chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Insurance issue, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: About a month after my fall 22 shot, I began having swelling in the center knuckle of my left hand...by thanksgiving both of my hands became inflamed to the point that cooking thanksgiving was nearly impossible.  The nerve in my left hand became pronounced in my palm. The swelling in my right hand lessened for a few months. Then in spring both hands swelled. I suffered for months until I went to a medcheck in June  and they gave me steroids that gave me some relief for about aweek. However by August the condition had spread to 3 fingers in my left and right hands and the joints in both my feet.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Nervous system disorder, Peripheral swelling, X-ray
Clinical narrative: About a month after my fall 22 shot, I began having swelling in the center knuckle of my left hand...by thanksgiving both of my hands became inflamed to the point that cooking thanksgiving was nearly impossible.  The nerve in my left hand became pronounced in my palm. The swelling in my right hand lessened for a few months. Then in spring both hands swelled. I suffered for months until I went to a medcheck in June  and they gave me steroids that gave me some relief for about aweek. However by August the condition had spread to 3 fingers in my left and right hands and the joints in both my feet.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness swelling - size of an orange, hot to touch in the tricep
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC20
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: the day following immunization patient developed significant erythema, edema, and tenderness of right lateral thigh. sought treatment in clinic and thought possible cellulitis and started on Keflex
Age: 28.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Tuberculin test
Clinical narrative: Patient was 7 weeks pregnant when they received these vaccines - including MMR and Varicella. Due date September 20th, 2024. Patient also received a PPD intradermal skin test during this visit.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram ambulatory, Magnetic resonance imaging heart, Myocarditis, Ventricular tachycardia
Clinical narrative: Myocarditis, ventricular tachycardia
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient was given COVID-19 vaccine formulated for patients who are 12 years and older. No reaction/adverse event reported by patient.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Skin induration, Skin warm, Ulcer
Clinical narrative: PATIENT CAME IN TO OFFICE WAS CHECKED MY DR, PATIENT HAD AREA RED,HARD AND HOT. PATIENT ALSO HAD 2 SORES WITH LIQUED COMING OUT. PATIENT WAS GIVEN MEDICATION
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The vaccine of record expired on 1/31/2024 per the box/vaccine label
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Induration, Lymphadenopathy, Nausea
Clinical narrative: Hard red knot on left arm, Nausea, fever, lymph node swelling, headache, chills
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hard red knot on left arm, Nausea, fever, lymph node swelling, headache, chills
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Nasopharyngitis, Pain in extremity
Clinical narrative: An expired vaccine was administered to the patient. They report no issues at this time. They stated they were sore (in the left arm) and felt a little like a cold all weekend. This would be typical vaccine response.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Nodule, Pain, Sleep disorder
Clinical narrative: Patient states she started having an adverse reaction 3 weeks after the injection. States the knot in her arm is sore to the touch, has a stinging/"pinging" pain when trying to sleep and feels there is an area around the knot that is reacting as well.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: medical assistant gave an expired MMRII to the patient
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: Product preparation error
Clinical narrative: I didn't mix the vaccine into the saline, so patient only recevied a dose of the saline.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abscess sterile, Antimicrobial susceptibility test, Culture urine, Skin infection, Urinary tract infection
Clinical narrative: STERILE ABCESS S/P VACCINATION(S)-REASSURANCE  SKIN INFECTION Discussed with pt/family superficial wound infections/skin infections Consider Culture: if done, will phone follow-up after cx back Discussed covering pathogens including MRSA Rx as prescribed:  Warm soaks in Epsom salts as directed Call if no better 48 hours, sooner for change/concerns/worsening or systemic signs of illness (fever/chills) Recheck in office prn  UTI In office urine dip reviewed Specimen sent to lab fo culture w/sensitivities Discussed pathophysiology of UTI with patient/family Discussed expected course/outcome including improvement in symptoms within 48 hours Increase fluids, encourage complete bladder emptying and avoidance of UTI trigge
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urine analysis, Wound infection
Clinical narrative: STERILE ABCESS S/P VACCINATION(S)-REASSURANCE  SKIN INFECTION Discussed with pt/family superficial wound infections/skin infections Consider Culture: if done, will phone follow-up after cx back Discussed covering pathogens including MRSA Rx as prescribed:  Warm soaks in Epsom salts as directed Call if no better 48 hours, sooner for change/concerns/worsening or systemic signs of illness (fever/chills) Recheck in office prn  UTI In office urine dip reviewed Specimen sent to lab fo culture w/sensitivities Discussed pathophysiology of UTI with patient/family Discussed expected course/outcome including improvement in symptoms within 48 hours Increase fluids, encourage complete bladder emptying and avoidance of UTI trigge
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Eschar, Fat necrosis, Pain
Clinical narrative: Redness, pain, fat necrosis and now 3x4cm eschar. Urgent referral made to surgeon
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram normal, Guillain-Barre syndrome, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Tremor
Clinical narrative: shakiness, severe tremors, having trouble holding things and getting food in mouth. Lost 16 pounds. Dr states it is guillain bray syndrome.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Weight decreased, X-ray normal
Clinical narrative: shakiness, severe tremors, having trouble holding things and getting food in mouth. Lost 16 pounds. Dr states it is guillain bray syndrome.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infectiom
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event. Patient was given an  ped/adol dose of Hep A
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 2x3 inches red spot at injection site, painful, hot to touch  48 hours later started to itch, 10 days later still visible
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Influenza like illness, Mobility decreased, Pain
Clinical narrative: I was due for my 2nd dose of shingles vaccine.     I received my second shingles vaccine shot on Tuesday January 30, 2024.  The next morning on Wednesday, I woke up at 6am and I felt very tired, my entire body ached and I felt like I have no movement in my body.  It was torture to move around and I was in much pain.  I have never felt like this before.  It felt like the aches of a bad flu.  I was not sick and I did not have the flu.  To best describe it, I felt completely paralyzed. I was in complete pain all over my body.  I could not get comfortable the second night while I slept and I kept waking up taking tylenol.  Nothing seemed to work at all.  Complete pain and could hardly move my body.  I rested that day as much as I could,  The next day after it  I made myself move around and I was taking 2 tylenol pills every 4 hours for 2 full days.  Yes, Thursday I was in pain as well.  On Friday morning when I woke up at 6am, I felt a little better.  On Saturday when I woke up at 6am, I felt like nothing happened to me at all.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: I was due for my 2nd dose of shingles vaccine.     I received my second shingles vaccine shot on Tuesday January 30, 2024.  The next morning on Wednesday, I woke up at 6am and I felt very tired, my entire body ached and I felt like I have no movement in my body.  It was torture to move around and I was in much pain.  I have never felt like this before.  It felt like the aches of a bad flu.  I was not sick and I did not have the flu.  To best describe it, I felt completely paralyzed. I was in complete pain all over my body.  I could not get comfortable the second night while I slept and I kept waking up taking tylenol.  Nothing seemed to work at all.  Complete pain and could hardly move my body.  I rested that day as much as I could,  The next day after it  I made myself move around and I was taking 2 tylenol pills every 4 hours for 2 full days.  Yes, Thursday I was in pain as well.  On Friday morning when I woke up at 6am, I felt a little better.  On Saturday when I woke up at 6am, I felt like nothing happened to me at all.
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Dizziness, Fatigue
Clinical narrative: diziness, fatigued, balance off
Age: 81.0
Sex: F
Vaccine: DF
Symptoms: Dry mouth, Dysphagia, Headache, Paraesthesia oral, Pruritus
Clinical narrative: itching of head, dry mouth, not able to swallow normally. headache, on edge feeling tingling of lips
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Patient reported to the pharmacy on 2/5/24 complaining that she had a reaction to the vaccine she received 13 days prior. She states that the morning after receiving her vaccine the site was hard, sore and warm to the touch and has been getting worse as time goes on. Over the last 13 days there is a area approximately the size of a half-dollar that is visibly raised and discolored. The area surrounding the elevated area is also mottled purple/red and is warm to the touch despite the patient taking 1000 mg of Tylenol. Patient was advised to seek medical attention to be evaluated for an infection or other serious reactions.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Livedo reticularis
Clinical narrative: Patient reported to the pharmacy on 2/5/24 complaining that she had a reaction to the vaccine she received 13 days prior. She states that the morning after receiving her vaccine the site was hard, sore and warm to the touch and has been getting worse as time goes on. Over the last 13 days there is a area approximately the size of a half-dollar that is visibly raised and discolored. The area surrounding the elevated area is also mottled purple/red and is warm to the touch despite the patient taking 1000 mg of Tylenol. Patient was advised to seek medical attention to be evaluated for an infection or other serious reactions.
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Lymphadenopathy, Pustule
Clinical narrative: pustules on posterior neck and cervical lymphadenopathy starting 5-7 days after vaccine
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pain, then itch at injection site.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient claims limited mobility and pain at injection site months after vaccine administration.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 78.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: He began with numbness to his feet, then difficulty walking, and then cannot walk at all to this day. Symtoms started 1/13/2024.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was given ProQuad vaccine that was expired with a beyond use date of 1/20/2024.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Angiogram cerebral, Blood test, Cardiac stress test abnormal, Cardiac ventricular thrombosis, Catheterisation cardiac normal
Clinical narrative: 11-02-23 VACCINES REEIVED.  11-7 TO 11-14-23 SINUS/RESPIRATORY INFECTION MILD AND WAS  NEGATIVE FOR COVID HOME TEST TWICE.  11-23-23 I HAD A STROKE, LEFT MCA AND HEART ECHO SHOWED LVEF 35% AND THROMBUS IN MURAL LAYER LEFT VENTRICLE HOSPITAL.  ON 10-12-23 I HAD JUST HAD AN ECHO AT ANOTHER HOSPITAL AND THE LVEF WAS 60%. THROMBECTOMY WAS PERFORMED AT HOSPITAL AND STROKE RECOVERY HAS BEEN OK.   CARDIOLOGIST, MD DIAGNOSED MYOCARDITIS AND THROMUS FROM MY HEART WENT TO MY HEAD CAUSING THE STROKE.  CARDIAC STRESS 12-29-2023 SHOWED LVEF 29%.  I AM STILL RECOVERING.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head, Disorientation, Echocardiogram abnormal
Clinical narrative: 11-02-23 VACCINES REEIVED.  11-7 TO 11-14-23 SINUS/RESPIRATORY INFECTION MILD AND WAS  NEGATIVE FOR COVID HOME TEST TWICE.  11-23-23 I HAD A STROKE, LEFT MCA AND HEART ECHO SHOWED LVEF 35% AND THROMBUS IN MURAL LAYER LEFT VENTRICLE HOSPITAL.  ON 10-12-23 I HAD JUST HAD AN ECHO AT ANOTHER HOSPITAL AND THE LVEF WAS 60%. THROMBECTOMY WAS PERFORMED AT HOSPITAL AND STROKE RECOVERY HAS BEEN OK.   CARDIOLOGIST, MD DIAGNOSED MYOCARDITIS AND THROMUS FROM MY HEART WENT TO MY HEAD CAUSING THE STROKE.  CARDIAC STRESS 12-29-2023 SHOWED LVEF 29%.  I AM STILL RECOVERING.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Ejection fraction decreased, Hypotension, Laboratory test, Middle cerebral artery stroke, Myocarditis
Clinical narrative: 11-02-23 VACCINES REEIVED.  11-7 TO 11-14-23 SINUS/RESPIRATORY INFECTION MILD AND WAS  NEGATIVE FOR COVID HOME TEST TWICE.  11-23-23 I HAD A STROKE, LEFT MCA AND HEART ECHO SHOWED LVEF 35% AND THROMBUS IN MURAL LAYER LEFT VENTRICLE HOSPITAL.  ON 10-12-23 I HAD JUST HAD AN ECHO AT ANOTHER HOSPITAL AND THE LVEF WAS 60%. THROMBECTOMY WAS PERFORMED AT HOSPITAL AND STROKE RECOVERY HAS BEEN OK.   CARDIOLOGIST, MD DIAGNOSED MYOCARDITIS AND THROMUS FROM MY HEART WENT TO MY HEAD CAUSING THE STROKE.  CARDIAC STRESS 12-29-2023 SHOWED LVEF 29%.  I AM STILL RECOVERING.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Respiratory tract infection, SARS-CoV-2 test negative, Sinusitis, Syncope, Thrombectomy
Clinical narrative: 11-02-23 VACCINES REEIVED.  11-7 TO 11-14-23 SINUS/RESPIRATORY INFECTION MILD AND WAS  NEGATIVE FOR COVID HOME TEST TWICE.  11-23-23 I HAD A STROKE, LEFT MCA AND HEART ECHO SHOWED LVEF 35% AND THROMBUS IN MURAL LAYER LEFT VENTRICLE HOSPITAL.  ON 10-12-23 I HAD JUST HAD AN ECHO AT ANOTHER HOSPITAL AND THE LVEF WAS 60%. THROMBECTOMY WAS PERFORMED AT HOSPITAL AND STROKE RECOVERY HAS BEEN OK.   CARDIOLOGIST, MD DIAGNOSED MYOCARDITIS AND THROMUS FROM MY HEART WENT TO MY HEAD CAUSING THE STROKE.  CARDIAC STRESS 12-29-2023 SHOWED LVEF 29%.  I AM STILL RECOVERING.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Cardiac failure congestive, Condition aggravated, Hyperglycaemia, Metabolic encephalopathy
Clinical narrative: Hospitalization for acute decompensated systolic CHF exacerbation, acute metabolic encephalopathy, pleural effusion, elevated troponin level, hyperglycemia, microcytic anemia, physical deconditioning  on dates 12/31/2023-1/31/2024. Treated with vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Microcytic anaemia, Physical deconditioning, Pleural effusion, Troponin increased
Clinical narrative: Hospitalization for acute decompensated systolic CHF exacerbation, acute metabolic encephalopathy, pleural effusion, elevated troponin level, hyperglycemia, microcytic anemia, physical deconditioning  on dates 12/31/2023-1/31/2024. Treated with vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: CHILD RECEIVED KINRIX VACCINE WHICH IS INAPPROPRIATE FOR HIS AGE.  GSK NOTIFIED.  NO ADVERSE OUTCOME NOTED.  NO ISSUES AFTER RECEIVING THE MEDICATION.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: KINRIX ADMINISTERED.  NOT THE CORRECT AGE APPROPRIATE MEDICATION.  NO ISSUES NOTED.  GSK NOTIFIED.  NO ADVERSE OUTCOME
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Immediate post-injection reaction, Injection site pain, Joint stiffness
Clinical narrative: as vaccine was injected patient felt typical burning in arm and then immediately felt a tightening in her throat and a "weird" feeling in her head (like a lightheadedness). we had the patient wait for almost an hour. we watched her, gave her water, protein, talked with her for consciousness, started experiencing muscle stiffness in her neck and jaw, had her take ibuprofen. after the hour she felt a bit better, so we had her start by just standing and then slowly walking around. around 7:55 pm we called the patient at home and she felt much better. called patient on Monday to see how she felt before reporting adverse event and she is doing great. she has decided to not get the 2nd shot in the series.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Throat tightness
Clinical narrative: as vaccine was injected patient felt typical burning in arm and then immediately felt a tightening in her throat and a "weird" feeling in her head (like a lightheadedness). we had the patient wait for almost an hour. we watched her, gave her water, protein, talked with her for consciousness, started experiencing muscle stiffness in her neck and jaw, had her take ibuprofen. after the hour she felt a bit better, so we had her start by just standing and then slowly walking around. around 7:55 pm we called the patient at home and she felt much better. called patient on Monday to see how she felt before reporting adverse event and she is doing great. she has decided to not get the 2nd shot in the series.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: Product preparation error
Clinical narrative: I never mixed the vaccine into the saline for Rotavirus, so the patient only got saline administered.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Men B vaccine administered to 11-year-old patient.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: per patients letter.    She complained of right arm hurting very bad three days after flu shot was given.    She  took aspirin daily for several days according to her report.  She came into the pharmacy   on November 25, 2023  stating that her arm was still hurting .   She was concerned that she had received the flu shot.    Records indicate that a Fluarix flu was given.  She was not sure that was the vaccine given.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: I did not mix the vaccine and saline together for Rotavirus, so patient only received the saline. No adverse reaction.
Age: 36.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluad was administered to a 36 year old; but Fluad is recommended for ages 65 years and older.  No issues reported after vaccination.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Feeling abnormal, Palpitations, Sensory disturbance, Vertigo, Vomiting
Clinical narrative: On Feb-3-2023 around 4:15 AM EST, when tried to get out of bed, I have felt that the room is spinning, used the rest room and took Gatorade, within 30 minutes, through up (vomited) Gatorade.  Feeling terrible and palpitations for 2 days.  Now no palpitations, but reeling sensation when lay-down on the bed and try to sleep, feeling terrible with this sensation.  No clue these vaccinations caused me vertigo like feeling.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies positive, Computerised tomogram, Electrocardiogram, Laboratory test, Pulmonary embolism
Clinical narrative: MULTIPLE BILATERAL PULMONARY EMBOLISM REQUIRING HOSPITALIZATION AND ANTICOAGULATION.  VENOUS THROMBOSIS NOT FOUND BY ULTRASOUND
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Pain started at insertion site started approx 12 hrs after injection. Bruising and inflammation noted at injection site on 2/5/24. Site of injury noted to be 2cm x 4.5cm noted at the time this form was completed.
Age: 62.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: After receiving Shingrix and Abrysvo vaccines pt indicated she was feeling dizzy.  She continued to feel light headed and dizzy so immunizer asked her to lie flat on the ground.  She continued to feel dizzy, light-headed, nauseated, and was diaphoretic for approximately 30 minutes.  At this time we called emergency medical services to evaluate her.  They determined she should be taken for further medical evaluation and medical care.  The chose to follow the advice of the paramedics and was taken out of the pharmacy on a stretcher.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: shortness of breath,fluttering heart
Age: 1.92
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large warm swollen red area at injection site and 102.6 temp
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Food intolerance, Functional gastrointestinal disorder, Mesenteric panniculitis
Clinical narrative: Severe on-going food intolerance, abdominal pain, bowel instability and zero abdominal surgery or trauma.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Pain of skin, Peripheral coldness, Tremor
Clinical narrative: Client complain of numbness in the cheeks, cold hands and shaking. Client move to the examination room, foot of bed slightly elevated. V/S- T - 97.8. HR - 78, R - 20, B/P- 110/70.  On examination, pt's skin pink, but cold to touch. client able to drink water, felt pain on slight pinch of the skin on  cheek bone. v/s monitoring continues every 15 minutes x 3 all within normal range. Client requessted to go home after 1hr, V/S before discharge : T - 97 6, HR - 78, R - 20, and B/P - 110/78. Client educated on signs and symptoms and to go to the emergency room if symptoms reoccur. Client verbalized understanding.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: COVID-19, Death, General physical health deterioration, SARS-CoV-2 test positive
Clinical narrative: Facility reports Covid deaths within 90 days of Covid vaccination.  Patient was previously on hospice prior to vaccination and contraction of Covid and declining.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swelling, warmth, erythema with inability to lift the left arm above 90 degrees. Pt states that symptoms started the next morning upon waking from receiving the vaccine.  Pt used Ibuprofen 800 mg  that evening and 400 mg this AM. Did apply ice to the area yesterday.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt developed redness and painful lump at injection site.  Provider advised watchful waiting, heat/ice, ibuprofen
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient describes pain and tingling in arm in which he received vaccine.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Hypopnoea, Injection site pain, Irritability
Clinical narrative: Rapid and shallow breathing, fever, irritability, fatigue, lack of appetite, pain at site of injection
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachypnoea
Clinical narrative: Rapid and shallow breathing, fever, irritability, fatigue, lack of appetite, pain at site of injection
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult was given a pediatric dose
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/; HCP calling to report expired MMRII was administered.; This spontaneous report was received from a registered medical assistant and refers to a 2-year-old patient of unknown gender. The patient's concomitant medications included: sterile diluent. The patient's medical history, concurrent conditions, drug reactions and allergies were not provided.  On 08-JAN-2024, the patient was vaccinated  with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live,  recombinant human albumin (rHa) (M-M-R II) injection, 0.5 ml, lot #W017557, expiration date: 07-JAN-2024, (strength,exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (expired product administered). It was also reported that the suspect vaccine had not experienced any previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine administered to two patients post excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# X017485, expiry date: 25-JUN-2025) had a temperature excursion. On 08-JAN-2024, after temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (product quantity: 1; dose, route of administration, and anatomical location not provided) as prophylaxis (product storage error).   This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA004678:
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered, Vaccination failure
Clinical narrative: negative Varicella antibody status; a third dose of VARIVAX was administered on 9AUG2023; negative Varicella antibody status; This spontaneous report was received from a physician via a company employee referring to a 19-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date (when the patient was 14 months old), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). On an unknown date (at patient's 6 years), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided), both vaccines for prevention of varicella. On an unknown date, the patient started therapy with sterile diluent (STERILE DILUENT) solution for injection/infusion  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  On 28-JUL-2023, the patient showed negative titers for nursing program. On 09-AUG-2023 (at 19 years old), the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot # W020540, expiry date 28-JUN-2024 (strength, route and anatomical site of administration was not provided) as booster dose for prevention of varicella due to negative antibody status (extra dose administered). On 06-JAN-2024, the patient repeated the titer, and it came back negative. Company employee did not report any issues with the varicella virus vaccine live (oka/merck) (VARIVAX) that were noted at time of administration. At the time of reporting, the outcome of the negative varicella antibody status (2 times) was unknown. The action taken with sterile diluent (STERILE DILUENT) and varicella virus vaccine live (oka/merck) (VARIVAX) was not applicable. The causal relationship between negative varicella antibody status (2 times) and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between negative varicella antibody status (2 times) and sterile diluent (STERILE DILUENT) was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Blindness transient, Encephalitis autoimmune, Gait inability, Homeopathy, Illness
Clinical narrative: got very ill; not being able to regulate body temp; Passing out/temporally blindness/going mute/being paralyzed/20seizures per day/not being able to walk/the vaccine has triggered autoimmune encephalitis; Pots; Small fiber neuropathy; On top of this we have to start using all kinds of vitamin ivs that will not be covered by our insurance and we are also looking into the hyperbaric chamber, that also isn't covered; This spontaneous report was received from a health care professional via company representative and referred to a female patient of unknown age.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in March 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose number, dosage vaccination scheme frequency, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown day in March 2023, after vaccination, the patient got very ill (illness) (per information provided assessed as severe). From passing out to not being able to regulate body temperature (temperature regulation disorder), temporally blindness to going mute and being paralyzed, up to 20 seizures per day. It was mentioned that the patient went from living her life to the fullest to not being able to walk. It was stated that the vaccine triggered autoimmune encephalitis, postural orthostatic tachycardia syndrome (POTS), and small fiber neuropathy.   On an unspecified date, the patient was admitted due to the events. At that moment, she had a nurse at the house and was receiving intravenous (ivig) and steroids as treatment for all events. On top of this, she had to start using all kinds of vitamin that would not be covered by the insurance. The patient was also looking into the hyperbaric chamber therapy, which was not covered either (insurance issue). Also, she had to start homeopathy, as well. At the reporting time, the patient had not recovered from the events.  The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Additionally, the events illness (severe), temperature regulation disorder, encephalitis autoimmune, postural orthostatic tachycardia syndrome and small fiber neuropathy were considered to be life threatening and disabling.  Upon internal review, the event encephalitis autoimmune was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Immunoglobulin therapy, Insurance issue, Loss of consciousness, Mutism, Paralysis
Clinical narrative: got very ill; not being able to regulate body temp; Passing out/temporally blindness/going mute/being paralyzed/20seizures per day/not being able to walk/the vaccine has triggered autoimmune encephalitis; Pots; Small fiber neuropathy; On top of this we have to start using all kinds of vitamin ivs that will not be covered by our insurance and we are also looking into the hyperbaric chamber, that also isn't covered; This spontaneous report was received from a health care professional via company representative and referred to a female patient of unknown age.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in March 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose number, dosage vaccination scheme frequency, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown day in March 2023, after vaccination, the patient got very ill (illness) (per information provided assessed as severe). From passing out to not being able to regulate body temperature (temperature regulation disorder), temporally blindness to going mute and being paralyzed, up to 20 seizures per day. It was mentioned that the patient went from living her life to the fullest to not being able to walk. It was stated that the vaccine triggered autoimmune encephalitis, postural orthostatic tachycardia syndrome (POTS), and small fiber neuropathy.   On an unspecified date, the patient was admitted due to the events. At that moment, she had a nurse at the house and was receiving intravenous (ivig) and steroids as treatment for all events. On top of this, she had to start using all kinds of vitamin that would not be covered by the insurance. The patient was also looking into the hyperbaric chamber therapy, which was not covered either (insurance issue). Also, she had to start homeopathy, as well. At the reporting time, the patient had not recovered from the events.  The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Additionally, the events illness (severe), temperature regulation disorder, encephalitis autoimmune, postural orthostatic tachycardia syndrome and small fiber neuropathy were considered to be life threatening and disabling.  Upon internal review, the event encephalitis autoimmune was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Small fibre neuropathy, Temperature regulation disorder
Clinical narrative: got very ill; not being able to regulate body temp; Passing out/temporally blindness/going mute/being paralyzed/20seizures per day/not being able to walk/the vaccine has triggered autoimmune encephalitis; Pots; Small fiber neuropathy; On top of this we have to start using all kinds of vitamin ivs that will not be covered by our insurance and we are also looking into the hyperbaric chamber, that also isn't covered; This spontaneous report was received from a health care professional via company representative and referred to a female patient of unknown age.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in March 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose number, dosage vaccination scheme frequency, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown day in March 2023, after vaccination, the patient got very ill (illness) (per information provided assessed as severe). From passing out to not being able to regulate body temperature (temperature regulation disorder), temporally blindness to going mute and being paralyzed, up to 20 seizures per day. It was mentioned that the patient went from living her life to the fullest to not being able to walk. It was stated that the vaccine triggered autoimmune encephalitis, postural orthostatic tachycardia syndrome (POTS), and small fiber neuropathy.   On an unspecified date, the patient was admitted due to the events. At that moment, she had a nurse at the house and was receiving intravenous (ivig) and steroids as treatment for all events. On top of this, she had to start using all kinds of vitamin that would not be covered by the insurance. The patient was also looking into the hyperbaric chamber therapy, which was not covered either (insurance issue). Also, she had to start homeopathy, as well. At the reporting time, the patient had not recovered from the events.  The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Additionally, the events illness (severe), temperature regulation disorder, encephalitis autoimmune, postural orthostatic tachycardia syndrome and small fiber neuropathy were considered to be life threatening and disabling.  Upon internal review, the event encephalitis autoimmune was determined to be medically significant.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A HCP called to report a TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 12/08/2023.; This spontaneous report was received from a medical assistant, referring to a 9-week-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 08-DEC-2023, the patient received improperly stored vaccines of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X003664, expiration date: 10-NOV-2025 (strength, and route of administration were not provided), 0.5 ml / once, administered for prophylaxis; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965644 (strength was not provided), expiration date: 02-OCT-2024, 1 dose, administered orally for prophylaxis (product storage error). The vaccines were exposed to 54.3 degrees Fahrenheit (F) for 9 hours 32 minutes (on 04-DEC-2023), 57.7 F for 15 hours 30 minutes (on 05-DEC-2023), 50.2 F for 5 hours 43 minutes (on 06-DEC-2023), 30.6 F for 1 hour 55 minutes (on 07-DEC-2023), 52.7 F for 11 hours 3 minutes (on 07-DEC-2023), and 48.4 F for 1 hour 47 minutes (on 11-DEC-2023). No other reported current or previous temperature excursions (TE). The patient did not report any adverse issues or side effects from the administration. And no other adverse event (AE) information was able to be provided during the call (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant called and reported that an expired dose of MMR II was administered to a patient. Caller stated the dose expired 1/7/2024 and was administered 1/30/2024. Caller stated patient has not had any symptoms. Caller stated product has not; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JAN-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #W019425, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).No additional adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product, Patient uncooperative
Clinical narrative: reports no side effects; HCP calling to report AE for PROQUAD. HCP reports a nurse in her clinic was administering PROQUAD to a patient, the patient was moving around "fighting during the administration", the needle accidentally slipped out from the patient's arm while the; the needle accidentally slipped out from the patient's arm while the nurse was simultaneously pushing to inject, and the nurse squirted PROQUAD into her (the nurse's) eye. HCP reports she does not know any; the needle accidentally slipped out from the patient's arm while the nurse was simultaneously pushing to inject; This spontaneous report was received from nurse and refers to a 33-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JAN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The nurse was administrating the vaccine to a patient, which was moving around. The needle accidentaly slipped out from the patient's arm while the nurse was simultaneously pushing to inject and the nurse squirted the vaccine into the nurse's eye (Occupational exposure to product, Accidental exposure to product and Vaccination error). There was no conformation which eye was it. The nurse used the in office eye wash to wahs her eye out immediately after the exposure. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored administered VARIVAX with multiple prior excursions; This spontaneous report has been received from a registered nurse, regarding a patient with unknown age and gender. The patients' concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date in January 2024, varicella virus vaccine live (oka/merck) (VARIVAX) occurred multiple temperature excursions. On 05-JAN-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml/dose, lot number X017484 has been verified to be a valid lot number and expiration date was 25-JUN-2025, frequency, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  The temperature and time frame duration were reported as 6.3 Fahrenheit degree (F) / 6 F up to 14 F for 0 hours 10 minutes 0 seconds. The previous temperature excursion occurred. The previous temperature and time frame duration were 5.7 F / 6 F up to 14 F for 0 hours 8 minutes 0 seconds; 5.9 F / 6 F up to 14 F for 0 hours 16 minutes 0 seconds; 9.5 F / 6 F up to 14 F for 0 hours 21 minutes 0 seconds; 5.4 F / 6 F to 14 F for 0 hours 18 minutes 0 seconds. No additional adverse event (AE).
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Trigeminal neuralgia
Clinical narrative: Trigeminal Neuralgia flare up; This non-serious case was reported by a other health professional via sales rep and described the occurrence of trigeminal neuralgia in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included trigeminal neuralgia.   On 12-JAN-2024, the patient received Arexvy. On 19-JAN-2024, 7 days after receiving Arexvy, the patient experienced trigeminal neuralgia (Verbatim: Trigeminal Neuralgia flare up). The outcome of the trigeminal neuralgia was not reported.   It was unknown if the reporter considered the trigeminal neuralgia to be related to Arexvy.     It was unknown if the company considered the trigeminal neuralgia to be related to Arexvy.   Additional Information: GSK Receipt date: 26-JAN-2024 The reporter was a medical assistant. The patient was diagnosed with trigeminal neuralgia years before receiving the Arexvy vaccine.  The patient had not had a flare up in a long time, she got Arexvy, and the trigeminal neuralgia flare up occurred.  The reporter stated that the flare up was severe. A reporter reported that he/she was not sure if patient's episode of trigeminal neuralgia was related to getting vaccinated with Arexvy.  The reporter agree to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed my Shingrix booster within the 6 months timeframe; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1 year ago, patient received 1st dose).   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: missed my Shingrix booster within the 6 months timeframe). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:26-JAN-2024 The patient was consumer. The patient missed booster dose of Shingrix within the 6 months timeframe. The patient received 1st dose and it has been 1 year. The patient asked if they should still get 2nd dose of the Shingrix vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter would follow up after they receive the second dose. Follow-up would not be possible as no contact details were available.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site scab, Injection site swelling, Injection site ulcer
Clinical narrative: swelling at the site of injection; ulceration at the site of injection; scabbing at the site of injection; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-DEC-2023, the patient received Arexvy (right arm). On an unknown date, less than a month after receiving Arexvy, the patient experienced injection site swelling (Verbatim: swelling at the site of injection), injection site ulcer (Verbatim: ulceration at the site of injection) and injection site scab (Verbatim: scabbing at the site of injection). The outcome of the injection site swelling, injection site ulcer and injection site scab were not reported.   It was unknown if the reporter considered the injection site swelling, injection site ulcer and injection site scab to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site ulcer and injection site scab to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-JAN-2024 The patient received Arexvy vaccine and no other vaccines administered that office encounter. The patient's daughter reported the adverse events on 04-JAN-2024, even showed a photo of her mother's arm. The office did not know the Arexvy lot number or expiration date. The patient had swelling, ulceration and scabbing at the site of injection. Consent to follow-up granted.