chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: mild bleeding at injection site and mild swelling at site. happened right after vaccination and patient was fine soon after when he left the pharmacy and he had no concerns
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: bivalent was administered for 2nd dose in primary series
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna Bivalent vaccine.  Patient's age at time of administration was 13, the authorized age for the vaccine is 18 and older.   At time of VAERS reporting, no adverse effects have been reported.
Age: 69.0
Sex: M
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: COVID vaccine administered was the Pfizer Pediatric COVID vaccine instead of the Pfizer Bivalent Booster vaccine. Pt has been advised to come back and receive the correct vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Large local cutaneous reaction to vaccinations on left thigh. No evidence of infection currently. Prescription for Keflex sent. Discussed heat and massage per Dr.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: COVID Vaccine administered was the Pfizer Pediatric COVID vaccine instead of the Pfizer Bivalent Booster vaccine. Pt has been advised to come back and receive the correct vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, FLUR4, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: COVID Vaccine administered was the Pfizer Pediatric COVID vaccine instead of the Pfizer Bivalent Booster vaccine. Pt has been advised to come back and receive the correct vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: PER MOM:  RASH, PAIN, ITCHY, AND RASH ON ARMS LEGS AND STOMACH X5 DAYS
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: THE PATIENT WAS TO START THEIR FIRST IN THE SERIES OF THE PFIZER COVID 19VACCINE..THE MONOVALENT. PT RECEIVED THE BIVALENT AS THEIR FIRST DOSE IN THE SERIES.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: patient under 65
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema
Clinical narrative: Red arm
Age: 29.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Vaccination error
Clinical narrative: Missed wheal on left arm, RN was successful on right arm
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia
Clinical narrative: Patient received her flu vaccine at 12:56 pm and around 7 pm, she started experiencing uncontrolled jerking of her hands and legs. She took 500 mg  tylenol and rested for a little while; she thinks she feel asleep around midnight after feeling comfortable.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: large swelling mass to injection site with redness, pain and intense itching mass spread down arm the next day with redness and itching
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Lethargy, SARS-CoV-2 test
Clinical narrative: Very Tired, Lethargic, Cough
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Constant, pounding headache upper left quadrant of skull for months.  Deep fatigue.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for a first dose and received a Bivalent Booster vaccine.  Pfizer has been notified. According to CDC guidelines with Pfizer Bivalent no repeat dose is necessary. Patient should return for the second dose  with the monovalent Pfizer
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Moderna  bivalent dose(09/16/2022) given only 1 month after the last moderna booster dose (08/11/2022) patinet was notified 1 hour after the shot and was  not experiencing any side effects except sore arm.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Wrong technique in product usage process
Clinical narrative: Missed wheel - left forearm success in R forearm
Age: 0.25
Sex: M
Vaccine: HIBV, UNK
Symptoms: Crying, Irritability, Pyrexia, Restlessness, Sleep disorder
Clinical narrative: The second vaccine was a pneumococcal conjugate but the nurse failed to write down which form of the vaccine he received on his vaccine card.  Pt. was very fussy from the time we got back home and for the rest of the day. He ran a fever of 101 at 12:30pm for which I gave Tylenol and the fever returned at 6pm which I treated with Tylenol again. The only time he has stopped crying is when I can get him to nurse or when he can fall asleep for an hour or so. He is very restless and waking up frequently. It is now 9pm and he has fallen asleep in the bath with mom. We are unsure how the night will progress, but plan to monitor his fever closely.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pt called started vomiting 4 hours after vaccination and had to go to er, where they gave her lots of anti nausea meds. she is doing well the day after.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Pt was not sure what booster he needed and upon enquiring  confirmed it's Covid booster, he received a Covid booster, just to realize later it should have been TDAP booster.
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLUC4, TDAP
Symptoms: Chills, Death, Fatigue, Pain
Clinical narrative: Provider was contacted by third party claiming to be family member of patient stating the day after vaccination, on September 15, 2022, patient complained of fatigue, chills and body aches.  Later that same day patient was found deceased in his car.  Cause of death is unknown to Provider at this time.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Labour induction
Clinical narrative: I didn't know I was pregnant when getting the vaccine. Roughly 2-3 week pregnant when getting the first dose. The due date early but baby was born by induction. The baby was born missing one toe of the right foot. Other wise the baby is developing fine.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Administered Bivalent Vaccine to 11 year old
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Aspiration, Biopsy kidney abnormal, Brain injury, Cardiac failure acute
Clinical narrative: My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Death, Dialysis, Electroencephalogram
Clinical narrative: My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemorrhage, Laboratory test, Magnetic resonance imaging
Clinical narrative: My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Renal tubular necrosis, Respiratory distress, Resuscitation, Syncope
Clinical narrative: My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion, Vomiting
Clinical narrative: My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site rash, Pruritus, Skin irritation
Clinical narrative: Rashes around the injection site, irritation and itchy, symptoms began on Tuesday 9/20/2022.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Severe full body urticaria dermatographia  not responding to antihistamine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Injection site pain, SARS-CoV-2 test positive
Clinical narrative: Again, I don't think it was a reaction to the booster. I think it was an unfortunate timing, that I contracted Covid at the same time as the booster.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have any adverse events or outcome.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal discomfort
Clinical narrative: patient had tickle in throat and started coughing.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac flutter, Electrocardiogram abnormal, Full blood count
Clinical narrative: I had my 6-month regular checkup with Dr on Jan.21, 2021. My blood pressure was around 120/70 as It had been consistently for several years (never high).  Two days later I received my first Pfizer vaccine injection & then 28 days later my second Pfizer injection. During the next two months I began to notice swelling in my feet and lower legs. There were no medical issues during that same time that I know of. I made an appointment with Dr on April 22, 2021 to see what what going on. That's when he discovered my atrial fibrillation. I consulted Dr, cardiologist with Cardiology Specialists on July 21, who referred me to another dr, their electro physiologist after consulting with him on  October 6, 2021 he scheduled me for a cardiac ablation which was performed at hospital on November 9, 2021. The ablation was very successful and have experienced no more Afib episodes since that time. Before the ablation  in I had extensive symptoms, heart fluttering and in  shoulders and neck high blood pressure, inability to sleep in bed (spent many nights in chair). Symptoms were not predictable. Sometimes they lasted as long as 25 hours. I experienced none of this until after I received my first two Pfizer vaccine injections.  I believe it was not coincidental that these unexpected symptoms occurred within two months of the injections.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Insomnia, International normalised ratio, Metabolic function test
Clinical narrative: I had my 6-month regular checkup with Dr on Jan.21, 2021. My blood pressure was around 120/70 as It had been consistently for several years (never high).  Two days later I received my first Pfizer vaccine injection & then 28 days later my second Pfizer injection. During the next two months I began to notice swelling in my feet and lower legs. There were no medical issues during that same time that I know of. I made an appointment with Dr on April 22, 2021 to see what what going on. That's when he discovered my atrial fibrillation. I consulted Dr, cardiologist with Cardiology Specialists on July 21, who referred me to another dr, their electro physiologist after consulting with him on  October 6, 2021 he scheduled me for a cardiac ablation which was performed at hospital on November 9, 2021. The ablation was very successful and have experienced no more Afib episodes since that time. Before the ablation  in I had extensive symptoms, heart fluttering and in  shoulders and neck high blood pressure, inability to sleep in bed (spent many nights in chair). Symptoms were not predictable. Sometimes they lasted as long as 25 hours. I experienced none of this until after I received my first two Pfizer vaccine injections.  I believe it was not coincidental that these unexpected symptoms occurred within two months of the injections.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Prothrombin time
Clinical narrative: I had my 6-month regular checkup with Dr on Jan.21, 2021. My blood pressure was around 120/70 as It had been consistently for several years (never high).  Two days later I received my first Pfizer vaccine injection & then 28 days later my second Pfizer injection. During the next two months I began to notice swelling in my feet and lower legs. There were no medical issues during that same time that I know of. I made an appointment with Dr on April 22, 2021 to see what what going on. That's when he discovered my atrial fibrillation. I consulted Dr, cardiologist with Cardiology Specialists on July 21, who referred me to another dr, their electro physiologist after consulting with him on  October 6, 2021 he scheduled me for a cardiac ablation which was performed at hospital on November 9, 2021. The ablation was very successful and have experienced no more Afib episodes since that time. Before the ablation  in I had extensive symptoms, heart fluttering and in  shoulders and neck high blood pressure, inability to sleep in bed (spent many nights in chair). Symptoms were not predictable. Sometimes they lasted as long as 25 hours. I experienced none of this until after I received my first two Pfizer vaccine injections.  I believe it was not coincidental that these unexpected symptoms occurred within two months of the injections.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have any adverse events or outcome.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have any adverse events or outcome
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have any adverse events or outcome.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: monovalent COVID-19 vaccine was administered as a booster shot instead of a bivalent. Patient did not have an adverse event or outcome.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent COVID-19 vaccine was administered as a booster shot instead of abivalent. Patient did not having an adverse event or outcome.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Monovalent COVID-19 Vaccine was administered as a booster shot instead of a bilavent. Patient did not have any adverse events or outcome.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache Chills, headache Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache, Myalgia, Fever, Swelling at injection site along with red, hot welt,  chills, tiredness.  Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pyrexia, Urticaria
Clinical narrative: Headache, Myalgia, Fever, Swelling at injection site along with red, hot welt,  chills, tiredness.  Narrative:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Swelling in left axilla.  Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Narrative: Headache, Myalgia, Fever, Swelling, Chills, tiredness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Narrative: Headache, Myalgia, Fever, Swelling, Chills, tiredness.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Narrative: Headache Tiredness & achenes in right arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Narrative: Headache, Myalgia, Fever & Nausea Vomiting, Tenderness right axillary lymph nodes. Lymph nodes are swollen and "puffy"
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Narrative: Headache, Myalgia, Fever & Nausea Vomiting, Tenderness right axillary lymph nodes. Lymph nodes are swollen and "puffy"
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain Narrative: The chest pain felt like a muscle pull on left side of chest  according to the employee. She text her PCP who recommended that she go to the urgent care/hospital to be assessed.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Headache, Fever, Diarrhea & NauseaVomiting  Narrative: Chills, Fever of 100.3 on 9/25/21.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, Diarrhea & NauseaVomiting  Narrative: Chills, Fever of 100.3 on 9/25/21.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Peripheral swelling, Rash, Swelling
Clinical narrative: Headache, Myalgia & Rash Narrative:  Swelling left hand. Glands in neck swollen. The swelling in her neck was still present on 9/27/21.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Musculoskeletal pain, Pain
Clinical narrative: Angina  Chest pain radiated down arm and shoulder blade for one evening and 2 full days  Narrative:
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: Patient received the covid booster (bivalent) Moderna  on 9/19/22 ,  then his blood pressure went up on 9/20/22 .  Patient saw MD,   MD increased the  dose of Losartan and will follow up in in 2 weeks.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea
Clinical narrative: Narrative:  90 YOM with family history of VTE and personal history of lymphoma (followed every 6 months by oncology in 2021, no current therapy in October 2021) developed idiopathic DVT and Saddle PE, diagnosed 11 days after his first Moderna COVID-19 vaccine booster given on 9/17/2021, but wife notes that symptoms started within 2-3 days after booster. Patient was admitted to MICU after he presented to ED with leg pain, chest pain and dyspnea. He was treated with enoxaparin and was switched to Eliquis for discharge. Date of discharge summary 10/18/2021. Patient continues Eliquis 5mg PO BID. Sonogram 9/1/22 shows improved clot burden.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST-T segment abnormal, Intensive care, Pain in extremity, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Narrative:  90 YOM with family history of VTE and personal history of lymphoma (followed every 6 months by oncology in 2021, no current therapy in October 2021) developed idiopathic DVT and Saddle PE, diagnosed 11 days after his first Moderna COVID-19 vaccine booster given on 9/17/2021, but wife notes that symptoms started within 2-3 days after booster. Patient was admitted to MICU after he presented to ED with leg pain, chest pain and dyspnea. He was treated with enoxaparin and was switched to Eliquis for discharge. Date of discharge summary 10/18/2021. Patient continues Eliquis 5mg PO BID. Sonogram 9/1/22 shows improved clot burden.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Venous occlusion
Clinical narrative: Narrative:  90 YOM with family history of VTE and personal history of lymphoma (followed every 6 months by oncology in 2021, no current therapy in October 2021) developed idiopathic DVT and Saddle PE, diagnosed 11 days after his first Moderna COVID-19 vaccine booster given on 9/17/2021, but wife notes that symptoms started within 2-3 days after booster. Patient was admitted to MICU after he presented to ED with leg pain, chest pain and dyspnea. He was treated with enoxaparin and was switched to Eliquis for discharge. Date of discharge summary 10/18/2021. Patient continues Eliquis 5mg PO BID. Sonogram 9/1/22 shows improved clot burden.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: Narrative: Patient presented to ED on 09/07/2022 with chief complaint of pain with deep breathing. No fever. Relevant past medical history includes asthma. Admitted and started on dexamethasone 6mg IV daily and remdesivir 200mg followed by 100mg IV daily.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Narrative:  Patient presented from home to ED on 09/07/2022 with chief complaint of increased dyspnea and tachycardia. Tested positive for COVID on 09/01/2022. Treated with acetylcysteine 3mL neb Q8hrs, dexamethasone 6mg IV daily, and remdesivir 100mg daily.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Respiratory failure
Clinical narrative: Narrative: Moderna #2 2/8/21 Moderna #1 3/9/21 reported minor MI, CHF, resp failure, covid pneumonia, 94 years, multiple comorbidities home with hospice/comfort care
Age: 56.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pyrexia
Clinical narrative: Narrative: Patient experienced 5 days of fever with the other above mentioned symptoms
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Inflammatory marker test, Oropharyngeal pain, Spirometry
Clinical narrative: Narrative:  Patient's COVID hospitalization did not require treatment for COVID itself. Monitoring O2 sat, spirometry, and trending inflammatory markers. Patient given throat spray for sore throat pain.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Asthenia, COVID-19, Flank pain, Haematuria, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient, moderna x 3, +covid while in ER of hematuria, weak, history of bladder cancer, flank pain. Given remdesivir, asymptomatic, room air. d/c home.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, Fall, Muscle spasms, Muscular weakness
Clinical narrative: Narrative: Facility-COVID +, Moderna #4, leg weakness, pain, fall, leg cramps, dec appetite, no treatment for covid, asymptomatic, myopathy, statin d/c
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myopathy, Pain, SARS-CoV-2 test positive
Clinical narrative: Narrative: Facility-COVID +, Moderna #4, leg weakness, pain, fall, leg cramps, dec appetite, no treatment for covid, asymptomatic, myopathy, statin d/c
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Narrative:  was sent to ER due to allergic reaction wheals/urticaria to the covid shot
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Narrative: Patient reported to primary care provider on 9/15/22 experienced a vaccine SE one year ago when received moderna vaccine. Patient received one dose of moderna on 9/20/21; then reported to provider one year later experienced lower leg numbness / tingling within 15 minutes after receiving the vaccine. Patient refuses additional COVID vaccinations and did not seek medical care after experiencing the potential SE a year ago; resolved.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster  dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead  of FDA approved bivalent booster. No adverse effects.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Respiratory failure
Clinical narrative: Narrative:  Patient received three doses of Moderna COVID-19 vaccine on 4/1/21, 4/27/21, and 11/30/21. Patient was transferred from emergency department on 8/19/2022 due to COVID-19 infection causing acute-on-chronic hypoxemic respiratory failure. Patient's wife tested positive for COVID recently. In hospital, received treatment with remdesivir.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead of FDA approved bivalent booster No adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm  pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022131400   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comment: The patient self-reported this case. The reporter did not wish to provide demographic or health care professional information. The patient received dose of Shingrix vaccine and experienced arm pain that eventually resolved.  The patient had given medical disclaimer The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose refer case US2022131400.; Sender's Comments:  US-GSK-US2022131400:Same reporter
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Cannot lift arm; Arm pain/Pain described sounds exclusively musculoskeletal; This spontaneous case was retrieved on 31-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0892293-1), reported by other healthcare professional and concerned a 78-year-old, female patient.  The patient's concurrent conditions included diabetes and foot/ankle pain. The patient's concomitant medications included ibuprofen, lisinopril, metformin, Aspirin (acetylsalicylic acid), Trulicity (dulaglutide) all used for an unreported indication. The patient had no known allergies.  On 21-Oct-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine inact sag 3v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 279734. (reported batch number was identified by Seqirus to be linked to suspect product Fluad (TIV) instead of reported suspect product Fluad Quadrivalent).  On the same date, after receiving Fluad (TIV) the patient experienced severe arm pain, and the patient could not lift her arm. The pain described sounded exclusively musculoskeletal. There were no signs or symptoms of allergic reaction reported.  At the time of the initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 78-year-old female patient developed arm pain and decreased mobility on the same day after vaccination with Fluad (TIV). Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A 78-year-old female patient developed arm pain and decreased mobility on the same day after vaccination with Fluad (TIV). Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Immune Thrombocytopenia; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  It was unknown that whether this blood disorder is related to the COVID vaccine.  No Treatment medication were reported.  One day after receiving first dose of Moderna vaccine, patient woke up with bruises on her arms and legs, and blsiters that bled inside her mouth. She was hospitalized that day, Jan 19, with a severe case of Immune Thrombocytopenia.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 72-year-old female patient, with no reported medical history, experienced medically significant event of Immune Thrombocytopenia that required hospitalization one day after receiving first dose of mRNA-1273  vaccine. Symptoms included bruises on her arms and legs, and blood blisters in her mouth. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A 72-year-old female patient, with no reported medical history, experienced medically significant event of Immune Thrombocytopenia that required hospitalization one day after receiving first dose of mRNA-1273  vaccine. Symptoms included bruises on her arms and legs, and blood blisters in her mouth. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.            No Concomitant and Treatment drug was provided by reporter.   Patient was hospitalized in February and spent nearly three days in the ICU, but returned to work.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Live Follow-up received and does not contain any new information; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 30-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Myocarditis, which occurred after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Patient was hospitalized and spent nearly 3 days in the intensive care unit. No information disclosed about diagnostic tests performed or treatments received. He has already returned to work. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Mobility decreased, Seizure
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (seizure) and ANAPHYLACTIC REACTION (anaphylaxis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant) and MOBILITY DECREASED (disruption of mobility). At the time of the report, SEIZURE (seizure), ANAPHYLACTIC REACTION (anaphylaxis) and MOBILITY DECREASED (disruption of mobility) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Swelling of throat and tongue were subsumed under Anaphylaxis. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. After receiving Moderna vaccine, within 20 minutes, patient presented events. The patient received ambulatory intervention then ER support for approximate 6 hours. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in. Company comment: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and, within 20 minutes after vaccination, experienced anaphylactic reaction with swelling of tongue an throat, followed by disruption of mobility then seizure (AES). Patient required ambulatory intervention then ER support for approximately 6 hours. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and, within 20 minutes after vaccination, experienced anaphylactic reaction with swelling of tongue an throat, followed by disruption of mobility then seizure (AES). Patient required ambulatory intervention then ER support for approximately 6 hours. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hormone level abnormal, Intermenstrual bleeding, Menstruation irregular, Weight increased
Clinical narrative: Menstrual cycle started nearly two weeks early; hormonal issues; cycle coming too early with spotting; weight gain; extreme pain over pancreas since; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual cycle started nearly two weeks early), HORMONE LEVEL ABNORMAL (hormonal issues), INTERMENSTRUAL BLEEDING (cycle coming too early with spotting), WEIGHT INCREASED (weight gain) and ABDOMINAL PAIN UPPER (extreme pain over pancreas since) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Epilepsy.   On 17-Mar-2021 at 9:00 AM, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual cycle started nearly two weeks early), HORMONE LEVEL ABNORMAL (hormonal issues), INTERMENSTRUAL BLEEDING (cycle coming too early with spotting), WEIGHT INCREASED (weight gain) and ABDOMINAL PAIN UPPER (extreme pain over pancreas since). At the time of the report, MENSTRUATION IRREGULAR (Menstrual cycle started nearly two weeks early), HORMONE LEVEL ABNORMAL (hormonal issues), INTERMENSTRUAL BLEEDING (cycle coming too early with spotting), WEIGHT INCREASED (weight gain) and ABDOMINAL PAIN UPPER (extreme pain over pancreas since) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Hormone level abnormal: abnormal. On 18-Mar-2021, Weight increased: increased.   No concomitant medications were reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was does not diagnosed with COVID-19 Prior to vaccination.  The patient does not test for COVID-19 since had vaccination.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.