chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to device use error, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: When injecting shingrix into the left arm patient felt the poke and then pulled their arm away immediately. No liquid was injected. When they pulled away the administration site started to swell in the area the size of a nickel/quarter. Monitored patient while the site stopped bleeding. The swollen site started to bruise and patient was directed to provider's office to further care. Patient said they feel fine and may just be bruise. They stated not on any anticoagulant medications and not on any antiplatelet medications. Unsure if getting checked up on by Doctor's office.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Severe pain in back and front of shoulder. Dully radiates down to hand. Started two days after the shot and is continuing. Patient has taking ibuprofen, fish oil, sombra, CBD, and tylenol without relief.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Fall, Syncope
Clinical narrative: Desk staff alerted nurse to check out desk where a patient had fainted and fell after receiving flu and covid-19 vaccines this morning. Dad reported catching pt and assisting the patient to the floor at the time of event. When nurse arrived to the scene pt was lying on the floor alert and could answer questions but did not remember what happened. Pt was assisted to sitting while Dr determined they were safe to stand . Pt walked with assistance of nurse and dad to an exam room where vitals were taken, pt was given apple juice, and Dr performed a more in depth exam. Pt reported feeling better and was deemed stable enough to leave and head to another appointment.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: Patients mother called from home to report event. Approximately 5 hours port -vaccination patient told mother heart was racing, not feeling just right. This was approximately 6:30pm on 10/04/2024. Mother, in act of precaution drove to Hospital to be examined. I believe it was hospital. Mother reported to me Heart Rate was elevated and Blood Pressure elevated. Hospital monitored patient until Heart rate and Blood pressure stabilized. Patient was released same day to the best of my knowledge. Mother asked this event be reported. Due to the time elapsed between vaccination and onset of symptoms being 4-5 hours later I concurred that it seemed an unusually delayed response.
Age: 50.0
Sex: M
Vaccine: COVID19, HEP, PNC20, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the Pharmacy on Oct 17, 2024 with pronounced erythema on the anterior aspect of the left arm from sites of injection down towards the elbow. Area approximately 6 inches in length. Patient states swelling and redness started a few days after injections and has expanded in area since then. Patient continues that it was mildly itching and warm to the touch as well.
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine series initiated after maximum age for 1st dose
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cardiac monitoring normal, Electrocardiogram normal, Heart rate increased
Clinical narrative: 08/29/24-They just happened to catch that patient's heart rate was fast, in the 140s. They went to their PCP and was evaluated.  They did an EKG and the heart rate was 104.  The referred him onto a cardiologist at Hospital. After his consult he wore a heart monitor for 3 days. They concluded his heart rate was just faster than most. The cardiologist saw no abnormalities and has no concerns.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Angiotensin converting enzyme, Antibody test, Antinuclear antibody, Ataxia assessment scale, Bacterial test
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Blood immunoglobulin A, Borrelia test, CSF immunoglobulin G index, CSF test abnormal
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram, Electromyogram, Electrophoresis protein, Full blood count, Gram stain
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Heavy metal test, Immunoglobulins, Immunology test, Immunophenotyping
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza A virus test, Influenza B virus test, Light chain analysis, Lipase, Liver function test
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Oligoclonal band assay
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Prothrombin time, Rheumatoid factor quantitative, SARS-CoV-2 test, Scan with contrast, Treponema test
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Troponin, West Nile virus test
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP)
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received two vaccines from pharmacy in June and August of 2023.  He then told his physician that he needed his second vaccine, and received a 3rd vaccine at his doctors office on Oct 18, 2024
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Rash, Rash erythematous
Clinical narrative: Employee received flu vaccine during hospital clinic in afternoon. of 10/16/2024 That night employee reported feeling itching and started to develop a rash. Rash still in place on this date 10/18/2024 note as diffused non raised red rash around neck and upper chest. Employee describes as itchy/burning. Has taken over the counter Benadryl with minimal relief.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: pt described a red warm injection site with a knot. She said the knot had gone away, but it was still red
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: patient says she has brusitis, sore arm since the vaccine was given
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES ON ARMS AND LEGS, SOME ON NECK FOR ONE DAY. HIVES STARTED ON WEDNESDAY (ONE DAY FOLLOWING THE VACCINE). TAKING ALLEGRA EVERYDAY WHICH IS HELPING WITH THE ITCHING. REPORTING TO VAERS AND INSTRUCTED TO CONTINUE MONITORING AND ALLEGRA DAILY, GOING TO EMERGENCY ROOM IF HIVES WORSEN OR AIRWAY IS IMPACTED
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Reddened area at injection site size of half dollar
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Palpitations
Clinical narrative: heart palpitations
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I am reporting a possible vaccine administration error. The four vaccines were documented as given inadvertently on two separate occasions. The date listed above (6/10/24) was the second time vaccines were administered. The first administration was on 4/17/24. The mother does not remember him getting the vaccines twice and it is unclear whether they were actually given twice or documented as given incorrectly. No adverse events occurred from the administration of the vaccines.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: I gave pt both flu and covid vaccines 1 " apart on the left arm IM deltoid.  Both her sister and mom got theirs at the same time.  We sat there and talked for a few minutes because the sister has a history of passing out with vaccines, bloodwork, needles, etc.  They all felt fine so they walked out.  She got light headed and fell.  Her sister braced her so she didn't hit the floor.  She was alert but pale.  She had some water and was able to get up on her own and talk like normal.  Mom didn't want EMS called and said she was going to be fine.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: vaccine site turned red and devolped a red circle around site about 8cm x 4cm. it got a little swollen and it was hot to the touch. 2nd day was worse but got better after the third day. i put ice on it and i helped with the heat
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out for less than a minute about 3 minutes after receiving vaccines. Was awake and talking right after. V/S were normal. BP 124/62, P 88 and Oxygen reading  98% without oxygen.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Feeling hot, Vision blurred
Clinical narrative: Random blurred vision. Also had periods of feeling feverish without a temperature. Feverish symptoms have resolved.  Blurred vision still happens occasionally.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pyrexia, Seizure
Clinical narrative: It was reported to me by the staff at the facility that the day after doing their flu and covid vaccine clinic, this resident had his first seizure in years and had a high fever.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Red / swollen injection site with ring around it, itching.  low grade fever started night of vaccination.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT ACCIDENTALLY ASKED FOR FLU VACCINATION INSTEAD OF COVID-19. AFTER GIVING THE SHOT SHE ALERTED US THAT SHE ALREADY TOOK THE FLUAD SHOT PREVIOUSLY A MONTH AGO AND NEEDED THE COVID VACCINE. SO SHE TOOK 2 FLUAD VACCINATIONS WITHIN 1 MONTH.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Reaction to previous exposure to any vaccine
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Left ventricular dysfunction, Myopericarditis
Clinical narrative: MODERNA #1 3/21/2021 MODERNA #2 4/28/2021 DEVELOPED SUBCLINICAL VACCINE MYOPERICARDITIS WITH REDUCED LV FUNCTION TREATED WITH CARVEDILOL, ENRESTO, VERQUVO, COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt under 65 was given this vaccine. No adverse events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation, Limb mass
Clinical narrative: Patient is complaining of a hard lump in her left arm after receiving on 09/13 and still has the lump as of 10/18.  States about the size of a small twizzler piece and that it continually itches at the site.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient previously received a dose of arexvy on 10/13/2023 and then received a second dose on 09/25/2024 which was unnecessary.  Patient was called and reported having no side effects from receiving an additional dose against recommendations
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt under age 65 was given FLUZONE high dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Malaise, Muscular weakness
Clinical narrative: I became very sick with extreme muscle weakness,chills, unable to lift mysef up from bed kept falling back down several times also fell to knees when trying to walk to bathroom. could not get up until next day and this is causing adversion to getting another shot next year is there any way to mitigate this very awful experience
Age: 16.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Dizziness, Pallor, Presyncope, Unresponsive to stimuli
Clinical narrative: Patient had left vaccination room after another pharmacist administered 2 vaccines. About 5 minutes (or less) later, his mother sat him down in a chair in the waiting area due to him feeling faint. I responded to patient and when I got to him he was pale in color and staring off into the distance and not responding to his mother or me. We made sure he was breathing and rubbed his sternum and he began to respond after a minute or so. Following the vasovagal reaction, his mother gave him sips of Coca-Cola and his color began to return and he began to speak with us. He continued to sit for 15 minutes or so before they felt ready to leave. No additional issues were reported to us.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Chest pain, Erythema, Odynophagia
Clinical narrative: Mom called after receiving MMR & Varicella vaccines (ProQuad) Per mom she was scratching at her chest and stating it hurts. Mom noted redness in the arm that has traveled up to Pt's shoulder and face.    Triage nurse prompted mom to ask if child was able to swallow. Child stated it hurt to do so. Asked if there is Benadryl in the house. Mom stated she has an epipen dt Pt's allergies.  Triage nurse advised mom to administer epipen and call 911. Pt was taken to ED and is now since been discharged
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Erythema located from shoulder and neck, heat, and itching.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: At rest pain at injection site is 1-2/10, 5/10 when she wakes up/tries to move arm. Pain is very localized to the area of the injection.  With use, pain gets worse.  Not hot to the touch, no redness, no drainage.  Pt has pain at injection site, no swelling.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Acoustic stimulation tests abnormal, Ear discomfort, Magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: By Saturday the left ear became cloudy and felt full. By Monday she had a significant loss of hearing where she could hardly hear.  She called her doctor and was referred to the ER. She went to Urgent Care. She was referred to an ENT. She was diagnosed with sudden hearing loss. She was referred to another ENT Dr.  She is currently getting steroid injections into the left ear. She feels like it is some better. It seems to better in the morning and progressively gets worse througout the day. She has 2 hearing test. The last test showed some improvement. She will continue treatments.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Patient received flu shot in right deltoid and novavax in left deltoid on 10-14-2024. Patient called pharmacy 10-18-2024 and states she has right shoulder pain for the last couple of days (can't remember exactly when it started). Pain sort of relieved with tylenol and ice. States it radiates down from her shoulder to her elbow. Patient does not want to follow up with a doctor.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dyskinesia, Eye movement disorder, Fall, Feeling cold
Clinical narrative: The patient came in fasting to her w/c appointment.  She was not anxious and felt fine before the injection,  After the vaccine was given and her blood was drawn (about 6-8 minutes), she felt nauseous, cold, clammy, and looked pale.  She then began a staggering fall toward the exam table.  Her body had some abnormal movements and stiffness.  Her eyes rolled a little and mucus started draining from her nose.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Rhinorrhoea
Clinical narrative: The patient came in fasting to her w/c appointment.  She was not anxious and felt fine before the injection,  After the vaccine was given and her blood was drawn (about 6-8 minutes), she felt nauseous, cold, clammy, and looked pale.  She then began a staggering fall toward the exam table.  Her body had some abnormal movements and stiffness.  Her eyes rolled a little and mucus started draining from her nose.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Inadvertantly administered the dose licensed only for children 6 months - 11 years instead of the correct dose which would have been the type licensed for children 12 years and older.
Age: 0.08
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No known adverse effect experienced.  Tdap was inadvertently given in place of DTaP.  Patient's guardian requests VAERS submission be completed.  Health department was contacted incident #M1339095 and CDC contacted with case id: CDC-3289665-Y5N7F7
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Describes a headache, generalized all over head since she received the Arexvy vaccination.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: Severe swelling (5" in diameter) for more than 3 days
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: This nurse entered room to assist RN with vaccine administration to family of 4. This nurse entered room with MA to assist in case a brief interpretation was needed. Asked for the client by name (redacted), the client nodded his head "yes" and rolled the sleeve of his left arm up. Client's parents did not verbalize any disagreement when this nurse vaccinated this client with vaccinations as follows:  18HEP A PED 2DOSE 18MENQUADFI PC 1, 18, 17 18IPV PC 01 17 18 18HPV PC 01,17, 18 18TDAP PC 01 17 18  This nurse was not made aware until RN inquired about vaccinations for this client. Informed her this nurse gave him the above mentioned vaccinations. RN stated the person this nurse vaccinated was not the client intended to receive mentioned vaccinations. Patient was fully vaccinated for Hepatitis A and UTD for Meningitis ACWY. H. RN was in posession of vaccinations intended for Patient. When error was realized this nurse obtained an interpretor using Lanaguage Line Solutions ID #: 401923, explained to parents what happend stating when I asked for the client by name of (redacted), Patient rolled his sleeve up and nodded his head yes. Informed parents that Patient received an extraneous dose of Hepatitis A and Menquadfi.When this nurse was informing the parents of the incident using a translator the father interrupted to further discuss his medical concerns. This nurse had to halt discussion of incident to encourage father to present to the PCP he was referred to in 09/2024, father verbalized understanding.  This nurse then continued educating parents of s/s to watch for, when to present to the ER. Parents verbalized understanding of all education provided, denied any questions at this time. Informed client need an additional dose of VZV, vaccination administered in left arm subcutaneous. Client monitored for an additional 30 minutes before being allowed to leave examination room.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site rash, Injection site warmth, Skin tightness, Throat tightness
Clinical narrative: "10-15 minutes after vaccine, skin under injection site became inflamed, bumpy, and was hot to the touch. Face started get tight and throat tight"
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Clostridium test negative
Clinical narrative: Severe GI disturbance that started roughly 36 hours after vaccination. 103.4F temperature, shivering, headache, achy joints and stomach pain were the first symptoms. Chronic diarrhea started about hour 38 and watery diarrhea still persists 10 days later. 9 lbs lost in 7 days time due to malabsorption.  All other symptoms have resolved, but the GI issues (which closely mimic IBD) persists. C-diff has been ruled out. Currently still waiting on stool study.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malabsorption, Metabolic function test, Stool analysis
Clinical narrative: Severe GI disturbance that started roughly 36 hours after vaccination. 103.4F temperature, shivering, headache, achy joints and stomach pain were the first symptoms. Chronic diarrhea started about hour 38 and watery diarrhea still persists 10 days later. 9 lbs lost in 7 days time due to malabsorption.  All other symptoms have resolved, but the GI issues (which closely mimic IBD) persists. C-diff has been ruled out. Currently still waiting on stool study.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Severe GI disturbance that started roughly 36 hours after vaccination. 103.4F temperature, shivering, headache, achy joints and stomach pain were the first symptoms. Chronic diarrhea started about hour 38 and watery diarrhea still persists 10 days later. 9 lbs lost in 7 days time due to malabsorption.  All other symptoms have resolved, but the GI issues (which closely mimic IBD) persists. C-diff has been ruled out. Currently still waiting on stool study.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: patient has swollen arm in the injection site, area is red, and per patient she is feeling a tingling sensation
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Acute kidney injury, Atrial fibrillation, Cardiac arrest, Cardio-respiratory arrest, Chest pain
Clinical narrative: Patient presented with complaints of two days of shortness of breath.  Pt had reported not feeling well with chills since Monday when he received his Covid and flu vaccine.  He woke up around midnight on 10/16  with dyspnea, chest pain, diaphoresis and vomiting.  En route to ED, patient was in a fib with RVR.  Labs demonstrated AKI, hypomagnesemia, hypophophatemia, leukocytosis.  He was hypotensive and received rehydration and pressor therapy.  CT showed left proximal ureter calculus and a calculus at the left ureterovesical junction.  Patient developed work of breathing in ED, suspected pulmonary embolism.  Emergent OR management for ureter calculus attempted but patient coded on arrival to OR after induction.  Patient received CPR, procedure conducted, upon completion patient had second cardiac arrest.  Despite efforts, he remained asystole.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Computerised tomogram abnormal, Dyspnoea, Hyperhidrosis, Hypomagnesaemia
Clinical narrative: Patient presented with complaints of two days of shortness of breath.  Pt had reported not feeling well with chills since Monday when he received his Covid and flu vaccine.  He woke up around midnight on 10/16  with dyspnea, chest pain, diaphoresis and vomiting.  En route to ED, patient was in a fib with RVR.  Labs demonstrated AKI, hypomagnesemia, hypophophatemia, leukocytosis.  He was hypotensive and received rehydration and pressor therapy.  CT showed left proximal ureter calculus and a calculus at the left ureterovesical junction.  Patient developed work of breathing in ED, suspected pulmonary embolism.  Emergent OR management for ureter calculus attempted but patient coded on arrival to OR after induction.  Patient received CPR, procedure conducted, upon completion patient had second cardiac arrest.  Despite efforts, he remained asystole.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hypophosphataemia, Hypotension, Laboratory test abnormal, Leukocytosis, Malaise
Clinical narrative: Patient presented with complaints of two days of shortness of breath.  Pt had reported not feeling well with chills since Monday when he received his Covid and flu vaccine.  He woke up around midnight on 10/16  with dyspnea, chest pain, diaphoresis and vomiting.  En route to ED, patient was in a fib with RVR.  Labs demonstrated AKI, hypomagnesemia, hypophophatemia, leukocytosis.  He was hypotensive and received rehydration and pressor therapy.  CT showed left proximal ureter calculus and a calculus at the left ureterovesical junction.  Patient developed work of breathing in ED, suspected pulmonary embolism.  Emergent OR management for ureter calculus attempted but patient coded on arrival to OR after induction.  Patient received CPR, procedure conducted, upon completion patient had second cardiac arrest.  Despite efforts, he remained asystole.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pulmonary embolism, Resuscitation, Ureterolithiasis, Urogram, Vomiting
Clinical narrative: Patient presented with complaints of two days of shortness of breath.  Pt had reported not feeling well with chills since Monday when he received his Covid and flu vaccine.  He woke up around midnight on 10/16  with dyspnea, chest pain, diaphoresis and vomiting.  En route to ED, patient was in a fib with RVR.  Labs demonstrated AKI, hypomagnesemia, hypophophatemia, leukocytosis.  He was hypotensive and received rehydration and pressor therapy.  CT showed left proximal ureter calculus and a calculus at the left ureterovesical junction.  Patient developed work of breathing in ED, suspected pulmonary embolism.  Emergent OR management for ureter calculus attempted but patient coded on arrival to OR after induction.  Patient received CPR, procedure conducted, upon completion patient had second cardiac arrest.  Despite efforts, he remained asystole.
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: The patient received a COVID and Influenza vaccine, both in the left arm, per the patient's request. The vaccines were given ~1 inch apart. The patient returned to the clinic 1 day later with a large portion of the arm red and inflamed. The site was painful to the touch but not hot. After assessing for systemic reaction, I determined that the reaction was a non-severe local reaction. Diphenhydramine 50 mg and 1% topical hydrocortisone was administered, and the patient was released from care. The patient was informed to report to the emergency room if throat swelling or if systemic rashes/symptoms occurred.
Age: 18.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient got the vaccine on her left arm and the next day broke out in hives on her right arm She is itching but states it is calm down some
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RED, WARM, SWELLING LEFT UPPER ARM. ADVISED ASSOCIATE TO TAKE TYLENOL, OR IBUPROPHEN, AND OTC ANTIHISTAMINE. HE DECLINED URGENT CARE EVALUATION. ADVISED TO CONTACT THIS RN AND/OR SEEK MEDICAL ATTENTION IF SYMPTOMS WORSEN.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time, the patient has not reported any adverse effects after accidentally receiving their SECOND flu vaccine of the '24-25 season.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: After giving the vaccine, I realized that it expired on 10/06/2024. I called Regional Nurse for the state, and left her a voicemail and email as well. Patient's mother was notified before they left the building of error. No vaccine reaction reported at this time.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: After patient waited complete 15 minutes, nurse checked injection sites for reaction. MMR and Varicella sites; nickle sized, localized swelling below injection sites (back of both left and right arms.) Called Dr. to notify about reaction after vaccines. Pictures were also sent to provider. Mom advised by provider to give just one dose of Zyrtec if needed and to apply cold compressions for 15 minutes to site. If any addition symptoms occur mom advised to F/U with PCP or go to ER. F/U call with mom; cold compress applied for 15 minutes. No swelling at this time.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Condition aggravated, Diarrhoea, Diverticulitis
Clinical narrative: Within 6-12 hrs I had began to have chills, lightheaded, abdominal cramping. WITHIN 12 hours I was in a full blown diverticulitis flare up due to the extreme inflammatory response through out my body as evidenced by extreme lower pelvic pain, inflammation in my bowels, diarrhea , chills, severe nausea all symptoms that are classic setons related to my diverticulitis flare up, which was first diagnosis in 2019. February 12, 2024 I had a robotic sigmoidectomy due to numerous flares and had no issues until this mandatory flu shot.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Inflammation, Nausea, Pelvic pain
Clinical narrative: Within 6-12 hrs I had began to have chills, lightheaded, abdominal cramping. WITHIN 12 hours I was in a full blown diverticulitis flare up due to the extreme inflammatory response through out my body as evidenced by extreme lower pelvic pain, inflammation in my bowels, diarrhea , chills, severe nausea all symptoms that are classic setons related to my diverticulitis flare up, which was first diagnosis in 2019. February 12, 2024 I had a robotic sigmoidectomy due to numerous flares and had no issues until this mandatory flu shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site rash, Rash erythematous
Clinical narrative: ABOUT 24 HRS AFTER ADMINISTRATION OF THE ABOVE VACCINES, MOM NOTICED A PALM SIZE ERYTHEMSTOUS RASH AT THE SITE OF THE DTaP/IPV . SHE OBSERVED OVERNIGHT & FOLLOWED UP IN THE OFFICE TODAY ABOUT 48 HRS AFTER SHOT. ERYTHEMATOUS PATCH INCREASING IN SIZE FROM MOM'S PHOTOS OF THE DAY BEFORE. ERYTHEMA STREAKING UP INTO THE GROIN AREA. MD HAS DX W/ CELLULITIS. RX'D CEPHALEXIN ABX 10 DAY COURSE
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Patient came in 32 days after administration questioning if her arm should still be hurting this much later. She states it is very painful when she tries to lift her arm and has been sore since administration. She states the pain is specifically in the muscle mid-arm and does not originate from or radiate to the shoulder. She states she has never had a reaction like this prior and just wanted to check in with us.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Depressed level of consciousness, Dyspnoea
Clinical narrative: Trouble breathing, gasping for air, almost loss of consciousness.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: THE PHARMACIST GOT EVERYTHING READY, ACKNOWLEDGE THE PATIENT AND VERIFIED HIS DATE OF BIRTH, PREP THE INJECTION SITE ON THE LEFT DELTOID AND APPLY THE INJECT THROUGH CIRLE BAND AID THEN INJECTED THE PATIENT WITH THE FLUZONE HIGH DOSE SEASONAL FLU VACCINE FOR 24/25, THEN PATIENT START TO BLEED UNDER THE BAND AID , THE PHARMACIST AFTER THET GRAB A COTTON BALL AND START FROM THE SIDE TO CLEAN THE BLOOD BUTTHE BLOOD SPLASHED FROM THE OTHER SIDE , SPLASHING FEW DROPS ON THE PATIENT SHIRT AND SHORTS THAT GOT HIM MAD. THE PHARMACIST CALLED ME ( MANAGER) TO HELP TALKING TO PATIENT , AND WHEN I ENCOUNTER PATIENT I ASKED HIM IF HE IS ON ANY BLOOD THINNERS HE SAID NO, I EXPLAINED TO HIM THAT SOMETIMES THIS HAPPEN IF WE HIT A SMALL BLOOD VESSEL DURING INJECTION , I EXCUSED HIM TO CLEAN HIS ARM, REMOVED THE BAND AID AND WIPES HIS ARM CLEAN AND APPLIED CLEAN BANDAID . PATIENT WAS STILL MAD JUST CONCERNED WITH HIS CLOTH AND WANTS A REPLACEMENT .
Age: 73.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PT had already received a 2024-2025 season flu vaccine on 8/2/24 at our facility. We neglected to notice that he was already vaccinated and he asked for the flu vaccine. Additionally, insurance paid for the duplicate vaccine on 10/17.       PT says he has a mildly sore arm in the arm it was administered in but no other symptoms.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site rash, Oropharyngeal pain
Clinical narrative: Pt screened at 10/17/2024 @ 0830 of vaccines with no contraindications noted at time of vaccination. Both vaccines administered to R arm per patient request @ 0900 with no complications during administration. Pt given VIS for vaccines and return precautions to include signs of allergic reaction(anaphylaxis), local skin reactions the spread and itch heavily, airway compromise, nausea and vomiting.  Pt went home and was ok until around 0800PM when she started to have pain at site of vaccinations. Pt stated she slept on opposite arm and when she woke up the next morning, she noted erythema, edema, pruritis on the surrounding tissue of R shoulder extending  3-4 inches on every side with some smaller patches outside of this  area. Pt tried to ignore symptoms assuming it might be local reaction but presented to clinic @ 1200 10/18/2024 for concerns after increased rash and itching. Pt examined by medic, nurse, and doctor in clinic. Pt denied airway compromise, difficulty breathing, SOB, nausea, vomiting. Pt noted edema, pruritis, erythema, and sore throat. No abnormal lungs sounds or vitals noted on exam with doctor stating likely local reaction. Doctor prescribed pt zyrtec tablets and hydrocortisone 1%. Pt took 10mg dose of zyrtec in front of staff and told to follow up immediately if symptoms progress or do not improve by either clinic in person or to dial EMS if airway compromise suspected. Pt skin marked on borders of rash to ensure accurate tracking. Pt left clinic at 1230. Pt came back to clinic @1312 10/18/2024 stating symptoms worsening. Pt to be examined and higher level care decided. ONGOING concerns at time of submission.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Pt screened at 10/17/2024 @ 0830 of vaccines with no contraindications noted at time of vaccination. Both vaccines administered to R arm per patient request @ 0900 with no complications during administration. Pt given VIS for vaccines and return precautions to include signs of allergic reaction(anaphylaxis), local skin reactions the spread and itch heavily, airway compromise, nausea and vomiting.  Pt went home and was ok until around 0800PM when she started to have pain at site of vaccinations. Pt stated she slept on opposite arm and when she woke up the next morning, she noted erythema, edema, pruritis on the surrounding tissue of R shoulder extending  3-4 inches on every side with some smaller patches outside of this  area. Pt tried to ignore symptoms assuming it might be local reaction but presented to clinic @ 1200 10/18/2024 for concerns after increased rash and itching. Pt examined by medic, nurse, and doctor in clinic. Pt denied airway compromise, difficulty breathing, SOB, nausea, vomiting. Pt noted edema, pruritis, erythema, and sore throat. No abnormal lungs sounds or vitals noted on exam with doctor stating likely local reaction. Doctor prescribed pt zyrtec tablets and hydrocortisone 1%. Pt took 10mg dose of zyrtec in front of staff and told to follow up immediately if symptoms progress or do not improve by either clinic in person or to dial EMS if airway compromise suspected. Pt skin marked on borders of rash to ensure accurate tracking. Pt left clinic at 1230. Pt came back to clinic @1312 10/18/2024 stating symptoms worsening. Pt to be examined and higher level care decided. ONGOING concerns at time of submission.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given 12+ COVID vaccine at 4 years old. No adverse outcomes noted.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time, the patient has not reported any adverse effects after accidentally receiving their SECOND flu vaccine of the '24-25 season.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient arm is red and swollen on the upper arm around injection site down to elbow. Site is also warm to touch.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event
Clinical narrative: The patient did not experience any adverse events from his vaccination. Parents did not report any adverse reactions to school staff
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event for patient, but when she filled out administration form, the patient listed her age as 65 (instead of 64) and she was given Fluzone HD instead of Fluarix based on that information (her 65th birthday is not until after vaccine administered).
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given the incorrect vaccine. He was supposed to receive Men B (Bexsero) but the MA grabbed MCV4 (MenQuadfi).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: ON 10/9/24. PT. RECEIVED THE COMIRNATY PFIZER COVID VACCINE.  Patient returned to our pharmacy on 10/14/24 stating that he is experiencing right arm pain and tingling sensations some times. Patient followed up with his PCP. We contacted the patient to follow and his primary care doctor had recommended physical therapy and prescribed him Gabapentin. On 10/18/224, upon follow up; patient did not pick up the Gabapentin and continue to complain of the right arm pain and tingling sensation at times. Pt. was advised to follow up as necessary with his provider and give us an update as necessary.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chest pain, Communication disorder, Injection site pain, Pain
Clinical narrative: Immobility, whole body pain and pain at injection site, brain fog and impaired communication, fever, extreme POTS symptoms, "pounding" heart and chest pain, vomiting
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, Pyrexia, Vomiting
Clinical narrative: Immobility, whole body pain and pain at injection site, brain fog and impaired communication, fever, extreme POTS symptoms, "pounding" heart and chest pain, vomiting
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Patient with significant swelling at injection site. Being treated for cellulitis
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: HEADACHE, BODY ACHES, LOW-GRADE FEVER (99.4), FATIGUE STARTED THE FOLLOWING AFTERNOON AFTER SHOT; FEVERISH FEELING & BODY ACHES STOPPED ON SATURDAY (3 DAYS LATER) BUT FATIGUE AND OCCASIONAL HEADACHE HAS CONTINUED 9 DAYS AFTER THE INJECTION.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient was sick for 2 days (fever, chills, nausea, aches) after COVID shot and arm was red, sore, and swollen at the injection site.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Patient was sick for 2 days (fever, chills, nausea, aches) after COVID shot and arm was red, sore, and swollen at the injection site.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20, RV1
Symptoms: Crying, Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient was given a flu vaccination today. Patient is too young for flu vaccination.  Patient cried with vaccination but had no other s/s to date. Called and consulted with Poison control and local health department who reported to look for injection site reaction but had not other advice.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling
Clinical narrative: The patient returned to the clinic reporting left upper arm swelling, stated she had received the influenza vaccine in that same arm. No history of previous reaction, no cough, throat irritation or SOB.  A cold pack was given to the patient to place on her arm for swelling and pain. The provider that she had seen was called and examined her arm and advised to continue to monitor, instructed to ice arm for 10 min increments, can take Ibuprofen, monitor for worsening symptoms and return to clinic.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Retinal artery occlusion, Vision blurred
Clinical narrative: Patient developed blurred vision 4 days after vaccination. Upon examination, he was diagnosed with an ocular stroke. Patient now has loss of vision in affected eye
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses 18 days apart. First dose given on 9/30/2024.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report possible inadvertent administrations of MMR-II, ROTATEQ, VAXELIS, and VARIVAX after a temperature excursion that occurred on 11SEP2024. Vaccines may have been administered to multiple patients with unknown demographics between th; This spontaneous report as received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender.   The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 11-SEP-2024, the following vaccines suffered a temperature excursion of 11.55 degree Celsius (C) for  9 hours and 45 minutes: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot numbers X020654, X022986 and X018902 with expiration dates 21-OCT-2024, 11-JUN-2025 and 12-JUL-2025 respectively; rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot numbers 2003174 and 2032350 with expiration dates 14-SEP-2025 and 09-OCT-2025 respectively and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) lot numbers U7899AA and U7907AA with expiration dates 31-AUG-206 and 30-SEP-2026 respectively and varicella virus vaccine live (oka/merck)(VARIVAX), lot numbers Y000201, Y004554 and Y006582 with expiration dates 03-JAN-2026, 20-FEB-2026 and 26-MAR-2026 respectively that had an excursion of 1.34 C for 12 hours. Between 16-SEP-2024 and 19-SEP-2024 the vaccines were administered as prophylaxis (doses and routes of administration not reported) (product storage error). No adverse event was reported (no adverse event).  No previous excursions were detected.  Follow-up information received from the nurse on 01-OCT-2024 referring to a 16-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included hepatitis a vaccine inact (HAVRIX).   On 19-SEP-2024, the patient was vaccinated with the improperly stored vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot #X020654, expiration date: 21-OCT-2024, administered subcutaneously on left thigh for prophylaxis (dose and strength not provided). It was reported that the temperature excursion was due to power outrage resulting in stored temperature higher than 8 C.  This is one of several reports received from the same reporters.; Sender's Comments:  US-009507513-2410USA001500: US-009507513-2410USA002565: US-009507513-2410USA002564: US-009507513-2410USA002222:
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist relayed the patient did not complete the full series of the; No side effects or symptoms reported.; This spontaneous report was received from a pharmacist referring to a 22-year-old patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date (reported as when the patient was 1 year old), the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date (reported as when the patient was 13 years old), the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). It was reported that the patient did not complete the full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (incomplete course of vaccination).  No side effects or symptoms reported (no adverse event).
Age: 34.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient did not receive the second dose until one year after the first dose; No other AE; This spontaneous report was received from a medical assistant and referred to a 34-year-old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided). It was reported that the patient had an interruption in the dosing of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and did not receive the second dose until one year after the first dose (inappropriate schedule of product administration). No other adverse event was reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; inadvertently administered doses of PROQUAD and VARIVAX today; This spontaneous report was received from nurse practitioner and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-OCT-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (0.5 milliliter/two dose series, lot #Y006582 was valid, expiration date: 26-MAR-2026) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, (0.5 milliliter/two dose series, lot #Y010291 was valid, expiration date: 01-DEC-2025) (route of administration and anatomical location were not provided) for prophylaxis during the same appointment(Accidental overdose). The patient had not reported any symptoms or medical concerns due to the administration of the vaccines. No additional information provided. No additional AE/PQC reported (No adverse event).