chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound scan abnormal
Clinical narrative: Within 24 hours of receiving left deltoid COVID by Valent vaccine, developed tenderness and swelling around left deltoid but also posterior scapular area, subaxillary, teres minor, and pectoralis minor area.  On exam tender and swollen, no discrete lesion and no lymph nodes, left breast within normal limits.  Referred for ultrasound, which was performed on 11/17/2022, 48 hours after onset of symptoms.  This showed "nonspecific 2.8X 1.8 cm partially solid and 2.2 x 2.2 x 1.1 cm cystic and anechoic structure is noted in the area of clinical concern in the left axilla.  No typical lymph nodes are seen."  On telephone follow-up with patient on 11/28/2022, patient says that symptoms completely resolved and feels back to normal with no tenderness or swelling, with resolution a few days ago.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Patient arrived at vaccination tent to receive  influenza vaccination on 11/28/22. Administered  Fluzone 0.7mL to patients right deltoid at 12:20pm. After removing flu vaccination from patients arm,  patient reports the nurse expelled fluid onto the ground before discarding syringe into sharps container. The patient did not convey his concerns to anyone at the time, but after leaving, escalated his concerns. Upon further investigation, it was determined that patient did not receive entire dose of Fluzone Vaccination, and per instructions, patient was contacted and offered re-vaccination with FluZone.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Cough, Fatigue, Headache
Clinical narrative: I had vaccination on 05/31/2022. I started to have a bad headache on 09/24/2022 with a cough a low grade temperature achiness and feeling fatigued. I could hardly get out of bed. I tested COVID-19 positive on 09/26/2022. I started PAXLOVID on 09/26/2022 after conferring with my doctor. The medication made me nauseous and could only take for 2 days. I am currently feeling on 11/30/2022 much better.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, SARS-CoV-2 test positive
Clinical narrative: I had vaccination on 05/31/2022. I started to have a bad headache on 09/24/2022 with a cough a low grade temperature achiness and feeling fatigued. I could hardly get out of bed. I tested COVID-19 positive on 09/26/2022. I started PAXLOVID on 09/26/2022 after conferring with my doctor. The medication made me nauseous and could only take for 2 days. I am currently feeling on 11/30/2022 much better.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: pt came in for primary series 1st dose and was given bivalent pfizer for 1st dose instead of monovalent
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Vaccinator mistakenly administered fluarix to patient instead of covid 19 moderna 6-11 y/o bivalent booster.  patient's mother states he already has had flu shot this year.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Pt received the Pfizer covid19 booster injection on 11/25/2022. Pt arrived to 11/28/2022 with swelling of the face and a rash on her face, ears, arms, legs, and abdomen. Dr. was contacted and ordered 50mg of Benadryl. A prescription for Medrol Dose Pack was also prescribed.  To note, patient also received IV contrast for a fistulagram the same day they received the vaccine. As of 11/30 patient still has rash.  On PO Medrol.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood follicle stimulating hormone normal, Blood luteinising hormone normal, Blood oestrogen normal, Blood testosterone normal
Clinical narrative: No longer have a menstrual cycle which has continued to this date. Also experienced SOB and intense pains 2-3 inches left of the mediastinum and it felt like a constriction around my heart or just deep within my thoracic cavity. These pains lasted less than ten seconds in duration and happened several times per day for a few weeks. Received an EKG roughly one month later and the only abnormal finding was a flattened T wave.  No other vaccinations were received, no changes to medications, no changes in lifestyle, diet, stress, etc. My PCP has been concerned about the lack of menses and we have not found an apparent cause. CBC, metabolic panel, LH, FSH, estrogen, and testosterone are all within normal ranges and I'm at a healthy weight.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram T wave amplitude decreased, Full blood count normal
Clinical narrative: No longer have a menstrual cycle which has continued to this date. Also experienced SOB and intense pains 2-3 inches left of the mediastinum and it felt like a constriction around my heart or just deep within my thoracic cavity. These pains lasted less than ten seconds in duration and happened several times per day for a few weeks. Received an EKG roughly one month later and the only abnormal finding was a flattened T wave.  No other vaccinations were received, no changes to medications, no changes in lifestyle, diet, stress, etc. My PCP has been concerned about the lack of menses and we have not found an apparent cause. CBC, metabolic panel, LH, FSH, estrogen, and testosterone are all within normal ranges and I'm at a healthy weight.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal
Clinical narrative: No longer have a menstrual cycle which has continued to this date. Also experienced SOB and intense pains 2-3 inches left of the mediastinum and it felt like a constriction around my heart or just deep within my thoracic cavity. These pains lasted less than ten seconds in duration and happened several times per day for a few weeks. Received an EKG roughly one month later and the only abnormal finding was a flattened T wave.  No other vaccinations were received, no changes to medications, no changes in lifestyle, diet, stress, etc. My PCP has been concerned about the lack of menses and we have not found an apparent cause. CBC, metabolic panel, LH, FSH, estrogen, and testosterone are all within normal ranges and I'm at a healthy weight.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Cough, Malaise, Productive cough
Clinical narrative: I had a cold weeks before my vaccination then I got better. A day after my vaccination I started to get sick again. I got the same phlegm in my throat and cough that got worst. I went into the doctor, and she sent me to get a chest X-ray which was clear. She prescribed me prednisone and FLONASE. It has been up and down I still have the cough today.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Error occured when administering a dose of the pediatric vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered 28 mcg instead of the intended 10 mcg.  Patient/caregiver did not report any adverse events.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had received two monovalent COVID vaccines, which was documented in database but not the internal medical record. Patient received monovalent COVID vaccine, thought to be primary series, when he should have received bivalent as a booster
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Error occured when administering a dose of the vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered 28 mcg instead of the intended 10 mcg.  Patient/caregiver did not report any adverse events.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Flushing, Injection site rash
Clinical narrative: flush, faintness, weakness, dizziness, large rash at injection site x 4 days
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Feeling hot, Hyperhidrosis, Lethargy, Syncope
Clinical narrative: Patient fainted - he slumped to his left side, leaning on his companion.  He was lethargic for about 3 minutes, sweaty and hot.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Pain in Left shoulder, radiating down arm toward elbow. Decreased range of motion in Left shoulder, decreased strength in Left shoulder, numbness in fingers.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain
Clinical narrative: Pain in Left shoulder, radiating down arm toward elbow. Decreased range of motion in Left shoulder, decreased strength in Left shoulder, numbness in fingers.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Fungal test, Immunisation reaction, Mycobacterium test negative
Clinical narrative: Red, extremely itchy patches started within 2 weeks of injection on the arm the vaccine was injected in. Patches multiplied quickly. Started on left armpit, migrated to right armpit, abdomen, upper legs within 2 months. Bruised where spots were present. Scarred skin. 1 year later and patches are still persistent.  Treatment includes topical steroid (triamcinolone) prescribed by doctor.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Pathology test, Pruritus, Rash, Scar
Clinical narrative: Red, extremely itchy patches started within 2 weeks of injection on the arm the vaccine was injected in. Patches multiplied quickly. Started on left armpit, migrated to right armpit, abdomen, upper legs within 2 months. Bruised where spots were present. Scarred skin. 1 year later and patches are still persistent.  Treatment includes topical steroid (triamcinolone) prescribed by doctor.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: Red, extremely itchy patches started within 2 weeks of injection on the arm the vaccine was injected in. Patches multiplied quickly. Started on left armpit, migrated to right armpit, abdomen, upper legs within 2 months. Bruised where spots were present. Scarred skin. 1 year later and patches are still persistent.  Treatment includes topical steroid (triamcinolone) prescribed by doctor.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: patient states arm and shoulder are swollen and having trouble lifting arm up
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse administered Menveo too early.  After reviewing the chart, it appears the patient had a menveo at 11 years.  Due to an interface issue b/t systems, the immunization showed up as Meningococcal C.  When the nurse reviewed "immunizations due today" in system it showed that the patient was due for menveo.  The patient did not have a reaction to the vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer BioNtech Bivalent was given as the very first dose. No adverse event reported from the patient.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Hello. I had a localized rash at the injection site day after vaccine administration. The next day the rash increased in size to approximately 2.5 inches by 2.5 inches with swelling surrounding the area. Call place to pharmacy who advised antihistamine administration. Rash not gone by day 4 post vaccine but has not gotten worse.
Age: 91.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient's caregiver states that pt had already received the flu vaccine 2 weeks prior.  He was given an additional one on this day inadvertently.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: our CMA, gave a covid vaccine from yesterday that was in the refrigerator and was officially over the number of hours that it could be used. The mother was informed of the error, along the the physician.  Dr. explained the situation to both parents. We are reporting it to our company, Hospital through a Safety Scoop.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had received 3 doses of monovalent COVID vaccine already, which was documented but not the internal medical record. Patient received monovalent COVID vaccine as a booster when, per CDC recommendations, he should have received bivalent COVID vaccine.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Hyperhidrosis, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Shortly after patient received the vaccine, she became faint and felt slightly nauseous. The patient was seated and was unresponsive for just a few seconds. She began to sweat and we applied an ice pack to her neck. Patient remained seated for 15 minutes and then we took her blood pressure. Blood pressure read 180/80. She was counseled to go the emergency room. Patient and husband said they were going to go home.  I then counseled patient to contact her doctor
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had received primary series with a dose of Johnson and Johnson COVID vaccine. Per CDC recommendations, patient was eligible to receive COVID bivalent vaccine as a booster, but received Pfizer COVID monovalent vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Bone pain, Cardiac monitoring, Cardiac stress test, Chest pain
Clinical narrative: Within 8-9 hours of receiving the booster, the bones in my chest were ?on fire.? My sternum, ribs and spine. The pain was 8 out of 10?. Pretty severe?I was rocking back and forth in pain, tears in my eyes, groaning and gasping for breath. It lasted for several hours. The pain was gone in the morning. I did not seek medical care in the ER, but should have. I started having ?extra beats? and palpitations and occasional runs of arrhythmias, for several months. Then after a scary episode of my heart rate in the 120?s-130?s all day, and a couple months later of skipping every other heartbeat, I made an appointment with my Primary Care Physician. She ordered cardiac testing and referred me to a Cardiologist.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Extrasystoles, Heart rate irregular, Lacrimation increased
Clinical narrative: Within 8-9 hours of receiving the booster, the bones in my chest were ?on fire.? My sternum, ribs and spine. The pain was 8 out of 10?. Pretty severe?I was rocking back and forth in pain, tears in my eyes, groaning and gasping for breath. It lasted for several hours. The pain was gone in the morning. I did not seek medical care in the ER, but should have. I started having ?extra beats? and palpitations and occasional runs of arrhythmias, for several months. Then after a scary episode of my heart rate in the 120?s-130?s all day, and a couple months later of skipping every other heartbeat, I made an appointment with my Primary Care Physician. She ordered cardiac testing and referred me to a Cardiologist.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Moaning, Musculoskeletal chest pain, Palpitations, Spinal pain
Clinical narrative: Within 8-9 hours of receiving the booster, the bones in my chest were ?on fire.? My sternum, ribs and spine. The pain was 8 out of 10?. Pretty severe?I was rocking back and forth in pain, tears in my eyes, groaning and gasping for breath. It lasted for several hours. The pain was gone in the morning. I did not seek medical care in the ER, but should have. I started having ?extra beats? and palpitations and occasional runs of arrhythmias, for several months. Then after a scary episode of my heart rate in the 120?s-130?s all day, and a couple months later of skipping every other heartbeat, I made an appointment with my Primary Care Physician. She ordered cardiac testing and referred me to a Cardiologist.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Pt. had Pfizer Bivalent vaccine on 09/10/2022 and today was given Moderna Bivalent vaccine (11/30/2022). Pt. was monitored for 15 minutes and had no adverse reactions. Pt. stated that she did not receive any Bivalent booster vaccines.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC13, RV1, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given Tdap instead of Dtap. No reaction noted but report filed.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Nasal congestion, Nausea, SARS-CoV-2 test positive
Clinical narrative: Covid positive on 11/28/2022 with nasal congestion, sneezing, scratchy throat, nausea and started with nausea and diarrhea.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing, Throat irritation
Clinical narrative: Covid positive on 11/28/2022 with nasal congestion, sneezing, scratchy throat, nausea and started with nausea and diarrhea.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: On 01/04/2021 since I work at the hospital our boss told us to take COVID-19 test because one of my colleagues tested positive for COVID-19. When I took my test I was negative. I received my dose 1 on 01/05/2021. The next day on 01/06/2021, in the morning I had headaches, I was coughing along with dizziness, muscle aches, and fever. I had all the symptoms of COVID-19. I tested positive. After 2-3 days when my symptoms got worse I contacted my doctor she gave me medication and also advised me to go to the ER since I had Asthma. Along with the medication my doctor gave me I also took zinc and vitamin C. After few days I went to the ER because I was having hard time breathing. They gave me antibiotics and cough medications. It took me a long time to recover from COVID-19 infection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: On 01/04/2021 since I work at the hospital our boss told us to take COVID-19 test because one of my colleagues tested positive for COVID-19. When I took my test I was negative. I received my dose 1 on 01/05/2021. The next day on 01/06/2021, in the morning I had headaches, I was coughing along with dizziness, muscle aches, and fever. I had all the symptoms of COVID-19. I tested positive. After 2-3 days when my symptoms got worse I contacted my doctor she gave me medication and also advised me to go to the ER since I had Asthma. Along with the medication my doctor gave me I also took zinc and vitamin C. After few days I went to the ER because I was having hard time breathing. They gave me antibiotics and cough medications. It took me a long time to recover from COVID-19 infection.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt given 0.2 ml of UNDILULTED  Pfizer bivalent 5-11 yo injection.  No symptoms at time of VAERS reporting.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Eye pruritus, Ocular hyperaemia, Rash
Clinical narrative: RASH ON TORSO, ITCHY RED EYES. BENADRL TAKEN ORALLY
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received two doses of Ped Moderna 6mo to 4yrs. He received a 3rd dose and should not have since he is not immunocompromised. No adverse reaction happened.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: really sore arm  for several days
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expiration date of this unopened vial was 06/01/2023, however, the Beyond Use Date in the refrigerator was 11/19/22. The vaccine was given 48 hours after the Beyond Use Date.  I contacted the manufacturer and obtained information that states "The vaccine administered on November 21, 2022 from lot number 021H22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration".  However, they cannot guarantee vaccine given after the 30 day BUD received protection similar to what was seen in clinical trials. I contacted the patient after I obtained information from the manufacturer and informed her to call me if she has an adverse reaction that she believes can be attributed to the COVID vaccine. NO ADVERSE EVENT WAS REPORTED BY PATIENT AT THIS TIME.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt received Pfizer bivalent, after 10 minutes states that she is having tingling sensation in her right deltoids that irradiated to her hand. VS -68, 135/75, 98%.  around 12:45 pm pt states that tingling sensation is improving, but she is experiencing pain in her right arm 4/10.  12:53 pm pt states that she was feeling better. ED precautions given, pt verbalized understanding. Pt was discharged home.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: I went into the room with patient, her mother and sister. I did confirm with patients' mother that I would administer COVID boosters for both patients. The mother agreed. After administering both vaccines I had come back to my computer to chart.  I noticed at this point that only one of the patients (the sibling) needed the booster and that the doctor had ordered the original series of the covid vaccination for pt. I called the mother to inform her of what had transpired, and she understood.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Biopsy skin abnormal, Electromyogram abnormal, Impaired gastric emptying, Nerve conduction studies abnormal
Clinical narrative: acute onset Small Fiber Neuropathy, Disautonomia, Postural Orthostatic Tachycardia Syndrome, Gastroparesis (from SFN)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Small fibre neuropathy
Clinical narrative: acute onset Small Fiber Neuropathy, Disautonomia, Postural Orthostatic Tachycardia Syndrome, Gastroparesis (from SFN)
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Bells Palsy was the diagnosis, pain and numbness started a few hours after the vaccine in the arm and face
Age: 58.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dyskinesia, Needle issue, Underdose
Clinical narrative: At 8:58 am, injection attempt of 0.1 ml of Jynneos given intradermally in the right forearm resulted with the following incident: during injection of vaccine, client made a sudden jerk/startled movement which in turn resulted in the needle dislodging and approximately 1/2 of the vaccine dose not being administered. Wheal measured <3 mm, which is less than the requirement and remaining vaccine leaked out onto the vaccination table. Outcome: Client received the repeat dose of Jynneos Intradermally at 9:08 without incident.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Arm swelling at injection site leading to welt and Severe itchiness at injection site as well as chest and legs. Patient to follow up with primary care
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: no adverse reaction-patient received 1 dose of undiluted ped Pfizer bivalent which is equal to 1 dose of adult pfizer so no actual harm to patient
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: no adverse reaction-patient received 1 dose of undiluted ped Pfizer bivalent which is equal to 1 dose of adult pfizer so no actual harm to patient
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Dialysis, Impaired work ability, Intensive care
Clinical narrative: On September 20, 2022, I came down with symptoms that were confirmed to be COVID-19 by my home test. On day 9, I went into cardiac arrest due to a pulmonary embolism. I did not have any symptoms other than a slight sore throat. I was planning to go back to work the following Monday. My wife found me collapsed in the bathroom and we called the ambulance. I went into cardiac arrest in the emergency room. They did CPR for about 40 minutes. They administered TPA and my heart restarted. I was in ICU for four days under critical care. I was then in the hospital for an additional 2 weeks. As of today, I have no brain damage. I did have kidney failure while in the hospital and I am on dialysis two days a week.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pulmonary embolism, Renal failure, Resuscitation
Clinical narrative: On September 20, 2022, I came down with symptoms that were confirmed to be COVID-19 by my home test. On day 9, I went into cardiac arrest due to a pulmonary embolism. I did not have any symptoms other than a slight sore throat. I was planning to go back to work the following Monday. My wife found me collapsed in the bathroom and we called the ambulance. I went into cardiac arrest in the emergency room. They did CPR for about 40 minutes. They administered TPA and my heart restarted. I was in ICU for four days under critical care. I was then in the hospital for an additional 2 weeks. As of today, I have no brain damage. I did have kidney failure while in the hospital and I am on dialysis two days a week.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: On September 20, 2022, I came down with symptoms that were confirmed to be COVID-19 by my home test. On day 9, I went into cardiac arrest due to a pulmonary embolism. I did not have any symptoms other than a slight sore throat. I was planning to go back to work the following Monday. My wife found me collapsed in the bathroom and we called the ambulance. I went into cardiac arrest in the emergency room. They did CPR for about 40 minutes. They administered TPA and my heart restarted. I was in ICU for four days under critical care. I was then in the hospital for an additional 2 weeks. As of today, I have no brain damage. I did have kidney failure while in the hospital and I am on dialysis two days a week.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Gait disturbance, Peripheral swelling
Clinical narrative: hand swelling, burning sensation in shoulders. can barely walk
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient reported bruising and swelling at the site of injection on the left deltoid.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Pfizer booster given on 9/26/22. Admitted for new onset atrial fibrillation 11/26/22
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient had localized swelling around the injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Ankle fracture, Atrial fibrillation, COVID-19 pneumonia, Cardiac failure
Clinical narrative: Patient received Moderna COVID vaccine on 7/28/21 (lot # 033C21A), 9/10/21 (lot # 034C21A), and 4/7/22 (lot # 065K21A).  On 11/25/22, patient had a mechanical fall with syncopal episode. On 11/26/22, patient admitted to our inpatient facility (med/surg unit) s/p mechanical fall with acute hypoxic respiratory failure secondary COVID pneumonia and HFrEF, acute metabolic encephalopathy, afib with RVR, and left ankle fracture s/p mechanical fall 11/25. As of today (11/30/22), patient is still admitted in the med/surg unit.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fall, Metabolic encephalopathy, SARS-CoV-2 test positive, Syncope
Clinical narrative: Patient received Moderna COVID vaccine on 7/28/21 (lot # 033C21A), 9/10/21 (lot # 034C21A), and 4/7/22 (lot # 065K21A).  On 11/25/22, patient had a mechanical fall with syncopal episode. On 11/26/22, patient admitted to our inpatient facility (med/surg unit) s/p mechanical fall with acute hypoxic respiratory failure secondary COVID pneumonia and HFrEF, acute metabolic encephalopathy, afib with RVR, and left ankle fracture s/p mechanical fall 11/25. As of today (11/30/22), patient is still admitted in the med/surg unit.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Axillary pain, Oedema peripheral, Pain
Clinical narrative: Pain and swelling in my axillary area. It persisted for 3-4 days making it very uncomfortable and painful to use my left arm.
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Condition aggravated, Fatigue, Feeling hot, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Gave Fluarix injection. Gave Moderna Bivalent injection. Patient stated "I feel...." and slunk over front-wise as if fainting. I was there to hold her from falling out of her chair. Her arms then started to stiffen with her wrists bent backwards and had a seizure lasting about 10 to 15 seconds. When she came out of the seizure, she asked what had happened. She stated she was tired, and felt very warm. She wanted to lay on the floor as she thought she would feel better. Ambulance was called. Police officer arrived at the scene. Ambulance arrived later as the police officer accessed the situation. She was coherent and speaking with us, but very tired. She had texted a friend and the friend was able to drive her home after the ambulance crew evaluated her. She wanted to go home and stated that she would follow up with her primary doctor.
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Seizure
Clinical narrative: Gave Fluarix injection. Gave Moderna Bivalent injection. Patient stated "I feel...." and slunk over front-wise as if fainting. I was there to hold her from falling out of her chair. Her arms then started to stiffen with her wrists bent backwards and had a seizure lasting about 10 to 15 seconds. When she came out of the seizure, she asked what had happened. She stated she was tired, and felt very warm. She wanted to lay on the floor as she thought she would feel better. Ambulance was called. Police officer arrived at the scene. Ambulance arrived later as the police officer accessed the situation. She was coherent and speaking with us, but very tired. She had texted a friend and the friend was able to drive her home after the ambulance crew evaluated her. She wanted to go home and stated that she would follow up with her primary doctor.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: On Nov 28th, patient reported that his arm is still sore and he has pain lifting arm above the shoulder level.  Deep ache all the time since the vaccinations.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation
Clinical narrative: chest inflammation 2 days after vaccine. HA ever since received vaccine
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Dysphonia, Endoscopy abnormal, Hyperkeratosis, Speech disorder
Clinical narrative: Patient had to travel after the Vaccination. She travelled and by the time she landed there her voice became very hoarse. She visited the Physician  and found to have Keratotic Patch on her vocal chord (Bilateral). Patient is a non-smoker and has no known allergies. This started on 17th Nov, 2022 and within a week she lost the voice almost completely. the voice back. Physicians/Specialists are treating her with medications and have advised if situation remains same may need surgery. She still have the symptom and cannot talk. She doesn't have any other symptoms - no fever, no runny nose, no allergic conditions.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Arthralgia, Computerised tomogram head, Conjunctival oedema, Deafness neurosensory
Clinical narrative: In order of onset: scleral hemorrhage,  scleral chemosis, lower extremity edema, acute onset labrynthitis (vertigo, tinnitus, R ear sensorineural hearing loss), joint pain, worsening hypertension.  At this time, hearing loss is permanent
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Labyrinthitis, Magnetic resonance imaging head, Oedema peripheral, Ophthalmological examination
Clinical narrative: In order of onset: scleral hemorrhage,  scleral chemosis, lower extremity edema, acute onset labrynthitis (vertigo, tinnitus, R ear sensorineural hearing loss), joint pain, worsening hypertension.  At this time, hearing loss is permanent
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Scleral haemorrhage, Tinnitus, Vertigo
Clinical narrative: In order of onset: scleral hemorrhage,  scleral chemosis, lower extremity edema, acute onset labrynthitis (vertigo, tinnitus, R ear sensorineural hearing loss), joint pain, worsening hypertension.  At this time, hearing loss is permanent
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: All my life since my menstrual cycle started  had regular periods, and after the vaccine I went for a while without my periods and ,my periods became irregular, increasing  painful and heavy,
Age: 11.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain upper, Incorrect dose administered
Clinical narrative: On 11/3/2022 Pt received 0.3ml instead of 00.2ml of Covid vaccine. I called mom to inform her. She was thankful for the call stated that patient was fine that he complained of a stomachache but mom did not think related to vaccine. She thought s/s something he ate. No vomiting, no fever, no other symptoms. On 11/4/2022 follow up call mom referred pt was perfectly fine, went to school, slept well, ate well and went to school. she had no concerns.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Decreased appetite, Fatigue, Poor feeding infant, Vomiting
Clinical narrative: Mom reports pt. had one episode of vomiting after the vaccines. Then pt. had low appetite, refusing to breast feed. Took 2 oz. formula only for 12 hours. Pt was more tired than usual. Mom took pt. to ED for evaluation. Tylenol given at hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Agitation, Bradycardia, COVID-19, Cardiac arrest
Clinical narrative: Discharge Provider:  Primary Care Physician at Discharge:  Admission Date: 11/18/2022  COVID positive date 11/18/2022 PRESENTING PROBLEM: Heart failure [I50.9] Acute decompensated heart failure [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: 78 y.o. male with ESRD on HD, HTN, DM2, OSA, paroxysmal afib, chronic systolic and diastolic heart failure, and iCMP admitted on 11/18 with shortness of breath felt to be secondary to heart failure (EF 24% on echo this admission), medication non-compliance, and COVID. His medications were adjusted with good effect and he was awaiting discharge to a skilled nursing facility.    Last night, he was noted to be more restless, agitated, and combative. He was treated with Haldol and appeared to have bitten his tongue. This morning, he was noted to be unresponsive to sternal rub. Code was called, no palpable pulses so code was called. Multiple rounds of epi, bicarb, Mg, Ca, amio, and defib x 2 (see code note). Patient was transferred to ICU.    Lost pulses again and coded 3 additional times while family en route to bedside. Each time ROSC was obtained but patient became bradycardic and pulseless when epi pushes wore off. When family arrived, code status was changed to DNR. Patient developed bradycardia and then asystole. Pronounced at 10:35a with family at bedside.   Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Cardio-respiratory arrest, Cardioversion, Condition aggravated, Death
Clinical narrative: Discharge Provider:  Primary Care Physician at Discharge:  Admission Date: 11/18/2022  COVID positive date 11/18/2022 PRESENTING PROBLEM: Heart failure [I50.9] Acute decompensated heart failure [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: 78 y.o. male with ESRD on HD, HTN, DM2, OSA, paroxysmal afib, chronic systolic and diastolic heart failure, and iCMP admitted on 11/18 with shortness of breath felt to be secondary to heart failure (EF 24% on echo this admission), medication non-compliance, and COVID. His medications were adjusted with good effect and he was awaiting discharge to a skilled nursing facility.    Last night, he was noted to be more restless, agitated, and combative. He was treated with Haldol and appeared to have bitten his tongue. This morning, he was noted to be unresponsive to sternal rub. Code was called, no palpable pulses so code was called. Multiple rounds of epi, bicarb, Mg, Ca, amio, and defib x 2 (see code note). Patient was transferred to ICU.    Lost pulses again and coded 3 additional times while family en route to bedside. Each time ROSC was obtained but patient became bradycardic and pulseless when epi pushes wore off. When family arrived, code status was changed to DNR. Patient developed bradycardia and then asystole. Pronounced at 10:35a with family at bedside.   Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Ejection fraction decreased, Heart rate decreased, Intensive care, Pulse absent
Clinical narrative: Discharge Provider:  Primary Care Physician at Discharge:  Admission Date: 11/18/2022  COVID positive date 11/18/2022 PRESENTING PROBLEM: Heart failure [I50.9] Acute decompensated heart failure [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: 78 y.o. male with ESRD on HD, HTN, DM2, OSA, paroxysmal afib, chronic systolic and diastolic heart failure, and iCMP admitted on 11/18 with shortness of breath felt to be secondary to heart failure (EF 24% on echo this admission), medication non-compliance, and COVID. His medications were adjusted with good effect and he was awaiting discharge to a skilled nursing facility.    Last night, he was noted to be more restless, agitated, and combative. He was treated with Haldol and appeared to have bitten his tongue. This morning, he was noted to be unresponsive to sternal rub. Code was called, no palpable pulses so code was called. Multiple rounds of epi, bicarb, Mg, Ca, amio, and defib x 2 (see code note). Patient was transferred to ICU.    Lost pulses again and coded 3 additional times while family en route to bedside. Each time ROSC was obtained but patient became bradycardic and pulseless when epi pushes wore off. When family arrived, code status was changed to DNR. Patient developed bradycardia and then asystole. Pronounced at 10:35a with family at bedside.   Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness, SARS-CoV-2 test positive, Tongue biting, Treatment noncompliance, Unresponsive to stimuli
Clinical narrative: Discharge Provider:  Primary Care Physician at Discharge:  Admission Date: 11/18/2022  COVID positive date 11/18/2022 PRESENTING PROBLEM: Heart failure [I50.9] Acute decompensated heart failure [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: 78 y.o. male with ESRD on HD, HTN, DM2, OSA, paroxysmal afib, chronic systolic and diastolic heart failure, and iCMP admitted on 11/18 with shortness of breath felt to be secondary to heart failure (EF 24% on echo this admission), medication non-compliance, and COVID. His medications were adjusted with good effect and he was awaiting discharge to a skilled nursing facility.    Last night, he was noted to be more restless, agitated, and combative. He was treated with Haldol and appeared to have bitten his tongue. This morning, he was noted to be unresponsive to sternal rub. Code was called, no palpable pulses so code was called. Multiple rounds of epi, bicarb, Mg, Ca, amio, and defib x 2 (see code note). Patient was transferred to ICU.    Lost pulses again and coded 3 additional times while family en route to bedside. Each time ROSC was obtained but patient became bradycardic and pulseless when epi pushes wore off. When family arrived, code status was changed to DNR. Patient developed bradycardia and then asystole. Pronounced at 10:35a with family at bedside.   Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Peripheral swelling, Pruritus, Rash, Scratch
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Temporomandibular joint syndrome
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune system disorder, Pruritus
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Depression, Feeling abnormal, Herpes zoster
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypotension, Immune system disorder, Insomnia, Pruritus
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Visual impairment, Vitamin B12, Vitamin B12 deficiency, Weight decreased
Clinical narrative: SEVERE ITCHING; IMMUNE SYSTEM ALSO BREAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe itching, and immune system also break. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe itching and immune system also break was not reported. This report was non-serious.