chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Oropharyngeal pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: Arm sore; congestion; Sore throat; Cough; pain on the injection site; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "unknown", described as "Arm sore"; COUGH (non-serious) with onset 2025, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 2025, outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 2025, outcome "unknown", described as "congestion"; VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "unknown", described as "pain on the injection site". Additional information: Patient stated, "I am retired OBGYN (Obstetrics and Gynecology), doctor and I had the Prevnar vaccine one week ago (last Thursday 29May2025). and I looked into the website, and I could not find common side effects. So, I am calling to see if you can tell me what may be is fairly common with this vaccine. I am in tip top shape, I am very healthy, I have no comorbidities, no blood pressure, no diabetes, blood sugar, no pulmonary symptoms, urinary, kidney issues, I am very healthy and other than when I got the vaccine. It really made my arm sore. I was expecting that the nurse told me probably that would happen but I have developed a congestion, a sore throat, a cough". The reporter wondered whether that is common with the Prevnar 20 vaccine. He also mentioned that he had pain on the injection site.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Syncope
Clinical narrative: faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours; A-Fib; chills; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmia" (unspecified if ongoing), notes: Heart; "syncope" (ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; SIMVASTATIN; DOXAZOSIN; VITAMIN D NOS; MELATONIN; MIRALAX. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary immunisation series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A-Fib"; CHILLS (non-serious), outcome "unknown".  Clinical course: The reporter has a history of heart arrhythmia and syncope, and was more recently diagnosed with atrial fibrillation (AFib). Their current medications include Metoprolol, Losartan, Finasteride, Doxazosin, Simvastatin, and Eliquis. When the initial two COVID-19 vaccine doses were administered, the only side effects reported were chills and soreness in the arm. For the first few booster shots, fatigue was also experienced, typically beginning around 12 hours after the injection and resolving within 24 hours. However, starting approximately three years ago, a new pattern began to emerge. Around 12 hours post-vaccination, chills would set in, followed by an episode of fainting within the next 12 hours. Although consciousness was quickly regained, the individual would remain disoriented, unstable, and would then sleep for several hours. Since the diagnosis of AFib and the initiation of treatment with Losartan and Eliquis, a change has occurred: the interval between receiving the booster and experiencing a fainting episode has gradually increased. After the most recent booster, given in the fall, the fainting did not occur until nearly two and a half days later. Now in their eighties, the reporter remains committed to continuing with COVID-19 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient, different dose/events;US-PFIZER INC-202500117115 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events;
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: was down and out for 2 days; Initial information received on 05-Jun-2025 regarding an unsolicited valid  non-serious case received from a patient.  This case is linked to case- US-SA-2025SA163745  This case involves an unknown age female patient who was down and out for 2 days after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received Influenza Quadrivalent Recombinant Vaccine (form, dose, strength, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient was down and out for 2 days (illness) (unknown latency).  Action taken: not applicable.  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; Sender's Comments:  US-SA-2025SA163745:Pateint 1
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 15 year old was given MENQUADFI a month early with no reported AE; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] a month early with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient who was given a dose 2 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection  Frequency = once (strength standard) (batch, dose, expiry date unknown) via unknown route in the left arm for Immunization a month early with no reported ae (inappropriate schedule of product administration) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event; Initial information received on 10-Jun-2025 (with live follow up process together with CSD: 10-Jun-2025) regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old male patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-May-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in the left thigh for Immunization; inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event (single component of a two-component product administered) (latency: same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Since a few hours after receiving the shot, I?ve had continuous both painless and painful CONSTANT muscle spasms. I?ve been the the hospital multiple times and they keep saying, ?it?s anxiety? when I know for a fact it is not.  It?s been well over a month I?ve been dealing with this and the hospital pushes it off like this is a joke. It?s effecting my daily life and SICK OF NOT BEING LISTENED TOO. They literally tell me it?s ?in my head? yet I?ve NEVER had this issue before.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a dose of IPOL when he was not eligible for the dose. Patient has not had any symptoms, but did receive an extra dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Headache, Immediate post-injection reaction, Tinnitus
Clinical narrative: Immediate 6/10 headache for one week, brain fog for one week. Approx one month later - tinnitus
Age: 0.83
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 10 month old patient delayed immunizations
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated, Faecal calprotectin abnormal
Clinical narrative: Reporting suspect effect of covid 19 vaccine and its causal relationship to autoimmune ulcerative colitis condition . this should be further investigated.    Patient  was first diagnosed with pancolitis  in 8/2024 by colonoscopy  (he has had numerous previous covid vaccines, He remains asymptomatic, however inflammation due to autoimmune response is increasing.  Note my intent on reporting is to report a suspect relationship. I have no actual causal proof.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count, Metabolic function test
Clinical narrative: Pt taken to ER, 3 seizures 6-5-25. Pt taking  Kepra BID.   At office visit 6-4-25, pt also had a rash to trunk, diaper area, no fever.  Diagnosed as viral exanthem.   Pt reported to have 1-2 minute seizures a few times a week.  Seizure on 6-5-25 lasted 8-10 minutes.   Hospitalized overnight and given fosphenytoin loading dose and contiued on Kepra.  Pt will habe follow up appointments with Peds neuro and pediatrician
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Rash, Seizure, Viral rash
Clinical narrative: Pt taken to ER, 3 seizures 6-5-25. Pt taking  Kepra BID.   At office visit 6-4-25, pt also had a rash to trunk, diaper area, no fever.  Diagnosed as viral exanthem.   Pt reported to have 1-2 minute seizures a few times a week.  Seizure on 6-5-25 lasted 8-10 minutes.   Hospitalized overnight and given fosphenytoin loading dose and contiued on Kepra.  Pt will habe follow up appointments with Peds neuro and pediatrician
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This RN did not reconstitute this vaccine, this RN only gave the adjuvant. No symptoms or issues after vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: received call from mom at 4:15pm that child had a rash from head to toe and his palms and feet were itchy. No problems with breathing or swelling in the throat or face. She gave him a Benadryl and the hives resolved several hours later.  The next morning I called and the hives are gone and he has no other problems.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given vaccine that had expired (two days) prior, expired 6/7/2025 and administered 6/9/2025. No noted effects or follow-up required at this time.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: 15 month old patient was in for WCC and was suppose to receive Pentacel. However, we discovered today that we had 1 "extra" vial of Hib powder and no vial of Dtap/Polio. I ran an audit and found that this patient is the only one that received that lot number. I came to the conclusion that he only received Dtap & Polio (no Hib).
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Cough
Clinical narrative: cough ,  croup like
Age: 0.67
Sex: F
Vaccine: RV1
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine given off schedule-reporting
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient given first dose in series on 07/31/24 and second dose on 9/6/24- less than the 2 month minimum. No side effects noted.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Provider reconstituted the diluent and the vaccine powder administered right vaccine reconstituted but clicked the wrong button on a vaccine sheet where it asks if provider is aware that the vaccine needs to be reconstituted.  Patient informed of that there is possibility he might have received partial component of Varicella vaccine . Recommendation for revaccination to ensure maximum protection benefits can be reached. Patient declined revaccination.  No adverse effects to the patient
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Dyspnoea, Nausea, Pruritus
Clinical narrative: Fever, Nausea, Skin Broke out into Blisters in Multiple Locations, Burning Sensations, Itchiness, Trouble Breathing for 6 Days
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Nausea, Skin Broke out into Blisters in Multiple Locations, Burning Sensations, Itchiness, Trouble Breathing for 6 Days
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Expired
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: Extreme Dizziness and vomiting and fatique
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap was given to patient rather than dTap. No adverse reaction or unusual symptoms occurred.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Laryngitis
Clinical narrative: non-febrile laryngitis lasting 3 days.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Bursitis, Fatigue, Headache, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Summary: Headache, post nasal drip, puffy cheeks, excessive tiredness, measles-like rash on face, torso and upper limbs (not itchy), fever 100.9, swollen tonsils and neck glands. Swollen bursae all over the body in all the major joints and hands, staggered timing over a period of 15 days. Still some residual stiffness and swelling in hands remaining.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling, Pyrexia, Rash, Rash morbilliform, Swelling face
Clinical narrative: Summary: Headache, post nasal drip, puffy cheeks, excessive tiredness, measles-like rash on face, torso and upper limbs (not itchy), fever 100.9, swollen tonsils and neck glands. Swollen bursae all over the body in all the major joints and hands, staggered timing over a period of 15 days. Still some residual stiffness and swelling in hands remaining.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Tonsillar hypertrophy, Upper-airway cough syndrome
Clinical narrative: Summary: Headache, post nasal drip, puffy cheeks, excessive tiredness, measles-like rash on face, torso and upper limbs (not itchy), fever 100.9, swollen tonsils and neck glands. Swollen bursae all over the body in all the major joints and hands, staggered timing over a period of 15 days. Still some residual stiffness and swelling in hands remaining.
Age: 28.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2 Live vaccines administered on 2 separate days outside the recommendation. MMR vaccine on 06/09/25 and Varicella vaccine on 06/10/25.  Patient has not currently reported experiencing any side effects.
Age: 77.0
Sex: M
Vaccine: PNC21, TDAP
Symptoms: Pain
Clinical narrative: Pt came in day after vaccine administration, said he could not move his arm without severe pain. No swelling or redness at injection site when checked
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Vaccine error - medical assistant gave the HPV vaccine ( that was meant for a different patient)  in error to this patient who is 6 months old.  No adverse reactions were noted during time in clinic for 30 minutes after vaccine was given.  Phone call  being made to parent to followup
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine was reconstituted with sterile water instead of normal saline. Patient not exhibiting any adverse events.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric Hep B was given instead of Adult.  Doctor was notified and she contacted patient and explained what happened and we will administer adult vaccine at next visit.
Age: 61.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Vaccination site infection
Clinical narrative: Patient came in on Thursday 5th of June and said the site of vaccination was infected. RPH advised patient to use triple antibiotic cream, patient came back on Sunday the 8th and reported that it was getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: erythematous raised lesion at site of injection, non tender, no fevers
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: child was in office for MMR and Varicella vaccines. Nurse drew up an MMRV and Varicella. Administered one vaccine before realizing the mistake and excused herself from the room when she realized she wasn't sure which vaccine was given. child was given a varicella but unaware if was given MMRV or Varivax
Age: 1.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt is 1 year 9 months and received DTAP-IPV combination vax .
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: OUTDATED VACCINE
Age: 29.0
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: I accidentally used a 5/8 inch needle to administer an IM vaccine to a pt over 130 lb instead of the recommended 1 inch needle. Pt will have an additional clinic visit to have the vaccine administered with the correct needle length.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 12/11/2024. Dose 2: 06/11/2024
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient had shingles vaccine on 03/26/2025 and states she noticed a rash on her ankles on  Easter Sunday (4/20/2025). She stated that she has seen her pcp and he doesn't not believe it is related to shingles vaccine, he believed it could be "flea or something"  but patient thinks it might be vaccine. She states she also "may have a rash on some of her body". She has taken prednisone and another medication she didn't not know the name of but took one every 7 days and stated she only saw small improvement. Advised patient to follow up with PCP
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 10/29/2024. Dose 2: 06/11/2025
Age: 54.0
Sex: M
Vaccine: ANTH, COVID19
Symptoms: Chest pain, Furuncle, Myocardial infarction, Peripheral swelling
Clinical narrative: took ivermectin, metax lotion, colloidal gold water , wormwood , and many other
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of a one-dose series.  The first dose was administered to the patient in August of 2023, but not reported to the State Immunization Registry.  The second dose was administered on June 6, 2025.  Patient reports no adverse effects following the second dose.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring, Postural orthostatic tachycardia syndrome
Clinical narrative: Onset of POTS and atrial fibrillation
Age: 8.0
Sex: M
Vaccine: HEP, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant therapies were not reported.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion on 19-MAR-2025. Because they did not know that temp TRED 30-16R was temperature. Excursion by power outage in the morning, and they did not know,  On 08-APR-2025, the patient was vaccinated with  an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X024656, expiration date: 09-APR-2025) (doses and routes of administration, were not reported) with  sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (Product storage error).   The administered dose of the vaccine experienced a temperature excursion 66 degrees Fahrenheit for 3 hours. There was no adverse effect reported. No product quality complaint was involved.   Follow up information was received from the pharmacist, on 28-MAY-2025. The patient was an 8-years-old boy, who on 24-MAR-2025 (previously reported as 08-APR-2025), received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot # X024656, expiring on 04-SEP-2025 (previously captured as 09-APR-2025), in the right deltoid (dose and route not reported) in a public health clinic/hospital, as required by school. Other vaccines administered on the same day included Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (lot #X004819, expiration date: 22-May-2025) in Left Deltoid and Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid (QUADRACEL) (lot #U7908AB, expiring on 03-OCT-2025) in the right deltoid. On 19-MAR-2025, the vaccines experienced a temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours, due to digital data logger issue. On 02-MAY-2025, the vaccine's potency was checked and was supported.  This is one of several reports form the same source
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 75D3A, expiry date 31-MAR-2027) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 02-JUN-2025, the patient received the 2nd dose of Shingrix. On 02-JUN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose.). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK receipt date: 05-JUN-2025 On 05/Jun/2025, a nurse called to inform about the early administration of the 2nd dose of Shingrix to a patient, according to reporter, first dose was given back in 11/Apr/2025, and the 2nd dose was administered on 2/Jun/2025 which led to which led to shortening of vaccinations schedule.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete Vaccination Schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 2 dosage last year).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete Vaccination Schedule). The outcome of the incomplete course of vaccination was not applicable.   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-JUN-2025 The pharmacist reported Someone called in reference to give a follow-up shot for Twinrix, they didn't get first ones here, so, we did determine it was Twinrix. Now, he is going to show up and he said that the last one he got was over a year ago and he is here to get his Third shot. So, does he have to start the series over again. HCP stated that the patient was new to them. He said that he did not have more information about the patient and previous doses. Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Age: 0.17
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse effects, i gave a 2 month old patient a RSV vaccine, the database only had one option pull up when i typed in RSV, it was the ABRYSVO RSV vaccine, after giving the vaccine i was trying to chart it in our computer and realized i couldn't, so i dug a little deeper and realized this vaccine was for older adults and pregnant women, not infants, so i called the pharmacy, they got ahold of Pfizer and asked what we needed to do/ what side effects would happen, they said the patient could be more fussy then normal,, be sore at injection site, and may run a low grade fever, which normally can happen with any vaccine given, the patient also received 3 other vaccines today so she will probably be sore and more fussy because of all the vaccines. I also informed my manager and the provider i work with about my mistake and they gave me the steps to follow to fill out the correct paperwork.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given booster when not immunocompromised or over the age of 65 in anticipation of travel
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was administered booster of Comirnaty but the vaccine was not indicated. Patient not immunocompromised or over 65
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Loss of color in face/pale. Dizziness, Nausea, vomiting, slight drop in blood pressure.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Given booster when not indicated in anticipation of family travel.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: IT BEGAN WITH MINOR ARM PAIN THAT EVENTUALLY WENT TO MY SHOULDER. EACH MORNING WAKING UP TO MY HANDS TINGLING AND ARM AND INJECTION SITE SORE AND HURTING. I WAS DIAGNOSED WITH SHOUDLER IMPINGEMENT  SYNDRONE. I RECEIVED A CORTISONE SHOT AND 30 DAYS LATER I AM IN THE WORSE PAIN AND AM UNABLE TO PERFORM MY NORMAL DAY TO DAY DUTIES, LIKE DRIVING, PUTTING ON CLOTHES (SHIRT OR DRESS OR NIGHT GOWN). I REACHED OUT TO MY DR TODAY  JUNE 10, 2025 AND SHE WANTS ME TO MAKE AN APPOINTMENT FOR PHYSICAL THERAPY.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rotator cuff syndrome, X-ray limb
Clinical narrative: IT BEGAN WITH MINOR ARM PAIN THAT EVENTUALLY WENT TO MY SHOULDER. EACH MORNING WAKING UP TO MY HANDS TINGLING AND ARM AND INJECTION SITE SORE AND HURTING. I WAS DIAGNOSED WITH SHOUDLER IMPINGEMENT  SYNDRONE. I RECEIVED A CORTISONE SHOT AND 30 DAYS LATER I AM IN THE WORSE PAIN AND AM UNABLE TO PERFORM MY NORMAL DAY TO DAY DUTIES, LIKE DRIVING, PUTTING ON CLOTHES (SHIRT OR DRESS OR NIGHT GOWN). I REACHED OUT TO MY DR TODAY  JUNE 10, 2025 AND SHE WANTS ME TO MAKE AN APPOINTMENT FOR PHYSICAL THERAPY.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient called the pharmacy on 6/11 to report increasing redness that is moving down the arm, pain and hot to the touch.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effect. duplicate vaccine. pt had a vaccine one month prior
Age: 0.17
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Dose inadvertently administered too early. as of now no adverse reaction
Vaccine: MMR, MMR, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP calling to report that patient received improperly stored VARIVAX and MMR II on 5/14/2025. No adverse effects reported. Caller was not able to provide time and temp details at time of call so precautionary AE filed. No additional AE. No PQC.; This spontaneous report was received from Nurse and refers to a specific patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 14-May-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y014868, expiration date: 03-Sep-2026, (strength, dose, dose number, route, anatomical location and vaccination scheme were not reported), as prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X022411, expiration date: 05-Jun-2025, (strength, dose, dose number, route, anatomical location and vaccination scheme were not reported), as prophylaxis. It was not reported temperature excursion details. No adverse events was reported.
Age: 19.0
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported; Caller reported AE on behalf of a patient who experienced a schedule interruption with GARDASIL 9 vaccination. Caller reported that a patient received their first dose at 19-years old and second dose on 05/28/2025 at 24-years-old. No additional patie; This spontaneous report was received from a pharmacist and refers to a 24-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date (at the age of 19 years), the patient was vaccinated with the first dose Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL/dose (route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. Then, on 28-MAY-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL/dose (route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration).  No symptoms reported (no adverse event).   Lot # is being requested and will be submitted if received.
Vaccine: MENB, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of shingles in a 49-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Bexsero and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Bexsero and Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix.     It was unknown if the company considered the shingles to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix.   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:04-JUN-2025 The patient received Shingrix shot and insurance denied coverage due to treatment not deemed to be effective.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Communication disorder, Dopamine transporter scintigraphy, Dysphagia, Gait inability
Clinical narrative: Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Genetic testing, Heavy metal test, Hypoaesthesia, Impaired work ability
Clinical narrative: Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging, Memory impairment
Clinical narrative: Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, Pain, Paraesthesia, Positron emission tomogram, Skin test
Clinical narrative: Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Tremor, X-ray
Clinical narrative: Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Havrix instead of an adult dose; Pediatric dose administered instead of an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number H3N97, expiry date 01-JAN-2027) for prophylaxis.   Previously administered products included Havrix pediatric (1st dose received on 5th December 2024).   On 05-JUN-2025, the patient received Havrix pediatric. On 05-JUN-2025, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of Havrix instead of an adult dose) and adult use of a child product (Verbatim: Pediatric dose administered instead of an adult dose). The outcome of the underdose and adult use of a child product were not applicable.   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-JUN-2025 Registered Nurse explained that a 19 year old patient received a pediatric dose of Havrix instead of an adult dose today on June 5th, 2025, which led to ult use of a child product and underdose. Patient received first pediatric dose of Havrix on December 5th, 2024. The caller did not have lot number or expiration date for the first dose.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 4 months and 12 days old patient was administered ACTHIB as well as VAXELIS in one day with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months and 12 days old male patient who was administered Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) Vaxelis as well as Hib (Prp/T) Vaccine [Act-Hib] in one day with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine and Rotavirus Vaccine, both for Immunisation.  On 09-Jun-2025, the patient received 0.5ml Dose 2 (once) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength standard, lot UK151AA and expiry date 30-Sep-2025 via intramuscular route in the left thigh for immunization and received an unknown dose of suspect Vaxelis, not produced by Sanofi Pasteur (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site both for prophylactic vaccination (immunization) with no reported adverse event (extra dose administered) (Latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Biopsy placenta, Blood test, Caesarean section, Exposure during pregnancy, Premature delivery
Clinical narrative: Prior to the vaccinations my pregnancy was normal including a normal ultrasound 2 weeks prior. I received both the Covid and flu vaccine on 10/21/2021 and began going into labor in the middle of the night on 10/29/2021 into 10/30/2021. On 10/30/2021 I ended up having Preterm Premature Rupture of Memebranes and delivering my son via emergency c-section at 10:23 AM on 10/30/2021 at 26 weeks 3 days gestation. My due date wasn?t until 2/2/2022. My son was 2lbs 8oz at birth and passed away at 6:15 on 10/30/2021 due to his underdeveloped lungs from preterm birth.
Age: 20.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Premature labour, Preterm premature rupture of membranes
Clinical narrative: Prior to the vaccinations my pregnancy was normal including a normal ultrasound 2 weeks prior. I received both the Covid and flu vaccine on 10/21/2021 and began going into labor in the middle of the night on 10/29/2021 into 10/30/2021. On 10/30/2021 I ended up having Preterm Premature Rupture of Memebranes and delivering my son via emergency c-section at 10:23 AM on 10/30/2021 at 26 weeks 3 days gestation. My due date wasn?t until 2/2/2022. My son was 2lbs 8oz at birth and passed away at 6:15 on 10/30/2021 due to his underdeveloped lungs from preterm birth.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No side effects or symptoms have been reported. No Additional AE/No PQC; HCP called to report a patient did not received their GARDASIL 9 doses according to the recommended dosing schedule. Caller states the patient recieved their first dose in 2020 (exact date unknown0, their second dose in 2021 (exact date unknown) and; This spontaneous report was received from a/an Pharmacist and refers to a(n) 22-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 2020, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 2021, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No side effects or symptoms have been reported (no adverse event).
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; HBP calling to report AE. 17 year old patient inadvertently received a 3rd dose of the GARDASIL 9 vaccine.  1st dose: March 31st, 2021 2nd dose: October 25, 2022 3rd dose: May 19th, 2025 No further information provided. No other AE/No PQC.; 2nd dose: October 25, 2022; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) 17-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 31-Mar-2021, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 25-Oct-2022, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). On 19-May-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), lot #Y013407, expiration date: 01-Feb-2027, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: PNC21, TDAP
Symptoms: Headache, Pain in extremity
Clinical narrative: arm pain; "throbbing headache"; This spontaneous report was received from a consumer and refers to a 36-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-MAY-2025 around 5:40 PM, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection at a dose of 0.5 mL, once, administered by intramuscular route in left arm (lot # and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP), administered by intramuscular route in left arm (dose, lot # and expiration date were not reported); both vaccines were administered for prophylaxis.  On the same day, roughly a hour later, at 6:47 PM, the patient started to have a "throbbing headache" and arm pain. His headache continued to get worse, but he stated he had no severe redness or swelling in the vaccinated arm.   At the reporting time, the outcome of "throbbing headache" and arm pain was unknown.   Causality assessment was not provided.  Additional information is not expected.
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: overall body aches; fever like symptoms; I felt fatigued; This spontaneous report was received from a female nurse of unknown age, referring to herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) at a dose of 0.5 mL, once, administered by intramuscular route (anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient had fever like symptoms, felt fatigued and had overall body aches.   On an unknown date, after about 48 hours, the patient recovered from the events.  Causality assessment was not provided.  Lot# is being requested and will be submitted if received.