chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Tdap was administered at 08:10 to the left deltoid. MenQuafi was administered at 08:11 to the right deltoid. At approximately08:11-08:12 pt slumped to the left et became unresponsive. Within approximately 10 seconds pt appeared to cough, went rigid et experienced tremors to his legs. Within 15 seconds rigidity ceased et pt began to speak loudly different phrases et names et stood up. Pt then regained his awareness of his surroundings et sat back down. Pt appeared to be drowsy at approximately 08:13-08:14. Mother et RN at chairside with pt. Pt states that his head "feels funny" et is slightly clammy. Mother states pt did not eat breakfast et has not slept. RN provided alert pt with a granola bar et box of apple juice x 2. Pt able to correctly state his full name, DOB, recognized his mother et aware of what he was in the office for today. BP at 08:15 was 110/70, pulse 88, lungs CTAB, RRR apical heart sounds, appropriate tracking with eyes, speech clear, hand grasps strong et equal bilat, no visual changes, no auditory changes noted, slight swaying when standing unassisted x 1. Pt sat back down with RN et mother at chairside where he drank another apple juice. Stood up again with no visible swaying but does admit to muscle soreness/weakness. Hepatitis A vaccine delayed for another day. Education was provided to pt et mother that they should report any changes to pt health or behaviors immediately to PCP. Mother states that they are going on for an orthodontic appointment et will go to the ER if needed. Pt et mother exited building unassisted at approx. 08:18 at their request.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: INDURATED AREA AT INJECTION SITE 1.5 X 1 INCHES  C/O ITCH RED NOT OPEN
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Detoxification, Echocardiogram, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: MODERNA #1 7/30/2021 MODERNA #2 9/7/2021 DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS, CHEST PAIN, POST EXERTIONAL MAILASE, EXERCISE INTOLERANCE AND VACCINE SMALL FIBER NEUROPATHY.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Laboratory test, Magnetic resonance imaging heart, Malaise, Myopericarditis
Clinical narrative: MODERNA #1 7/30/2021 MODERNA #2 9/7/2021 DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS, CHEST PAIN, POST EXERTIONAL MAILASE, EXERCISE INTOLERANCE AND VACCINE SMALL FIBER NEUROPATHY.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: MODERNA #1 7/30/2021 MODERNA #2 9/7/2021 DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS, CHEST PAIN, POST EXERTIONAL MAILASE, EXERCISE INTOLERANCE AND VACCINE SMALL FIBER NEUROPATHY.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was due for a Meningitis B vaccination and staff accidently pulled and administered an Adult Hep B vaccine. No know adverse reaction
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope/fainting immediately afterwards
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: This patient and 1 more patient was to receive the DTaP/IPV/Hib vaccine on 7/29/2024.  At the end of the day, it was discovered that  one of the patients had only received the DTaP/IPV component of the vaccine as one of the Hib vials was left in the box.   We were unable to determine which patient had received the full dose.  After consulting with a Department of Health nurse, it was decided to give one more dose of Hib to both patients in 8 weeks.  The parents were called and appointments were scheduled in 8 weeks for Hib vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: This patient and 1 more patient was to receive the DTaP/IPV/Hib vaccine.  At the end of the day, it was discovered that  one of the patients had only received the DTaP/IPV component of the vaccine as one of the Hib vials was left in the box.   We were unable to determine which patient had received the full dose.  After consulting with a Department of Health nurse, it was decided to give one more dose of Hib to both patients in 8 weeks.  The parents were called and appointments were scheduled in 8 weeks for Hib vaccine.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No reaction to patient, vaccine was administered/given early
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: vaxelis and prevnar 20 were  given to patient under 6 weeks age. DOB was entered wrong in chart at that time
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: Pt called stating she began to experience hives/rash on right arm (not injection site arm), legs, abdomen)
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Exposure during pregnancy, Live birth
Clinical narrative: I was given the vaccine on 02SEP2016. I did not know, but at the time I was a few (2-4) weeks pregnant. My daughter was born and was diagnosed with liver cancer (hepatoblastoma) on 12NOV2018. This was my second live birth, both resulting in living children. Birth weight was 7lbs.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received Kinrix before the age of 4.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was potentially given sterile water dilutent instead of adjuvant that goes with vaccine. Patient was 1 of 2 patients that this was potentially given to. Per Department of health, VAERS report should be reported in case patient has a reaction to it or the next dose. Patient was informed of this error, and was encouraged to come back to the clinic for a repeat dose as she was not given the full protection from the first dose of the vaccine.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Malaise, Pain, Peripheral swelling
Clinical narrative: On 6/11/2024 at 4:40AM, patient submitted medical concern request to clinic, "I'm having a reaction to the tetanus shot I received in your office on Wednesday. First I got really sick at work in Thursday the day after the shot and had a fever of 99.8 and was feeling achy so I was sent home by the school nurse. I feel better but my arm is still red and now it's bigger and has a knot on it. But it's not directly where I got the shot." On 6/11/2024 at 9:09AM, patient was contacted by clinic team member and appointment was made with provider on same day at 10:40AM.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported noticing daughter's left arm was red, warm and swollen at injection site "about the size of the palm of her hand", the Sunday after the vaccine was given on Friday. Mother denied rash or fever. Gave child Tylenol for discomfort. Notified Health Department on Tuesday 8/6/24, report from Mother taken by RN, MD called and notified. Assessed as localized reaction and instructed mother to watch child closely for fever or worsening symptoms, recommended to mother to use pen to mark swelling on child's arm, and to go to PMD if symptoms continue to worsen. Encouraged mother to treat at home with OTC ibuprofen/Tylenol as needed per package instructions. Mother was called back by RN, and information given, mother verbalized understanding, given contact information of Health Department should she have further questions or concerns.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Immunization was given too soon after last dose.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was potentially given sterile water dilutent instead of adjuvant that goes with vaccine. Patient was 1 of 2 patients that this was potentially given to. Per department of health, VAERS report should be reported in case patient has a reaction to it or the next dose. Patient was informed of this error,  and was encouraged to come back to the clinic for a repeat dose as he was not given the full protection from the first dose of the vaccine. He did come back on 8/7/2024 for a repeat injection.
Age: 8.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Syncope
Clinical narrative: Patient had vasovagal syncope leaving the office after vaccines and hemoglobin, patient was very anxious before vaccine administration. She was brought back to the exam room and hydrated with Gatorade, vitals stable.
Age: 18.0
Sex: F
Vaccine: MNP, MNQ
Symptoms: Blindness, Brain oedema, Cluster headache, Guillain-Barre syndrome, Malaise
Clinical narrative: GBS. Lost leg function for 2 years. Lost eye vision for 2 years. Day immediately of the vaccination became very ill, the next days brain swelling and severe cluster headaches occured. Headaches did not go away for 2 years, they were daily and severe, had to take imitrex for years after receiving Meningitis shot. Did not have previous history of severe headches. Permanent nerve pain, leg weakness that needs cane to move, spine pain. Reported this to Dr and another male dr that was in his clinic during the years 2009-2012. Asked for records in 2014 to see exactly which brand vaccine they gave me and they claimed they discard patient records. I have reported this event and the sequential long lasting effects to other drs such as clinics.
Age: 18.0
Sex: F
Vaccine: MNP, MNQ
Symptoms: Muscular weakness, Musculoskeletal disorder, Neuralgia, Spinal pain, Walking aid user
Clinical narrative: GBS. Lost leg function for 2 years. Lost eye vision for 2 years. Day immediately of the vaccination became very ill, the next days brain swelling and severe cluster headaches occured. Headaches did not go away for 2 years, they were daily and severe, had to take imitrex for years after receiving Meningitis shot. Did not have previous history of severe headches. Permanent nerve pain, leg weakness that needs cane to move, spine pain. Reported this to Dr and another male dr that was in his clinic during the years 2009-2012. Asked for records in 2014 to see exactly which brand vaccine they gave me and they claimed they discard patient records. I have reported this event and the sequential long lasting effects to other drs such as clinics.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Gave MMRV expired by one day.
Age: 0.17
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Was given wrong vaccine HPV Gardasil . No side effects at this time
Age: 0.17
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Was given wrong vaccine HPV Gardasil . No side effects at this time
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Detoxification, Fatigue, Immunisation reaction, Postural orthostatic tachycardia syndrome, Small fibre neuropathy
Clinical narrative: PFIZER #1 3/19/2021 PFIZER #2 4/10/2021 PFIZER #12/17/2021 PFIZER 4/10/2021 PATIENT DEVELOPED VACCINE INDUCED POTS, SMALL FIBER NEUROPATHY, POST-EXERTIONAL FATIGUE, TREATED WITH TRAZODONE, FLOURINEF, ADRENAL CORTEX, NICOTINE PATCH, PROTOCOL BASE SPIKE DETOXIFICATION
Age: 54.0
Sex: F
Vaccine: FLU4, HEPAB, PNC20, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm got red and warm to the touch in a circle around the Shingrix shot, after a few day it had gotten bigger.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Injection given too high on left shoulder and too deep - developed hard, painful lump at injection site, swelling, heat and redness beyond what is normal for a vaccine, shoulder and upper arm pain and nerve pain all the way down the arm to the hand, making the fingers numb when arm is held or turned a certain way for over 3 weeks as of today. Shoulder was fine before the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Neuralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Injection given too high on left shoulder and too deep - developed hard, painful lump at injection site, swelling, heat and redness beyond what is normal for a vaccine, shoulder and upper arm pain and nerve pain all the way down the arm to the hand, making the fingers numb when arm is held or turned a certain way for over 3 weeks as of today. Shoulder was fine before the vaccine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Large swelling in the injection site, small fever, injection site hot to touch, soreness/tenderness
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Headache, Herpes zoster, Pain, X-ray
Clinical narrative: Around four days after receiving the vaccine, the client developed severe pain and burning around the left side of her head, the back of her head, and upper right chest and shoulders. She went to a Urgent Care facility and then the called 911 and she was sent to the ER. At the ER they deteremined that she had developed Shingles. The ER told her that it was a concidence that she developed Shingles so close to getting the vaccine.  She was prescribed Acyclovir for the Shingles at the hospital.  They gave her medication for the pain as well, but she isnt taking it anymore. She is working with Dr to get more of the medication to treat the shingles.
Age: 20.0
Sex: F
Vaccine: COVID19-2, RAB
Symptoms: Cognitive disorder, Dizziness, Fatigue, Vomiting
Clinical narrative: Severe fatigue, lightheadedness and cognitive change
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthma, Condition aggravated, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Severe asthma symptoms, numbness in hands, increased heart rate, dizziness, fatigue
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Severe asthma symptoms, numbness in hands, increased heart rate, dizziness, fatigue
Age: 0.25
Sex: M
Vaccine: PNC15
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Irritability
Clinical narrative: Injection site was very swollen, hard, and red for the following 2-3 days after injection. Each time he received a course of PCV15, he was more irritable and tired.
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Unevaluable event
Clinical narrative: Was given when patient was 15 years 11 months
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was given when patient was 15 years 11 months
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Crying, Faeces discoloured, Frequent bowel movements, Haematemesis, Infant irritability
Clinical narrative: Fussy and irritable with increased frequency of stools, and now mucousy and green stools starting the next morning after after receiving his 2 month vaccines.  This has continued with ongoing mucousy stools and fussiness x 10 days, but color has returned to more of a yellow stool in the last few days.  Fussiness was quite severe for the first 7 days with multiple 1 hour crying periods overnight.  Per mom he was such as happy baby prior to the vaccines.   In the last 2 days the fussiness has improved but still not back to baseline.   Yesterday had a blood tinged spitup once with a more forceful spitup.  This hasn't continued.  No blood in the stool.  Concerns that the cause could be the rotavirus vaccine vs. cow's milk protein intolerance.   Mom cut out dairy for the last 4-5 days.    Eating well now, for the first 4-5 days intake was down.  Making normal wet diapers.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Mucous stools
Clinical narrative: Fussy and irritable with increased frequency of stools, and now mucousy and green stools starting the next morning after after receiving his 2 month vaccines.  This has continued with ongoing mucousy stools and fussiness x 10 days, but color has returned to more of a yellow stool in the last few days.  Fussiness was quite severe for the first 7 days with multiple 1 hour crying periods overnight.  Per mom he was such as happy baby prior to the vaccines.   In the last 2 days the fussiness has improved but still not back to baseline.   Yesterday had a blood tinged spitup once with a more forceful spitup.  This hasn't continued.  No blood in the stool.  Concerns that the cause could be the rotavirus vaccine vs. cow's milk protein intolerance.   Mom cut out dairy for the last 4-5 days.    Eating well now, for the first 4-5 days intake was down.  Making normal wet diapers.
Age: 0.42
Sex: M
Vaccine: PNC15
Symptoms: Fatigue, Infant irritability, Injection site induration, Injection site swelling
Clinical narrative: Injection site was very swollen, hard, and red for the following 2-3 days after injection. Each time he received a course of PCV15, he was more irritable and tired.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had no immediate adverse reaction. These vaccines were administered unnecessarily based upon an old record found after vaccines were administered. Attempts were made to advise parent and the child's school by phone that these vaccines were unnecessary, with the exception of the varicella component of MMRV.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given a second dose of  Meningococcal MCV4 (MenQuadfi) on  07/29/2024, first dose was given on 06/03/2024. Patient filled out consent and verbally gave consent as well. Patient name and DOB were verified at check in and prior to immunization. Patient gave verbal consent at time of vaccination and was told they were receiving menquadfi.  It was the correct dose per ago, correct route of administration. Patient returned on 08/06/2024 stating she needed the MENINGOCOCCAL Men B VACCINE and she thought that is what she received last visit. It was then discovered that she was given 2 doses of the same Meningococcal MCV4 (MenQuadfi). She had no adverse effects, no ill symptoms. She then received the Men B vaccination. This was reports to the direct manager and the NP that administered the menquadfi.
Age: 0.67
Sex: M
Vaccine: PNC15
Symptoms: Fatigue, Injection site erythema, Injection site infection, Injection site swelling, Irritability
Clinical narrative: Injection site was very swollen, hard, and red for the following 2-3 days after injection. Each time he received a course of PCV15, he was more irritable and tired.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, pain, hot to the touch
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: pt reported experiencing pain and swelling on left deltoid and said we administered the shot too high that caused it. he said he checked with his dr and also looked up on the internet
Age: 26.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling of entire limb from shoulder to finger tips, redness around injection site spreading approx 3-4 inches, tissue felt very firm, painful to touch. Pt cried if anyone even grazed his arm.  Swelling was extensive, digits were double sized. Question Arthus-type reaction.
Age: 68.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Malaise, Nausea
Clinical narrative: Had vaccine on Sunday. On Tuesday, started experiencing increasing severe pain in left shoulder and upper arm. Pain is so bad, I'm unable to sleep for the past 2 nights. My shoulder and arm is almost frozen in the morning. Lifting my arm and all movement of my upper arm is excruciating.  Ibuprofen and lidocaine patches (which I wore constantly for the past 2 days) have not helped at all.  It seems to be getting worse.  The pain is so intense, I feel generally unwell and nauseous.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Sleep disorder
Clinical narrative: Had vaccine on Sunday. On Tuesday, started experiencing increasing severe pain in left shoulder and upper arm. Pain is so bad, I'm unable to sleep for the past 2 nights. My shoulder and arm is almost frozen in the morning. Lifting my arm and all movement of my upper arm is excruciating.  Ibuprofen and lidocaine patches (which I wore constantly for the past 2 days) have not helped at all.  It seems to be getting worse.  The pain is so intense, I feel generally unwell and nauseous.
Age: 25.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 0.33
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: PATIENT WAS ONLY DUE FOR PCV20 AND WAS GIVEN PPV23 IN ERROR
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, DTPPVHBHPB, HEPA, IPV, MMR
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: My daughter has a rash from head to toe now for over two weeks that can only be traced back to the vaccinations. She is itchy and it looks as if she has chicken pox all over her body
Age: 62.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse reactions noted. Checked with provider for recommendations.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired dose of 0.5mL subcutaneously to the outer aspect of the right arm. The patient was monitored for approximately one hour and thirty minutes with no reaction noted during this time. The Senior Medical Officer on site cleared the patient and the patient left with instructions to follow-up if needed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: PT HAS BUMP ON ARM FROM INJECTION SITE THAT IS STILL PRESENT 6 MONTHS LATER.
Age: 73.0
Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 61.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received first dose of Shingrix on 07/20/2024 on his left deltoid and returned to the pharmacy on 08/08/2024 with an itchy and painful rash on  left side of his body (left forearm and leg). He stated this had been going on for a week and was referred to his PCP, which he said he would see today.
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 54.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 66.0
Sex: F
Vaccine: FLU4, RSV, TDAP, VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Pt reporting swelling of both eyelids, like she "had been punched"
Age: 71.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Estimated date of delivery: 04/14/2024.  Actual:  Given the 5 day span between administration of Tdap vaccine and PROM and my undergraduate + basic graduate training in immunology, I thought that time span was too mechanistically coincidental not to report to VAERS. Delay in reporting is my own fault as I adjusted to being a father. (Delivery was performed by MD at hospital while visiting one last time before birth.) We arrived on March 10th, had a stress free time with no alcohol, tobacco, or other smoke. Night before PROM/delivery had Pizza and walked a mile across the bridge in town. Wife woke me up at 7am saying she noticed amniotic fluid. Contacted Dr who said to take her to the local hospital. 12 hours later, vaginal (pitocin) delivery of daughter at 35 weeks, 2 days. I marked this as an urgent/emergency visit with hospitalization for item 21 of the VAERS form, since it was unexpected delivery with 2 day hospital admission.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Fatigue, Headache, Irritability
Clinical narrative: Diarrhea, tiredness, irritability and headache
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: Developed shingles rash on left thigh about 3.5 months after vaccine.  Left anterior thigh with vesicular cluster rash: not pruritic, mildly uncomfortable.  Worsened with hydrocortisone.  Sent picture to pediatric dermatologist who agrees it is a shingles rash.  Patient is in good spirits, afebrile and otherwise well appearing.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus
Clinical narrative: itchiness on the right arm an hour after
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Nodule, Pain
Clinical narrative: knot, redness around arm, pain
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Lt thigh is red, swollen, hot to the touch, and firm. Tylenol and Ibuprofen as needed with no relief of symptoms.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site discomfort, Injection site pain, Malaise
Clinical narrative: Day 1 - Normal discomfort at injection site   Day 2 - a.m. general malaise, p.m. fatigue, fever, chills   Day 3 - No fever, spaced out, fatigue, trouble sleeping   Day 4 mild pain at injection site, still a little spaced out but feeling much better
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Day 1 - Normal discomfort at injection site   Day 2 - a.m. general malaise, p.m. fatigue, fever, chills   Day 3 - No fever, spaced out, fatigue, trouble sleeping   Day 4 mild pain at injection site, still a little spaced out but feeling much better
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Syncope
Clinical narrative: patient was fine after I administer the vaccine, but few seconds after she left the immunization room she had syncope and collapsed in front of the pharmacy counter and hit her head, we got her up and let her sat on a chair  and called an ambulance and they came fairly quickly and assessed her and took her to the hospital
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Detoxification, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: PFIZER #1 8/2/2021 PFIZER #2 9/15/2021 DEVELOPED VACCINE INDUCED PERICARDITIS AND POST-EXERTIONAL MALAISE.  HOSPITALIZED FOR ACUTE PNEUMONIA IN 2022.  TREATED WITH ANTIBIOTICS COLCHICINE AND  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pericarditis, Pneumonia
Clinical narrative: PFIZER #1 8/2/2021 PFIZER #2 9/15/2021 DEVELOPED VACCINE INDUCED PERICARDITIS AND POST-EXERTIONAL MALAISE.  HOSPITALIZED FOR ACUTE PNEUMONIA IN 2022.  TREATED WITH ANTIBIOTICS COLCHICINE AND  PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Blood culture negative, Blood gases normal, Blood lactic acid increased, C-reactive protein normal, Culture urine negative
Clinical narrative: Sudden onset of hypotonia, pale appearance, and difficult to arouse.  Event lasted about 20mins per parents.  CPR given by family member. When EMS arrived infant conscious with improved color.  A second event occurred in the ED - brief episode of face becoming pale, threw head back. No shaking.  Responded to sternal rub.  Maintained a pulse.  Episode lasted a few minutes.   Noted to have a low grade fever to 38.2 in the ED (no previous fevers).   Admitted to hospital.  Cardiology, Neurology evaluation did not reveal a cause of episode.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Depressed level of consciousness, Drug screen negative, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Sudden onset of hypotonia, pale appearance, and difficult to arouse.  Event lasted about 20mins per parents.  CPR given by family member. When EMS arrived infant conscious with improved color.  A second event occurred in the ED - brief episode of face becoming pale, threw head back. No shaking.  Responded to sternal rub.  Maintained a pulse.  Episode lasted a few minutes.   Noted to have a low grade fever to 38.2 in the ED (no previous fevers).   Admitted to hospital.  Cardiology, Neurology evaluation did not reveal a cause of episode.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Hypotonia, Metabolic function test normal, Pallor, Procalcitonin increased, Pyrexia
Clinical narrative: Sudden onset of hypotonia, pale appearance, and difficult to arouse.  Event lasted about 20mins per parents.  CPR given by family member. When EMS arrived infant conscious with improved color.  A second event occurred in the ED - brief episode of face becoming pale, threw head back. No shaking.  Responded to sternal rub.  Maintained a pulse.  Episode lasted a few minutes.   Noted to have a low grade fever to 38.2 in the ED (no previous fevers).   Admitted to hospital.  Cardiology, Neurology evaluation did not reveal a cause of episode.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Red blood cell sedimentation rate normal, Respiratory viral panel, Resuscitation, White blood cell count increased
Clinical narrative: Sudden onset of hypotonia, pale appearance, and difficult to arouse.  Event lasted about 20mins per parents.  CPR given by family member. When EMS arrived infant conscious with improved color.  A second event occurred in the ED - brief episode of face becoming pale, threw head back. No shaking.  Responded to sternal rub.  Maintained a pulse.  Episode lasted a few minutes.   Noted to have a low grade fever to 38.2 in the ED (no previous fevers).   Admitted to hospital.  Cardiology, Neurology evaluation did not reveal a cause of episode.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Limb mass
Clinical narrative: PT GOT LUMP ON RIGHT ARM IMMEDIATELY AFTERTHE VACCINE. PT WAITED FOR 30 MINUTES TO ENSURE NO ALLERGIC RXN.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Vaccine error: Patient was given Pentacel immunization instead of Hib immunization. Making that an extra dose for Dtap, and Polio.
Age: 28.0
Sex: M
Vaccine: PNC20
Symptoms: Haemorrhage, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt. came in and complained of sore arm.  He stated that when he got home is arm bled.  After the shot  sometime he said he lost feeling in arem or it is numb and tingling.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; product storage error; This spontaneous report was received from physician and refers to a 4-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant vaccine included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).  On 01-MAY-2024, the patient started therapy with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot #W03504 was not valid but expiration date was reported as 24-MAY-2024, in right thigh); varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X010531 was valid, expiration date: 11-APR-2025, in right thigh) for prophylaxis (Product storage error). No additional adverse event (AE). No product quality complaint (PQC). Temperature excursions were identified some time last week (reported as from 10-JUN-2024 to 14-JUN-2024). The vaccines were occurred temperature excursion as a result of a reading from a digital data logger. The vaccines were back in range. There was no previous excursions.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported; administered an expired dose of ROTATEQ; the administered expired dose of ROTATEQ did in fact undergo a temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 03-JUN-2024, Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 milliliter oral liquid, 2ml / series, lot #1933923, expiration date: 28-APR-2024) experienced temperature excursion with 50.9 degree Fahrenheit for 40 minutes 0 seconds (but customer stated that the product did not have any excursions, conflicting information). On 29-JUL-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter oral liquid, 2ml / series, lot #1933923, expiration date: 28-APR-2024, administered orally for prophylaxis (expired product administered, product storage error) by a Health Professional. No symptomatic adverse events were reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Dysphemia, Electroencephalogram normal, Laboratory test normal
Clinical narrative: HBP reported that her daughter was administered GARDASIL 9, and exactly 2 weeks and 2 days later she experienced what was described as an unexplained neurological event, in which she was unable to speak.; This spontaneous report was received from a consumer via a company representative referring to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2021, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2021, exactly 2 weeks and 2 days later, she experienced what was described as an unexplained neurological event, in which she was unable to speak (Aphasia). The patient was hospitalized in 2021 (exact date unknown), and lab work and electroencephalograms (EEGs) were done to diagnose what happened, and all tests/labs were normal.  The patient did eventually regain her ability to speak, but still speaks with a stutter (recovered with sequelae). The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding aphasia was not applicable.  The causal relationship between aphasia and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Lot # is being requested and will be submitted if received.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine excursion; This spontaneous report was received from a registered nurse and referred to a 12-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 28-JUN-2024, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced temperature excursion with 12.8 degree with unknown time frame (too cold for administration) as a result of a reading from a digital data logger. No previous temperature excursion. On the same day, 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, lot #X022737, expiration date: 12-APR-2026, administered intramuscularly at right deltoid for prophylaxis (strength was not provided) (Product storage error). No additional adverse events reported. No additional information provided at this time. No prescription drug treatment for the experience.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Blood test, Infantile diarrhoea, Infantile vomiting, Stool analysis normal
Clinical narrative: Infantile vomiting; Infantile diarrhea; This spontaneous report was received from the patient's parent and referred to a 5-month-old female patient. There was no pertinent medical history, concomitant medications and drug reactions/allergies.  On 25-JUL-2024 at 11:00, the patient received the third dose with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided) at local clinic.  On 26-JUL-2024 at 09:00 (about 20 hours after vaccination), the patient started infantile vomiting. On an unknown date in July 2024, the patient also had Infantile diarrhea. On 29-JUL-2024, the patient was admitted to hospital. The patient was treated with saline intravenous, potassium, and suppository. The stool screen did not verify any active signs of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The routine bloodwork was preformed (result not reported). Currently, the patient was in hospital for treatment. At time of reporting, the patient had not recovered from both events.  The causal relationship between both events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not ruling out (considered as related).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was inadvertently administered 2 doses of the PROQUAD Vaccine at a clinic on the same day; No other AE and no PQC; This spontaneous report was received from a nurse referring to a 5 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the second dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # X025823, expiration date: 29-APR-2025 (strength, dose, route, and anatomical location were not provided) for prophylaxis.        It was mentioned that the patient was inadvertently administered 2 doses of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) at a clinic on the same day (Overdose).  No adverse event reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Patient received second dose of ROTATEQ but a threw up after receiving the dose.; Patient received second dose of ROTATEQ but a threw up after receiving the dose.; This spontaneous report was received from Other Health Professional and refers to a 20-week-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-AUG-2024, the patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003174 (who had been verified to be a valid lot number, expiration date reported as 14-SEP-2025 and upon internal validation established as the same), administered orally for prophylaxis (strength was not provided).  The patient was receiving the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) but threw up after (vomiting) receiving the dose. The reporter stated that it seems patient was able to get about 1ml out of the total of 2ml (accidental underdose).   The outcome of the event was not reported.  The causal relationship between vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received First dose of Heplisav-B, and 6 Weeks Later Received Twinrix; Initial report received on 17-Jul-2024.  A reporter reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and six weeks later had a hepatitis A/hepatitis B combination vaccine.  No relevant medical history was reported. No relevant concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported). On an unknown date, six weeks after having been vaccinated with HEPLISAV-B, the patient received a hepatitis A/hepatitis B combination vaccine.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: First Dose Prehevbrio,  and Second Dose Heplisav-B; Initial report received on 24-Jul-2024.  A pharmacy student reported a patient  (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, but initially received PREHEVBRIO (hepatitis B vaccine [recombinant]) as the first dose in a 2 part series..   Medical history and concomitant medications were not reported.   In Jan-2024, the patient received PREHEVBRIO (Lot # and expiration date not reported) as the first dose  in the hepatitis B vaccination series.  In Mar-2024,  the patient received HEPLISAV-B (Lot #, expiration date, NDC #, route and site not reported) as the second dose in the hepatitis B vaccination series. The patient did not inform the pharmacy that they received PREHEVBRIO previously.  The status of product use was not reported.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received unknown hepatitis B vaccine and then HEPLISAV-B; Initial report received on 29-Jul-2024.  A pharmacist reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after receiving an unknown brand of an adjuvanted hepatitis B vaccine  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 26-Jan-2024, the patient received the first dose of an unspecified adjuvanted hepatitis B vaccine (Lot #, expiration date, route, and site not provided) at a provider's office.  On 27-Jul-2024, 184 days after receiving an unspecified brand of an adjuvanted hepatitis B vaccine, the patient received the first dose of HEPLISAV-B (lot #943912, expiration date 08-Mar-2026, and NDC # 43528-003-05).  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.