chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Tachycardia
Clinical narrative: Patient developed lightheadedness and palpitations while walking a few minutes after vaccine administration.  She was hypertensive with SBP 160s-170s and tachycardic with HR 130s.  No difficulty breathing, shortness of breath.  She developed left arm heaviness and tingling.  She felt improved with rest and HR decreased to 93.  Physician recommended transfer to the Emergency Department for evaluation and pt declined.  Pt escorted to her workplace in the same medical facility.   No recurrence of symptoms with walking.  Pt advised to report to the ED for recurrence of symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypertension, Limb discomfort, Palpitations, Paraesthesia
Clinical narrative: Hypertension, Tachycardia, Palpitations, feeling of impending doom, left arm heaviness and tingling
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tachycardia
Clinical narrative: Hypertension, Tachycardia, Palpitations, feeling of impending doom, left arm heaviness and tingling
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Electrocardiogram, Hypertension, Limb discomfort, Palpitations
Clinical narrative: Hypertension, Tachycardia, Palpitations, feeling of impending doom, left arm heaviness and tingling
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Tachycardia
Clinical narrative: Hypertension, Tachycardia, Palpitations, feeling of impending doom, left arm heaviness and tingling
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt received pediatric COVID dose
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: When patient received Flu shot, he felt a sharp pain during administration, and as of 11/19/24, he still had arm pain. The site of the injection is still tender without redness and swelling.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received additional dose of Prevnar 20 when it was not indicated. Patient is not experiencing any symptoms related to additional vaccine since he has received it.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo
Clinical narrative: Loss of balance. Vertigo
Age: 83.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Gingival bleeding
Clinical narrative: Client received the Spikevas 24-25 formulation on 12.04/2024 and concurrently received Shingrix. She returned to clinic at 10:00 am with c/o new, sudden onset of bleeding gums. Bleeding was observed at the clinic.  Bleeding was enough to be staining her teeth and her gums were bright red. No swelling of lips, face, throat observed, or reported any where else on her body. No respiratory distress noted. No redness, swelling, or hives noted at either injection site.  Client alert and oriented to person, place, and time. Skin warm and dry.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Administered vaccine outside of approved age range. Only sore arm reported as adverse event
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Administered Vaccine outside of approved age range. Only adverse reaction was sore arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA after COVID vaccination
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eyelid rash, Headache, Pustule, Swelling of eyelid
Clinical narrative: The mild rash on my left eye worsened dramatically - including bumps/pustules, severe swelling, headaches, pain in and around the left eye
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 12/3/24 PT REQUESTED A COVID SHOT.  PT WAS CONFUSED ABOUT WHAT SHE GOT PREVIOUSLY SO STAFF CHECKED THE VACCINES TAB AND SAW NOTHING ELSEWHERE AND PROCEEDED TO DO IT.  WHEN DONE SHE ASKED WHAT SHOTS SHE STILL NEEDED, AND WASN'T SURE WHAT SHE GOT AT (REDACTED). STAFF FAXED (REDACTED) FOR VACCINATION HISTORY. WHEN IT CAME, IT SHOWED SHE GOT A COVID SHOT 3 WEEKS AGO. STAFF SPOKE WITH PT. AFTER SHE ASKED, TOLD HER NOT LIKELY TO HAVE SERIOUS REACTION. ALSO TOLD HER TO TRY TO GET MOST VACCINES AT ONE PLACE OR TO KEEP A LIST. FINALLY GOT TO GET INTO DATABASE AND SAW THE SHOTS FROM (REDACTED). THEY WERE NOT IN THE VACCINES TAB STILL. NOT RELIABLE I GUESS.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Eye irritation, Joint stiffness, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes in neck, joint pain and stiffness, irritated eyes, testicular pain with movement that 12-14 days after vaccine given. Mother called today (12/5/24) to report. Mother had never allowed him to have vaccine due to step sibling having adverse reaction as a child. College that he will be attending requires vaccine so mother consented for vaccine to be given.  She agrees to call his PCP for a visit soon.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Testicular pain
Clinical narrative: Swollen lymph nodes in neck, joint pain and stiffness, irritated eyes, testicular pain with movement that 12-14 days after vaccine given. Mother called today (12/5/24) to report. Mother had never allowed him to have vaccine due to step sibling having adverse reaction as a child. College that he will be attending requires vaccine so mother consented for vaccine to be given.  She agrees to call his PCP for a visit soon.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Swollen Arm, Hives progressing from localized reaction to systemic with Hives covering arm , scalp, and torso
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Random red bumps (or rash) arms, legs trunk of body.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered incorrect dose.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient started feeling lightheaded and dizziness after administration of the covid then flu vaccine. She did faint and go unconscious for a few seconds before gaining consciousness. Patient was sweaty upon consciousness then after water and ice packs, she felt ok to leave on her own will. Patient has a vagal response to vaccines in past.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, Cellulitis orbital, Drainage, Heart failure with reduced ejection fraction
Clinical narrative: myocarditis, orbital cellulitis, pericardial effusion, a cute HFrEF, sepsis (HCC), pneumonia (from COVID-19), anemia, elevated troponin, elevated LFT s. Visited Hospital 12/1, with a high fever and flu like symptoms, where i was diagnosed with covid and sent home. I then returned later that night with worse symptoms, that only got worse in the hospital involving my head swelling and blood O2 dropping. I waited for bad weather to pass to be sent by jet to another hospital, where they performed surgery to remove the fluid from my face and diagnose me with a long list of conditions, many of which i found out later are common for COVID vaccinated individuals..  Thanks to those brave and awesome doctors I am back to 100% full health now.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Liver function test increased, Myocarditis, Oxygen saturation decreased, Pericardial effusion
Clinical narrative: myocarditis, orbital cellulitis, pericardial effusion, a cute HFrEF, sepsis (HCC), pneumonia (from COVID-19), anemia, elevated troponin, elevated LFT s. Visited Hospital 12/1, with a high fever and flu like symptoms, where i was diagnosed with covid and sent home. I then returned later that night with worse symptoms, that only got worse in the hospital involving my head swelling and blood O2 dropping. I waited for bad weather to pass to be sent by jet to another hospital, where they performed surgery to remove the fluid from my face and diagnose me with a long list of conditions, many of which i found out later are common for COVID vaccinated individuals..  Thanks to those brave and awesome doctors I am back to 100% full health now.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, Sepsis, Swelling, Troponin increased
Clinical narrative: myocarditis, orbital cellulitis, pericardial effusion, a cute HFrEF, sepsis (HCC), pneumonia (from COVID-19), anemia, elevated troponin, elevated LFT s. Visited Hospital 12/1, with a high fever and flu like symptoms, where i was diagnosed with covid and sent home. I then returned later that night with worse symptoms, that only got worse in the hospital involving my head swelling and blood O2 dropping. I waited for bad weather to pass to be sent by jet to another hospital, where they performed surgery to remove the fluid from my face and diagnose me with a long list of conditions, many of which i found out later are common for COVID vaccinated individuals..  Thanks to those brave and awesome doctors I am back to 100% full health now.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Student was given HEP A #2 too early
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Infant irritability, Rash, Skin warm
Clinical narrative: Patient received vaccines Monday morning 12/2/24. Per mom by Monday evening patient felt warm to touch and some fussiness noted. Mom then noticed a mild rash on chest and spreading to face. By Tuesday around noon rash "became generalized".  Mom came back to clinic on 12/4/24 to see PCP regarding rash. Per providers note "PO intake good, no irritability, no swelling erythema around the vaccine injections sites, no pruritus, no cough, no fever, no diarrhea, no vomiting. Rash seems to get worse when patient cries. positive bowel sounds." It was noted that mom gave patient Tylenol twice during the timeframe from Monday evening to patient being seen by provider on Wednesday 10am. Patients vitals on 12/4/24 Wt- 5.32kgs, Ht- 57.15cm, HR- 162bpm, O2- 100% RA, RR- 40, T- 97.8 F.
Age: 36.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was erroneously given the Abrysvo vaccine at 17 weeks gestation which is before the recommended time of 32 weeks gestation. No adverse side effects have been noted or reported.
Age: 40.0
Sex: M
Vaccine: COVID19, HEP, IPV, MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given MMRV. This RN went to scan patient out on system and realized patient "aged out of this vaccine" After more research, this vaccine age limit is 12 years old.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: SARS-CoV-2 test, Sinusitis
Clinical narrative: Appears to be sinus infection.  Not sure if it's related to vacinnes
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Insomnia, Myalgia
Clinical narrative: Myalgias (neck, shoulders, back), chills, ambulatory dysfunction,  headache, insomnia.
Age: 6.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Child inadvertently given Tdap instead of Flu
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Impaired work ability, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient notified our clinic on 12/2 that she has been experiencing persistent arm pain since receiving the HPV vaccine on 11/20/24 which has not resolved or improved. She was seen on 12/4 by her provider to evaluate the pain. She reports that the pain affects her neck and shoots down to her hand and affects her ability to work. The patient expressed concern for appropriate landmarking and possible "incorrect technique" during the vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Laboratory test normal, Pruritus, Skin test negative, Urticaria
Clinical narrative: Developed red, itchy bumps known as hives and still have. Show up anywhere: stomach, mostly arms, neck and face!
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Beyfortus 50mg was given in combination to other vaccines to an older than 8 month old. The dosage was for a patient under 5kg and not the correct dose. The patient was also found to not need the RSV vaccine due to not having any known medical issues.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inflammation, Ocular hyperaemia
Clinical narrative: Bloodshot eyes, eye redness from irritated or inflamed blood vessels on the surface of the white part of the eye for a duration of 7 days, currently treating with eye drops for 7 days, 4 drops per day (anti-bacterial) for precautionary measures, as potential to exposure to mice droppings also
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Musculoskeletal stiffness
Clinical narrative: Pain and shoulder stiffness with decreased strength
Age: 72.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Both sites are inflamed and red.  The site of the Comirnity vaccine is about 2 inches in diameter and raised, red, warm to touch.  The Boostrix site is much smaller but still red and inflamed two days later.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Patient was seen for an ED visit (unrelated to COVID-19 vaccination) on  12/3/24. At that time her EMR was updated to include an allergic reaction to any of the COVID-19 vaccines with a reaction type as anaphylaxis. There is no additional information available in the EMR to collect for reporting on the event. Of note, it appears that she received the Pfizer-BioNTech vaccine on 1/29/2021 (Lot # EL9265) , 2/20/2021 (Lot # EL9266) , and 10/27/2021 (Lot # EW0217). Presumably the reaction happened following the dose in Oct 2021, however that cannot be confirmed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient experienced swelling, redness, bumps, and itching on injection arm, hands, feet, and legs. Patient was given steroid shots at urgent care and taking Benadryl and famotidine.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Local redness and swelling (resolved). New headache last week, different than usual. May or may not be related to vax
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years old received Heplisav B
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache
Clinical narrative: PT REPORTS FATIGUE AND HEADACHE.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On the left arm where the Cominarty (pfizer) vaccine was given, below the injection site pt developed a rash and erythema about arms width and 1.5 inches thick. Pt stated that it first started with a rash and then itching, then got hot to touch. Pt came into the pharmacy 12/5/24 around 10am and I asked how long it has been going on and including today its been 3 days and its still hot to touch and visibly red. I asked if the itching  has disappeared and she stated no and recommended to take a benadryl, watch the injection site and if any pain occurs go to the emergency and if it gets any worse then now go to ER or even post benadryl if it gets worse to go to MD. Also pt confirmed no new allergies or  no allergies to latex.  Right arm where flu shot was given had no reaction.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Contusion, Mood swings, Oedema peripheral, Spinal pain
Clinical narrative: Swollen armpit on the right side, Bruise on the right thigh, pain on the spine area, mood swings
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Flu vaccine (unspecified brand) given in left arm. Pt immediately felt pain. Reduced mobility and  pain in left shoulder x 2 weeks. Seen by PCP office. Instructed to use OTC pain medication and PT referral placed
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to patient on 11/25/24, but it had expired on 11/21/24.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient started with redness and swelling around the injection site the day after the vaccines were administered. The area of redness grew to about 5-6 inches and patient was seen in clinic today.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine positive, Dysuria, Haematuria, Hypophagia, Micturition urgency
Clinical narrative: Urinary urgency/frequency/dysuria starting 11/30/24 with gross hematuria (mild), no fevers or flank pain, inserting of surgical menopause for 1 yr, recent sexual activity, and reduced fluid intake.  Telemedicine 12/1/24 (Sunday) was prescribed nitrofurantoin x 5 days and given orders for UA and urine culture.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urine analysis
Clinical narrative: Urinary urgency/frequency/dysuria starting 11/30/24 with gross hematuria (mild), no fevers or flank pain, inserting of surgical menopause for 1 yr, recent sexual activity, and reduced fluid intake.  Telemedicine 12/1/24 (Sunday) was prescribed nitrofurantoin x 5 days and given orders for UA and urine culture.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3, HEP, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving 4 vaccines .  Pt was put in supine position and became conscious after 10 seconds of episode. Patient then was evaluated by provider and was okay to proceed with the rest of appointment.
Age: 18.0
Sex: M
Vaccine: MNP, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time patient has not had an adverse reaction to both vaccines being given.
Age: 18.0
Sex: F
Vaccine: MNP, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time patient has not had an adverse reaction to both vaccines being given.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Received adult dose of Havrix vs pediatric.
Age: 17.0
Sex: F
Vaccine: MNP, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time patient has not had an adverse reaction to both vaccines being given.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Muscle twitching
Clinical narrative: At approximately 11:15 am, he had 30-40 sec whole body twitching and was tired/out of it after episode. Mom took his temperature approximately 30 min later and he had a temperature of 101.5.
Age: 17.0
Sex: M
Vaccine: MNP, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time patient has not had an adverse reaction to both vaccines being given.
Age: 7.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient inadvertently given an extra vaccine, no adverse event, did not cause harm to patient.  Patient called to room, Interpreter via phone used.  Patient's mother answered yes to all of the identifying information but did not have her appointment slip in hand.  Patient's name was similar to that of patient for whom MMR was ordered.  Patient inadvertently given MMR vaccine when she was not due for it.  Provider was notified and assessed patient and reviewed the chart.  Did not cause harm to patient.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: Patient had no symptoms. Patient was instructed to call if she developed any.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: I was preparing a COVI 19 vaccination for a patient when I reached for our private stock COVID box that appeared to have just been opened. I then reached for the very first syringe in the box. I removed the label and placed it on our vaccination form. I proceeded to administer the vaccine. I noticed the lot number discrepancy when I went to chart it, noticing that the lot number corresponded with a pediatric dose of COVID19 vaccine. I contacted the patient and informed him that he could return to the clinic and receive another dose of the vaccination in order to be completely covered.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of RSV vaccine rather than just the 1 recommended dose.  Patient did not have a reaction. Patient sister was notified by nurse, and voiced understanding, she did not have any concerns or questions.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Death
Clinical narrative: Patient deceased on 12/1/2024. Obligated to report to VAERS due to vaccine administration within 1 week. of time of death.
Age: 87.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait inability
Clinical narrative: Patient's wife came into the pharmacy on 12/5/24 to let us know that patient could not walk the next day. They went to the ER and stayed at hospital for 3 days.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of RSV vaccine. No adverse reaction. Patient was notified by provider, she had no concerns or questions .
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: patient had red itchy rash on upper left arm in the deltoid region. This appeared on 12/5/2024. The patient was referred to contact his primary care provider if symptoms do not approve or get worse. The patient was advised to use over the counter diphenhydramine and hydrocortisone to manage the rash.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a flu shot in July and December. No reactions
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient did not have an adverse reaction however, she did already receive this vaccination on 10/17/2023.  After administering the vaccine, she informed us that her physician told her to get the RSV vaccine every year.
Age: 44.0
Sex: M
Vaccine: COVID19, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: No treatment was needed. No reactions observed. No Shortness of breath, rashes, muscle weakness, or pain.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: PATIENT STATED THAT HIS ARM HAS A TINGLING SENSATION.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Abrysvo vaccine was administered on 11/21/24 and then again on 12/2/25.
Age: 42.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: no adverse events
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction occurred. Patient received IPV and Pediarix. Nurse Practitioner called the IR nurse on call and discussed error. Parents informed of extra dose of Polio given.
Sex: U
Vaccine: HPV9
Symptoms: Product contamination physical
Clinical narrative: Medical assistant called to report 3 pre-filled stringed for GARDASIL 9 have foreign matter inside the syringe. caller states " it looks like sediment and even when we mix the product it stays but settles at the bottom" . Caller states there was thre; Product sedimentation present; No adverse event; This spontaneous report has been received from a medical assistant, regarding three patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters (ml), as prophylaxis, lot number X024251 which has been verified to be valid, expiration date reported and validated as 15-MAY-2026 (route of administration and anatomical site of injection were not provided). Additionally, it was reported that the vaccines had sediment and even when mixing the product it stayed but settled at the bottom (Poor quality product administered, Product deposit).   No additional adverse events were reported in the patient.  This case was determined to be non-valid due to the lack of patient identifiers.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP called and reported that a 15-month-old patient received a first dose of PROQUAD on 19SEP2024 and inadvertently received a second dose of PROQUAD on 07OCT2024.; No additional AE; This spontaneous report was received from registered nurse and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y012075, expiration date: 05-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided). On 07-OCT-2024, the patient was inadvertently vaccinated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y012075, expiration date: 05-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided). No additional information was provided. No additional Adverse events.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP calling to report that 13 y/o received 1.0 ml of the VAQTA adult formulation instead of pediatric formulation.  No adverse effects reported. No additional information provided. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a 13-year-old patient with unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-OCT-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #Y009094, expiration date: 29-NOV-2025, administered for prophylaxis (strength, anatomical location and route of administration were not provided). The patient received adult formulation instead of pediatric formulation (Incorrect dose administered). No adverse effects reported. No additional information provided. No additional adverse event (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Eyelid function disorder
Clinical narrative: Bell's Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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 bell's palsy (Verbatim: Bell's Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was resolved (duration 4 months).   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 21-NOV-2024 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Reporter stated that be aware of the side effects to the vaccination, as should be aware with any vaccination.  Also stated that he/she never had a reaction to any vaccine but this time had Bell's Palsy on the left side.  Which lasted almost four months and was not able to close eye lid.; Sender's Comments: Bell's palsy  is an unlisted event which is considered unrelated to GSK vaccine  Shingrix.
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Malaise
Clinical narrative: Malaise; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of malaise in a 52-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) for asthma and chronic obstructive pulmonary disease, Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   Concurrent medical conditions included asthma and chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine, Dupixent 300 mg, Influenza vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced malaise (Verbatim: Malaise). The action taken with Dupixent was unknown. The outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to RSV vaccine.     It was unknown if the company considered the malaise to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 05-NOV-2024 On an unknown date in Aug-2024, the patient started taking subcutaneous Dupixent (dupilumab) Solution for injection at a dose of 300 mg QOW (every other week) (strength: 300 mg/2ml) via prefilled pen for Asthma and Chronic obstructive pulmonary disease. On an unknown date in 2024, the patient received a dose of Influenza vaccine for immunization. On an unknown date in 2024, the patient received a dose of RSV vaccine and COVID-19 vaccine for immunization. On an unknown date in 2024 the patient developed a non-serious event not feeling too well after getting them and advised can be normal to feel a little bad after getting a vaccine (malaise) following the first dose intake of Dupilumab, COVID-19 vaccine, Influenza vaccine and RSV vaccine. It was reported that the patient reported got covid or flu and RSV (respiratory syncytial virus vaccine) vaccines and wanted to confirm no issues with dupixent. Unknown exact date patient received the vaccines. The patient reported not feeling too well after getting them and advised could be normal to feel a little bad after getting a vaccine however advised to continue to monitor and if not improving to contact Doctor of Medicine. Dupilumab (dupixent) was continued for the event. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. It was unknown if the reporter considered the malaise to be related to Dupixent, Influenza vaccine, COVID-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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, 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). 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 unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-NOV-2024  This case was reported by a patient via interactive digital media. Consumer reported that he/she took the Shingrix vaccine and that shots don't work that well. It was personal experience of consumer.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: throbbing headache; puked; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of throbbing headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced throbbing headache (Verbatim: throbbing headache) and vomiting (Verbatim: puked). The outcome of the throbbing headache was not reported and the outcome of the vomiting was resolved (duration 3 days).   It was unknown if the reporter considered the throbbing headache and vomiting to be related to Shingrix.     It was unknown if the company considered the throbbing headache and vomiting to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-NOV-2024 This case was reported by a patient via interactive digital media. The patient had shot of Shingrix.  The patient puked for 3 days straight and had a throbbing headache.  The reporter stated that it was a nightmare but he/she was sure not as bad as shingles.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling; Injection site warmth; some redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a 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 injection site swelling (Verbatim: Injection site swelling), injection site warmth (Verbatim: Injection site warmth) and injection site erythema (Verbatim: some redness). The outcome of the injection site swelling, injection site warmth and injection site erythema were not reported.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site warmth and injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-NOV-2024 Reporter stated that what should one do if they do have injection site swelling, warmth and some redness.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Boostrix given to a patient on 10/7/ and 10/25; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 28-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX).   On 25-OCT-2024, the patient received the 2nd dose of Boostrix. On 25-OCT-2024, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix given to a patient on 10/7/ and 10/25). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2024 A patient was given Boostrix on 07th October 2024 and 25th October 2024 which led to extra dose administered.  The reporter asked that were there any risk for the patient receiving a duplicate dose days apart.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (twice diagnosed with shingles). Concurrent medical conditions included renal disease.   In AUG-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: Tired). The outcome of the tiredness was resolving.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     It was unknown if the company considered the tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024139063   Additional Information: GSK Receipt Date: 07-NOV-2024 The patient self-reported this case. The patient had his first dose of Shingrix administered and the only adverse event he had was that he was tired. Today (on the reporting day) he did felt tired but felt some better. This case is linked with US2024139063, reported by same reporter; Sender's Comments:  US-GSK-US2024139063:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shot didn't help me came down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shot didn't help me came down). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles 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-NOV-2024 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and shot hot did not help came down two weeks after shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My friend gets shingles every time she gets the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: My friend gets shingles every time she gets the vaccine). 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 unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-NOV-2024 The case was received from the patient's friend via interactive digital media. The patient got shingles every time she got the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingle shots only made me have shingles 8 times; 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: Shingle shots only made me have shingles 8 times). 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 unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-NOV-2024 The case was received from the patient via interactive digital media. The reporter was the patient. The reporter reported that shingles shots only made the patient had shingles 8 times afterward and still get them often. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine that was received with the temp slightly our of range; 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 78-year-old male patient who received Herpes zoster (Shingrix) (batch number FY9NL, expiry date 16-JUN-2026) and (batch number 94SE2, expiry date 09-AUG-2026) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 23-JUN-2024).   On 26-SEP-2024, the patient received the 2nd dose of Shingrix (intramuscular). On 26-SEP-2024, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: vaccine that was received with the temp slightly our of range). The outcome of the incorrect storage of drug was unknown.   Additional Information: Follow up information received on 05-NOV-2024 The other health professional reported that the vaccine arrived with temperature out of range which led to incorrect storage of drug, staff did not notice the out range and gave vaccine to patient.  The patient was contacted no adverse effect the patient was asked to come back and received the vaccine again. The other health professional reported that the staff had been in touch with patient and patient had no adverse effects from vaccine. The other health professional reported, not other steps taken vaccine arrived in office, the patient was there for vaccine and box was opened and vaccine given. The nurse then saw that the temperature in the shipping container was out of range slightly.  The other health professional called GlaxoSmithKline immediately to ask what to do, contacted patient, patient had no adverse reaction.  The patient was asked to come back in a week to get re-vaccinated.. Summary of changes: Patient details, product details, event details and narrative were updated.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received her 2nd and 3rd shingrix doses in the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced overdose (Verbatim: received her 2nd and 3rd shingrix doses in the same day). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 05-NOV-2024 The web form was received from health care provider which stated that the patient received her second and third dose of Shingrix in the same day, which led to an overdose.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise
Clinical narrative: was feeling dizzy.; Not feeling good; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On 02-NOV-2024, 1 days after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: Not feeling good). On 03-NOV-2024, the patient experienced dizziness (Verbatim: was feeling dizzy.). The outcome of the feeling abnormal and dizziness were not resolved.   It was unknown if the reporter considered the feeling abnormal and dizziness to be related to Shingrix.     It was unknown if the company considered the feeling abnormal and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-DEC-2024 The caller was the husband of the patient. He stated his wife received Shingrix dose 1 in left arm on November 1, 2024. The next day she was starting not to feel good. 2 days after getting the shot she was feeling dizzy. Her symptoms had not gone away. They were reaching out to healthcare professional.
Sex: F
Vaccine: UNK
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Product storage error and use of FLUARIX following activation of the Prefilled Syringe; Product storage error and use of FLUARIX following activation of the Prefilled Syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 45-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number DA7P5, expiry date 30-JUN-2025) for prophylaxis.   On 04-NOV-2024, the patient received Fluarix 2024-2025 season. On 04-NOV-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced wrong technique in product usage process (Verbatim: Product storage error and use of FLUARIX following activation of the Prefilled Syringe). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Product storage error and use of FLUARIX following activation of the Prefilled Syringe). The outcome of the wrong technique in product usage process 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-NOV-2024 The reporter called to ask about guidance to revaccinate/proceed due to the following situation. Last Wednesday (30th October 2024), an un-caped (activated) vaccine fell on the floor, they put it in the fridge.  Unfortunately, the day before reporting a person at the site used this it on a patient, which led to wrong technique in product usage process and incorrect storage of vaccine. The vaccination date, vaccine detail and patient demographics were retrieved from the Pharmacist´s end during this call. No further information was provided from the Pharmacist´s end during this call.  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.