chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Speech disorder
Clinical narrative: per husband - flu like-symptoms the day following the immunization (11/4). The next day (11/5) felt sicker, no appetite, headache, by the end of the night  "talking nonsense" . The following day (11/6) - seems "out of it" husband stayed home to watch her. She fell out of bed, couldn't talk, hard time swallowing, could not physically move to get dressed so called EMS.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Systemic: Diarrhea-Medium, Additional Details: Customer reported that he started to have diarrhea 1 day after the date of Moderna Bivalent vaccination, but he thought it was from the salad that he ate.  He changed his diet to brat diet. He had about 7-8 diarrheas within 11/22 to 11/25.  He took pepto bismol but it didn't help. He went to pharmacy on 11/25/22 to report the adverse reaction.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram cerebral normal, Blood glucose normal, Cranial nerve paralysis, Diplopia, Eye pain
Clinical narrative: Left third cranial nerve palsy, causing severe diplopia. Started with pain in the left eye, which  progressed to diplopia associated with vertigo.  Retinal and corneal examinations were completely normal. Pain (requiring analgesics) and diplopia continued to progress over the next 5 days. Ultimately presented to the emergency room and diagnosis of third nerve palsy was made. Started on 60 mg of prednisone with rapid and dramatic improvement in the pain after 2 hours of dosing.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Glycosylated haemoglobin normal, Laboratory test normal, Magnetic resonance imaging normal, Red blood cell sedimentation rate normal, Vertigo
Clinical narrative: Left third cranial nerve palsy, causing severe diplopia. Started with pain in the left eye, which  progressed to diplopia associated with vertigo.  Retinal and corneal examinations were completely normal. Pain (requiring analgesics) and diplopia continued to progress over the next 5 days. Ultimately presented to the emergency room and diagnosis of third nerve palsy was made. Started on 60 mg of prednisone with rapid and dramatic improvement in the pain after 2 hours of dosing.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4, VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient told pharmacy she wanted flu and Shingrix. Before administration the pharmacist confirmed with the patient which vaccines she was getting.  During administration the patient stated she said Moderna and Shingrix (not Flu). The flu vaccine had already been administered by this time. This is the second Flu shot she recieved this season.  First one on 9/18/22
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient-
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a bivalent booster instead of monovalent first dose. No adverse effects noted.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site scab, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: scabbing over of site-Medium
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: scabbing over of site-Medium
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a bivalent booster instead of monovalent first dose. No adverse effects noted.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired vaccine. It was noticed after patient got the vaccine. Called and notified patient, he doesn't experience any adverse event. Did recommended patient to come back to re-vaccinate per CDC and manufacture recommendation.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site rash
Clinical narrative: 2 Days after injection, red rash at injection site  from shoulder to elbow and spreader to inside of the arm.  Inflamed, swollen , red, burning and painful.     I had a Flu shot 2 weeks prior to shingles shot at the same pharmacy but can?t find the paperwork.  I did not have any side effects from the shot. It was in the right arm.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Interchange of vaccine products
Clinical narrative: Patient received Pfizer COVID vaccine on 6/19/21 (lot # EW0180), 7/29/21 (lot # EW0181), and Moderna COVID vaccine on 1/24/22 (lot # 084J21A). On 11/21/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID pneumonia, acute sepsis, acute UTI, and acute kidney injury. As of today (11/28/22), patient is still admitted in the med/surg unit.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Urinary tract infection
Clinical narrative: Patient received Pfizer COVID vaccine on 6/19/21 (lot # EW0180), 7/29/21 (lot # EW0181), and Moderna COVID vaccine on 1/24/22 (lot # 084J21A). On 11/21/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID pneumonia, acute sepsis, acute UTI, and acute kidney injury. As of today (11/28/22), patient is still admitted in the med/surg unit.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: Intermittent chest pain and tightness. Felt most strongly when sitting down.  Worst of pain/tightness subsided after a few months, but consistent 1/10 chest tightness still present and felt.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccine positive rechallenge
Clinical narrative: I've had tinnitus since the first dose in April 2021. It starts to subside and the ramps up again with each dose or booster.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Asthma, Choking, Cough, Urticaria
Clinical narrative: urticaria all over body, and  violent cough, child choking, asthma attacks In 2 days the baby started to take antihistamine syrup, but the syrup doesn't help much.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Aspiration, COVID-19 pneumonia, Endotracheal intubation, Intensive care
Clinical narrative: Patient received monovalent Pfizer COVID vaccine on 1/15/22 (lot # FJ1614), 2/11/22 (lot # FJ1614), 8/22/22 (lot # FW1331), and bivalent Pfizer COVID vaccine on 11/9/22 (lot # GJ3277). On 11/21/22, patient was intubated in the field and admitted to our CCU with acute respiratory failure with hypoxia in the setting of COVID-19 pneumonia and bilateral bacterial pneumonia superinfection or aspiration, septic shock, UTI, and thrombocytopenia. As of today (11/28/22), patient is still in CCU intubated.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia, Pneumonia bacterial, SARS-CoV-2 test positive, Septic shock, Thrombocytopenia
Clinical narrative: Patient received monovalent Pfizer COVID vaccine on 1/15/22 (lot # FJ1614), 2/11/22 (lot # FJ1614), 8/22/22 (lot # FW1331), and bivalent Pfizer COVID vaccine on 11/9/22 (lot # GJ3277). On 11/21/22, patient was intubated in the field and admitted to our CCU with acute respiratory failure with hypoxia in the setting of COVID-19 pneumonia and bilateral bacterial pneumonia superinfection or aspiration, septic shock, UTI, and thrombocytopenia. As of today (11/28/22), patient is still in CCU intubated.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urinary tract infection
Clinical narrative: Patient received monovalent Pfizer COVID vaccine on 1/15/22 (lot # FJ1614), 2/11/22 (lot # FJ1614), 8/22/22 (lot # FW1331), and bivalent Pfizer COVID vaccine on 11/9/22 (lot # GJ3277). On 11/21/22, patient was intubated in the field and admitted to our CCU with acute respiratory failure with hypoxia in the setting of COVID-19 pneumonia and bilateral bacterial pneumonia superinfection or aspiration, septic shock, UTI, and thrombocytopenia. As of today (11/28/22), patient is still in CCU intubated.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Arthralgia, Swelling face, Urticaria
Clinical narrative: Hives for 6 weeks, anaphylaxis reaction 3 weeks after shot, joint pain, facial swelling. I have taken steroids for the past 3 weeks and the hives have shown back up after completion of steroids.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Abdominal X-ray, Asthenia, Central venous catheterisation, Chest X-ray, Computerised tomogram head
Clinical narrative: Admitted 11/21/2022 from ED to ICU with at least 1 week history of severe weakness with frequent falls associated with lower extremity weakness in particular.  Mostly having proximal muscle weakness.  She is now weak to the point that she requires assistance of 2 people to get into a wheelchair.  She has had 4 falls at home over the past 48 hours.  She was intubated 11/25 and remains intubated in ICU at this time.  She received 5 doses of IVIG.  She is on day 5 of antibiotics.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Electrocardiogram, Endotracheal intubation, Fall, Immunoglobulin therapy, Intensive care
Clinical narrative: Admitted 11/21/2022 from ED to ICU with at least 1 week history of severe weakness with frequent falls associated with lower extremity weakness in particular.  Mostly having proximal muscle weakness.  She is now weak to the point that she requires assistance of 2 people to get into a wheelchair.  She has had 4 falls at home over the past 48 hours.  She was intubated 11/25 and remains intubated in ICU at this time.  She received 5 doses of IVIG.  She is on day 5 of antibiotics.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Wheelchair user
Clinical narrative: Admitted 11/21/2022 from ED to ICU with at least 1 week history of severe weakness with frequent falls associated with lower extremity weakness in particular.  Mostly having proximal muscle weakness.  She is now weak to the point that she requires assistance of 2 people to get into a wheelchair.  She has had 4 falls at home over the past 48 hours.  She was intubated 11/25 and remains intubated in ICU at this time.  She received 5 doses of IVIG.  She is on day 5 of antibiotics.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral, Mobility decreased, Sensory loss
Clinical narrative: Admitted 11/21/2022 from ED to ICU with at least 1 week history of severe weakness with frequent falls associated with lower extremity weakness in particular.  Mostly having proximal muscle weakness.  She is now weak to the point that she requires assistance of 2 people to get into a wheelchair.  She has had 4 falls at home over the past 48 hours.  She was intubated 11/25 and remains intubated in ICU at this time.  She received 5 doses of IVIG.  She is on day 5 of antibiotics.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Arrhythmia, Blood test, Computerised tomogram abdomen abnormal
Clinical narrative: Splenic Infarct - symptoms began after the second dose which I received 04/12/2021. I began bloating and having upper left side pain under my ribs starting 04/18/2021. I saw the nurse practitioner in Dr.'s office numerous times to complainant be examined. After insisting on a ct scan, it was discovered I had an of my spleen. I was admitted to the local Hospital on May 5, 2021 and discharged on May 7, 2021. I have been under the care of a hematologist since. My spleen has reduced in volume and there is scarring. I still have intermittent pain in my upper left quadrant. Despite numerous blood tests, genetic tests, scans, and x-rays, there has never been an explanation for my infarct. I have also developed an arrythmia and am under the care of a cardiologist as well as an electro-physiologist. I don't know when the arrythmia developed but it was sometime after the second dose and my time in the hospital.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Gene mutation identification test, Magnetic resonance imaging, Musculoskeletal chest pain, Scan
Clinical narrative: Splenic Infarct - symptoms began after the second dose which I received 04/12/2021. I began bloating and having upper left side pain under my ribs starting 04/18/2021. I saw the nurse practitioner in Dr.'s office numerous times to complainant be examined. After insisting on a ct scan, it was discovered I had an of my spleen. I was admitted to the local Hospital on May 5, 2021 and discharged on May 7, 2021. I have been under the care of a hematologist since. My spleen has reduced in volume and there is scarring. I still have intermittent pain in my upper left quadrant. Despite numerous blood tests, genetic tests, scans, and x-rays, there has never been an explanation for my infarct. I have also developed an arrythmia and am under the care of a cardiologist as well as an electro-physiologist. I don't know when the arrythmia developed but it was sometime after the second dose and my time in the hospital.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Scar, Spleen disorder, Splenic infarction, X-ray
Clinical narrative: Splenic Infarct - symptoms began after the second dose which I received 04/12/2021. I began bloating and having upper left side pain under my ribs starting 04/18/2021. I saw the nurse practitioner in Dr.'s office numerous times to complainant be examined. After insisting on a ct scan, it was discovered I had an of my spleen. I was admitted to the local Hospital on May 5, 2021 and discharged on May 7, 2021. I have been under the care of a hematologist since. My spleen has reduced in volume and there is scarring. I still have intermittent pain in my upper left quadrant. Despite numerous blood tests, genetic tests, scans, and x-rays, there has never been an explanation for my infarct. I have also developed an arrythmia and am under the care of a cardiologist as well as an electro-physiologist. I don't know when the arrythmia developed but it was sometime after the second dose and my time in the hospital.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Blood catecholamines normal, Catecholamines urine normal, Diagnostic procedure, Echocardiogram normal
Clinical narrative: Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram normal, Electromyogram normal, Fatigue
Clinical narrative: Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate abnormal, Heart rate decreased, Hypotension, Immediate post-injection reaction
Clinical narrative: Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Muscle twitching, Presyncope, Tachycardia, Tilt table test
Clinical narrative: Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Tremor, Ventricular tachycardia
Clinical narrative: Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Site of injection turned red on date of vaccination. A rash was noticable the next morning. The rash spread across and under the left arm, all the way across the left breast by 1pm the day after the vaccination. The rash lasted @ 10 days.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Cardiac stress test, Coronary arterial stent insertion, Coronary artery occlusion, Low density lipoprotein decreased
Clinical narrative: I had no cardiac  risk factors , very physically active,  extremely low LDL and developed coronary blockage requiring cardiac stent
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event from invalid pediatric dose of Hep A vaccine, no treatment required. Patient was 19 y/o
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Blepharitis, Condition aggravated, Erythema of eyelid, Eyelids pruritus, Swelling of eyelid
Clinical narrative: Next day 11/18/22 mom took him to ER. Eye lids reddish, swollen, itchy. Per ER doctor's report mom had given Claritin and he was improving. No other symptoms. He had L eye lid dermatitis on 11/17/22 which mom stated that he gets in winter. He had also vomited once on the way to clinic 11/17/22.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Contusion, Differential white blood cell count, Full blood count, Laboratory test normal, Rash
Clinical narrative: Rash on bilateral legs. Not quite petechial but more like small bruises under the skin. Non-tender, no nodules, and the lesions are confined to the lower extremities.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cardiac failure congestive, Cardiac pacemaker insertion, Cognitive disorder
Clinical narrative: After shot 1 - violent diarrhea, ill, confused after shot 2 - worse diarrhea, sick + weak, much congnitive impairment AFTER BOOSTER  ER Violent diarrhea, weakness, collapse afibrillation could not be controlled required pacemaker went into congestive heart failure - rapid decline-> died in hospice  Following pacemaker installation, patient went into rapid decline, was in and out of the ER and stayed in cardiac ICU repeatedly until she died in hospice on September 23, 2022 She had been strong and active, entirely independent, residing in an independent  living residence for active seniors. She went to the gym took exercise classes, had only intermittent afibrillation. Her 2nd Covid shot impacted her cognition. She did not recover. Very intelligent professional woman. Fully competent.. Following her booster shot the afib became uncontrollable in the heart hospital. She became disoriented and very sick. After the surgery she returned to normal cognition progressed well through her rehab but began to experience all the symptoms of congestive heart failure from which she died.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Death, Diarrhoea, Disorientation
Clinical narrative: After shot 1 - violent diarrhea, ill, confused after shot 2 - worse diarrhea, sick + weak, much congnitive impairment AFTER BOOSTER  ER Violent diarrhea, weakness, collapse afibrillation could not be controlled required pacemaker went into congestive heart failure - rapid decline-> died in hospice  Following pacemaker installation, patient went into rapid decline, was in and out of the ER and stayed in cardiac ICU repeatedly until she died in hospice on September 23, 2022 She had been strong and active, entirely independent, residing in an independent  living residence for active seniors. She went to the gym took exercise classes, had only intermittent afibrillation. Her 2nd Covid shot impacted her cognition. She did not recover. Very intelligent professional woman. Fully competent.. Following her booster shot the afib became uncontrollable in the heart hospital. She became disoriented and very sick. After the surgery she returned to normal cognition progressed well through her rehab but began to experience all the symptoms of congestive heart failure from which she died.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, General physical health deterioration, Intensive care, Laboratory test
Clinical narrative: After shot 1 - violent diarrhea, ill, confused after shot 2 - worse diarrhea, sick + weak, much congnitive impairment AFTER BOOSTER  ER Violent diarrhea, weakness, collapse afibrillation could not be controlled required pacemaker went into congestive heart failure - rapid decline-> died in hospice  Following pacemaker installation, patient went into rapid decline, was in and out of the ER and stayed in cardiac ICU repeatedly until she died in hospice on September 23, 2022 She had been strong and active, entirely independent, residing in an independent  living residence for active seniors. She went to the gym took exercise classes, had only intermittent afibrillation. Her 2nd Covid shot impacted her cognition. She did not recover. Very intelligent professional woman. Fully competent.. Following her booster shot the afib became uncontrollable in the heart hospital. She became disoriented and very sick. After the surgery she returned to normal cognition progressed well through her rehab but began to experience all the symptoms of congestive heart failure from which she died.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Surgery, Syncope
Clinical narrative: After shot 1 - violent diarrhea, ill, confused after shot 2 - worse diarrhea, sick + weak, much congnitive impairment AFTER BOOSTER  ER Violent diarrhea, weakness, collapse afibrillation could not be controlled required pacemaker went into congestive heart failure - rapid decline-> died in hospice  Following pacemaker installation, patient went into rapid decline, was in and out of the ER and stayed in cardiac ICU repeatedly until she died in hospice on September 23, 2022 She had been strong and active, entirely independent, residing in an independent  living residence for active seniors. She went to the gym took exercise classes, had only intermittent afibrillation. Her 2nd Covid shot impacted her cognition. She did not recover. Very intelligent professional woman. Fully competent.. Following her booster shot the afib became uncontrollable in the heart hospital. She became disoriented and very sick. After the surgery she returned to normal cognition progressed well through her rehab but began to experience all the symptoms of congestive heart failure from which she died.
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Muscle contracture
Clinical narrative: Per patient statement on the day of vaccination, she had a sore right arm localized to shot area with shoulder pain and gradually had gotten to the point were it is hard to move arm around and painful at the site. No visual swelling. Upon movements feels like contractions to the muscles. No warmth to right arm. Denies fever/chills. No erythema. Denies nausea or vomiting. Denies headaches or dizziness. She states she does not plan to see PCP/Urgent Care or ER.
Age: 94.0
Sex: M
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine adjuvant Fluad Quadrivalent 0.5 ml GTIN: (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 LOT (10): 312866
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine Adjuvant Fluad Quadrivalent 0.5ml GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml  GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine adjuvanted Fluad Quadrivalent 0.5ml GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza vaccine Adjuvanted Fluad Quadrivalent 0.5ml GTIN (01): 0037046112103 SN (21): 3PWARB8CDF EXP (17: June 30, 2022 LOT (10): 312866
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml GTN (01): 00370461121034 SN (21): 3PWARBCDF EXP (17): June 30, 2022 LOT (10): 312866
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered
Clinical narrative: Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5 ml  GTIN (01): 00370461121034 SN (21): 3PWARB5CDF EXP (17): June 30, 2022 Lot (10): 312866
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Hypoaesthesia oral, Lip swelling, Paraesthesia, Swelling face
Clinical narrative: Client reports waking up at 6:45am the day after receiving the Pfizer booster @ approx 3:15pm. States that she went to brush her teeth and when she looked in the mirror, she noticed that both of her lips and jaw/cheeks were swollen. Other symptoms included numbness of both lips and some difficulty swallowing. Client call at approx 9:30am on 11/15/22 to report symptoms, at which time, she was advised to notify and be seen by her PCP. At the time she called, she said that the swelling had improved but she continued to have numbness in both lips with some tingling sensations described as the numbness wearing off after a dental appointment. Denies any difficulty breathing, tongue or throat swelling. Spoke with client on 11/17/22. Per client she was advised to take Tylenol by her PCP. Reported that she continued to have numbness in in lower lip. Client presented to clinic 11/21/22 for and stated that she continues to have numbness in her mid-lower lip.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: HOSPITALIZATION
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Groin pain, Herpes zoster, Impaired work ability
Clinical narrative: Right neck pain after a couple of days, right flank and groin pain a week which kept getting worse, rash on the right thigh on 11/17/2022. Rash worsenend in the next couple of days with pain in the right chest and mid and low back. Some improvement in 3 to 4 days for 1 to 2 days but then worsening with bunring, tightness and skin sensitivity on the right side from the neck down which has persisted. Pain is moderate to severe.  Had to postpone the travel plans for 11/22/22 to 11/28/2022 but since pain still intense, had to cancel the trip.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle strain, Neck pain, Skin sensitisation
Clinical narrative: Right neck pain after a couple of days, right flank and groin pain a week which kept getting worse, rash on the right thigh on 11/17/2022. Rash worsenend in the next couple of days with pain in the right chest and mid and low back. Some improvement in 3 to 4 days for 1 to 2 days but then worsening with bunring, tightness and skin sensitivity on the right side from the neck down which has persisted. Pain is moderate to severe.  Had to postpone the travel plans for 11/22/22 to 11/28/2022 but since pain still intense, had to cancel the trip.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Burning sensation, Chest pain, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: Right neck pain after a couple of days, right flank and groin pain a week which kept getting worse, rash on the right thigh on 11/17/2022. Rash worsenend in the next couple of days with pain in the right chest and mid and low back. Some improvement in 3 to 4 days for 1 to 2 days but then worsening with bunring, tightness and skin sensitivity on the right side from the neck down which has persisted. Pain is moderate to severe.  Had to postpone the travel plans for 11/22/22 to 11/28/2022 but since pain still intense, had to cancel the trip.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flank pain, Groin pain, Laboratory test, Loss of personal independence in daily activities, Neck pain
Clinical narrative: Right neck pain after a couple of days, right flank and groin pain a week which kept getting worse, rash on the right thigh on 11/17/2022. Rash worsenend in the next couple of days with pain in the right chest and mid and low back. Some improvement in 3 to 4 days for 1 to 2 days but then worsening with bunring, tightness and skin sensitivity on the right side from the neck down which has persisted. Pain is moderate to severe.  Had to postpone the travel plans for 11/22/22 to 11/28/2022 but since pain still intense, had to cancel the trip.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash, Sensitive skin
Clinical narrative: Right neck pain after a couple of days, right flank and groin pain a week which kept getting worse, rash on the right thigh on 11/17/2022. Rash worsenend in the next couple of days with pain in the right chest and mid and low back. Some improvement in 3 to 4 days for 1 to 2 days but then worsening with bunring, tightness and skin sensitivity on the right side from the neck down which has persisted. Pain is moderate to severe.  Had to postpone the travel plans for 11/22/22 to 11/28/2022 but since pain still intense, had to cancel the trip.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Roughly 6 minutes after my vaccine I had a tingling pepper feeling in my mouth on my tongue/roof of mouth.   By 10 minutes my throat felt tight and sore, swallowing became painful and by 15 minutes I had hives on my neck. I went back into  the pharmacy and they administered 50mg of Benadryl and we discussed using my Epi Pen but decided to wait.  I had some difficulty swallowing the water and medication.   At 250pm I was allowed to go home with instructions for care. At 330  the hives had spread to my whole chest and neck as well as my upper back . My cheeks were red and puffy looking and all my red skin felt hot.   20 mg of Preenisone was recommended once I got home at Benadryl was given at 6:30pm and again at 1030pm at the direction of my pharmacist. Hives resolved but the resurfaced a few time, along with the near constant  pain in the throat a still apparent at 1245am.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysphagia, Erythema, Odynophagia, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Roughly 6 minutes after my vaccine I had a tingling pepper feeling in my mouth on my tongue/roof of mouth.   By 10 minutes my throat felt tight and sore, swallowing became painful and by 15 minutes I had hives on my neck. I went back into  the pharmacy and they administered 50mg of Benadryl and we discussed using my Epi Pen but decided to wait.  I had some difficulty swallowing the water and medication.   At 250pm I was allowed to go home with instructions for care. At 330  the hives had spread to my whole chest and neck as well as my upper back . My cheeks were red and puffy looking and all my red skin felt hot.   20 mg of Preenisone was recommended once I got home at Benadryl was given at 6:30pm and again at 1030pm at the direction of my pharmacist. Hives resolved but the resurfaced a few time, along with the near constant  pain in the throat a still apparent at 1245am.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Swelling face, Throat tightness, Urticaria
Clinical narrative: Roughly 6 minutes after my vaccine I had a tingling pepper feeling in my mouth on my tongue/roof of mouth.   By 10 minutes my throat felt tight and sore, swallowing became painful and by 15 minutes I had hives on my neck. I went back into  the pharmacy and they administered 50mg of Benadryl and we discussed using my Epi Pen but decided to wait.  I had some difficulty swallowing the water and medication.   At 250pm I was allowed to go home with instructions for care. At 330  the hives had spread to my whole chest and neck as well as my upper back . My cheeks were red and puffy looking and all my red skin felt hot.   20 mg of Preenisone was recommended once I got home at Benadryl was given at 6:30pm and again at 1030pm at the direction of my pharmacist. Hives resolved but the resurfaced a few time, along with the near constant  pain in the throat a still apparent at 1245am.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 01-SEP-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, lot number W002601 which was determined to be a valid lot number with expiration date: 24-JAN-2024, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided) (product storage error).   The temperature excursion occurred for 1 hours (h), 45 minutes (min). It was reported that there was a previous temperature excursion.   No additional adverse events (AE) were reported.; Sender's Comments:  US-009507513-2210USA001064:
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional Ae; Pharmacist called to report that MMR II vaccine was administered via IM route rather than SC route to 48 year old patient on 11/16/22.; Pharmacist called to report that MMR II vaccine was administered via IM route rather than SC route to 48 year old patient on 11/16/22.; This spontaneous report has been received from a pharmacist, referring a 48-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications were not provided.  On 16-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection 0.5 milliliter once (strength, lot number, and expire date were not reported) (product administered to patient of inappropriate age) indicated as prophylaxis.  The measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) vaccine was administered via intramuscular rather than subcutaneously (incorrect route of product administration).   No additional adverse events were reported.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Peripheral swelling, Rash, Skin discolouration, Swollen tongue
Clinical narrative: HCP states that this specific patient experienced swelling of her arm,; an arm rash; bruise-like discoloration of whole arm; This patient also reported experiencing tongue swelling.; This spontaneous report has been received from a pharmacist, referring to a 79-year-old female patient. The patient's medical history, concurrent conditions,  and concomitant medications were not provided.  On 17-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscular injection (lot number W021636 has been verified to be a valid lot number, expiry date 01-OCT-2023) (strength, and frequency were not reported) indicated as prophylaxis.  On an unknown date, the patient  experienced swelling of her arm (peripheral swelling), an arm rash (rash) and bruised like discoloration of whole arm, not just the injection site (skin discolouration). The patient also reported experiencing tongue swelling (swollen tongue). The reporter states that the patient sought medical attention on 18-NOV-2022  The outcome of the events was reported as recovering.  The causality assessment was reported as unknown.; Sender's Comments:  US-009507513-2211USA006955:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified (senior) age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. The cause of death was unknown. The date of death was not reported. It was unknown whether an autopsy was performed. Reporter stated that, "I knew healthy people, one senior who died shortly after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221152742, 20221152749 and 20221152816.; Sender's Comments: V0: 20221152669- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Monovalent vaccine administered instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Oct-2022 at 4:24 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related and WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) to have an unknown relationship.    Concomitant products were not provided. Treatment medication were not reported.  The gave Monovalent vaccine instead of bivalent booster to a patient. Patient was informed and they will come back in 2 months to get the correct Moderna Bivalent booster dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-677171, US-MODERNATX, INC.-MOD-2022-662852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-677171:same reporter, US-MODERNATX, INC.-MOD-2022-662852:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Ear pain, Headache, Inappropriate schedule of product administration, Infection
Clinical narrative: THROAT SWELL UP; low energy; Infection; Lingering Nasal congestion; Earache; Sore lymph nodes; Severe headaches; Rashes; Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion) and EAR PAIN (Earache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021). On an unknown date, the patient experienced PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion), EAR PAIN (Earache), LYMPH NODE PAIN (Sore lymph nodes), HEADACHE (Severe headaches) and RASH (Rashes). At the time of the report, PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion), EAR PAIN (Earache), LYMPH NODE PAIN (Sore lymph nodes), HEADACHE (Severe headaches), RASH (Rashes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter  On unknown date(s), the patient experienced Humira pen Misfired/malfunction in tip.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of earaches, infections, lingering nasal congestion, rashes, severe headaches, sore lymph nodes, throat swell up and low energy with Moderna COVID-19 vaccine was reasonable possibility.   No treatment medication was provided by the reporter.