chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Photophobia, Vertigo, Vision blurred, Visual impairment
Clinical narrative: Vertigo, severe headaches, eye aches, blurry vision, extreme sensitivity to light, tingling on bottom of feet, flu-like aches, especially in shoulders and neck, dizziness, upset stomach (belch, gas, diarrhea), pixelated vision at 6-8 ft from object, vivid dreams/nightmares, extremely tired, sleeping  10-12 hours/night and napping during the day, inability to function in daily life. Cancelled trip in December. Unable to attend meeting. Convention as a participant. Unable to Chair mtg of  Action Committee.  Not able to drive, attend church, celebrate holidays w family, socialize, be a normal humam.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS NOTED. CALLED PATIENT AND SPOKE TO DAUGHTER. DID NOT REPORT ANY ADVERSE EVENTS POST VACCINE, WAS TOLD TO GIVE US A CALL TO FOLLOW UP IF ANY SYMPTOMS SHOULD OCCUR AND TO SPEAK TO PHYSICIAN
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Condition aggravated, Magnetic resonance imaging head abnormal
Clinical narrative: Moderna vaccine was given on 1/9/2023,
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Influenza virus test, SARS-CoV-2 test positive
Clinical narrative: 01/14/2023 took Quidel home test, 01/15/2023 diagnosed with covid from rapid test with employer.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Laboratory test
Clinical narrative: Diarrhea
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Gastrointestinal disorder, Gastrointestinal pathogen panel, Rotavirus test positive
Clinical narrative: Diarrhea
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Pt returned to the Clinic 1 hour post vaccination and stated his throat was feeling tight and if he looked down it would close off his airway. While in Clinic Pt's speech changed and an EpiPen was administered, per vaccine administrator and then transported via ambulance to ED.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Magnetic resonance imaging, Tinnitus
Clinical narrative: Severe tinnitus in right ear with severe hearing loss.  I qualify for a cochlear implant. I was diagnoses by the ENT department, Dr. Oral steroids, Steroid injection into the inner ear.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Foot fracture, Joint dislocation, Seizure
Clinical narrative: Pt got the vaccine on 12/28 and he said within a week he started having seizures. The second time he had seizures again was on 1/12 and was hospitalized.  He said the seizures this time is more severe as he had dislocated his shoulders and broke his foot.  Pt described these seizures as abnormal. Pt do have a hx of seizures and is on seizure med.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due temperature excursion. No adverse events experienced/reported by patient.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received an original dose of the Moderna vaccine instead of the bivalent booster
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was due for their second monovalent dose but received a Bivalent booster instead.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, RV1, VARCEL
Symptoms: Product administration error
Clinical narrative: Dr had given orders for the MA to give vaccines. Which was done, but two were given incorrectly. Employee had noticed mistake after vaccines were administrated. I did let Dr know and he will be in contact with Mom.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Cardiolipin antibody positive, Chest pain, Headache, Hemiplegic migraine
Clinical narrative: 5 days after shot my righ had went numb and I had an ice pick headache worse than I've had before.  About three weeks after the palpitations that I had gotten after shot 2 and 3 came back but much worse.  I had to spend 90% of my time in bed because of chest pain.  I could not go up the stairs, do laundry or wash dishes.  I am currently 7 months post shot and being treated by an neurologist, cardiologist and rhematologist.  I have elevated anticardiolipin antibiofies so being checked for antiphospholipid syndrome.  Also have had three MRIs of my brain for inc head pain, it is intense squeezing.  In the last month they have progressed to hemiplegic migraines where I cannot move my right leg.  This is the same leg that got swollen after shot number 3 but since I was pregnant at the time my doc thought it was that.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Musculoskeletal disorder, Palpitations
Clinical narrative: 5 days after shot my righ had went numb and I had an ice pick headache worse than I've had before.  About three weeks after the palpitations that I had gotten after shot 2 and 3 came back but much worse.  I had to spend 90% of my time in bed because of chest pain.  I could not go up the stairs, do laundry or wash dishes.  I am currently 7 months post shot and being treated by an neurologist, cardiologist and rhematologist.  I have elevated anticardiolipin antibiofies so being checked for antiphospholipid syndrome.  Also have had three MRIs of my brain for inc head pain, it is intense squeezing.  In the last month they have progressed to hemiplegic migraines where I cannot move my right leg.  This is the same leg that got swollen after shot number 3 but since I was pregnant at the time my doc thought it was that.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Endotracheal intubation, Intensive care, Lethargy
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 1/15/22 AFTER BECOMING LETHARGIC, TACHYPNEIC. PERSON REQUIRED BILEVEL POSITIVE PRESSURE VENTILATION AND APPEARED SEPTIC.  PREVIOUSLY POSITIVE FOR COVID-19 AND HOSPITALIZED IN OCTOBER 2020. SENT TO ICU AND IMMEDIATELY INTUBATED.  PERSON'S CONDITION REMAINED CRITICAL AND WENT INTO CARDIAC ARREST; FAMILY CHANGED CODE STATUS TO DNR AND PERSON DIED UPON RECURRENT CARDIAC ARREST.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mechanical ventilation, Polymerase chain reaction positive, Positive airway pressure therapy, Proteus test positive, Serratia test positive
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 1/15/22 AFTER BECOMING LETHARGIC, TACHYPNEIC. PERSON REQUIRED BILEVEL POSITIVE PRESSURE VENTILATION AND APPEARED SEPTIC.  PREVIOUSLY POSITIVE FOR COVID-19 AND HOSPITALIZED IN OCTOBER 2020. SENT TO ICU AND IMMEDIATELY INTUBATED.  PERSON'S CONDITION REMAINED CRITICAL AND WENT INTO CARDIAC ARREST; FAMILY CHANGED CODE STATUS TO DNR AND PERSON DIED UPON RECURRENT CARDIAC ARREST.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Staphylococcus test positive, Tachypnoea
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 1/15/22 AFTER BECOMING LETHARGIC, TACHYPNEIC. PERSON REQUIRED BILEVEL POSITIVE PRESSURE VENTILATION AND APPEARED SEPTIC.  PREVIOUSLY POSITIVE FOR COVID-19 AND HOSPITALIZED IN OCTOBER 2020. SENT TO ICU AND IMMEDIATELY INTUBATED.  PERSON'S CONDITION REMAINED CRITICAL AND WENT INTO CARDIAC ARREST; FAMILY CHANGED CODE STATUS TO DNR AND PERSON DIED UPON RECURRENT CARDIAC ARREST.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Hypersomnia, Infection, Injection site erythema, Injection site swelling
Clinical narrative: Brought in by mom. Seen 8 days ago for 2 year well child visit. Usual vaccines given with Dtap and Flu vaccines given on L thigh. Left clinic in no distress. Mom noticed the next day the area on L thigh where vaccines were given becoming red and swollen, with erythema moving down thigh to lower leg. Brought to urgent care where child diagnosed with infection and placed on Cephalexin which he refused to take. Mom denies any fever and erythema has completely resolved. Mom states child taking excessively long naps in the afternoon since incident. Sleeps at usual nap time of 3pm and will sleep until 11 pm.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: Patient after 10 minutes form getting the shot started to faint. family helped her to have a seat. patient  never lost consciousness, she was able to answer our questions. patient felt light headed and weak. she mentioned that her head was foggy. she felt warm and starting sweating . patient felt little better moved to out side the store.I followed her out and stayed with the family for 10 more minutes she was able stand on her own and breath normally. patient went home.I called the family at 8 pm at I was told that she is doing fine.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, COVID-19, Cardiac arrest, Death, Ear pain
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 12/6/2021 WITH CONGESTION, BODY ACHES, EAR PAINS FOR A MONTH. FOUND UNRESPONSIVE AT HOME BY FAMILY.  FOUND HYPERTHERMIC, TACHYCARDIC, AND HYPOXIC ON ADMISSION.  HAD AN EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE, THEN INTUBATED. FAMILY CHANGED CODE STATUS TO DNR AND PERSON HAD AN ANOTHER EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE. PRONOUNCED DEAD ON 12/7/2021.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Human rhinovirus test positive, Hyperthermia, Hypoxia, Pain
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 12/6/2021 WITH CONGESTION, BODY ACHES, EAR PAINS FOR A MONTH. FOUND UNRESPONSIVE AT HOME BY FAMILY.  FOUND HYPERTHERMIC, TACHYCARDIC, AND HYPOXIC ON ADMISSION.  HAD AN EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE, THEN INTUBATED. FAMILY CHANGED CODE STATUS TO DNR AND PERSON HAD AN ANOTHER EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE. PRONOUNCED DEAD ON 12/7/2021.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Tachycardia, Unresponsive to stimuli
Clinical narrative: PERSON ADMITTED TO HOSPITAL ON 12/6/2021 WITH CONGESTION, BODY ACHES, EAR PAINS FOR A MONTH. FOUND UNRESPONSIVE AT HOME BY FAMILY.  FOUND HYPERTHERMIC, TACHYCARDIC, AND HYPOXIC ON ADMISSION.  HAD AN EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE, THEN INTUBATED. FAMILY CHANGED CODE STATUS TO DNR AND PERSON HAD AN ANOTHER EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE. PRONOUNCED DEAD ON 12/7/2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Dyspnoea, Infusion, Spinal fusion surgery
Clinical narrative: Iron level dropped to 4 causing SOB, required 2 iron infusions to correct.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Endotracheal intubation, SARS-CoV-2 test positive
Clinical narrative: ADMITTED TO HOSPITAL ON 1/7/2022 WITH COVID-19 PNEUMONIA AND WORSENING ACUTE TOXIC RESPIRATORY FAILURE. INTUBATED ON 1/12/2022.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Death
Clinical narrative: Death.  He was doing well,  working full time.  Came home from a full day's work.  Had chest pains, died within 1 hour.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram cerebral abnormal, Atelectasis, Cerebral small vessel ischaemic disease, Chest X-ray abnormal, Endotracheal intubation
Clinical narrative: The patient was found unresponsive in shelter and reportedly had witnessed seizure activity.  He was intubated for altered mental status with hypercarbia and admitted to ICU.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hiatus hernia, Hypercapnia, Intensive care, Lung opacity, Mental status changes
Clinical narrative: The patient was found unresponsive in shelter and reportedly had witnessed seizure activity.  He was intubated for altered mental status with hypercarbia and admitted to ICU.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: The patient was found unresponsive in shelter and reportedly had witnessed seizure activity.  He was intubated for altered mental status with hypercarbia and admitted to ICU.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: UNKNOWN
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diagnostic procedure, Haematuria, Immediate post-injection reaction, Laboratory test, Lethargy
Clinical narrative: Fever, aches, lethargy immediately afterwards for two days?.  AND SIGNIFICANT GROSS HEMATURIA that began within two weeks of third shot and continues daily and  presently (1/26/2023)
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aches, lethargy immediately afterwards for two days?.  AND SIGNIFICANT GROSS HEMATURIA that began within two weeks of third shot and continues daily and  presently (1/26/2023)
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Aphasia, COVID-19, Cough
Clinical narrative: Tested positive for COVID-19, Symptoms included fatigue, stiff neck, fever, runny nose, cough, body aches, brain fog, loss sense of smell and taste.  Out of work for 5 days Frequent cough for 6 weeks, minor cough still continues after 8 weeks. Still continuing - brain fog, trouble retrieving words, using the wrong words in sentences
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Impaired work ability, Musculoskeletal stiffness, Pain
Clinical narrative: Tested positive for COVID-19, Symptoms included fatigue, stiff neck, fever, runny nose, cough, body aches, brain fog, loss sense of smell and taste.  Out of work for 5 days Frequent cough for 6 weeks, minor cough still continues after 8 weeks. Still continuing - brain fog, trouble retrieving words, using the wrong words in sentences
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Speech disorder
Clinical narrative: Tested positive for COVID-19, Symptoms included fatigue, stiff neck, fever, runny nose, cough, body aches, brain fog, loss sense of smell and taste.  Out of work for 5 days Frequent cough for 6 weeks, minor cough still continues after 8 weeks. Still continuing - brain fog, trouble retrieving words, using the wrong words in sentences
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Erythema, Immunisation reaction, Peripheral swelling
Clinical narrative: Developed COVD toes one week after vaccine. Started on 4th toe on L foot and at time of reporting is now on dorsal aspects of 2nd, 3rd, and 4th toes of L foot. Toes are red and swollen, without heat, and with blisters ranging from 3mm to 8mm in size. Blisters come and go and appear in different places on dorsal and lateral aspects of toes. Issue has worsened over past 3 weeks. Have attempted to soak toes in epsom salts, puncture and drain blisters with sterile lancet, applied betadyne, and covered with bandaids. Any of these measures provides temporary relief for 2-8 hours.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood thyroid stimulating hormone normal, Cardiac monitoring, Echocardiogram normal
Clinical narrative: New onset atrial fibrillation.   Heart rate 170's irregularly irregular.  Rhythm confirmed 2 weeks later  with one episode of A-Fib recorded with a ZioPatch.  Echo, TSH, labwork all normal.  Had a 3rd short episode of A-Fib confired with a Mobile device about 6 weeks after the bivalent vaccine.  Since that time I don't believe I have had additional episodes of A-Fib.  Treatment has consisted of Eliquis and Flecainide as needed.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Heart rate irregular, Laboratory test normal
Clinical narrative: New onset atrial fibrillation.   Heart rate 170's irregularly irregular.  Rhythm confirmed 2 weeks later  with one episode of A-Fib recorded with a ZioPatch.  Echo, TSH, labwork all normal.  Had a 3rd short episode of A-Fib confired with a Mobile device about 6 weeks after the bivalent vaccine.  Since that time I don't believe I have had additional episodes of A-Fib.  Treatment has consisted of Eliquis and Flecainide as needed.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site dysaesthesia, Injection site pain
Clinical narrative: dysesthesia to left upper arm/ shoulder from day 1 through now (2wks later)- pain without swelling or induration, no numbness or tingling, no weakness.  not improving.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Periorbital dermatitis, Vaccine positive rechallenge
Clinical narrative: I got a similar bilateral periorbital dermatitis with real COVID 12/22, had to get new bivalent booster for work.  I have the exact same bilateral periorbital dermatitis 5 days after the vaccine w/o new medication, soaps etc
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Injection site cellulitis
Clinical narrative: Current dose: Cellulitis (impressive) L upper arm. No fever. Not feeling ill. Starting Augmentin.  Dose one month and one day earlier than this dose. Similar pinkness, time of onset, pain, and rate of progression. Allergy unlikely. Large bruise was present which made family not seek diagnosis, but in hind sight, the early symptoms were identical to those of this infection. I am concerned that there may have been infection present in BOTH doses and that there may be a public health concern with possibly contaminated doses of vaccine causing infection with TWO doses.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Blood test normal, Diarrhoea, Fatigue, Heavy menstrual bleeding
Clinical narrative: Severe abdominal pain, menstrual periods  lasting for up to two weeks, vomiting, diarrhea and extreme fatigue.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound scan normal, Vomiting
Clinical narrative: Severe abdominal pain, menstrual periods  lasting for up to two weeks, vomiting, diarrhea and extreme fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Osteonecrosis, X-ray
Clinical narrative: Avascular necrosis of the right hip
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Blood pressure increased, Dysgeusia, Headache
Clinical narrative: Fifteen minutes post vaccination, patient complained of metallic taste in her mouth and headache. Patient was provided with a glass of water and was assessed by RN. Vital signs were taken and monitored by RN. Blood pressure was 160/70, heart rate was 87, and oxygen 97%. Patient denied history of high blood pressure, but stated she had a busy stressful day. Blood pressure was repeated about 5 minutes later and read 148/72. Patient denied any shortness of breath, chest pain, palpitations, rash or itchiness. Patient reported feeling better after finishing her glass of water, and taking a few deep breaths. Patient reported feeling less anxious after this. Patient was advised to seek immediate medical attention at Emergency Department if symptoms return, or any new symptoms arise in the next few hours or days. Patient left vaccine clinic alert, oriented, and stable with her husband around 2:35PM. All symptoms resolved prior to patient leaving vaccine clinic.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Dysgeusia, Hypersensitivity, Paraesthesia, Swollen tongue
Clinical narrative: PT c/o s/s allergic Rxn c/o metalic taste, tingling, & enlarged tongue. Prior Hxn allergic Rxn & Bees. Self admin Benedryl 25 mg PO. No effect. EMS called for continueing s/s. Care transferred to hospital. VS 152/96 99% Room Air, Lungs clear, 0 drooling. PT continued with normal conversation during episode.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antibody test, Arthralgia, Blood creatinine, C-reactive protein, Conjunctivitis
Clinical narrative: Received booster on left arm 1/8/2023. Left arm sore and warm remainder of the day. 1/9/2023 felt fatigued. 1/10/2023 felt fine. 1/11/2023 fatigue returned. 1/12/2023 enlarged lymph node right side of neck. 1/14/2023 pain cervical spine radiated to right arm lasted a few days. 1/17/2023 rash under arms down trunk also groin area above buttocks which was itchy. 1/18/2023 pink eye in left eye. 1/21/2023 developed arthralgias in both legs, shoulders, knees and ankles. Sore throat since injection.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Full blood count, Laboratory test, Lymphadenopathy, Metabolic function test
Clinical narrative: Received booster on left arm 1/8/2023. Left arm sore and warm remainder of the day. 1/9/2023 felt fatigued. 1/10/2023 felt fine. 1/11/2023 fatigue returned. 1/12/2023 enlarged lymph node right side of neck. 1/14/2023 pain cervical spine radiated to right arm lasted a few days. 1/17/2023 rash under arms down trunk also groin area above buttocks which was itchy. 1/18/2023 pink eye in left eye. 1/21/2023 developed arthralgias in both legs, shoulders, knees and ankles. Sore throat since injection.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Received booster on left arm 1/8/2023. Left arm sore and warm remainder of the day. 1/9/2023 felt fatigued. 1/10/2023 felt fine. 1/11/2023 fatigue returned. 1/12/2023 enlarged lymph node right side of neck. 1/14/2023 pain cervical spine radiated to right arm lasted a few days. 1/17/2023 rash under arms down trunk also groin area above buttocks which was itchy. 1/18/2023 pink eye in left eye. 1/21/2023 developed arthralgias in both legs, shoulders, knees and ankles. Sore throat since injection.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate, Skin warm, Spinal pain, Urine analysis
Clinical narrative: Received booster on left arm 1/8/2023. Left arm sore and warm remainder of the day. 1/9/2023 felt fatigued. 1/10/2023 felt fine. 1/11/2023 fatigue returned. 1/12/2023 enlarged lymph node right side of neck. 1/14/2023 pain cervical spine radiated to right arm lasted a few days. 1/17/2023 rash under arms down trunk also groin area above buttocks which was itchy. 1/18/2023 pink eye in left eye. 1/21/2023 developed arthralgias in both legs, shoulders, knees and ankles. Sore throat since injection.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON CHEEKS, NEAR MOUTH, NECK AND UPPER CHEST. DEFINED BORDERS. NOT RAISED, NO SWELLING, NO ITCHINESS, NO AIRWAY COMPROMISE. LUNGS CLEAR. Sp02=100% PROGRESSED OVER 10 MINUTES. REFUSED TREATMENT AND TRANSPORT. PERSONAL VEHICLE TO OBTAIN OTC ANTIHISTAMINE WITH FAMILY
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Pt felt light head after shot
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: UNUSUAL TINGLING SENSATION FELT DURING AND POST VACCINATION. AFFECTED ARM (LEFT) IS ARM THAT RECEIVED VACCINE. DENIES PAIN, SHORTNESS OF BREATH, SECONDARY/NEUROLOGICAL EXAMS NORMAL. REFUSED TRANSPORT.
Age: 64.0
Sex: U
Vaccine: COVID19-2
Symptoms: Dysgeusia
Clinical narrative: Administered at 11:39 During observation period Pt reports metallic taste in mouth PO2 97 Pulse 70
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING IN EXTREMITIES POST VACCINATION. HYPERVENTILATING. DENIES PAIN OR SHORTNESS OF BREATH. ALERT/ORIENTED, VITALS NORMAL. SECONDARY/NEUROLOGICAL EXAMS NORMAL. REFUSED TRANSPORT.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Brain natriuretic peptide increased, COVID-19, Chest pain
Clinical narrative: Patient with single J+J COVID vaccine who admitted with COVID detected PCR.  Provider d/c note:  "72 YO male with PMH of AKI, COPD, CAD, HTN, DM2 who presents to the ER with shortness of breath and difficulty breathing on exertion. Patient was found to be hypertensive BP 205/144 and elevated BNP. He was given blood pressure medication to decrease his blood pressure slowly. He also presented with edema in his lower extremities. He was given diuresis with IV lasix 40mg bid and his edema improved. He was on 2 to 2.5L of O2 while in the hospital and on a walk test was able to sustain above 90% saturations. He also complained of chest pain, back pain, and abdominal pain difficult to relieve with any pain medications. This pain is possibly due to his COVID infection as most of it occurs when he coughs. As a result we have aggressively treated his cough with dextromethorphan - mucinex & tessalon. It is our assessment that the patient is back to his respiratory status at baseline and can safely be discharged home. He should follow up with his primary care physician and cardiologist. "
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Diuretic therapy, Dyspnoea, Dyspnoea exertional
Clinical narrative: Patient with single J+J COVID vaccine who admitted with COVID detected PCR.  Provider d/c note:  "72 YO male with PMH of AKI, COPD, CAD, HTN, DM2 who presents to the ER with shortness of breath and difficulty breathing on exertion. Patient was found to be hypertensive BP 205/144 and elevated BNP. He was given blood pressure medication to decrease his blood pressure slowly. He also presented with edema in his lower extremities. He was given diuresis with IV lasix 40mg bid and his edema improved. He was on 2 to 2.5L of O2 while in the hospital and on a walk test was able to sustain above 90% saturations. He also complained of chest pain, back pain, and abdominal pain difficult to relieve with any pain medications. This pain is possibly due to his COVID infection as most of it occurs when he coughs. As a result we have aggressively treated his cough with dextromethorphan - mucinex & tessalon. It is our assessment that the patient is back to his respiratory status at baseline and can safely be discharged home. He should follow up with his primary care physician and cardiologist. "
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Oedema peripheral, SARS-CoV-2 test positive, Walking distance test
Clinical narrative: Patient with single J+J COVID vaccine who admitted with COVID detected PCR.  Provider d/c note:  "72 YO male with PMH of AKI, COPD, CAD, HTN, DM2 who presents to the ER with shortness of breath and difficulty breathing on exertion. Patient was found to be hypertensive BP 205/144 and elevated BNP. He was given blood pressure medication to decrease his blood pressure slowly. He also presented with edema in his lower extremities. He was given diuresis with IV lasix 40mg bid and his edema improved. He was on 2 to 2.5L of O2 while in the hospital and on a walk test was able to sustain above 90% saturations. He also complained of chest pain, back pain, and abdominal pain difficult to relieve with any pain medications. This pain is possibly due to his COVID infection as most of it occurs when he coughs. As a result we have aggressively treated his cough with dextromethorphan - mucinex & tessalon. It is our assessment that the patient is back to his respiratory status at baseline and can safely be discharged home. He should follow up with his primary care physician and cardiologist. "
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Insomnia, Nodule, Pain in extremity
Clinical narrative: cannot sleep at night; pain in legs; 1st dose on 05-05-22, never got 2nd dose; lumps on both legs, lower legs, thighs and hips, painful lumps; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 6th May 2022, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and chills. On 19th May 2022, the patient experienced painful nodule. On an unknown date, the patient experienced difficulty sleeping, leg pain and incomplete course of vaccination. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the painful nodule, difficulty sleeping and leg pain were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills, painful nodule, difficulty sleeping and leg pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was the patient. The patient received first Shingrix vaccine in the right arm.  The reporter reported that the day after the vaccine the patient experienced fever and chills, which was resolved.  The reporter reported that about 2 weeks after the Shingrix vaccine the patient get painful lumps on both her legs.  The right leg has more lumps than the left leg. The lower legs had smaller lumps than the lumps on her thighs.  In the last couple of weeks, the lumps had spread to both her hips.  The reporter said she could not sleep at night from the pain in her legs from the lumps. The doctor and chiropractor did not know what was causing the painful lumps.  The reporter said she was getting an MRI (Magnetic resonance imaging) on Saturday.  The patient never got the second Shingrix vaccine.  The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: cannot sleep at night; pain in legs; 1st dose on 05-05-22, never got 2nd dose; lumps on both legs, lower legs, thighs and hips, painful lumps; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 6th May 2022, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and chills. On 19th May 2022, the patient experienced painful nodule. On an unknown date, the patient experienced difficulty sleeping, leg pain and incomplete course of vaccination. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the painful nodule, difficulty sleeping and leg pain were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills, painful nodule, difficulty sleeping and leg pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was the patient. The patient received first Shingrix vaccine in the right arm.  The reporter reported that the day after the vaccine the patient experienced fever and chills, which was resolved.  The reporter reported that about 2 weeks after the Shingrix vaccine the patient get painful lumps on both her legs.  The right leg has more lumps than the left leg. The lower legs had smaller lumps than the lumps on her thighs.  In the last couple of weeks, the lumps had spread to both her hips.  The reporter said she could not sleep at night from the pain in her legs from the lumps. The doctor and chiropractor did not know what was causing the painful lumps.  The reporter said she was getting an MRI (Magnetic resonance imaging) on Saturday.  The patient never got the second Shingrix vaccine.  The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Abdominal pain, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Condition aggravated
Clinical narrative: Patient up to date on COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "64 yr old male with a past medical history significant for esophageal adenocarcinoma (s/p esophagectomy/ McKeown procedure on 03/2022) with current chemotherapy, diverticulosis, hyperlipidemia who presented to the hospital for left hand weakness and abdominal pain. CXR with left hemidiaphragm hiatal hernia and pulmonary vascular congestion. Patient placed on NG tube to suction for partial SBO. Tested COVID positive and suspected COVID pneumonia and started on dexamethasone, remdesvir. Repeat CXR on 12/26 with right basilar consolidation and pleural effusion, likely progression of COVID pneumonia vs aspiration pneumonia. Surgery rec transfer where patient had original surgery performed. Neurology consulted for left weakness, recommended oupatient follow-up and evaluation. Currently, stable for transfer. "
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Diaphragmatic hernia, Gastrointestinal tube insertion, Hemiparesis, Hiatus hernia, Lung consolidation
Clinical narrative: Patient up to date on COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "64 yr old male with a past medical history significant for esophageal adenocarcinoma (s/p esophagectomy/ McKeown procedure on 03/2022) with current chemotherapy, diverticulosis, hyperlipidemia who presented to the hospital for left hand weakness and abdominal pain. CXR with left hemidiaphragm hiatal hernia and pulmonary vascular congestion. Patient placed on NG tube to suction for partial SBO. Tested COVID positive and suspected COVID pneumonia and started on dexamethasone, remdesvir. Repeat CXR on 12/26 with right basilar consolidation and pleural effusion, likely progression of COVID pneumonia vs aspiration pneumonia. Surgery rec transfer where patient had original surgery performed. Neurology consulted for left weakness, recommended oupatient follow-up and evaluation. Currently, stable for transfer. "
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Muscular weakness, Pleural effusion, Pneumonia aspiration, Pulmonary congestion, SARS-CoV-2 test positive
Clinical narrative: Patient up to date on COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "64 yr old male with a past medical history significant for esophageal adenocarcinoma (s/p esophagectomy/ McKeown procedure on 03/2022) with current chemotherapy, diverticulosis, hyperlipidemia who presented to the hospital for left hand weakness and abdominal pain. CXR with left hemidiaphragm hiatal hernia and pulmonary vascular congestion. Patient placed on NG tube to suction for partial SBO. Tested COVID positive and suspected COVID pneumonia and started on dexamethasone, remdesvir. Repeat CXR on 12/26 with right basilar consolidation and pleural effusion, likely progression of COVID pneumonia vs aspiration pneumonia. Surgery rec transfer where patient had original surgery performed. Neurology consulted for left weakness, recommended oupatient follow-up and evaluation. Currently, stable for transfer. "
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Small intestinal obstruction
Clinical narrative: Patient up to date on COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "64 yr old male with a past medical history significant for esophageal adenocarcinoma (s/p esophagectomy/ McKeown procedure on 03/2022) with current chemotherapy, diverticulosis, hyperlipidemia who presented to the hospital for left hand weakness and abdominal pain. CXR with left hemidiaphragm hiatal hernia and pulmonary vascular congestion. Patient placed on NG tube to suction for partial SBO. Tested COVID positive and suspected COVID pneumonia and started on dexamethasone, remdesvir. Repeat CXR on 12/26 with right basilar consolidation and pleural effusion, likely progression of COVID pneumonia vs aspiration pneumonia. Surgery rec transfer where patient had original surgery performed. Neurology consulted for left weakness, recommended oupatient follow-up and evaluation. Currently, stable for transfer. "
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bed rest, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient reported redness and paralysis in right arm.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Monoplegia
Clinical narrative: Patient reported redness and paralysis in right arm.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Ischaemic stroke
Clinical narrative: ISCHEMIC STROKE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient was a healthy individual and she does not have many risk factors at the time of vaccination. The patient had previously vaccinated with dose 1 of covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following first dose of vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following second dose of vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2).  The patient also received dose 3 with non-company suspect vaccine Comirnaty (tozinameran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on an unspecified date in AUG-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The patient stated that at the time of vaccination she did not have any side effects. On 10-DEC-2022, the patient experienced ischemic stroke (Dose number in series 3), that she described as mild and deep in the brain. She reports that it came out of from nowhere. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the ischemic stroke and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230147372-Ischemic stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Ischaemic stroke
Clinical narrative: ISCHEMIC STROKE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient was a healthy individual and she does not have many risk factors at the time of vaccination. The patient had previously vaccinated with dose 1 of covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following first dose of vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following second dose of vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2).  The patient also received dose 3 with non-company suspect vaccine Comirnaty (tozinameran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on an unspecified date in AUG-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The patient stated that at the time of vaccination she did not have any side effects. On 10-DEC-2022, the patient experienced ischemic stroke (Dose number in series 3), that she described as mild and deep in the brain. She reports that it came out of from nowhere. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the ischemic stroke and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230147372-Ischemic stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 91.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Death, Interstitial lung disease, Ventilation/perfusion scan
Clinical narrative: interstitial pneumonia; ill; death; Initial information received on 20-Jan-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 91 years old female patient (172 cm and 112 kg) who was ill, developed interstitial pneumonia and died after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s), concomitant disease, risk factor and family history were not provided.  On 03-Oct-2022, the patient received an unknown dose of suspect influenza quadrival A-B multidose vaccine preserved, suspension for injection (strength, lot number and expiry date - not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient was ill (illness), developed interstitial pneumonia (interstitial lung disease) and died (unknown latency) following the administration of influenza quadrival A-B multidose vaccine preserved.  Reportedly, Patient was in good health until vaccine. Confirmed by Hospital this reaction was due to the flu vaccine.  Final diagnosis was (fatal) Not Applicable death.  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (ill and interstitial pneumonia).  At time of reporting, the outcome was Unknown for the event ill, interstitial pneumonia and was Fatal for the event death.  No autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria: Medically significant and hospitalization on 09-Oct-2023 for the event interstitial pneumonia and  fatal for the event death.; Sender's Comments: Sanofi company comment dated 26-Jan-2023: This case involves a 91 years old female patient (172 cm and 112 kg) who was ill, developed interstitial pneumonia and died unspecified time after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone]. Latency is unknown. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. No autopsy was done. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Not provided