chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Renal transplant, Spinal X-ray normal, Urinary tract infection
Clinical narrative: Subject prior to receiving study medication: (Janssen ad26.CoV2. vaccine) subject during their clinical annual follow up post kidney transplant visit on 9/26/2022, subject complained of progressively worsening fatigue and weakness as well as worsening lower extremity edema. Subject was sent to the Emergency Department for work up. Subject had been recently diagnosed with a UTI and prescribed a 10-day course of ciprofloxacin. A chest x-ray was done 9/26/2022 in the Emergency department and showed signs of worsening pulmonary edema. He was administered 40 mg of IV Lasix and had a good urine output (-2.6 L during this admissions). Subject spent 1 night at the hospital when he did not have any acute events. Notably, no shortness of breath, chest pain, palpitations, fever or chills. He had a few episodes of hypertension that were controlled with his home antihypertensive regimen. We were concerned for prostate cancer recurrence because of his worsening back pain and hypercalcemia. An x-ray of the lumbar spine was done and did not show any signs of focal lesions. PSA was also measured. Subject was discharged on 9/27/2022 with diagnosis of Nonrheumatic Aortic Valve Stenosis Upon discharge, the patient was stable clinically and hemodynamically. He had no signs of dyspnea, chest pain, palpitations or other worrisome symptoms. Subject has history of aortic valve stenosis, fatigue and weakness, prostate cancer, diabetes mellitus type 2, hyperlipidemia, pulmonary edema, rheumatoid arthritis, dysphagia, spondylosis. Causality by P.I. is not related to study medication
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood thyroid stimulating hormone increased, Dizziness, Electrocardiogram abnormal
Clinical narrative: Subject with recent complicated hospitalization 8/23/2022 - 9/21/022 for bilateral pulmonary embolism requiring heparin drip with right IJ thrombus (not removed) complicated by mesenteric hematoma, atrial fibrillation during this hospitalization. Patient medical history consists of: BPH, bilateral renal cell carcinoma, kidney transplant 2013, Graft failure 2022, Hypertension, bilateral pleural effusions, Hypothyroidism, hematuria, covid19 August 2022. Subject presented to the emergency department on 10/16/2022 due to 3 episodes of syncope at home. He described each episode similarly as him standing up from a seated position, not preceded by any prodrome. He blacked out for a few moments before regaining consciousness. ECG in the ED revealed frequent premature atrial contractions in a pattern of atrial bigeminy. After the episodes he is not had any neurologic or extremity weakness. After the fall he said he laid down a bit but felt dizzy. He still feels dizzy since this morning and had a low blood pressure in the morning. He denies fevers/chest pain/palpitations/abdominal pain. During this hospitalization, his metoprolol was increased from 25 mg daily to twice daily, with improvement to atrial contractions. The syncopal episodes were suspected to be secondary to orthostatic hypotension due to hypovolemia. Nephrology was consulted for management of his dialysis regimen. He was also found to have a TSH of 80. Endocrinology was consulted and the patient was started on IV levothyroxine for 2 days with good response, and subsequently transitioned to oral. 10/18/2022 Subject feeling well and was discharged to home with instructions to continue his medications including metoprolol succinate 25 mg twice daily, furosemide 80 mg daily, apixaban 5 mg twice daily, continue hemodialysis as per usual routine and follow up with endocrinology as an outpatient. Causality per study site P.I. is not related to study medication.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hypotension, Hypovolaemia, Jugular vein thrombosis, Loss of consciousness
Clinical narrative: Subject with recent complicated hospitalization 8/23/2022 - 9/21/022 for bilateral pulmonary embolism requiring heparin drip with right IJ thrombus (not removed) complicated by mesenteric hematoma, atrial fibrillation during this hospitalization. Patient medical history consists of: BPH, bilateral renal cell carcinoma, kidney transplant 2013, Graft failure 2022, Hypertension, bilateral pleural effusions, Hypothyroidism, hematuria, covid19 August 2022. Subject presented to the emergency department on 10/16/2022 due to 3 episodes of syncope at home. He described each episode similarly as him standing up from a seated position, not preceded by any prodrome. He blacked out for a few moments before regaining consciousness. ECG in the ED revealed frequent premature atrial contractions in a pattern of atrial bigeminy. After the episodes he is not had any neurologic or extremity weakness. After the fall he said he laid down a bit but felt dizzy. He still feels dizzy since this morning and had a low blood pressure in the morning. He denies fevers/chest pain/palpitations/abdominal pain. During this hospitalization, his metoprolol was increased from 25 mg daily to twice daily, with improvement to atrial contractions. The syncopal episodes were suspected to be secondary to orthostatic hypotension due to hypovolemia. Nephrology was consulted for management of his dialysis regimen. He was also found to have a TSH of 80. Endocrinology was consulted and the patient was started on IV levothyroxine for 2 days with good response, and subsequently transitioned to oral. 10/18/2022 Subject feeling well and was discharged to home with instructions to continue his medications including metoprolol succinate 25 mg twice daily, furosemide 80 mg daily, apixaban 5 mg twice daily, continue hemodialysis as per usual routine and follow up with endocrinology as an outpatient. Causality per study site P.I. is not related to study medication.
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric haematoma, Orthostatic hypotension, Pulmonary embolism, Supraventricular extrasystoles, Syncope
Clinical narrative: Subject with recent complicated hospitalization 8/23/2022 - 9/21/022 for bilateral pulmonary embolism requiring heparin drip with right IJ thrombus (not removed) complicated by mesenteric hematoma, atrial fibrillation during this hospitalization. Patient medical history consists of: BPH, bilateral renal cell carcinoma, kidney transplant 2013, Graft failure 2022, Hypertension, bilateral pleural effusions, Hypothyroidism, hematuria, covid19 August 2022. Subject presented to the emergency department on 10/16/2022 due to 3 episodes of syncope at home. He described each episode similarly as him standing up from a seated position, not preceded by any prodrome. He blacked out for a few moments before regaining consciousness. ECG in the ED revealed frequent premature atrial contractions in a pattern of atrial bigeminy. After the episodes he is not had any neurologic or extremity weakness. After the fall he said he laid down a bit but felt dizzy. He still feels dizzy since this morning and had a low blood pressure in the morning. He denies fevers/chest pain/palpitations/abdominal pain. During this hospitalization, his metoprolol was increased from 25 mg daily to twice daily, with improvement to atrial contractions. The syncopal episodes were suspected to be secondary to orthostatic hypotension due to hypovolemia. Nephrology was consulted for management of his dialysis regimen. He was also found to have a TSH of 80. Endocrinology was consulted and the patient was started on IV levothyroxine for 2 days with good response, and subsequently transitioned to oral. 10/18/2022 Subject feeling well and was discharged to home with instructions to continue his medications including metoprolol succinate 25 mg twice daily, furosemide 80 mg daily, apixaban 5 mg twice daily, continue hemodialysis as per usual routine and follow up with endocrinology as an outpatient. Causality per study site P.I. is not related to study medication.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Condition aggravated, Eosinophilic granulomatosis with polyangiitis, Fear, Sinus congestion
Clinical narrative: Took Prevnar 23 vaccine. Within two days I had tremendous sinus clogging and sharp stomach pain. These symptoms correspond with my EGPA (diagnosed incidentally some time after have a myriad of life threatening and strange symptoms post taking Prevnar 13 in 2017). I've been on mepolizomab and have had virtually no symptoms for years until 2 days after taking the Prevnar 23 vaccine. I took 35 mg prednisone and within a day the symptoms abated. Prednisone is the medication my physicians prescribed for me in emergency situations with EGPA symptoms. Needless to say, the symptoms are so different from other things I've experienced and so unique that I know when the EGPA is acting up. I don't know if the link to the Prevnar vaccines is casual but this is not the second time. It's odd and scary.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, General physical health deterioration, Laboratory test
Clinical narrative: date above is approximate. received Lymerix, had 50% energy/health after,; took many years of treatments to get to 85 % energy/health approximate date above. I have all medical records from time of vaccine given before/after
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Angioedema, Dysphagia, Salivary hypersecretion, Swollen tongue
Clinical narrative: Narrative: 22yF with a hx of bipolar disorder and PTSD who presented to the ED with hypersalivation and tongue swelling for the past 1.5 weeks. Pt reported receiving hep B vaccine 1.5 weeks ago and since that time has experienced hypersalivation and tongue swelling every night after taking latuda. Symptoms resolve after a period of hours (wakes up without symptoms). She reported some difficulty swallowing due to tongue swelling but no hives, stridor, difficulty breathing, or other signs of anaphylaxis. She expressed concern this was related to hep B vaccine, though symptoms have been consistently temporally associated with taking her pm lurasidone. Per chart review, dose was increased to 60mg July 3rd and from last psychiatry note 8/31/22 she was tolerating it well without side effects. She has been otherwise stable from a psychiatric perspective. her other medications include tylenol, famotidine prn for gerd, sronyx and medroxyprogesterone inj q3 months. No recent changes to these medications. On review of possible adverse reactions, does appear there have been cases of angioedema (<1%) and reports of tongue edema on postmarketing. Unclear whether this is related to lurasidone but given the high potential medical risk associated with tongue swelling and apparent association of her symptoms with lurasidone doses, would recommend stopping the mediation.  Symptoms: Symptoms: 1. Angioedema
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Condition aggravated, Relapsing-remitting multiple sclerosis
Clinical narrative: Biogen Vumerity-Welcome call was completed. Patient indicated she has relapsing remitting MS. Medication dosing, titration, and schedule discussed w/ patient. Informed patient that if taken with food, avoid taking Vumerity with a high-fat, high calorie meal or snack. Meal or snack should contain no more than 700 calories and no more than 30 g of fat. Reviewed importance of proper storage, side effect management and addressed patient questions and concerns. Advised that Vumerity can affect WBC and liver enzymes and the importance of Lymphocyte monitoring every 6 months per label recommendation. Reviewed medication and allergy list. Patient reported change from Tecfidera due to insurance payment. Allergic to Pfizer covid vaccine- was hospitalized for 6 days. Adverse event survey completed.
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Chest pain, Death, Myocardial infarction
Clinical narrative: My mother took the Pfizer vaccine on 08/28/2021 and complained about chest pains a few days after. It got so painful that she contacted EMS on 9/03/2021 and was transported to the emergency room at Hospital for chest pains. She was released later on that day but the pains persist. On the day of 9/04/2021 my mother was found in her bedroom deceased. I had an examination performed on her body and it was found that she passed away due to a heart attack. My mother has never had any heart conditions before, she was vaccinated and not even a week later she was found dead.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received co-administration of Menveo and Flulaval vaccines. After standing up and walking, patient fainted. Immediately after fainting, patient was responsive, although patient stated she was light-headed and dizzy. Patient caregiver requested calling EMS even though patient was responsive. EMS arrived and assessed patient. Patient was not transported and left the pharmacy of their own accord.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fall, Loss of consciousness, Pallor, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt had a brief blackout, fainted-Severe, Additional Details: Patient stated he didn't like needles so he looked away, I gave the flu shot he was fine, but then after the Moderna shot, he went pale and fainted...and he went to sit but he slowly fell on the floor, he came to after about a minute and was able to sit in the chair.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt had a brief blackout, fainted-Severe, Additional Details: Patient stated he didn't like needles so he looked away, I gave the flu shot he was fine, but then after the Moderna shot, he went pale and fainted...and he went to sit but he slowly fell on the floor, he came to after about a minute and was able to sit in the chair.
Age: 67.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient describes a severe pain in the left arm starting the morning after injection that originally traveled down his elbow to his wrist and up to his neck. Neck and elbow have since resolved, but patient describes a current pain in the wrist, inability to move arm to shoulder height, unable to rotate arm around the shoulder joint, and a pain in the upper arm, still ongoing after 12 days
Age: 67.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Mobility decreased, Neck pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient describes a severe pain in the left arm starting the morning after injection that originally traveled down his elbow to his wrist and up to his neck. Neck and elbow have since resolved, but patient describes a current pain in the wrist, inability to move arm to shoulder height, unable to rotate arm around the shoulder joint, and a pain in the upper arm, still ongoing after 12 days
Age: 67.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Injection site nerve damage, Neck pain, Pain in extremity, Product administration error
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient describes a severe pain in the left arm starting the morning after injection that originally traveled down his elbow to his wrist and up to his neck. Neck and elbow have since resolved, but patient describes a current pain in the wrist, inability to move arm to shoulder height, unable to rotate arm around the shoulder joint, and a pain in the upper arm, still ongoing after 12 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid.   Congestion, fatigue, fever
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: I noticed a bad, inexplicable lower backache while traveling a week later, starting a familiar hotel with what I knew was a good mattress. From there, I?ve struggled with persistent lower back pain that doesn?t go away. My lifestyle hasn?t changed during this period.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Headache, Night sweats
Clinical narrative: 12/09/2022 I started coughing and had a tickle in my throat. I had been exposed to COVID. I started taking day time severe cold and flu. I tested and was negative. On 12/10/2022, I had a cough and headache and I tested positive that evening. I continued with a cough and headache. On 12/11/22 I also had night sweats. On 12/12/22, I began feeling better, had more energy, coughing less and a little congestion. I called my doctor on 12/12/22 and he said I sounded good, mild symptoms and gave me a prescription for PAXLOVID which I did not need to take. As long as I took my 1 tablet of severe cold and flu, I was good, my symptoms were gone. I had recovered by 12/13/22.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 12/09/2022 I started coughing and had a tickle in my throat. I had been exposed to COVID. I started taking day time severe cold and flu. I tested and was negative. On 12/10/2022, I had a cough and headache and I tested positive that evening. I continued with a cough and headache. On 12/11/22 I also had night sweats. On 12/12/22, I began feeling better, had more energy, coughing less and a little congestion. I called my doctor on 12/12/22 and he said I sounded good, mild symptoms and gave me a prescription for PAXLOVID which I did not need to take. As long as I took my 1 tablet of severe cold and flu, I was good, my symptoms were gone. I had recovered by 12/13/22.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: 5 pm began itching at nape of neck. By 8 pm I noticed itching  in crook of both elbows. By 9 pm I had rash on arms, legs, neck, trunk front and back. Took 2 benadryl capsules. Rash was mostly gone next day and I didn't take more benadryl until bedtime, 1 capsule. Rash persisted in patches on my upper abdomen, under breasts, for about 3 days.
Age: 1.08
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 13 month old due Dtap, polio on 12/14/22. Patient was given Kinrix instead of individual injections of each vaccine. Pt showed no adverse reactions post vaccination. Pt did not require any treatments. 12/15/22 called father with no answer. On 12/15/22 @ 1009 spoke with grandmother who reported child had no issues or negative outcomes, at 1140 spoke to child's father who reported child had no adverse reactions,
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event occurred. Patient had no reaction
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: fatigue, tiredness, body aches, soreness at injection site, headache, loss of appetite, nausea first pregnancy, expected due date June 2023
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pregnancy
Clinical narrative: fatigue, tiredness, body aches, soreness at injection site, headache, loss of appetite, nausea first pregnancy, expected due date June 2023
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 3/31/21, 4/29/21. Positive on 12/15/22
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/12/21, 5/3/21, 1/8/22. Positive on 12/18/22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 3/3/21, 3/31/21, 12/16/21, 8/3/22. Positive on 12/14/22
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lip oedema, Pruritus
Clinical narrative: PT. A 37 year old female which when completing the 15 minute wait in the observation area refers feeling of itching and edema in the upper lip which was observed when removing the mask. Vital signs within normal parameters. PT refers to being allergic to the above mentioned in the report .25mg of Benadryl P.O is administered according to medical order and observed for an additional 30 minutes.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Myalgia, Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding, anemia, joint and muscle aches
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cystitis, Urine analysis normal
Clinical narrative: 10/31/22 Cystitis day 5. Urinalysis showed no blood or bacteria this time.  11/16/21 - Previous Pfizer cystitis day 6  (without any anti-inflammatory pre-med) booster had hematuria 2/10/21 - Moderna left pleurisy with pleural effusion  day #5
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Magnetic resonance imaging, Rheumatoid arthritis, Systemic lupus erythematosus, Ultrasound scan
Clinical narrative: Amid the COVID series I was diagnosed with rheumatoid arthritis and later lupus.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I woke up with a head cold and did not think a thing about it because I have sinus issues. The next day I woke up feeling better but over the next few days sinus and congestion issues continued so on Tuesday November 22 2022 I tested for COVID-19 the result was positive.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anger, Cardiac ablation, Cardiac disorder, Confusional state
Clinical narrative: neurological event, instant memory loss confusion , couldnt remember basic this like how to get home, use phone, passwords, missing time, couldnt do job any more, she was nurse responsible to distribute meds to 50 patients, angry, frustration , had to quit job, later heart issues started within 2 months of 2nd shot, had cardiac dr, ablation therapy ,shortness of breath, tachycardia, rapid heart beat, dizziness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Frustration tolerance decreased, Heart rate increased, Impaired work ability
Clinical narrative: neurological event, instant memory loss confusion , couldnt remember basic this like how to get home, use phone, passwords, missing time, couldnt do job any more, she was nurse responsible to distribute meds to 50 patients, angry, frustration , had to quit job, later heart issues started within 2 months of 2nd shot, had cardiac dr, ablation therapy ,shortness of breath, tachycardia, rapid heart beat, dizziness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging head, Nervous system disorder, Tachycardia
Clinical narrative: neurological event, instant memory loss confusion , couldnt remember basic this like how to get home, use phone, passwords, missing time, couldnt do job any more, she was nurse responsible to distribute meds to 50 patients, angry, frustration , had to quit job, later heart issues started within 2 months of 2nd shot, had cardiac dr, ablation therapy ,shortness of breath, tachycardia, rapid heart beat, dizziness
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Patient reported swelling in right arm from elbow to wrist starting the day following Prevnar20 vaccination.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Patient reported small hive-like rashes down the entire left arm (arm that received the vaccine). The rashes were itchy, red, and blotchy.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient called pharmacy on 12/19/22 and informed that she experienced itching all over body ( stomach, both arm, legs )at in 5. am next morning  (12/16/22) so took some Benadryl and feeling better now ( almost 80 %) recovery
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Interchange of vaccine products
Clinical narrative: Client reported a mild CVA 2 weeks to the day from receiving the vaccine. She has received 4 covid vaccines 1/4/2021, 02/04/2021, 10/22/2021, 06/09/2022. All these where Moderna . The one on 11/29/2022 was the Pfizer Bivalent. Client was at the local Hospital and has not risk factors other than age.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: I developed a rash on my left breast that lasted nine weeks and spread to the entire breast
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Amnesia, Blood test, Dissociation, Disturbance in attention, Dizziness
Clinical narrative: Emergency Department 10/21/22 and 10/25/22 - Extreme Fatigue, Muscle Weakness, Light Headed, Muscle Spasms Ended up being diagnosed with Hypocalcemia. Symptoms mildly improved and then tapered off again. I no longer have the muscle spasms but my depression/anxiety medication has stopped working. I have taken this medication at a dose of 20mg for around 8 years and always been great on it. We have since increased the dosage to 40mg and still no effect. Extreme fatigue, concentration issues, memory loss, emotionless and numb.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Hypocalcaemia, Muscle spasms, Muscular weakness
Clinical narrative: Emergency Department 10/21/22 and 10/25/22 - Extreme Fatigue, Muscle Weakness, Light Headed, Muscle Spasms Ended up being diagnosed with Hypocalcemia. Symptoms mildly improved and then tapered off again. I no longer have the muscle spasms but my depression/anxiety medication has stopped working. I have taken this medication at a dose of 20mg for around 8 years and always been great on it. We have since increased the dosage to 40mg and still no effect. Extreme fatigue, concentration issues, memory loss, emotionless and numb.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test
Clinical narrative: Emergency Department 10/21/22 and 10/25/22 - Extreme Fatigue, Muscle Weakness, Light Headed, Muscle Spasms Ended up being diagnosed with Hypocalcemia. Symptoms mildly improved and then tapered off again. I no longer have the muscle spasms but my depression/anxiety medication has stopped working. I have taken this medication at a dose of 20mg for around 8 years and always been great on it. We have since increased the dosage to 40mg and still no effect. Extreme fatigue, concentration issues, memory loss, emotionless and numb.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: 11/05/22 presents to ED for "fatigue". PMHx of ". fib on Eliquis, HTN, HLD, CKD, kidney stones, hypothyroidism"
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Myalgia, Pyrexia
Clinical narrative: soreness at injection site,  muscle and joint aches, fever of 101
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PATIENT STATES ARM (SHOULDER) IS STILL HURTING AFTER THE INJECTION A MONTH AGO.
Age: 62.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Dizziness, Fatigue
Clinical narrative: I am feeling extremely tired and light headed.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state, Death, Fatigue, Feeling abnormal
Clinical narrative: Patient expressed that she felt bullied by PCP to take covid vax. Took vax around noon, and cousin called patient to check on her around 8pm. Patient expressed feeling very fatigued and wasn't feeling good. Mentioned feeling confused upon doing normal activities. Cousin (reporter) felt like things sounded wrong and was exhibiting symptoms. Patient normally sharp, but was shocked by the confusion. Patient was found dead in her recliner by midnight - stating from police that she was dead for hours. No autopsy, body was "donated to science". Found that she died from stroke.  Last person left in her immediate family.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Anaemia, Blood immunoglobulin A increased, Blood smear test abnormal, Blood test
Clinical narrative: 11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Differential white blood cell count abnormal, Full blood count abnormal, Gastrooesophageal reflux disease, Haemoglobin abnormal
Clinical narrative: 11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hepatic enzyme increased, Hepatitis viral test negative, Iron binding capacity total normal, Lipase abnormal, Liver function test abnormal
Clinical narrative: 11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Mononucleosis heterophile test negative, Pancreatic enzymes increased, Pyrexia, Renal function test abnormal
Clinical narrative: 11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Serum ferritin abnormal
Clinical narrative: 11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION ERROR: 17-YEAR-OLD FEMALE PATIENT RECEIVES SECOND DOSE OF MODERNA
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Worklist trigger for Covid.  Added to Covid log
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pollakiuria, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Two days after receiving the Moderna bivalent vaccine, I experienced a UTI. I do not get UTI's, so I was a bit shocked. The UTI started out with frequent urination, but it was not severe. On 12/14/2022, the UTI became severe. I never experienced any pain, but I did have to use the restroom every 5 minutes. I had a urinalysis completed on 12/14/2022 and was given antibiotics.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: It was discovered at teh end of the day on 12/12/2022 that the pfizer bivalent vaccine that was given was taken out of the fridge on 12/8/2022 at 8:55 AM. Vaccine was given on 12/12/2022 at 12:40PM. This was beyond the 12 hours that the vaccine was good for. Patient did not have a reaction at the time vaccine was given or 15 minutes following administration and has not reported reaction to the vaccine that was given.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid.  Added to Covid log
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Foreign travel, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: My wife and I were on an overseas trip we had received a prescription of Paxlovid from our PCP as prevention. On 11/01/22 I had a sore throat, that by 11/02/22 it started to get worse I tested on 11/03/22 with a home COVID-19 test that came back positive. I started taking the Paxlovid immediately. The first two days were the worst, then I started to feel better. By that Tuesday I was feeling much better.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Pt diagnosed with Covid.  Added to Covid log
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Death, Neurological symptom, Pneumonia aspiration
Clinical narrative: 6/8/22 pt hospitalized with aspiration pneumonia and positive for COVID, dc'd to SNF; 7/3/22 back to hospital with sx of stroke; dx with stroke; and still positive for COVID; family wants no aggressive measures, but does want pt to receive medical management; DNR; eventually changed status to comfort care and pt passed away in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 6/8/22 pt hospitalized with aspiration pneumonia and positive for COVID, dc'd to SNF; 7/3/22 back to hospital with sx of stroke; dx with stroke; and still positive for COVID; family wants no aggressive measures, but does want pt to receive medical management; DNR; eventually changed status to comfort care and pt passed away in the hospital
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION ERROR: 17-YEAR-OLD FEMALE PATIENT RECEIVES SECOND DOSE OF MODERNA.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received bivalent Covid vaccine as first dose in series instead of monovalent. No symptoms or adverse reactions
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: No reaction at all to the injection.   3 months later tested positive for covid.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abnormal, Ear pain, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Severe jaw, ear, throat, head pain, ringing in the ears
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in jaw, Tinnitus, Ultrasound scan abnormal, X-ray normal
Clinical narrative: Severe jaw, ear, throat, head pain, ringing in the ears
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest discomfort, Dyspnoea, Feeling abnormal, Impaired driving ability
Clinical narrative: I felt "speedy"  and had to stay seated after the shot.  I could not leave to drive. I felt breathless.  I went home and felt okay, but next day I woke   up feeling breathless all day.  That was on the 17th. On the 18th I felt pressure on my chest and I had to sit up.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Photophobia, Pyrexia
Clinical narrative: Fever, chills, fatigue, severe headache, sensitivity to light   Tried normal routes of Ibuprofen but did not help until I took Benadryl on 11/19/2022 which was the only thing that helped.  I took Pfizer the first 2 vaccines but it seems every time I get a booster my reaction is getting worse. At least no vomiting this time
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case   dose 1  Moderna  3/26/2021 018B21A dose 2  Moderna  4/23/2021  040B21A
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Biopsy muscle, Blood creatine phosphokinase increased, Blood test, Myositis
Clinical narrative: symptoms/tests: loss of strength, weight loss, high ck levels on blood test ~9000 diagnosis: Inflammatory myositis treatment: prednisone and azathioprine
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Weight decreased
Clinical narrative: symptoms/tests: loss of strength, weight loss, high ck levels on blood test ~9000 diagnosis: Inflammatory myositis treatment: prednisone and azathioprine
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was placed back into refrigerator and was given to this patient when arrived. No reported adverse reaction experienced.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was placed back into refrigerator and was given to this patient when arrived. No reported adverse reaction experienced.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Breast swelling, Muscle discomfort, Oedema peripheral
Clinical narrative: Patient states that she experience soreness and swelling under her right arm extending to her breast. She described that it felt almost like she pulled a muscle.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was placed back into refrigerator and was given to this patient when arrived. No reported adverse reaction experienced.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: There  was no adverse reaction just the wrong vaccine given. Pt was in for his second initial shot and received the  Bivalent shot instead of the Monovalent. Dr. was contacted by nurse and he educated that pt. would his second monovalent when he came in for his booster in 2 months.  Pt. has been difficult to reach to make him aware of this due to nurse being unable to get a hold of him . Nurse will keep trying to contact him to make him aware of this. incident report filled out and on file.
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  All Pfizer dose 1 1/18/21  EL1283 dose 2 2/8/21  EL9269 dose 3 8/26/21  FC3183 dose 4 4/4/22  FM0698
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: PT reports having ongoing shoulder stiffness and occasional ROM issues since vaccine administration x1 month ago
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Encephalopathy, Fall, General physical health deterioration
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 10/11/21, LOT #002C21A; 6/15/22 pt found to be positive for COVID in SNF; pt had been on hospice in facility; 6/23/22 pt admitted to hospital after a fall; laceration to left hand; encephalopathic; hospice revoked due to hospitalization; found to be positive for COVID; pt's condition worsened; admitted for GIP hospice; pt passed away in the hospital
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Skin laceration
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 10/11/21, LOT #002C21A; 6/15/22 pt found to be positive for COVID in SNF; pt had been on hospice in facility; 6/23/22 pt admitted to hospital after a fall; laceration to left hand; encephalopathic; hospice revoked due to hospitalization; found to be positive for COVID; pt's condition worsened; admitted for GIP hospice; pt passed away in the hospital
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer 5/11/21  EW0179
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen upper arm below injection site.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Tightness in chest, difficulty breathing, chest pain, elevated heart rate and blood pressure all stemming from an increase in size of the right hilar lymph nodes.  Began upon waking 12/06/2022.  Given antibiotics (augmentin BID #20) but pain and elevated heart rate persist as of 12/19/2022.  BP decreased to normal levels and tightness of chest decreased as well.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abnormal, Dyspnoea, Electrocardiogram, Epstein-Barr virus antibody positive, Heart rate increased
Clinical narrative: Tightness in chest, difficulty breathing, chest pain, elevated heart rate and blood pressure all stemming from an increase in size of the right hilar lymph nodes.  Began upon waking 12/06/2022.  Given antibiotics (augmentin BID #20) but pain and elevated heart rate persist as of 12/19/2022.  BP decreased to normal levels and tightness of chest decreased as well.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Pregnancy test negative, SARS-CoV-2 test negative
Clinical narrative: Tightness in chest, difficulty breathing, chest pain, elevated heart rate and blood pressure all stemming from an increase in size of the right hilar lymph nodes.  Began upon waking 12/06/2022.  Given antibiotics (augmentin BID #20) but pain and elevated heart rate persist as of 12/19/2022.  BP decreased to normal levels and tightness of chest decreased as well.
Age: 83.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid.  had Covid Vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast cancer female, Magnetic resonance imaging breast abnormal
Clinical narrative: Diagnosed with Breast cancer 12/15/21
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: PATIENT CALLED 12/19 STATING HE HAS RXN FROM FLU SHOT. HE STATED THAT SHOT WAS GIVEN BIT HIGH WITH LIMITED RANGE OF MOTION. HE MENTIONED THAT HE HAD BRUISING THIS MORNING THAT IS ABOUT 6 YO 8 CM DIAMETER. ADVISED HIM TO USE SOME ICE PACKS AND CALLED PCP TO FOLLOW UP. HE DID MENTIONED THAT IT'S GETTING BETTER AFTER FEW DAYS. PHARMACVIST ADVISED TO FOLLOW UP WITH PCP TO GET IT CHECKED OUT. PHARMACIST WILL DO A FOLLOW UP PHONE CALL 2 DAYS LATER.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, COVID-19, Dehydration, Mental status changes
Clinical narrative: Pt was diagnosed with COVID in the ER on 12/15 and placed on Paxlovid. Arrived to the ED today due to altered mental status and bradycardia. Admitted due to previous and COVID-19 as well as dehydration.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received monovalent instead of the intended Bivalent (pt has already received 3 injections of the primary - monovalent)  no adverse side effects known
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Contusion, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: 24 hours after, severe pain in arm and needed help to perform normal tasks. Just 12/12, visited hospital for COPD. Soreness to touch and bruising. Was told by NP to stop taking Eliquis. Bruising subsided eventually and light pain.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tenderness
Clinical narrative: 24 hours after, severe pain in arm and needed help to perform normal tasks. Just 12/12, visited hospital for COPD. Soreness to touch and bruising. Was told by NP to stop taking Eliquis. Bruising subsided eventually and light pain.
Age: 82.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, General physical health deterioration, SARS-CoV-2 test positive
Clinical narrative: pt in SNF due to Parkinson's Disease; poor prognosis; on hospice. 6/23/22 pt had a positive COVID test; placed in isolation; O2 supplementation via NC; antiviral medication given; pt's condition worsened and he passed away on hospice in the SNF
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Chest pain, Coronary arterial stent insertion, Myocardial infarction, Troponin
Clinical narrative: On 11/24/2022 I started having back and chest pain that came and went for 2 days. On 11/28/2022 I again started having chest and back pain. I went to the ER and was diagnosed with a myocardial infarction. I had a stent placed in the mid LAD.