chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient mentioned that there was a "lemon-sized lump" at the site of injection, there is some pain at the lump site and warm to the touch, but no issues with range of motion or impacting other daily activities. Patient stated she has never had a reaction like this to her previous 5 doses of pfizer covid vaccine. Patient concerned that the shot felt like it was lower than previous doses. Has had for 3 days but has done nothing to treat. Recommended she try cold compress on the area.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: pain in shoulder-Medium, Additional Details: Pain in shoulder after 2 nd dose of Shingrix
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash on stomach and back-Mild, Additional Details: pt complained of still have arm pain/redness/swelling 2 days after vaccine and now has a rash on his stomach and back.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Foreign travel, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Additional Details: Patient also mentioned she was out of Country last week and cameback on Monday day after arrival, sypmtoms are getting better starting today, never had to see Dr or urgent care
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Injection site bruising, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Hypertension-Mild, Additional Details: she stated that her blood pressure went up but no numbers were given to me
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: potential cellulitis-Medium, Additional Details: Patient received vaccine on 6/17/24. Patient prescribed cephalexin 500 mg 4x/day for 5 days on 6/20 by primary care provider for suspected cellulitis and instructed to seek urgent/emergent medical care if rash (at injection site) grew in size. Patient went to ER on 6/23 for that reason (rash spread to upper back/neck) and was prescribed triamcinolone 0.1% cream to be applied BID.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Large red area that resolved after several days
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Flushing, Hyperhidrosis, Vision blurred
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was dizzy, flushed, sweating, blurred vision. He has history of needle phobia and vasovagal syncope from vaccination. He stated that the needle phobia is psychological and manifests into physical symptoms. He was given water and he ate something afterwards. Felt back to 100% normal after about 20 mins. No follow up needed, Other Vaccines:  VaccineTypeBrand: Tdap (Boostrix); Manufacturer: GSK; LotNumber: z7l7h; Route: im; BodySite: left arm; Dose: 1; VaxDate: 06/23/2024
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Herpes zoster, Hypoaesthesia, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient broke out into shingles/chickenpox like rash (with blisters and open wound), they have lasted for the last 45 days and patient is now attending wound care for them. patient has been to dermatologist,podiotrist,urgent care, and primary care for this rash. patient has received cipro,mupirocin, and acyclovir for treatment. patient has been dealing with pain from reaction since and is still currently
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Wound
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient broke out into shingles/chickenpox like rash (with blisters and open wound), they have lasted for the last 45 days and patient is now attending wound care for them. patient has been to dermatologist,podiotrist,urgent care, and primary care for this rash. patient has received cipro,mupirocin, and acyclovir for treatment. patient has been dealing with pain from reaction since and is still currently
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diplopia, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: COULD NOT SEE, BLURRY VISSION, DOUBLE VISION, EYELIDS CLOSED-Medium, Systemic: Weakness-Medium
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site swelling, Vision blurred
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: COULD NOT SEE, BLURRY VISSION, DOUBLE VISION, EYELIDS CLOSED-Medium, Systemic: Weakness-Medium
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Per floater RPh, this is a "suspected" case of cellulitis with little to know demarcation. Reporting to cover bases. Reported to Dr. (pcp) on 6/22/24. Patient has not reported back or called back after numerous attempts to follow up. Doctor has no reported issue with patient as well.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash, Rash erythematous
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient broke out red, bumpy rash 10 days after vaccine administration
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Mobility decreased
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: patient states after injection movement is limited, she is having an mri if rotator cuff is the issue, but patient states it started after her vaccine
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient stated that she has experienced pain in the area of the vaccination since "June". Patient has an upcoming doctor's appointment that she was intending to discuss the pain with the provider and have the provider examine her arm. I asked the patient to call me after the appointment with her provider. Patient called on 6/25/24 and I submitted a VAERS report at that time however did not receive confirmation and after consulting with District Leader who could not find report am re-submitting
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: after waiting in the vacination area the patient fainted while we were preparing  her documentation striking her head on the floor. EMS came and checked vital signs and released her to her mother's care
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Autoimmune disorder, Dysphagia, Guillain-Barre syndrome, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Severe, Systemic: THE SYMTOMS STARTED ABOUT 1 MONTH LATER FROM THE SHOT, PT WAS HOSTITALIED AND CHECKING AND HOSPITAL FOUND THAT PT GOT GUILLAIN-BARRE SYNDOME.-Severe, Systemic: Weakness-Severe, Additional Details: WHEN HE OGT A SHOT HE WAS OK , BUT SYMTOMS STARTED ABOUT 3 DAYS LATER AND LATER MORE AT HE END OG MAY.THE SYMTOMS STARTED ABOUT 1 MONTH FROM LAST SHOT OF SHINGLE ( END OFMAY)  HE ADMITTED TO HOSPITAL, AND DOCTOR FOUND OUT THAT HE HAS GBS( GUILLAIN-BARRE SYNDROME). NOW HE IS AT HOME, AND DOING PT, AND SEEN NEUROLOGIST. HE USED WALKER., HE IS RECOVERING, BUT STILL NEDD LONT TIME THERAPY, Other Vaccines:  VaccineTypeBrand: ZOSTER (SHINGRIX); Manufacturer: GLAXOSMITHKLINE; LotNumber: LL5C2; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Severe, Systemic: THE SYMTOMS STARTED ABOUT 1 MONTH LATER FROM THE SHOT, PT WAS HOSTITALIED AND CHECKING AND HOSPITAL FOUND THAT PT GOT GUILLAIN-BARRE SYNDOME.-Severe, Systemic: Weakness-Severe, Additional Details: WHEN HE OGT A SHOT HE WAS OK , BUT SYMTOMS STARTED ABOUT 3 DAYS LATER AND LATER MORE AT HE END OG MAY.THE SYMTOMS STARTED ABOUT 1 MONTH FROM LAST SHOT OF SHINGLE ( END OFMAY)  HE ADMITTED TO HOSPITAL, AND DOCTOR FOUND OUT THAT HE HAS GBS( GUILLAIN-BARRE SYNDROME). NOW HE IS AT HOME, AND DOING PT, AND SEEN NEUROLOGIST. HE USED WALKER., HE IS RECOVERING, BUT STILL NEDD LONT TIME THERAPY, Other Vaccines:  VaccineTypeBrand: ZOSTER (SHINGRIX); Manufacturer: GLAXOSMITHKLINE; LotNumber: LL5C2; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Rash pruritic, Skin warm
Clinical narrative: Patient presented to the pharmacy on 7/1/24 stating he got the first dose of a SHINGRIX vaccine on 6/24/24 and now has a rash on the forehead above left eyebrow. He says that the reash showed up after the vaccination, it is currently itchy and tingly but not painfull. Patient said that the rash feels warm to the touch and he is not experiencing any vision problems.
Age: 28.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient in office for vaccine (MMR) MD was questioned if all patient needed was a MENQUADFI and MD stated Yes MENQUADFI was given to patient per verbal order patient should of gotten MMR.  Patient was vaccinated with both vaccines on the same day.  Only MMR was needed.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4, MENB, PNC13, PPV
Symptoms: Hypergammaglobulinaemia benign monoclonal, Light chain analysis
Clinical narrative: Kappa protein chains, MGUS
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: After vaccine administration, patient stated that she felt dizzy and fainted. Patient was provided juice. Patient ambulated out of clinic without assistance.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Visual impairment, Vomiting
Clinical narrative: 48 hours after receiving the moderna spike vax I experienced visual changes, dizziness, unable to walk unassisted, and uncontrolled vomiting. I went to the urgent care and received an injection of Zofran  followed by oral zofran and antivert. My symptoms resolved with 2 days of treatment.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Ear pain, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: He had an earache in left ear which started 2 days after shot. He also had tingly tongue, both lips were numb and tingly. Left side of tongue was more tingly.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Periorbital swelling, Pruritus, Rash erythematous, Rash macular
Clinical narrative: child started gagging and screaming that his hands and feet were itching approximately 10 min post vaccine, child returned to office he had No SOB, he was sleepy, had macular blanching rash arms, legs, ears, abdomen, and mildly on face. No hives, no lip, tongue, hand, feet swelling, although mom said his eyes looked puffy. No wheezing, vomiting, or diarrhea. Redness started to improve after arriving in office. Benadryl given at 4:20 pm.  4: 45pm rash has lightened patient is more interactive and talkative. 4:53 pm rash still mildly red on legs but the rest of the skin changes have resolved
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Retching, Screaming, Somnolence
Clinical narrative: child started gagging and screaming that his hands and feet were itching approximately 10 min post vaccine, child returned to office he had No SOB, he was sleepy, had macular blanching rash arms, legs, ears, abdomen, and mildly on face. No hives, no lip, tongue, hand, feet swelling, although mom said his eyes looked puffy. No wheezing, vomiting, or diarrhea. Redness started to improve after arriving in office. Benadryl given at 4:20 pm.  4: 45pm rash has lightened patient is more interactive and talkative. 4:53 pm rash still mildly red on legs but the rest of the skin changes have resolved
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: Sore throat, chills, body aches, cough
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Patient called an stated that she was having fatigue and body aches that started less than 24 hrs after injection
Age: 1.25
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: Patient was here for 15 month  Well check, Mom requested RSV Vaccine, I informed provider before he went it to examined the patient. After he fully examined patient and talked to mom, he order the RSV Vaccine.  I had a written order confirmed before giving it.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted
Age: 22.0
Sex: M
Vaccine: HEPA, IPV, YF
Symptoms: Dizziness, Fatigue, Loss of consciousness, Syncope
Clinical narrative: Approximately 2 minutes after administration of vaccines, pt stated "I'm feeling lightheaded" and then promptly experienced an episode of syncope. Pt lost consciousness for about 45 seconds. Pt was sitting on exam table and RN held pt in place until he regained consciousness and laid down. Pt stated he felt very tired and was a still a little dizzy. Pt stated he had lost consciousness in the past during a blood draw. Pt stated he had a snack about 5 hours ago, but nothing since. Snack and water were provided, VS were taken, and pt was monitored for approximately 15 minutes. BP 106/67, HR 58, O2 Sat 97%.  Pt then said he was feeling much better, no lingering dizziness, and ambulated steadily out of clinic.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in Left Deltoid
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Muscle soreness in left upper arm with movement, limited movement with arm.  Discomfort noted when sleeping on left side.  Have to position myself to not put pressure on left shoulder.  On 6.22.24, noted pain radiating from left shoulder to left side of neck.  Treated with heat pad, tylenol/ ibuprofen.  Tuesday, 6.25.24, I noted increase pain in left neck and having to move my body versus moving my head.  Friday, 6.28.24, I had a upper body massage in efforts to relieve pain and increase mobility.  Sunday, 6.30.24 noted swelling in left neck area with continued pain.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Swelling, X-ray limb normal
Clinical narrative: Muscle soreness in left upper arm with movement, limited movement with arm.  Discomfort noted when sleeping on left side.  Have to position myself to not put pressure on left shoulder.  On 6.22.24, noted pain radiating from left shoulder to left side of neck.  Treated with heat pad, tylenol/ ibuprofen.  Tuesday, 6.25.24, I noted increase pain in left neck and having to move my body versus moving my head.  Friday, 6.28.24, I had a upper body massage in efforts to relieve pain and increase mobility.  Sunday, 6.30.24 noted swelling in left neck area with continued pain.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Loss of personal independence in daily activities, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient developed scattered red, itchy, vesiculo/papular rash (red spots) on chest, arms, legs after MMRV vaccine. Spots showed up within 6 - 8 hours of vaccine. Seen in ER 48 hours after vaccine. Parents reported rash had been increasing since vaccination, had a few vesicles. Dx/Treatment: Rash after MMRV can occur. Pt prescribed amoxicillin and hydroxine HCl, can give acetaminophen and comfort measures for itching, topical benedryl cream if needed. Presume he can transmit chicken pox to unvaccinated and medically fragile people. No school until lesion are healed.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Malaise
Clinical narrative: Client came in with previous reaction to vaccines, but family did not know what vaccine caused it as he had multiple in one leg in one trip. He had previously had hives occur to one leg after his vaccination in March of 2020.  There was no specification as to what leg each vaccine was given. After we consulted with the local health officer we decided to proceed with the vaccine and monitor the child for 30 minutes after with an EPI pen on hand. No reaction occurred from 5pm-5:30pm on 6/27/2024 when vaccine was given, so we sent the child home. The child was itching at the site however he told us it had itched beforehand as he had bug bites there. On 7/1/2024 I called the phone number on file to check in on the client and it was reported the arm that got the MMRV vaccine had a small raised red bump that occurred later on the night of the vaccination and the child had gone home sick from daycare the next day on 6/28/2024. They reported he is fine now. There was no reaction to the DTaP/IPV vaccine site in the left arm that he got on the same day and the same time.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I gave the patient a pediatric/adolescent dose 0.5 to adult patient. There were no adverse effects at the time of the immunization, nor were there any adverse effects after patient received the immunization. Patient was notified right away of the incident.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Detoxification, Echocardiogram, Electrocardiogram, Hypertension
Clinical narrative: MODERNA #1 4/5/2021 MODERNA 3 5/6/2021 DEVELOPED WORSENED HYPERTENSION REQUIRING INCREASED ANTIHYPERTENSIVE DRUGS.  COVID-19 VACCINE INDUCED WORSENED HYPERTENSION HAS LASTED FOR 3 YEARS AND ASSOCIATED WITH POST-EXERTIONAL MAILASE.  TREATED WITH BENZEPRIL NADOLOL COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test
Clinical narrative: MODERNA #1 4/5/2021 MODERNA 3 5/6/2021 DEVELOPED WORSENED HYPERTENSION REQUIRING INCREASED ANTIHYPERTENSIVE DRUGS.  COVID-19 VACCINE INDUCED WORSENED HYPERTENSION HAS LASTED FOR 3 YEARS AND ASSOCIATED WITH POST-EXERTIONAL MAILASE.  TREATED WITH BENZEPRIL NADOLOL COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Mistakenly the patient was given either a 3rd or 4th dose of the Shingrix shot.  Still unclear.  The system (immunization reporting) had 2 from 2023 and one from April of this year.  Unclear if one of the ones from 2023 was a duplicate.  The previous vaccination was noted that this patient needed no more doses, but the note was missed due to just checking the lot and expiration of vaccine and not previous notes section on images.  The refill was even intentionally left off, but it was believed to be an error.  His pharmacy profile was checked and the vaccine from April was the only one seen.  System was not checked prior.  Additionally, the patient thought it was needed by filling out paperwork.  He was accompanied by his wife, who also was actually due for the same vaccine.  The patient was made aware around a half hour later, reported no ill effects, and was quite pleasant given the circumstances.  Said things like that happen.  In short if system was checked or the image of previous vaccine was checked, the extra vaccine could have been avoided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Inflammation
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA, extremely high blood  pressure which resulted in being medicated, inflammation in upper left arm requiring physical therapy and pain medication.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash macular
Clinical narrative: On 6/20-/24 tolerated vaccines well with DTAP-IPV Kinrix age 4 y/o and MMRV #2.  Reported beginning of rash to face/cheeks on 6/24/24. Denies fever or other s/s. Over weekend reports giving Benadryl without relief. Presented to clinic on 7/1/24 with macular rash spreading cephalocaudal. Otherwise very mild s/s. Still no rash or vesicles to indicate varicella. Counseled family live attenuated vaccine with measles response.
Age: 54.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient was needing a TDAP and was given HPV-9 in error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Client's mother called 3 days after the vaccines were administered, stating she had taken him to the pediatrician due to redness, and a knot on his left arm. The mother stated the pediatrician recommended Benadryl and an ice pack to the area. The client's mother stated she noticed some slight redness to the upper left arm on Saturday, and it worsened by Sunday. Client's mother plans on adhering to the pediatricians recommendations until the redness is gone.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: itching near site of injection, swelling and soreness below site of injection, fever, took tylenol for fever and soreness.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Death, Myocarditis, Pneumonitis
Clinical narrative: After recovering from covid, 2020, patient, wanting ?to be on the safe side?, and also ?to be able to travel?, received a pfizer covid shot and booster. Her roommates discovered her in her bed after many unanswered  texts. We waited seven, 7, months to the very day, for her AUTOPSY results.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac arrest, Death, Dilated cardiomyopathy, Unresponsive to stimuli
Clinical narrative: WE WERE NOTIFIED THE MORNING OF 7-1-2024 VIA HOME HEALTH AGENCY THAT PATIENT PASSED AWAY 6-30-24. THEY APPARENTLY WENT TO WAKE THE CHILD THAT MORNING AND HE WAS UNRESPONSIVE. ER RECORD STATES CARDIAC ARREST AND DIALATED CARDIOMYOPATHY AS DISCHARGE DIAGNOSES
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: started within 24hrs after vaccine administration with redness, warmth of L thigh area, area progressively larger and some blister-like eruptions noted to center of erythema/warmth on 2nd day after vaccine administration
Age: 5.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects as of 15 minutes post vaccination.  Call placed to Poison Control to confirm any expected adverse effects, was told expect nothing outside of normal reactions.  Follow up appointment made for 7/5/2024
Age: 36.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: pruritus and rash over arms , face , neck no bug or tick bite; erythematous maculopapular blanching rash over B/l UL, B/l face , posterior to the ear  and neck  a few scattered blanching erythematous papules over upper back and upper trunk sparing the lower trunk and legs
Age: 0.5
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Clinical staff administered second dose of covid (moderna) and Flu (seasonal) vaccine too early. Date of administration: 4/27/2024 and Expected date of administration: 05/03/2024
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Periarthritis
Clinical narrative: Acute frozen shoulder/adhesive capsulitis in the shoulder vaccine was given.  Vaccine location for administration checked after and appropriate mid deltoid, not a problem with administration.  Referred to PT and to ortho for steroid injection.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Detoxification, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 5/26/2021 PFIZER #2 6/16/2021.   HAD SEVERE COVID IN FEBRUARY OF 2021 AND AFTER COVID VACCINATION DEVELOPED COVID AGAIN IN 2022.  SHORTLY AFTER VACCINE DEVELOPED SOB AND OXYGEN DESATURATION AFTER EXERTION.  CT RULED OUT PE BUT SHOWED SOME PARENCHYMAL ABNORMALITIES.  WENT TO MULTIPLE LONG-COVID CENTERS.  DIAGNOSIS IS COVID VACCINE INDUCED OXYGEN DESATURATION LIKELY DUE TO VACCINE INDUCED HEMAGLUTTINATION.  TREATED WITH HYDROXYCHLOROQUINE AND COLCHICINE WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Oxygen saturation decreased, Pulmonary function test, Red blood cell agglutination
Clinical narrative: PFIZER #1 5/26/2021 PFIZER #2 6/16/2021.   HAD SEVERE COVID IN FEBRUARY OF 2021 AND AFTER COVID VACCINATION DEVELOPED COVID AGAIN IN 2022.  SHORTLY AFTER VACCINE DEVELOPED SOB AND OXYGEN DESATURATION AFTER EXERTION.  CT RULED OUT PE BUT SHOWED SOME PARENCHYMAL ABNORMALITIES.  WENT TO MULTIPLE LONG-COVID CENTERS.  DIAGNOSIS IS COVID VACCINE INDUCED OXYGEN DESATURATION LIKELY DUE TO VACCINE INDUCED HEMAGLUTTINATION.  TREATED WITH HYDROXYCHLOROQUINE AND COLCHICINE WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 11.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Edema and redness down the lateral side of the upper left arm
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported PROQUAD was administered to a patient on an unspecified date during a temperature excursion (case 02613440). No additional AE. No PQC.  Names of vaccines involved (including lot/exp) PROQUAD X011981 07/19/2024 Temperature 12°F Time fram; no additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, drug reactions/allergies, concurrent condition were not provided. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) 1 dose as medication dilution.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin, rHA) (PROQUAD) injection 1 dose (lot # x011981 has been verified to be a valid lot number, expiration date was reported and validated as 19-JUL-2024), administered for prophylaxis (strength, exact dose, route of administration and anatomical location were not provided) by health professional.   It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion with temperature 12 Fahrenheit (F) for 1 hour (product storage error). There was no previous temperature excursion. There was no additional adverse event (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Exposure via breast milk, Varicella virus test positive
Clinical narrative: vesicular skin lesions on an erythematous base; VZV of vesicle fluid performed at a commercial lab was positive for VZV; She did breast feed; This spontaneous retrospective report has been received from a consumer, referring to a 4-week-old patient of an unspecified gender, who was born and breastfed by a 29-year-old mother. The mother's medical history included chickenpox (not verified). The patient's mother last menstrual period was on an unknown date in approximately 2023, estimated date of delivery (EDD) and pregnancy outcome date were estimated as an unknown date in 2024. The pregnancy outcome was live birth, and the fetal outcome was unknown. The information regarding the patient's concurrent conditions, concomitant therapies or medical history, and the mother's concurrent conditions or concomitant therapies was not reported.   On an unknown date in approximately 2024, 3 days after the baby was delivered, the patient's mother was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (doses, routes of administration, anatomical locations, lot numbers and expiry dates were not provided). The patient was exposed to the suspect vaccines via transmammary route (Exposure via breast milk).  On an unspecified date in 2024, the patient experienced a limited number of vesicular skin lesions on an erythematous base; the patient was otherwise not ill. On an unspecified date in 2024, Varicella zoster virus test of vesicle fluid (performed at a commercial laboratory) was positive. There were no known exposures of the patient to chickenpox or shingles. The patient's mother did not develop vesicles and was not symptomatic in any way.  The outcome of the events was not reported.  Causality assessment was not provided.  Lot# has been requested and will be submitted if received.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; first dose of GARDASIL 9 at 14 yo on 12/21/2022 and her second dose on 5/24/2024; This spontaneous report was received from a physician assistance (P.A.) and refers to a adolescent patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided.  On 21-DEC-2022, at the age of 14 years, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, exact dose,  lot #, expiry date, route of administration, and anatomical site of vaccination  were not provided) for prophylaxis. On 24-MAY-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, exact dose,  lot #, expiry date, route of administration, and anatomical site of vaccination  were not provided) (Inappropriate schedule of product administration ). No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Vaccine Coordinator called reporting a patient had been administered ROTATEQ on 6/25/20224 after its expiration date of 6/21/2024. Product has no previous excursion and is supported by the post-exposure expiry memo. Caller did not wish to provide pat; Vaccine Coordinator called reporting a patient had been administered ROTATEQ on 6/25/20224 after its expiration date of 6/21/2024. Product has no previous excursion and is supported by the post-exposure expiry memo. Caller did not wish to provide pat; This spontaneous report was received from a consumer and refers to a patient of unknown and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 25-JUN-2024, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number 1947648 with an expiration date of 21-JUN-2024) (strength, and route of administration were not provided) (expired product administered ). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 4-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-MAR-2024 the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X022920 and expiration date 12-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) that experienced temperature excursion (product storage error and no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 11-MAR-2024 the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X022920 and expiration date 12-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) that experienced temperature excursion (product storage error and no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Pigmentation disorder, Skin reaction, Skin swelling
Clinical narrative: Localized skin reaction; Sore; red ring; bluish-brown pigmentation; slightly raised; This non-serious case was reported by a other health professional and described the occurrence of localized skin reaction in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2C9Y2) for prophylaxis.   On 06-JUN-2024, the patient received Arexvy (intramuscular). On 12-JUN-2024, 6 days after receiving Arexvy, the patient experienced localized skin reaction (Verbatim: Localized skin reaction). In JUN-2024, the patient experienced pain (Verbatim: Sore), red rash (Verbatim: red ring), abnormal pigmentation (Verbatim: bluish-brown pigmentation) and skin disorder (Verbatim: slightly raised). The outcome of the localized skin reaction was not resolved and the outcome of the pain, red rash, abnormal pigmentation and skin disorder were not reported.   It was unknown if the reporter considered the localized skin reaction, pain, red rash, abnormal pigmentation and skin disorder to be related to Arexvy.     It was unknown if the company considered the localized skin reaction, pain, red rash, abnormal pigmentation and skin disorder to be related to Arexvy.   Additional Information: GSK Receipt date: 21-JUN-2024 A reporter reported that the patient had local skin reaction started 1 week after injection with bluish-brown pigmentation, sore, slightly raised, surrounded by red ring, measures about 4 into 3.5cm. (Localized skin reaction). The symptoms were not treated.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: injection site pain; Arm pain; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain) and pain in arm (Verbatim: Arm pain). The outcome of the injection site pain was not reported and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix. The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2024 The patient had arm pain and visited emergency room (ER) with injection site pain or reaction following a dose of Shingrix.
Age: 1.58
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This non-serious case was reported by a physician via other manufacturer and described the occurrence of incorrect storage of drug in a 19-month-old patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Hiberix and Infanrix. On an unknown date, an unknown time after receiving Hiberix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-JUN-2024 An HCP reported that Hiberix and Infanrix were administered to a patient during a temperature excursion which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the 1st vaccine, but still have not gotten the second and it has been longer than 6 months; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (Received 1st dose of Shingrix vaccine on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got the 1st vaccine, but still have not gotten the second and it has been longer than 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2024 The reporter asked that did patients have to restart the Shingrix series if they got the 1st vaccine, but still have not gotten the second and it has been longer than 6 months. Kindly note that medical information specialist did not speak with the health care provider, so please follow up with the sales representative for more information. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: a patient mistakenly received a third Shingrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 25-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 29th November 2021) and Shingrix (received 2nd dose of Shingrix vaccine on 14th March 2022).   On 22-MAR-2024, the patient received the 3rd dose of Shingrix. On 22-MAR-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: a patient mistakenly received a third Shingrix dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2024 The nurse was reported that a patient mistakenly received a 3rd dose of Shingrix vaccine, which led to extra dose administered. The healthcare professional asked for safety data regarding this situation.
Age: 65.0
Sex: F
Vaccine: DTAP, DTAP, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they administered a Kinrix vaccine on June 10th 2024,; Infanrix on  March 2nd 2022.; of Infanrix on July 19th 2021; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis and DTPa (Infanrix) (batch number 9BC23, expiry date 30-JAN-2022) for prophylaxis.   The patient's past medical history included bone marrow transplant.   On 10-JUN-2024, the patient received the 1st dose of Kinrix. On 02-MAR-2022, the patient received Infanrix. On 19-JUL-2021, the patient received the 1st dose of Infanrix. On 19-JUL-2021, not applicable after receiving Kinrix and Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: of Infanrix on July 19th 2021 ). On 02-MAR-2022, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix on  March 2nd 2022.). On 10-JUN-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: they administered a Kinrix vaccine on June 10th 2024, ). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 21-JUN-2024 Medical Assistant explained that a 68 year old patient had a bone marrow transplant, and for that reason the doctor indicated protection against diphtheria, tetanus, and pertussis, and inactivated polio vaccine, so they administered a Kinrix vaccine and 2 prior doses of Infanrix, which led to inappropriate age at vaccine administration.  Caller is aware that those vaccines are for patients 4 to 6 years of age. Consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient aged eleven was given infanrix dtap which is for up to age six; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Previously administered products included Dtap (received Dtap vaccine on 18th November 2013) and Dtap-IPV vaccine (received Dtap-IPV vaccine on 31st July 2019).   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient aged eleven was given infanrix dtap which is for up to age six). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:21-JUN-2024 The nurse reported that the patient aged eleven year received Infanrix dtap vaccine which was for up to age six year, which led to inappropriate age at vaccine administration. The nurse wanted to clarify the corrective action since she received the Infanrix dtap vaccine and she was eleven-year-old. The reporter consented to follow up via fax or phone.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: going to receive 3rd dose of twinrix but was given hepatitis B, the Engerix instead of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received HBV (Engerix B adult) (batch number 9LK2G, expiry date 21-AUG-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On 21-JUN-2024, the patient received the 1st dose of Engerix B adult. On 21-JUN-2024, an unknown time after receiving Engerix B adult, the patient experienced wrong vaccine administered (Verbatim: going to receive 3rd dose of twinrix but was given hepatitis B, the Engerix instead of Twinrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUN-2024 The healthcare professional reported that the patient was going to receive the 3rd dose of Twinrix vaccine but was given hepatitis B (Engerix B adult) instead of Twinrix, which led to wrong vaccine administered.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inadvertent administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo (Without powder); Inadvertent administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo (Without powder); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 25-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA986A, expiry date 30-SEP-2025) for prophylaxis.   On 31-MAY-2024, the patient received Menveo. On 31-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertent administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo (Without powder)) and inappropriate dose of vaccine administered (Verbatim: Inadvertent administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo (Without powder)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 21-JUN-2024 A nurse reported that she had a staff member take only the liquid CWY-135 portion of 2 vial formulation of Menveo, mix it with a sterile diluent and administer it to a patient. The lyophilized meningococcal A component was not used or administered which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The case US2024078116 was identified as duplicate of case US2024078107. All future correspondence would be added in case US2024078107, which stands as case of record for this patient and the case US2024078116 would be deleted.