chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fall, Muscular weakness
Clinical narrative: Patient with pre-existing peripheral neuropathy secondary to diabetes, causing thigh atrophy and mild weakness, of about 5 years duration.   Thigh weakness abruptly increased 1-2 days post vaccine booster (his 6th dose overall)  and he fell a few times since.  After almost 4 weeks, the weakness is perhaps a little improved.  I am a physician and would like to know what you know about this - it has been reported!  In your experience does it eventually remit?  Patient's neurologist, a specialist in peripheral neuropathy, did  not have experience with such a possible side effect, but mentioned post-vaccine  Guillain-Barre as related issue.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Patient with pre-existing peripheral neuropathy secondary to diabetes, causing thigh atrophy and mild weakness, of about 5 years duration.   Thigh weakness abruptly increased 1-2 days post vaccine booster (his 6th dose overall)  and he fell a few times since.  After almost 4 weeks, the weakness is perhaps a little improved.  I am a physician and would like to know what you know about this - it has been reported!  In your experience does it eventually remit?  Patient's neurologist, a specialist in peripheral neuropathy, did  not have experience with such a possible side effect, but mentioned post-vaccine  Guillain-Barre as related issue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: pain in upper arm/shoulder/upper back lasting until at least today, 11/22/24 (not resolved yet)  Injection was possibly given incorrectly; we did not give so unknown.  Radicular shooting pain into left arm
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Nausea, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: SWOLLEN ARM(size of soup can), warm to the touch. low grade fever, nausea,vomiting,diarrhea. symptoms cleared up on 11/17/2024
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: SWOLLEN ARM(size of soup can), warm to the touch. low grade fever, nausea,vomiting,diarrhea. symptoms cleared up on 11/17/2024
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest X-ray, Cough, Nasal congestion, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Nasal congestion, chest congestion, cough, vomiting
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: Nasal congestion, chest congestion, cough, vomiting
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Pt came in for hep b from county employment
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Hives all over my body, swollen lips, itching
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Inflammation, Muscle spasms, Sinusitis
Clinical narrative: Sinusitis with bacterial infection. Muscle spasms in shoulder/neck. General inflammation
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTIONS EXPERIENCED.  PATIENT RECEIVED A SECOND FLUSHOT IN THE SEASON.  RECEIVED 1ST FLU SHOT ON 8/31/24 AND REQUESTED ONE FROM US NOT REMEMBERING SHE ALREADY RECEIVED.  PATIENT DOES NOT REPORT HAVING ANY REACTION TO EITHER VACCINE GIVEN
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: Focal near-occlusive thrombus of the right proximal brachial vein.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac pacemaker insertion, Cardioversion, Laboratory test
Clinical narrative: Severe AFib; Saw Dr at Urgent Care (March 16, 2024). Treated by doctor (Cardiology) 3 Cardioversions, one Cardio abalation, (over 6 months) and finally a Pacemaker (November 1, 2024) .
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Client was inadvertently administered the Flumist vaccine. School nurse and Flumist staff did not verify full name and dob of child. No treatment indicated. Mother of child was notified of incident.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blister, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client reports began with muscle aches 11/16 and 11/17/24.  Woke up on 11/16/24 with swollen top of left arm - red/warm at site of COVID vaccination.  Reports 11/18/24 began with fever, night sweats, continued muscle aches, chills, and fever.  Reports did not take temp but knows had one as was shivering when went to bed and awoke drenched in sweat next day.  Developed blister on right forearm where band aid had been from a blood draw done on 11/15/24.  Missed work 11/18 and 11/19/24.  Beginning 11/20/24, symptoms began to improve.  Spoke with client 11/22/24 and client reports feels fine now.  Blister to right forearm scabbed.  Swelling/redness/warm site of left deltoid resolved but reports is still sore to touch.  Has gone back to work.  Client reports tested herself for COVID but was negative.  Did not seek medical care.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth, Myalgia, Night sweats, Pyrexia, Scab
Clinical narrative: Client reports began with muscle aches 11/16 and 11/17/24.  Woke up on 11/16/24 with swollen top of left arm - red/warm at site of COVID vaccination.  Reports 11/18/24 began with fever, night sweats, continued muscle aches, chills, and fever.  Reports did not take temp but knows had one as was shivering when went to bed and awoke drenched in sweat next day.  Developed blister on right forearm where band aid had been from a blood draw done on 11/15/24.  Missed work 11/18 and 11/19/24.  Beginning 11/20/24, symptoms began to improve.  Spoke with client 11/22/24 and client reports feels fine now.  Blister to right forearm scabbed.  Swelling/redness/warm site of left deltoid resolved but reports is still sore to touch.  Has gone back to work.  Client reports tested herself for COVID but was negative.  Did not seek medical care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: Unexplained seizure 08/04/22
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Unexplained seizure 08/04/22
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac monitoring, Catheter placement, Drooling, Dyspnoea, Feeling abnormal
Clinical narrative: 11/21/2024 1910 pt to er door per wife in privately owned vehicle with c/o AMS. pt sitting upright but head down and to the lt with saliva streaming down to chest. pt not breathing, no pulse detected. pt removed from car per 4 staff members onto a stretcher. pt taken to er2 with CPR in progress, placed on cardiac monitor, bagging per RT. wife stated pt was seen at clinic 11/20/2024 for routine check up and got a flu shot. wife stated pt started feeling bad last night and had c/o difficulty breathing today that got progressively worse this evening. 1911 dr at bedside.  1912 hl to lt ac with 20 g  angiocath.  no pulse noted. amp epi given ivp and flushed. CPR resumed. 1915 amp epi given ivp and flushed. CPR resumed.   1918 no pulse noted. ns bolus started. amp epi given ivp. CPR  in resumed. 1920 no pulse, epi given ivp. CPR resumed. 1922 no pulse , epi given ivp. CPR resumed 1923 no pulse per dr , code stopped, iv stopped. wife informed per dr. will give family time with body. 1950 called facility for coroner on call. 1958 okay to release body per Assistant Coroner. 2020 spoke with individual with facility. they will call wife latter.  2106 contacted funeral for pick up of body. 2123 spoke with individual about pick up of body. 2140 body care per 2 nurses.  belongings given to wife. 2150 body removed with Funeral directors.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Mental status changes, Posture abnormal, Pulse absent, Respiratory arrest, Resuscitation
Clinical narrative: 11/21/2024 1910 pt to er door per wife in privately owned vehicle with c/o AMS. pt sitting upright but head down and to the lt with saliva streaming down to chest. pt not breathing, no pulse detected. pt removed from car per 4 staff members onto a stretcher. pt taken to er2 with CPR in progress, placed on cardiac monitor, bagging per RT. wife stated pt was seen at clinic 11/20/2024 for routine check up and got a flu shot. wife stated pt started feeling bad last night and had c/o difficulty breathing today that got progressively worse this evening. 1911 dr at bedside.  1912 hl to lt ac with 20 g  angiocath.  no pulse noted. amp epi given ivp and flushed. CPR resumed. 1915 amp epi given ivp and flushed. CPR resumed.   1918 no pulse noted. ns bolus started. amp epi given ivp. CPR  in resumed. 1920 no pulse, epi given ivp. CPR resumed. 1922 no pulse , epi given ivp. CPR resumed 1923 no pulse per dr , code stopped, iv stopped. wife informed per dr. will give family time with body. 1950 called facility for coroner on call. 1958 okay to release body per Assistant Coroner. 2020 spoke with individual with facility. they will call wife latter.  2106 contacted funeral for pick up of body. 2123 spoke with individual about pick up of body. 2140 body care per 2 nurses.  belongings given to wife. 2150 body removed with Funeral directors.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Large bruise approximately 4 inches in diameter at site of injection, yellowing around edges. No heat upon touch, no discomfort, no limit to range of motion.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: ONSET OF ITCHING ALL OVER THE BODY
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Impaired work ability
Clinical narrative: Pt received vaccine at approximately 10:10am. Pt is a teacher at an elementary school and the clinic took place in the teacher's lounge by the Health Department. At approximately 10:13am, pt reported feeling dizzy while sitting in chair. Nurse instructed pt to breathe deeply in through the nose and out through the mouth. Pt reported feeling "very warm", so she removed her sweater. Pt was brought a cup of water and a cold pack which was placed on the back of her neck. Pt repeatedly declined nurse's offers to call emergency services. School nurse was brought to the room, who checked pt's O2, pulse, and BP. O2 >95%, pulse within normal limits, BP slightly elevated above pt's normal, approximately 130/80. Both nurses asked pt to lay down on the floor and pt refused. Pt again declined nurse's request to call EMS. Over the course of approximately 10 minutes, pt reported feeling less dizzy. School nurse offered to use a wheelchair to transport pt to the nurse's office to rest, pt declined the use of a wheelchair. At approximately 10:30am, both PHN and school nurse walked pt to the school nurse's office, where she rested for another half an hour until recovered. Pt again declined receiving medical treatment but reported she will be calling her doctor today to report the adverse reaction. School nurse sent pt home from work for the day and one of the pt's coworkers drove her home. Pt never lost consciousness.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong formulation given.  Pt is 8yo and should have received the 5-11yo formulation, but they received the 12+ formulation instead.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood homocysteine, Blood test, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: Sick with fever, chills, and extreme fatigue for two days.  Then fatigue for one week.  developed deep vein thrombosis resulting in three-hour Emergency Room visit.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fatigue, Malaise, Pyrexia, Ultrasound Doppler
Clinical narrative: Sick with fever, chills, and extreme fatigue for two days.  Then fatigue for one week.  developed deep vein thrombosis resulting in three-hour Emergency Room visit.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt age 10, received wrong formulation of covid 19 vaccine.  Should have received the 5-11yo formulation, but received the 12+ formulation in error.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Flushing, Skin discolouration, Somnolence
Clinical narrative: pts daughter says after her mothers covid vaccines  in october or november of 2021, her skin started turning gray, she became easily short of breath and would start falling asleep more often during the day. In the last 3 or 4 weeks of her life her skin was bright red  and flushed looking.  She past on March 14, 2022. Her daughter is very upset that the government being so irresponsible with issuing new vaccines to elderly obese patients. She was a very active community leader that was healthy until being vaccinated and now her daughter feels like she was stolen from her.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: CC: right arm red and swollen post vaccination  HPI: patient presents for 2 days ago got his MCV 4 vaccination. he seemed fine until yesterday when his right arm swelled up, got red and hard and painful. he is having a hard time lifting his arm above 90 degrees. he had last night as well a Tactile temperature.  Mother is worried as his sister had a similar reaction and wound up with viral meningitis 2 months later.  Mother applied a cold cloth, gave him ibuprofen and Benadryl. he said right arm is feeling better as a result of the Benadryl as it is not hurting quite as much.      (Sister had the same reaction and ended up with dx of meningitis)
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Electroencephalogram normal, Magnetic resonance imaging head normal, Posture abnormal, Strabismus
Clinical narrative: Within hours of receiving vaccines my daughter was tilting her head back showing signs that something was wrong with her eyes. We then noticed her eyes were misaligned and took her to the Optometrist the following day. A couple of days later she started tilting her head to the side as well and misalignment significantly became worse. It quickly progressed to the point the Optometrist was surprised and worried and suggested we urgently see a Neurologist and Ophthalmologist. Ophthalmologist said sudden onset at her age is rare and said it could possibly be caused by vaccinations.
Age: 1.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling, redness on left thigh
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 2nd dose of the fluad trivalent 2024-2025 vaccine, after receiving first dose of the same vaccine on 8/6/24 (lot number 388459 also given im in the left arm. Patient reports no adverse effects from duplicate administration.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Headache, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received the RSV vaccine in the office on 11/22/2024 at approximately 10:41am. She is currently 35 weeks 5 days pregnant, estimated due date is 12/22/2024. She called the office at 12:59pm on 11/22/2024 and reported a red rash on her abdomen and arms that is extremely itchy. Patient denied "hive-like" appearance, however reported that it "feels like there are bumps" when she feels the rash. Patient also reported headache at that time. Patient denied difficulty breathing, swelling, numbness/tingling, fast heartbeat, dizziness, or weakness. Patient was instructed to take a Benadryl which she agreed to do. Also instructed patient to continue to monitor her rash/symptoms and if she develops any of the following symptoms or if her rash spreads, she was instructed to go to the ER immediately: difficulty breathing, swelling, numbness/tingling, fast heartbeat, dizziness, or weakness.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Gradual onset of hives on R arm, progressing to chest and face starting on the night of November 15th to November 22nd. Patient took benadryl on November 21st.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Respiratory tract congestion, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Head and chest congestion, shortness of breath, unproductive cough
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Induration
Clinical narrative: Localized skin reaction erythema and induration
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Dtap ordered and Pediarix given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Pain in shoulder. Decreased range of motion. She feels it was given too high. Sharp pain  with movement. No temperature.  Has been addressing the issue with heat and naproxen
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Aphasia, Drooling, Hemiplegia, Intensive care
Clinical narrative: Patient developed L MCA ischemic stroke with aphasia and R hemiplegia on the evening of 11/19, per PICU admission notes: "She went to a Powder Puff practice in the evening 11/19. While there her friends said she started to not seem herself -- she started tapping her L arm where she received her Men B vaccination and then subsequently wasn't able to speak, had to be helped to a chair, and couldn't move her R side of her body. Friends tried to give her a sip of water but she drooled. One of her friend's brothers unfortunately had passed away from a stroke at a young age so she recognized stroke sx and called Pt's parents at 6:38pm within a few minutes of sx onset. " She was initially brought to Hospital ED and subsequently transferred to Hospital PICU.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Middle cerebral artery stroke, Mobility decreased, Neurological symptom
Clinical narrative: Patient developed L MCA ischemic stroke with aphasia and R hemiplegia on the evening of 11/19, per PICU admission notes: "She went to a Powder Puff practice in the evening 11/19. While there her friends said she started to not seem herself -- she started tapping her L arm where she received her Men B vaccination and then subsequently wasn't able to speak, had to be helped to a chair, and couldn't move her R side of her body. Friends tried to give her a sip of water but she drooled. One of her friend's brothers unfortunately had passed away from a stroke at a young age so she recognized stroke sx and called Pt's parents at 6:38pm within a few minutes of sx onset. " She was initially brought to Hospital ED and subsequently transferred to Hospital PICU.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT'S MOTHER CALLED SCHOOL NURSE STATING THAT THE PATIENT GOT HOME FROM SCHOOL ON 11/21/2024 WITH WELTS AND ITCHYNESS ALL OVER HIS BODY. MOTHER GAVE HIM BENADRYL WICH HELPED SOME BUT WOKE UP THIS MORNING 11/22/2024 WITH THE SAME SYMPTOMS. MOTHER WAS GOING TO TAKE THE PATIENT TO THE DOCOTOR.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient has allergy to eggs, egg-free flu vaccine ordered. Administered egg -free vaccine for 18years+.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Tdap ordered and Dtap given.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Rash
Clinical narrative: 14 days post immunization with high fever to 105F and rash on scrotum and face starting today. Also with slight cough today.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: SARS-CoV-2 test negative, Scrotal dermatitis
Clinical narrative: 14 days post immunization with high fever to 105F and rash on scrotum and face starting today. Also with slight cough today.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient presents for evaluation of arm pain.   The patient  reports experiencing deep, non-superficial pain throughout her left arm that started after she had her flu shot. The pain is not characterized as burning or sharp.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Glossodynia, Oropharyngeal pain
Clinical narrative: Sore throat on right side. Sore tongue on right side.  Trouble swallowing water and food. I was told by doctor to just take IBUPROFEN 3 times a day. It's been 2 weeks and I still have a sore throat and a sore tongue on right side. I was told by doctor this is not a symptom of the vaccine and to just let my natural antibodies take care of it.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was getting well child check and was due for 2nd dose of ped/adolescent Hep A. Patient was supposed to receive Hep A and a Flu Vaccine. Patient instead was given Hep A and Beyfortus 100mg. Parent was notified by pediatrician and informed of vaccine error.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Pruritus, Swelling face
Clinical narrative: Patient is here today with swelling on face.  She was here on 11/19 for annual physical.She received flu, COVID and HPV.Next morning patient started to have swelling on her face and itching. She reports that her left cheek was very swollen.  Was able to control swelling and itching with ice and Benadryl.No difficulty breathing, no difficultly eating, no stomach pain.   Patient had received all 3 vaccines in the past, although COVID and Flu vaccine are seasonal vaccines.  Provider ordered Benadryl po and Zyrtec PO for patient.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Fever daily for 2 weeks after vaccine. Had same response after 2nd dose of vaccine at 4 months old.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Product administered at inappropriate site
Clinical narrative: injection site reaction, swelling and redness at site, site did appear to be below deltoid muscle
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Dizziness
Clinical narrative: chills same night as administration.  Severe dizziness next morning.  Had to lay on floor 10
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered Flublok instead of Fluzone.  Patient didn?t experience any reactions during observation. No treatment necessary.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AND ITCH AT SITE
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: 2.5cm circular area of induration, erythema, significant tenderness to palpation, and warmth without fever
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Bell's palsy, Computerised tomogram head normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Bell's palsy, treated with prednisone and valacyclovir
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Family came into the clinic for vaccines were being administered. Vaccines were administered. Chart review reflected that a Flublok documentation was completed on the patient. Therefore if it was documented as a Flublok given to the patient and it must be a medical administration error until proven otherwise as I usually document immediately after administration with the vaccine sticker and lot number as well as expiration date. No adverse effects were reported. So I informed the chart reviewer and then management that a VAERS will be completed as well as an incident report.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Thrombosis, X-ray
Clinical narrative: Blood clotting causing hospital visit emergency care to prevent death. 2 days after injection
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site Redness, warm to touch.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site urticaria
Clinical narrative: Vaccine given Monday 11/19/2024 with no adverse reaction.  Five days later on 11/22/24 mid afternoon injection site raised (hived) and the area surrounding became itchy, inflamed, turned red with multiple small pin sized hives.  Red area surrounding the injection site that was inflamed was the diameter of a softball.  Injection site hive was around a nickle size and raised about a nickle height.  Patient was given diphenhydramine .
Age: 1.0
Sex: F
Vaccine: DTAP, FLU3, HIBV, HPV9, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: today patient was given HPV vaccine in error; no immediate visible adverse outcome while in office
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diabetes mellitus inadequate control
Clinical narrative: Per pt he experienced shivers that started about 2 am in the morning and he said that his sugars were out of control and, no appetite and BP reading 112/70 pulse 98. Patient called on 11/22/24 @ approximately 4:30 in the afternoon. Patient said that he would go to ER
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient given incorrect dilution of 1.1mL of sterile 0.9% Sodium Chloride and 0.3mL of Covid vaccine concentration by another staff member. No adverse signs or symptoms immediately after administration.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions but reporting duplication in administration of FLU vaccine in 2 months. First dose was 10/17/2024 (FLUARIX) and second dose was administered 11/22/24 (AFLURIA).
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Loose tooth
Clinical narrative: Crown on tooth was loose because the tooth was about to fall out. Doesn?t seem related to vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: fever, chills, diarrhea, headache
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out in the office after vaccine administration. She became unconscious for about 10 minutes. Was otherwise ok. Breathing normally. She has had the COVID vaccine before and states this only happens with the COVID vaccine. She is able to tolerate other vaccines.
Age: 10.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis
Clinical narrative: mouth sores on ruff of mouth
Age: 47.0
Sex: U
Vaccine: MMR
Symptoms: Chromaturia, Fatigue, Haemolysis, Laboratory test
Clinical narrative: The employee stated that in February of this year he was diagnosed with the disease and the medication he is on is what makes him immunocompromised. His immune system is very strong so it will destroy his red blood cells without this medication. The employee had the flu one week before receiving the flu vaccine on 9/30/2024 and then also had the MMR vaccine that week on 10/3/2024. The next day following the MMR vaccine (10/4/2024) the employee experienced fatigue, and dark urine, which the employee stated are symptoms of hemolysis. The employee then went and got labs drawn and saw his provider the following week to prove the hemolysis.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Patient flinched and pulled her arm away as I was injecting.  Some of the vaccine spilled out on to her arm.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Fall, Gait disturbance, Nausea
Clinical narrative: Patient was sitting on exam bed, she was crying at the time of vaccine, when she stepped out of the room she stumbled and fell medical assistant told her to lay down on the floor and called provider to check on her, patient reported feeling nauseas, when she was able to get up medical assistant took her back into the room to lay down, provider checked in on her again in exam room patient laid down medical assistant  checked vitals gave her apple juice and water. Medical assistant let parent and patient know if she felt ok they are able to leave.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC20, VARCEL
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: Morbiliform rash from head, trunk and arms and legs. Fever noted as well.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Musculoskeletal stiffness
Clinical narrative: Patient received the COVID-19 mRNA seasonal vaccine (Moderna) during an appointment on 11/15/24.  Within minutes of receiving the vaccine, she complained of having intense pain in bilateral upper back/posterior shoulder, LEFT worse than RIGHT.  At the time, it was thought that pt's symptoms were due to her being tense/nervous when the vaccine was administered.  She was given a heat pack, observed for ~14 minutes then discharged.  However, according to the patient, the pain got worse after she left so she returned to the clinic.  Vitals were stable.  There was no evidence of rash, shortness of breath and/or swelling at the time.  She was given a heat pack and monitored for 30 minutes.  She was advised to take Ibuprofen with food as needed for pain. She missed work that Saturday and Sunday due to the pain.  She followed up at the walk in clinic on Monday 11/18/24 concerned that she continued to have pain in her upper back LEFT > RIGHT--although less intense compared to Friday.  She reported that the pain/stiffness in her back had not completely gone away--about 2 out of 10.  She reported that taking hot showers helped.  She stated that she had been told to take Tylenol as needed.  She reported that her job required physical activity that could affect her pain and so requested a work excuse note not only to cover the  Saturday and Sunday she missed but to also cover a few more days this past week.  She was also open to a rx for a muscle relaxant.  She was prescribed rx Diazepam 2mg to take three times a day as needed--#10 tablets only.  She was informed the medication can help with muscle spasms as well as anxiety.  She was advised to avoid driving during the day if needing to take the medication since it can cause drowsiness.  She was also advised not to take the medication at night if possible given her other medications taken at night.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Sensation of foreign body
Clinical narrative: Patient stated that arm is bruised and still painful 1 week after vaccination.  Also stated that felt like something was in her arm.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; No adverse event; This spontaneous report as received from a registered nurse refers to a 5 years old female patient. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    It was reported that the patient was administered an early dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Initial vaccine administered 01-FEB-2024 when child was 5 years old (strength, dose, route of administration, lot #, expiration date and indication were not reported). On 24-OCT-2024 (reported as today), the second Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # reported as X027446 is an invalid lot number, but the expiration date reported as 27-NOV-2025) (strength, dose, route of administration, and indication were not reported) was administered, and it was also noted that patient received varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # Y007955 and expiration date was 17-APR-2026) (strength, dose, route of administration, and indication were not reported) simultaneously (Product administered to patient of inappropriate for both vaccines). No adverse side effects were reported. No additional information available at this time. No additional adverse event (AE)/No produce quality compliance (PQC) (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; who received their first dose of MMR II in 2015 as an adult and; This spontaneous report was received from a pharmacist and refers to an adult patient (unknown gender).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2015, the adult patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse event was reported (No adverse event).  No further information was expected.
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headache; Pain; Muscle soreness; Fatigue; This spontaneous case report received on 30-Oct-2024 from other health care professional regarding a male adult patient (patient six) who had "pain" (PT: Pain), "muscle soreness" (PT: Myalgia), "fatigue" (PT: Fatigue), and "headache" (PT: Headache).   The patient's medical history, concurrent conditions and allergies were not reported.  The patient's past vaccination included BioThrax.    On an unknown date, the patient was administered one doses of Cyfendus (AVA + CPG 7909, lot number: unknown) through the military for postexposure prophylaxis   The patient experienced pain, muscle soreness, fatigue, and headache. All events were considered as mild. The vaccine was tolerated well.   There was no labs/imaging reported.   The outcome of the reported events was unknown.  Company comment: A male patient received one dose of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient's past vaccination included BioThrax. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment.; Sender's Comments: A male patient received one dose of Cyfendus for postexposure prophylaxis and experienced pain, muscle soreness (myalgia), fatigue, and headache. All events were considered mild. The patient's past vaccination included BioThrax. Further information regarding the events was limited. Considering the case information and potential of Cyfendus to cause these events, the causality of pain, myalgia, fatigue, and headache is assessed as possible. The case is considered non serious as per the medical assessment. US-EMERGENT BIOSOLUTIONS-24000179:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000180:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000181:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000183:Cyfendus PMR Study- same reporter US-EMERGENT BIOSOLUTIONS-24000182:Cyfendus PMR Study- same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22 January 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2024 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MMR
Symptoms: Incomplete course of vaccination
Clinical narrative: inappropriate schedule of vaccination; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a 38-year-old patient who received MMR (Priorix) for prophylaxis.   Previously administered products included Priorix (1st dose received on 21st May 2014).   On an unknown date, the patient received the 2nd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccination). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-OCT-2024 A Healthcare professional called to inquire about catch up vaccination and reported that a 38 year old patient received only one dose of Priorix was seeking to obtain an additional dose on day of reporting. The Healthcare professional stated the patient received the Priorix dose at a location outside of the country No other adverse issues or side effects were reported by the HCP. No other information was able to be provided during the call. No additional AE. No PQC. Till the time of reporting, the patient did not receive 2nd dose of Priorix, which led to incomplete course of vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Migraine, Pain, Pyrexia
Clinical narrative: low level migraine headache; full body pummel with fever; body aches; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lyme disease.   In OCT-2024, the patient received the 1st dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: full body pummel with fever), general body pain (Verbatim: body aches) and migraine headache (Verbatim: low level migraine headache). In OCT-2024, the outcome of the fever and general body pain were resolved (duration 2 days). The outcome of the migraine headache was not reported.   It was unknown if the reporter considered the fever, general body pain and migraine headache to be related to Shingrix.     It was unknown if the company considered the fever, general body pain and migraine headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024 The reporter stated that her friend shared that she received a shingles vaccine. She was not sure of manufacturer, but shared a second dose was needed. The reporter believed it was Shingrix and even if not, the reporter knew she need to report this in the event it was. Patient proactively shared they had full body pummel with fever which took them down for two full days. Patient received first dose of what she is unsure of Shingrix or not, 3 or 4 days ago and was planning on receiving 2nd dose. She said had fever, body aches. The reporter did not believe she went to work, stayed home. She did not go to emergency room or hospital.  She said that she had low level migraine headache.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: products have been administered to patients after stored improperly; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a unspecified number of patients who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: products have been administered to patients after stored improperly). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2024  The other health professional reported that Kinrix had administered to patients after stored improperly which led to incorrect storage of drug. No side effects or symptopms reported.  No Additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 5 years since my first shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received the first dose of Shingrix more than 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: more than 5 years since my first shingles shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2024 The patient received first dose of Shingrix more than 5 years ago and wanted to know that if the series should be started again. Patient also asked about the maximum amount of time between shots. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Malaise, Myalgia, Neck pain
Clinical narrative: bad headache; neck hurts to turn; muscles ache; stomach upset; fever; my arm kills me; i feel terrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: bad headache), neck pain (Verbatim: neck hurts to turn), muscle pain (Verbatim: muscles ache), upset stomach (Verbatim: stomach upset), fever (Verbatim: fever), arm discomfort (Verbatim: my arm kills me) and feeling bad (Verbatim: i feel terrible). The outcome of the headache, neck pain and muscle pain were not resolved and the outcome of the upset stomach, fever, arm discomfort and feeling bad were not reported.   It was unknown if the reporter considered the headache, neck pain, muscle pain, upset stomach, fever, arm discomfort and feeling bad to be related to Shingrix.     It was unknown if the company considered the headache, neck pain, muscle pain, upset stomach, fever, arm discomfort and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024  The patient self-reported this case for herself. The patient reported that got first shot for shingles vaccine she go back in December for second shot. The patient asked does she have to do this every year. The patient feel terrible. The patient had bad headache, neck hurts to turn all my muscles ache on the day of reporting she was feeling all of this but stomach upset fever too kinda like covid vaccine. The patient reported that her arm kills her she got shot on Tuesday morning
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: bad headache; neck hurts to turn; muscles ache; stomach upset; fever; my arm kills me; i feel terrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: bad headache), neck pain (Verbatim: neck hurts to turn), muscle pain (Verbatim: muscles ache), upset stomach (Verbatim: stomach upset), fever (Verbatim: fever), arm discomfort (Verbatim: my arm kills me) and feeling bad (Verbatim: i feel terrible). The outcome of the headache, neck pain and muscle pain were not resolved and the outcome of the upset stomach, fever, arm discomfort and feeling bad were not reported.   It was unknown if the reporter considered the headache, neck pain, muscle pain, upset stomach, fever, arm discomfort and feeling bad to be related to Shingrix.     It was unknown if the company considered the headache, neck pain, muscle pain, upset stomach, fever, arm discomfort and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024  The patient self-reported this case for herself. The patient reported that got first shot for shingles vaccine she go back in December for second shot. The patient asked does she have to do this every year. The patient feel terrible. The patient had bad headache, neck hurts to turn all my muscles ache on the day of reporting she was feeling all of this but stomach upset fever too kinda like covid vaccine. The patient reported that her arm kills her she got shot on Tuesday morning