit without pain. I was covered in warts and the cream I was prescribed wasn?t helping so on 09/21/2021 I went to Hospital for another opinion and was diagnosed with genital herpes in the emergency room. After the emergency room they sent me back to the hospital I was supposed to give birth at which wasn?t helping me. Finally my health team addressed my pain concerns when my symptoms were exacerbated. I had my lesions tested. I was given valrex and my sores started to heal.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Skin discharge, Skin irritation, Skin papilloma
Clinical narrative: On 8/29/21 I received a Covid vaccine in my third trimester while pregnant at a pharmacy.  A few days later I had some tingling and irritation that I assumed was due to pregnancy. On 09/14/2021 I called my provider in pain and concerned. On 09/17/2021 I saw my doctor and she believed it was a yeast infection and prescribed a tolical antifungal. Now I have leisons completely sobering my genitalia area. 30+ sores all touching eachother and oozing pus. Absolutely horrific pain urinating. I couldn?t walk or sit without pain. I was covered in warts and the cream I was prescribed wasn?t helping so on 09/21/2021 I went to Hospital for another opinion and was diagnosed with genital herpes in the emergency room. After the emergency room they sent me back to the hospital I was supposed to give birth at which wasn?t helping me. Finally my health team addressed my pain concerns when my symptoms were exacerbated. I had my lesions tested. I was given valrex and my sores started to heal.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Skin test positive
Clinical narrative: On 8/29/21 I received a Covid vaccine in my third trimester while pregnant at a pharmacy.  A few days later I had some tingling and irritation that I assumed was due to pregnancy. On 09/14/2021 I called my provider in pain and concerned. On 09/17/2021 I saw my doctor and she believed it was a yeast infection and prescribed a tolical antifungal. Now I have leisons completely sobering my genitalia area. 30+ sores all touching eachother and oozing pus. Absolutely horrific pain urinating. I couldn?t walk or sit without pain. I was covered in warts and the cream I was prescribed wasn?t helping so on 09/21/2021 I went to Hospital for another opinion and was diagnosed with genital herpes in the emergency room. After the emergency room they sent me back to the hospital I was supposed to give birth at which wasn?t helping me. Finally my health team addressed my pain concerns when my symptoms were exacerbated. I had my lesions tested. I was given valrex and my sores started to heal.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Arthralgia, Computerised tomogram thorax, Culture positive, Echocardiogram, Injected limb mobility decreased
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Magnetic resonance imaging, Scan with contrast, Staphylococcus test positive, Ultrasound scan, X-ray
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: X-ray limb
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Bacteraemia, Blood culture, C-reactive protein, Chest pain, Computerised tomogram
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Echocardiogram, Full blood count, Immediate post-injection reaction, Injection site pain, Laboratory test
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Magnetic resonance imaging, Metabolic function test, Pain, Red blood cell sedimentation rate, X-ray
Clinical narrative: Extreme left shoulder pain within 24 hours of vaccination. Pt also had trouble moving his left arm.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired.  Given on 8/15/2024. Expired on 6/30/2024
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Underdose
Clinical narrative: Administered a pediatric dose of hepatitis A rather than an adult dose.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: morning after injection developed symptoms of arm felt sore, looked swollen, red, itchy. later developed blisters
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: meingococcal group b - bexsero given instead of menveo
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Injection site discomfort, Injection site paraesthesia, Loss of consciousness, Malaise
Clinical narrative: Pt became diaphoretic and complained she didn't feel well approximately 5 minutes after bexsero and menquadfi injections.  She sat down on the ground prior to losing consciousness.  Her father was holding her, so she did not fall or injure herself in any way.  Patient was gently laid on the ground on her back with knees elevated, normal pulse and respirations noted.  She became alert and oriented approximately 30 seconds later but remained diaphoretic and with hand tremors.  Juice provided (pt states she had not yet eaten today).  Pt feeling back to baseline approximately 5 minutes later except for discomfort and tingling at injection sites.  Monitored for 15 minutes and then ambulated out of clinic without issue accompanied by her father.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tremor
Clinical narrative: Pt became diaphoretic and complained she didn't feel well approximately 5 minutes after bexsero and menquadfi injections.  She sat down on the ground prior to losing consciousness.  Her father was holding her, so she did not fall or injure herself in any way.  Patient was gently laid on the ground on her back with knees elevated, normal pulse and respirations noted.  She became alert and oriented approximately 30 seconds later but remained diaphoretic and with hand tremors.  Juice provided (pt states she had not yet eaten today).  Pt feeling back to baseline approximately 5 minutes later except for discomfort and tingling at injection sites.  Monitored for 15 minutes and then ambulated out of clinic without issue accompanied by her father.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Vaccine spillage during administration, about quarter of the dose spilled. The spillage run down the patient arm. Patient will come in for a repeat dose in about 2 weeks.
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Agency has been notified of this vaccination administration error.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endometrial disorder, Hysterectomy, Neoplasm malignant, Postmenopausal haemorrhage, Ultrasound pelvis abnormal
Clinical narrative: Intermittent symptoms began 8/2022 including vaginal bleeding. Being post menopausal, sought care from my Gynocologist November 8, 2022.. Pelvic Ultrasound conducted showing abnormal endometrium. D&C January 2023 concluded cancer diagnosis. Stat Hysterectomy procedure February 2023.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Intermittent symptoms began 8/2022 including vaginal bleeding. Being post menopausal, sought care from my Gynocologist November 8, 2022.. Pelvic Ultrasound conducted showing abnormal endometrium. D&C January 2023 concluded cancer diagnosis. Stat Hysterectomy procedure February 2023.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: Patient states she is here today because she currently has a rash. She received the Gardasil injection 3 weeks ago, and states she started noticing the rash the next day. It was on the abdomen, erythematous, and in two distinct locations above the umbilicus. Patient states it was itchy at this time.  She was prescribed Benadryl and hydrocortisone cream by the hospital and the rash now is no longer itchy, but in the same shape as before. She states the rash now is "brown" but is otherwise asymptomatic.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash pruritic
Clinical narrative: Per Mom, the patient woke up on 8/15/24 at approx. 3am and had a rash on the bilateral legs that was very itchy. Mom stated that the patient was given a children's dose of Benadryl and then fell back to sleep. Mom stated that the rash did not improve but continued to move up the body over the next day. Mom called the family doctor on 8/16/24 and they recommended that he be checked at an Urgent Care. Mom took the patient to the Urgent Care where they believed that he was having a reaction to the vaccine that was given. They did prescribe a steroid, Zyrtec and a Probiotic. They told Mom to discontinue the Amoxicillin also due to the possibility of an allergy to the medication.
Age: 17.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction, invalid immunization given
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to left upper arm
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received a Tdap on 07/30/2023.  Teen received an additional Tdap in our clinic that was not needed for school entry. No adverse reactions noted.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Neuralgia
Clinical narrative: nerve pain from hand all the way up to jaw
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event
Clinical narrative: The patient was triaged and assessed with no apparent symptoms. A review of the patient's vaccination history was performed. It was noted that the school paper form lacked a stamp and signature from another facility, which resulted in the oversight regarding prior vaccination status. The patient exhibited no immediate adverse reactions or symptoms following the vaccination. The patient was stable and showed no signs of distress. Upon further review of the patient's vaccination card, it was confirmed that the vaccination had indeed been administered as per the required schedule. No further action was required at this time.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood magnesium, Differential white blood cell count, Full blood count, Headache, Metabolic function test
Clinical narrative: patient experienced headache and decreased vision on right side of her visual field.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Visual field defect, Visual impairment
Clinical narrative: patient experienced headache and decreased vision on right side of her visual field.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: NONE
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Varicella was administered on Left arm, parent noticed swelling and redness to arm the next day of administration. Parent brought patient to the clinic 2 days after to be evaluated. Patients left arm was hot to the touch, swelling, rash from shoulder to below the elbow. Patients' vitals within normal, no fever present during exam. Patient was added to providers schedule to be further evaluated. The provider instructed parent to give ibuprofen every 6 hours and antihistamine for a couple of days. Parent to bring patient on 8/16/24 if not getting better or sooner if he is getting worse.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no symptoms or signs at the time of vaccination
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Extra dose of Kinrix given to patient.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood glucose normal, Immediate post-injection reaction, Muscle contracture, Pallor, Syncope
Clinical narrative: Patient in sitting position had a syncopal episode with contracture, pale in color,  started immediately after Hep A.  start time of episode 1:10-1:13, monitored for 30 min until EMS arrived.  Transported to hospital accompanied with Mother.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Computerised tomogram, Dementia, Dizziness, Encephalitis
Clinical narrative: Eyesight affected, bleeding in right eye; encephalitis, memory loss dementia, Meniere's disease, vertigo, vomiting, dizziness, was suspected by multiple docs bit not diagnosed until May 2024. Hospitalized for vertigo, vomiting, dizziness in 2019 but suffered various symptoms before that after 2016, not knowing the cause. The Meniere's is presently being suppressed with Valacyclovir, but unless some effective treatment [or surgery], it will be fatal. If one dose of Valacyclovir is missed,, I become suicidal. PC had another Meniere's patient suicided. It's not psychological or a matter of choice, but an existential necessity. Have immune response symptoms, ruled out MS via  CAT scan. Ruled out BPPV. It's Meniere's from the herpes zoster live virus vaccine, and it destroyed my life, ultimately fatal. ENT specialists were all grossly incompetent, as were all but one ER personnel. I am going to die.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Immune system disorder, Loss of personal independence in daily activities, Meniere's disease, Suicidal ideation
Clinical narrative: Eyesight affected, bleeding in right eye; encephalitis, memory loss dementia, Meniere's disease, vertigo, vomiting, dizziness, was suspected by multiple docs bit not diagnosed until May 2024. Hospitalized for vertigo, vomiting, dizziness in 2019 but suffered various symptoms before that after 2016, not knowing the cause. The Meniere's is presently being suppressed with Valacyclovir, but unless some effective treatment [or surgery], it will be fatal. If one dose of Valacyclovir is missed,, I become suicidal. PC had another Meniere's patient suicided. It's not psychological or a matter of choice, but an existential necessity. Have immune response symptoms, ruled out MS via  CAT scan. Ruled out BPPV. It's Meniere's from the herpes zoster live virus vaccine, and it destroyed my life, ultimately fatal. ENT specialists were all grossly incompetent, as were all but one ER personnel. I am going to die.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo, Visual impairment, Vomiting
Clinical narrative: Eyesight affected, bleeding in right eye; encephalitis, memory loss dementia, Meniere's disease, vertigo, vomiting, dizziness, was suspected by multiple docs bit not diagnosed until May 2024. Hospitalized for vertigo, vomiting, dizziness in 2019 but suffered various symptoms before that after 2016, not knowing the cause. The Meniere's is presently being suppressed with Valacyclovir, but unless some effective treatment [or surgery], it will be fatal. If one dose of Valacyclovir is missed,, I become suicidal. PC had another Meniere's patient suicided. It's not psychological or a matter of choice, but an existential necessity. Have immune response symptoms, ruled out MS via  CAT scan. Ruled out BPPV. It's Meniere's from the herpes zoster live virus vaccine, and it destroyed my life, ultimately fatal. ENT specialists were all grossly incompetent, as were all but one ER personnel. I am going to die.
Age: 1.08
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 13mo F was erroneously given a dose of HPV vaccination rather than PCV as ordered.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient woke next morning with a sore throat, swollen lymph nodes and a fever.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Loss of consciousness, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: when the vaccine was given she locked up, and passed out, said the vaccine hurt. now she can no longer lift her arm outward to the side says an intense pain shoots up the arm. and has been in pain since, arm cant hang loose  or it will be in pain.  cant use arm to complete daily task of living
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: patient received vaccination at 11:56 am, she answered "no" to the question of if patient is allergic to vaccine components, medications, food components or latex (eg: bovine protein, gelatin, gentamicin, polymyxin, neomycin. phenol, yeast, thimerosal) patient stated that she has been having shortness of breath. she never had any side effects or reactions post vaccination. we instructed her to go to the ER as that looked like an allergic reaction
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: body rash and scalp itching
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Tuberculin test
Clinical narrative: Patient returned to the clinic for a TB test result and vaccinated arm appeared swollen, red and hard to the touch. Parent stated that the child did not have any other reactions nor rashes and simply applied cold packs to arm. No fevers reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy alert test negative, Angioedema, Blood test normal, Urticaria chronic
Clinical narrative: Chronic urticaria, angioedema lower lip, and eyes. Try different medications but none work, fexofenadine, cetirizine, hydroxyzine, famotidine, levocetirizine, and steroids work but then everything starts again a few days after finishing the steroid cycle.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reports of symptomatic adverse events; expired dose of PROQUAD was inadvertently administered to the patient; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The information regarding the patient's concurrent conditions or medical history was not provided.  On 22-JUL-2024, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) at a dose of 0.5 mL, lot# X011980, expiry date 19-JUL-2024, for prophylaxis (route of administration and anatomical location were not reported (Expired product administered). No reports of symptomatic adverse events (No adverse event).
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; pediatric patient (age 3) was given and adult dose of VAQTA 1ML instead of the 0.5ML dose; This spontaneous report was received from a Medical Assistant and refers to a 3-year-old pediatric patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 24-JUL-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter (adult dose), lot #X024966, expiration date: 23-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided), instead of 0.5 ml (Overdose). No adverse event.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: 7 week old patient spit up after the administration of a ROTATEQ dose; 7 week old patient spit up after the administration of a ROTATEQ dose; This spontaneous report was received from a medical assistant referring to a 7-month-old female patient. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 25-JUL-2024, the patient was administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, orally for prophylaxis, lot number 2003138 which has been verified to be valid, expiration date reported and validated as 29-APR-2025 (strength, dose, route of administration not reported).   After the administration, the patient spit up the product (infantile spitting up) (accidental underdose).  No additional details provided and no other information provided as to why this may have occurred or how much was spit out. No other adverse event reported. At the time of reporting, the outcome of the event infantile spitting up was unknown  The causality assessment  for infantile spitting up was unknown.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP calling to report RECOMBIVAX HB was given to a patient two days earlier than recommended in the PI. No side effects reported. HCP stated 'I know this is not an adverse event.; This spontaneous report was received from a physician and refers to a 33-year-old female patient. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 28-JUL-2024, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #Y006601, expiration date: 23-NOV-2026, which was confirmed that was a vial product, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  It was reported that the dose was given two days early (inappropriate schedule of vaccine administered).  No adverse events.
Age: 0.33
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where products were administered to a patient .; This spontaneous report was received from an other health care professional, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   On 22-JUL-2024, the patient was vaccinated with with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003158, expiration date: 16-JUN-2025, administered orally for prophylaxis (strength was not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) (V419), 0.5 milliliter injection, 0.5 milliliter, lot #U7801AA, expiration date: 30-JUN-2026, administered for prophylaxis (route of administration was not provided). Before the patient was vaccinated, the vaccines had temperature excursion (TE) at 62.4 Degrees Fahrenheit (f) for 10 hours 45 minutes at this time (Product storage error). The vaccines also have a previous TE at 47.6f for 15 minutes. No symptoms were reported. No Additional Information was provided. No additional adverse event (AE)/ no product quality concern (PQC) was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; six months broke out again/Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: six months broke out again/Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt date: 09-AUG-2024 This case was reported by patient via interactive digital media. He/she had the Shingles vaccine, shingles 2 years after been on antiviral medication for six months broke out again. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles outbreak and yes I was vaccinated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreak and yes I was vaccinated). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-AUG-2024 This case was reported by a patient via (social media) interactive digital media. The patient stated that the doctor's failed to share was its not a one time vaccination and they can't seemed to agree on how often we should vaccinate. The patient stated that he or she sitting there with a shingles outbreak and yes he or she was vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This is 1 of the 4 cases, reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Fatigue, Flushing, Headache
Clinical narrative: Nausea; Headache; Chills; Increased temperature; Flushed skin; Fatigue extreme; Interrupted sleep; Sleep paralysis; Pain injection site; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 23-year-old female patient who received Men B NVS (Bexsero) (batch number X4BK3) for prophylaxis.   Concomitant products included clonidine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) and alprazolam (Xanax).   On 05-AUG-2024, the patient received Bexsero .5 ml. On 05-AUG-2024, less than a day after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site). On 06-AUG-2024, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Headache), chills (Verbatim: Chills), body temperature increased (Verbatim: Increased temperature), flushed skin (Verbatim: Flushed skin), fatigue (Verbatim: Fatigue extreme), sleep disturbance (Verbatim: Interrupted sleep) and sleep paralysis (Verbatim: Sleep paralysis). The outcome of the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis were not resolved.   It was unknown if the reporter considered the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-AUG-2024 The patient experienced nausea, headache, increased temperature, flushed skin, fatigue extreme, interrupted sleep and pain injection site. The symptoms were not treated.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Nausea, Sleep disorder, Sleep paralysis
Clinical narrative: Nausea; Headache; Chills; Increased temperature; Flushed skin; Fatigue extreme; Interrupted sleep; Sleep paralysis; Pain injection site; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 23-year-old female patient who received Men B NVS (Bexsero) (batch number X4BK3) for prophylaxis.   Concomitant products included clonidine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) and alprazolam (Xanax).   On 05-AUG-2024, the patient received Bexsero .5 ml. On 05-AUG-2024, less than a day after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site). On 06-AUG-2024, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Headache), chills (Verbatim: Chills), body temperature increased (Verbatim: Increased temperature), flushed skin (Verbatim: Flushed skin), fatigue (Verbatim: Fatigue extreme), sleep disturbance (Verbatim: Interrupted sleep) and sleep paralysis (Verbatim: Sleep paralysis). The outcome of the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis were not resolved.   It was unknown if the reporter considered the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, nausea, headache, chills, body temperature increased, flushed skin, fatigue, sleep disturbance and sleep paralysis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-AUG-2024 The patient experienced nausea, headache, increased temperature, flushed skin, fatigue extreme, interrupted sleep and pain injection site. The symptoms were not treated.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Dysuria, Fatigue
Clinical narrative: I felt into sick; body pain; fever; Headache; painful Urinating; dizziness; tiredness; weakness; joint pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, reference case US2024AMR100985).   On 05-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, several hours after receiving Shingrix, the patient experienced sickness (Verbatim: I felt into sick), general body pain (Verbatim: body pain), fever (Verbatim: fever), headache (Verbatim: Headache), painful urination (Verbatim: painful Urinating), dizziness (Verbatim: dizziness), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness) and joint pain (Verbatim: joint pain). Rechallenge with Shingrix was positive. The outcome of the sickness, general body pain, fever, painful urination, dizziness, tiredness, weakness and joint pain were resolving and the outcome of the headache was not resolved.   It was unknown if the reporter considered the sickness, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingrix.     It was unknown if the company considered the sickness, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR100985   Additional Information: GSK Receipt Date: 07-AUG-2024 The patient self-reported this case. The patient received the 2nd dose of Shingles vaccine and after few hours of vaccination, he/she felt into sick by severely body pain, fever, headachy, painful urinating, dizziness, tiredness, weakness, joint pain and etcetera. Now (at the time of reporting) after about 48 hours passed, still his/her headache was not feeling better but all other symptoms were some better. The patient stated his/her 1st dose did all these symptoms mildly but this 2nd dose side effects are severely. On the day of reporting he/she had all symptoms as moderately and headache did not feel better. The reporter requested an advise on what he/she could do for this matter as soon as possible. This case had been link with US2024AMR100985, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR100985:same patient/ First dose
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: I felt into sick; body pain; fever; Headache; painful Urinating; dizziness; tiredness; weakness; joint pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, reference case US2024AMR100985).   On 05-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, several hours after receiving Shingrix, the patient experienced sickness (Verbatim: I felt into sick), general body pain (Verbatim: body pain), fever (Verbatim: fever), headache (Verbatim: Headache), painful urination (Verbatim: painful Urinating), dizziness (Verbatim: dizziness), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness) and joint pain (Verbatim: joint pain). Rechallenge with Shingrix was positive. The outcome of the sickness, general body pain, fever, painful urination, dizziness, tiredness, weakness and joint pain were resolving and the outcome of the headache was not resolved.   It was unknown if the reporter considered the sickness, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingrix.     It was unknown if the company considered the sickness, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR100985   Additional Information: GSK Receipt Date: 07-AUG-2024 The patient self-reported this case. The patient received the 2nd dose of Shingles vaccine and after few hours of vaccination, he/she felt into sick by severely body pain, fever, headachy, painful urinating, dizziness, tiredness, weakness, joint pain and etcetera. Now (at the time of reporting) after about 48 hours passed, still his/her headache was not feeling better but all other symptoms were some better. The patient stated his/her 1st dose did all these symptoms mildly but this 2nd dose side effects are severely. On the day of reporting he/she had all symptoms as moderately and headache did not feel better. The reporter requested an advise on what he/she could do for this matter as soon as possible. This case had been link with US2024AMR100985, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR100985:same patient/ First dose
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: drug dose interval too short; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too short in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 20-FEB-2024, the patient received the 2nd dose of Shingrix. On 20-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: drug dose interval too short). The outcome of the drug dose administration interval too short was not reported.   Additional Information: GSK receipt date: 08-AUG-2024 Shingrix 2nd dose was given 2 weeks after first dose but the patient was being scheduled for actual second now (at the time of reporting), which led to shortening of vaccination schedule.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included pneumonia (three times in life).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 09-AUG-2024 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine because he/she had pneumonia about three times in his/her life and the vaccine was supposed to prevent it. The only side effect was sore arm for several days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Dysuria, Fatigue
Clinical narrative: I felt into sick; body pain; fever; Headache; painful Urinating; dizziness; tiredness; weakness; joint pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: I felt into sick), general body pain (Verbatim: body pain), fever (Verbatim: fever), headache (Verbatim: Headache), painful urination (Verbatim: painful Urinating), dizziness (Verbatim: dizziness), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness) and joint pain (Verbatim: joint pain). The outcome of the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain were not reported.   It was unknown if the reporter considered the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR098800   Additional Information: GSK Receipt Date: 07-AUG-2024 The patient self-reported this case. After few hours of 2nd vaccine received, the patient  felt into sick by severely body pain, fever, headachy, painful Urinating, dizziness, tiredness, weakness, joint pain and etc.  The 1st dose did all these symptoms mildly but this 2nd dose's side effects were severely.; Sender's Comments:  US-GSK-US2024AMR098800:
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: I felt into sick; body pain; fever; Headache; painful Urinating; dizziness; tiredness; weakness; joint pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: I felt into sick), general body pain (Verbatim: body pain), fever (Verbatim: fever), headache (Verbatim: Headache), painful urination (Verbatim: painful Urinating), dizziness (Verbatim: dizziness), tiredness (Verbatim: tiredness), weakness (Verbatim: weakness) and joint pain (Verbatim: joint pain). The outcome of the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain were not reported.   It was unknown if the reporter considered the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell, general body pain, fever, headache, painful urination, dizziness, tiredness, weakness and joint pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR098800   Additional Information: GSK Receipt Date: 07-AUG-2024 The patient self-reported this case. After few hours of 2nd vaccine received, the patient  felt into sick by severely body pain, fever, headachy, painful Urinating, dizziness, tiredness, weakness, joint pain and etc.  The 1st dose did all these symptoms mildly but this 2nd dose's side effects were severely.; Sender's Comments:  US-GSK-US2024AMR098800:
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 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 male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 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: 05-AUG-2024 The pharmacist called to inform that a patient above 50 years old (didn't specify age) receive the 2nd dose of Twinrix almost 2 months after receiving the 1st one, which led to lengthening of vaccination schedule.  After that, reporter mentioned that per patient request of receiving an accelerated schedule, such patient received a 3rd dose of Twinrix 21 days after receiving the 2nd one.  No specific dates were provided for the doses administered. Did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Menveo 1 vial temperature went down to -2.9 °C; Boostrix temperature went down to -2.9 °C; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number NR394, expiry date 31-JUL-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   On an unknown date, the patient received Menveo. On 05-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Menveo and not applicable after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Menveo 1 vial temperature went down to -2.9 °C) and incorrect storage of drug (Verbatim: Boostrix temperature went down to -2.9 °C). The outcome of the incorrect storage of drug and incorrect storage of drug 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: 05-AUG-2024 A nurse reported that a problem with the refrigerator, temperature went down to minus 2.9 degree Celsius, and then 8 hours later the vaccine was given to a patient, which led to incorrect storage of drug. The reporter wanted to know did have to revaccinate him. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024097595:Same reporter/Different patient US-GSK-US2024097585:Same reporter/Different patient