chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer vaccine administered in error instead of the Bivalent Booster
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent Pfizer vaccine was administered in error instead of the Bivalent Booster dose
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Monovalent Pfizer dose given in error instead of the Bivalent Booster
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Pain in extremity
Clinical narrative: Patient presented to pharmacy to receive the COVID19 adult bivalent Moderna booster vaccine. The pharmacist preparing the vaccine drew up the incorrect vaccination, instead administering the pediatric monovalent Moderna vaccine to the patient. The patient reported that he experienced a sore arm following the vaccination that resolved on 12/05/22, but no other symptoms at this time. Patient did not have a primary care provider for followup, and upon discussion with the pharmacy manager agreed to return to pharmacy in 2 months after the time of the incorrect monovalent administration to receive the correct bivalent formulation.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Hearing aid therapy, Tinnitus
Clinical narrative: As I got the vaccine, I noticed ringing in my ear and I thought it would be a temporary thing. It didn't go away and it's been almost 3 years now. A year in, I went to see an audiologist. I also went to get hearing aids because I couldn't hear what people were saying in the background. The audiologist did notice some hearing loss. Some days are a lot worse than others. It's pretty constant and I can't avoid it. I did notice it got worse every time I took a Moderna vaccination. I did take a Pfizer vaccine in between these Moderna doses and there didn't seem to be a change. I just know that prior to these vaccinations, I did not have any ringing in my ears.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: Pain cold headache sore throat
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Incorrect product formulation administered, Pain in extremity, Underdose
Clinical narrative: Patient presented to pharmacy for the COVID19 adult bivalent booster vaccine. The pharmacist preparing the vaccination drew up an incorrect vaccine, the pediatric monovalent Moderna booster, and administered it to the patient. The error was discovered on 12/05/22 when pharmacy manager returned from weekend off and found the incorrect vial on the counter. The patient was contacted to discuss the incident. The patient stated that he had been experiencing weakness and fatigue since 12/04/22 that had been persisting to present, and a sore arm that resolved on 12/06/22. After discussing options with patient, the patient stated that he would return 2 months following the administration of the incorrect monovalent vaccine to receive the correct bivalent vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Neuropathy peripheral, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 11/04/2022. I have a history of Neuropathy. Forty eight hours after vaccination I had a flare-up that has yet to go away as of 12/06/2022. The Neuropathy has spread to all of my toes ankles and feet. I saw my nurse practitioner mid November 2022. She recommended TYLENOL acupuncture. I cannot get in to referral to neurologist until 02/2023. I did have COVID-19 positive in 06/2022.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Back pain, Balance disorder, COVID-19, Chills
Clinical narrative: On November 15, 2022, I had severe stomach pain and lower back pain. I had diarrheas, nausea vomiting and chills, cough, headache, dizziness, restlessness and loss of balance. I visited the doctor at urgent care on 11/22/2022 I was prescribed ondansetron. Emergency room on 11/23/2022 and the I was prescribed dicyclomine. These symptoms began to fade on Friday, 11/25/2022. As of today, I am not 100 percent recovered.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: On November 15, 2022, I had severe stomach pain and lower back pain. I had diarrheas, nausea vomiting and chills, cough, headache, dizziness, restlessness and loss of balance. I visited the doctor at urgent care on 11/22/2022 I was prescribed ondansetron. Emergency room on 11/23/2022 and the I was prescribed dicyclomine. These symptoms began to fade on Friday, 11/25/2022. As of today, I am not 100 percent recovered.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Restlessness, SARS-CoV-2 test positive, Vomiting
Clinical narrative: On November 15, 2022, I had severe stomach pain and lower back pain. I had diarrheas, nausea vomiting and chills, cough, headache, dizziness, restlessness and loss of balance. I visited the doctor at urgent care on 11/22/2022 I was prescribed ondansetron. Emergency room on 11/23/2022 and the I was prescribed dicyclomine. These symptoms began to fade on Friday, 11/25/2022. As of today, I am not 100 percent recovered.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: ADULT DOSE GIVEN TO PEDIATRIC PATIENT
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac disorder, Palpitations, Panic attack
Clinical narrative: this was my 4th shot. 2nd booster. I had all the usual symptoms but this time I also experienced heart issues, racing heart, almost like a panic attack. I almost called 911 but decided to first do some yoga deep breathing to slow down my heart. this even scared me so much I will not be taking any more boosters
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Cardiac function test, Computerised tomogram, Dyspnoea
Clinical narrative: Received booster on Sat and on Sunday felt funny, slightly  sob. Thought I was getting an infection, drove to my daughter's house.  Had to wear oxygen while driven because of increase sob. My daughter took me to urgent care  to get antibiotics and  steroids. They sent me to the hospital. They did bld work , cat scan,  ekg, and was diagnosed with a bad clot and admitted to hosp. Started on heparin and switched to eliquise
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Laboratory test, Thrombosis, Ultrasound pelvis
Clinical narrative: Received booster on Sat and on Sunday felt funny, slightly  sob. Thought I was getting an infection, drove to my daughter's house.  Had to wear oxygen while driven because of increase sob. My daughter took me to urgent care  to get antibiotics and  steroids. They sent me to the hospital. They did bld work , cat scan,  ekg, and was diagnosed with a bad clot and admitted to hosp. Started on heparin and switched to eliquise
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Received booster on Sat and on Sunday felt funny, slightly  sob. Thought I was getting an infection, drove to my daughter's house.  Had to wear oxygen while driven because of increase sob. My daughter took me to urgent care  to get antibiotics and  steroids. They sent me to the hospital. They did bld work , cat scan,  ekg, and was diagnosed with a bad clot and admitted to hosp. Started on heparin and switched to eliquise
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Deep vein thrombosis, Pulmonary embolism, Venogram
Clinical narrative: bilateral pulmonary emboli and R upper extremity DVT on 9/9/22
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I received my 1st dose of Moderna on 01/07/2021. My adverse event started on the next day with a fever of 101.00. The fever was gone after few days of taking TYLENOL. On 01/11/2021-01/16/2021 I noticed swelling on my left arm on the injection site. It was itching, pain, redness and warmth. It was from my left deltoid area extended to the bottom. I didn't seek care from a doctor but I took BENADRYL 2 times a day for 3-4 days. Overall my problem resolved within 10 days period. It took me 2 weeks for the redness to go away.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I received my 1st dose of Moderna on 01/07/2021. My adverse event started on the next day with a fever of 101.00. The fever was gone after few days of taking TYLENOL. On 01/11/2021-01/16/2021 I noticed swelling on my left arm on the injection site. It was itching, pain, redness and warmth. It was from my left deltoid area extended to the bottom. I didn't seek care from a doctor but I took BENADRYL 2 times a day for 3-4 days. Overall my problem resolved within 10 days period. It took me 2 weeks for the redness to go away.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Erythema, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Entire right arm was wollen red and warm. Spread to breasts, should blades, and down to elbow. Sore to the touch. No anaphylactic reactions. Just swelling. By 12/5/22, swelling was still present but better.
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID symptoms first night September 6, 2022. Tested positive for COVID two days later, September 8, 2022. Strong symptoms the first two days then weakened symptoms. Completely clear within seven days of onset. I had a phone consultation with Dr. on September 9, 2022. No special treatment needed. No after affects.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Joint swelling
Clinical narrative: Started with golf ball size fluid filled ball on knee cap appearing 11/23/22 which progressed to Very large Right knee/leg bruising of unknown origin measuring 6 inches a-crossed knee area and 10 inches up/down leg/knee. No known injuring creating this event
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Interchange of vaccine products
Clinical narrative: On 11/26/2022, I inadvertently gave patient Flucelvax instead of Moderna Bivalent Booster. Patient had already received one dose of Flucelvax for the 2022-2023 season on 10/08/2022.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune thyroiditis, Condition aggravated, Dyspepsia, Exercise tolerance decreased
Clinical narrative: Day 1: mild flu-like symptoms Day 6: Pain from head (tooth ache) to toe (ingrown toenail) and places in between that had experienced some type of pain in the last year or so.  Specifically, arthritic knee pain (which had not been a problem prior), sciatica, heartburn, hashimoto itch.  I had great difficulty walking, going up or down stairs, getting out of a chair, etc.  The day before I had been to the gym and was increasing the levels of weights on my routine, but the next day I felt like a cripple, especially when I tried to exercise.  Most of the pain has ceased except in my legs.    I tire easily.  The Hashimotos itch re-occurs frequently, which makes me wonder if the vaccine didn't mess up my thyroid more.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Influenza like illness, Ingrowing nail, Mobility decreased
Clinical narrative: Day 1: mild flu-like symptoms Day 6: Pain from head (tooth ache) to toe (ingrown toenail) and places in between that had experienced some type of pain in the last year or so.  Specifically, arthritic knee pain (which had not been a problem prior), sciatica, heartburn, hashimoto itch.  I had great difficulty walking, going up or down stairs, getting out of a chair, etc.  The day before I had been to the gym and was increasing the levels of weights on my routine, but the next day I felt like a cripple, especially when I tried to exercise.  Most of the pain has ceased except in my legs.    I tire easily.  The Hashimotos itch re-occurs frequently, which makes me wonder if the vaccine didn't mess up my thyroid more.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Sciatica, Toothache
Clinical narrative: Day 1: mild flu-like symptoms Day 6: Pain from head (tooth ache) to toe (ingrown toenail) and places in between that had experienced some type of pain in the last year or so.  Specifically, arthritic knee pain (which had not been a problem prior), sciatica, heartburn, hashimoto itch.  I had great difficulty walking, going up or down stairs, getting out of a chair, etc.  The day before I had been to the gym and was increasing the levels of weights on my routine, but the next day I felt like a cripple, especially when I tried to exercise.  Most of the pain has ceased except in my legs.    I tire easily.  The Hashimotos itch re-occurs frequently, which makes me wonder if the vaccine didn't mess up my thyroid more.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Abdominal pain, Antibody test, Aphasia, Aphthous ulcer, Arthralgia
Clinical narrative: I started with some unexplained reflux (never before) and abdominal pain, some tmj, teeth grinding during the night.  THEN AFTER THE 3 DOSE I experienced night sweats, and severe teeth grinding, for many days, joint pain, feeling severely tired disturbed sleep and very brained fogged and impaired cognitively: short memory and speech ( couldn't find words). Then after some days I had a severe mouth canker sores breakout. then abdominal pain. Doctors foind very low wbc (2.8) no virus, no bacteria infection was found. I have never had low wbc before.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Blood immunoglobulin G, Blood test, Bruxism, Cognitive disorder, Colonoscopy
Clinical narrative: I started with some unexplained reflux (never before) and abdominal pain, some tmj, teeth grinding during the night.  THEN AFTER THE 3 DOSE I experienced night sweats, and severe teeth grinding, for many days, joint pain, feeling severely tired disturbed sleep and very brained fogged and impaired cognitively: short memory and speech ( couldn't find words). Then after some days I had a severe mouth canker sores breakout. then abdominal pain. Doctors foind very low wbc (2.8) no virus, no bacteria infection was found. I have never had low wbc before.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Memory impairment, Night sweats
Clinical narrative: I started with some unexplained reflux (never before) and abdominal pain, some tmj, teeth grinding during the night.  THEN AFTER THE 3 DOSE I experienced night sweats, and severe teeth grinding, for many days, joint pain, feeling severely tired disturbed sleep and very brained fogged and impaired cognitively: short memory and speech ( couldn't find words). Then after some days I had a severe mouth canker sores breakout. then abdominal pain. Doctors foind very low wbc (2.8) no virus, no bacteria infection was found. I have never had low wbc before.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Oesophagogastroduodenoscopy, Sleep disorder, Temporomandibular joint syndrome, White blood cell count decreased
Clinical narrative: I started with some unexplained reflux (never before) and abdominal pain, some tmj, teeth grinding during the night.  THEN AFTER THE 3 DOSE I experienced night sweats, and severe teeth grinding, for many days, joint pain, feeling severely tired disturbed sleep and very brained fogged and impaired cognitively: short memory and speech ( couldn't find words). Then after some days I had a severe mouth canker sores breakout. then abdominal pain. Doctors foind very low wbc (2.8) no virus, no bacteria infection was found. I have never had low wbc before.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: PATIENT CALLED AND REALIZED SHE RECEIVED 2 FLU VACCINES FOR THIS SEASON. SHE CAME IN FOR A PNEUMONIA SHOT, BUT FILLED OUT A FLU FORM AND THEREFORE RECIEVED A SECOND FLU SHOT.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered, Injection site pain, Underdose
Clinical narrative: Patient requested/scheduled to received 0.5 ml of COVID 19 Moderna Bivalent booster. Patient was given 0.5ml of COVID 19 Moderna monovalent pediatric dosage for ages 5-11 years old. Patient reports arm tenderness at injection site, no other reported symptoms. Moderna Manufacturer notified of event, awaiting further instructions from manufacturer. Patient notified of event, and will be updated with further instructions for future COVID 19 vaccines doses, as per manufacturer instructions.
Age: 23.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Blood glucose normal, Discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Pt received Tdap and Moderna bivalent vaccine at approx 4:20 pm. Pt reports SOB, 8/10 HA, sudden fatigue minutes after Tdap and Moderna bivalent vaccine. Pt has GDM, last ate local sandwich shop at 1:50 pm. BS at 4:28 141 mg/dl. BP 136/84 HR 92 O2 100% Temp 98.6. Pt denies CP, dizziness. Asked about swelling, pt reports pressure in throat, can speak and breathe but feels difficult. Thinks anxiety related, has not had reaction like this before. Reports latex allergy. Reports last Tdap in childhood, no documentation.  Dr. notified and assessed pt. Pt came via bus, advised to have family member pick her up and observe, any worsening s/s proceed to hospital. Pt verbalized understanding. No one able to pick her up at this time, 40 minutes since vaccine, pt feels OK to take bus home, will be with family. ER preCx given for worsening s/s. Pt verbalized understanding.
Age: 23.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Oropharyngeal discomfort, Speech disorder
Clinical narrative: Pt received Tdap and Moderna bivalent vaccine at approx 4:20 pm. Pt reports SOB, 8/10 HA, sudden fatigue minutes after Tdap and Moderna bivalent vaccine. Pt has GDM, last ate local sandwich shop at 1:50 pm. BS at 4:28 141 mg/dl. BP 136/84 HR 92 O2 100% Temp 98.6. Pt denies CP, dizziness. Asked about swelling, pt reports pressure in throat, can speak and breathe but feels difficult. Thinks anxiety related, has not had reaction like this before. Reports latex allergy. Reports last Tdap in childhood, no documentation.  Dr. notified and assessed pt. Pt came via bus, advised to have family member pick her up and observe, any worsening s/s proceed to hospital. Pt verbalized understanding. No one able to pick her up at this time, 40 minutes since vaccine, pt feels OK to take bus home, will be with family. ER preCx given for worsening s/s. Pt verbalized understanding.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Eyelid margin crusting, Eyelid skin dryness, Grip strength decreased, Hypoaesthesia
Clinical narrative: Patient's occupation: PRIVATE. complains of numbness in the right hand, inability to full grip on equipment. Also complains of very dry eye lids forming crust around the eyelids.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Laboratory test abnormal, Optic nerve injury, Vitreous floaters
Clinical narrative: Shadow in left eye. Optic nerve damage, partial vision loss.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED EXPIRED BOOSTER VACCINED.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site warmth, Pain
Clinical narrative: Fever, body aches. Headache, and Hot, red,  rash below injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, body aches. Headache, and Hot, red,  rash below injection site.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Bone pain, Hyperhidrosis, Loss of consciousness, Myalgia
Clinical narrative: Total body bone/ muscle pain for  8 plus hours / could not sleep all night Got up to use the bathroom in morning and started passing out/sweating profusely Could not call out for help nor make any noise to get husband?s help
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder
Clinical narrative: Total body bone/ muscle pain for  8 plus hours / could not sleep all night Got up to use the bathroom in morning and started passing out/sweating profusely Could not call out for help nor make any noise to get husband?s help
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered an adult bivalent dose instead of dose for their age.  Patient guardian was contacted and patient has not had any side effects at this time.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash macular, Vasculitis
Clinical narrative: vasculitis on both arms and legs.  itching and red blotchy areas on all limbs
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED EXPIRED BOOSTER VACCINE.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the Moderna Bivalent vaccine approved for 6 years and older. Patient is only 5 years old.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient requested/scheduled to received 0.5 ml of COVID 19 Moderna Bivalent booster. Patient was given 0.5ml of COVID 19 Moderna monovalent pediatric dosage for ages 5-11 years old. Patient reports no symptoms at this time. Moderna Manufacturer notified of event, awaiting further instructions from manufacturer. Patient notified of event, and will be updated with further instructions for future COVID 19 vaccines doses, as per manufacturer instructions.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block second degree, Cardiac pacemaker insertion, Catheterisation cardiac, Echocardiogram, Electrocardiogram
Clinical narrative: 2nd degree AV block; pacemaker fitted July 25, 2022
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise electrocardiogram, Troponin
Clinical narrative: 2nd degree AV block; pacemaker fitted July 25, 2022
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a second moderna primary series after receiving both a pfizer primary series and moderna primary series. Provider mistakenly read the guidelines that a second dose of the same manufacturer was needed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood test abnormal, Cardiac monitoring abnormal, Computerised tomogram thorax normal, Electrocardiogram ambulatory normal
Clinical narrative: Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Fatigue, Gait disturbance, Headache
Clinical narrative: Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovitaminosis, Impaired driving ability, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Migraine
Clinical narrative: Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Nerve conduction studies normal, Orthostatic hypertension, Sinus tachycardia, Syncope
Clinical narrative: Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test positive
Clinical narrative: Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Exfoliative rash, Impaired work ability, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Scaly painful sometimes itchy, episodic rash on hands. Still continues as of current time significantly effecting my ability to do my work due to requiring hand washing and wearing of gloves etc., that cause significant pain.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has received a yearly flu vaccine for 4 years. Each year his arm or leg becomes very swollen, red and hard. I gathered the lot #'s from his records, but I do not know which exact vaccine he received, but the above section made me chose a specific vaccine. I picked Fluarix since it is one of the flu vaccines made by GSK.   influenza, injectable, quadrivalent, preservative free 10/20/19 R Vastus Lateralis GSK  PVT-T9N35 10/12/20 R Vastus Lateralis GSK PVT-N549A 10/14/20 message to his MD erythema has spread and area still edematous, hard and hot. Going to give a dose of Benadryl. He complains of itching, but otherwise seems okay 10/19/20 message to his MD The erythema had progressed down to his knee and now it is only on his upper thigh. It was still a little hard yesterday, but today is soft. Not hot or swollen anymore. He is acting normally (very playful and energetic) 10/18/21 L Vastus Lateralis GSK PVT-NK45F 10/20/22 R Deltoid GSK PVT-953Y2 He had reactions each time- the area became very swollen and hot. From what I can remember, the reaction will start as a red lump and then spread for about a week and then eventually get better for following week. The last reaction was the worst. The entire arm was hard and hot. He was guarding the arm as well.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Oedema, Peripheral swelling, Pruritus
Clinical narrative: Patient has received a yearly flu vaccine for 4 years. Each year his arm or leg becomes very swollen, red and hard. I gathered the lot #'s from his records, but I do not know which exact vaccine he received, but the above section made me chose a specific vaccine. I picked Fluarix since it is one of the flu vaccines made by GSK.   influenza, injectable, quadrivalent, preservative free 10/20/19 R Vastus Lateralis GSK  PVT-T9N35 10/12/20 R Vastus Lateralis GSK PVT-N549A 10/14/20 message to his MD erythema has spread and area still edematous, hard and hot. Going to give a dose of Benadryl. He complains of itching, but otherwise seems okay 10/19/20 message to his MD The erythema had progressed down to his knee and now it is only on his upper thigh. It was still a little hard yesterday, but today is soft. Not hot or swollen anymore. He is acting normally (very playful and energetic) 10/18/21 L Vastus Lateralis GSK PVT-NK45F 10/20/22 R Deltoid GSK PVT-953Y2 He had reactions each time- the area became very swollen and hot. From what I can remember, the reaction will start as a red lump and then spread for about a week and then eventually get better for following week. The last reaction was the worst. The entire arm was hard and hot. He was guarding the arm as well.
Age: 95.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered, Injection site pain
Clinical narrative: Patient requested/scheduled to received 0.5 ml of COVID 19 Moderna Bivalent booster. Patient was given 0.5ml of COVID 19 Moderna monovalent pediatric dosage for ages 5-11 years old. Patient reports arm tenderness at injection site, no other reported symptoms. Moderna Manufacturer notified of event, awaiting further instructions from manufacturer. Patient notified of event, and will be updated with further instructions for future COVID 19 vaccines doses, as per manufacturer instructions.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Skin discolouration, Stress
Clinical narrative: PT self reported feeling light headed and dizzy approxiamately 10 minutes post vaccination. Pt was seated and blood pressure taken (BP:183/105, HR:108). Pt relocated to vaccination room and instructed to lie down with legs propped on a chair. BP retaken approxiamately 15 minutes later by onsite nurse practitioner (BP: 181/104, HR: 105). Pt monitored and then given emergency supply of blood pressure medications that they normally take same time each evening around when vaccine was administered (losartan 50mg x1, HCTZ 25mg x1, metoprolol succ ER 50mg x1). Vitals taken again 20min later (BP: 163/101, HR: 101). Pts color returning and positioned upright. Vitals taken 20 min later (BP: 152/93, HR:97). Pt personal cardiologist consulted, recoomended pt return home since vitals were lowering and trending back to normal (base BP: 130/80, HR:85). Pt had prior to vaccination had stressful interaction with another pt and stated  its been a "stressful weekend". Pt had also previously been placed on a "drug holiday" from levothyroxine by their endocrinologist 3 weeks prior to advers event.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: patient received Pfizer instead of Moderna per his request
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Administered flu shot and Pfizer in the same left arm and they are separated by 1/2 in ch Vs 1 in on the same arm little pain felt but nothing happened
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Death, Fall, Hypotension
Clinical narrative: Patient immediately felt I'll.  Over the next few days he fell a few times and was hypotensive and taken to hospital.  He was diagnosed with COVID 19 and placed in ICU. His kidneys and heart were shutting down and on the 15th, 3 days after the shot, he was placed on hospice.  He died the 19th.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Intensive care, Malaise, Renal failure
Clinical narrative: Patient immediately felt I'll.  Over the next few days he fell a few times and was hypotensive and taken to hospital.  He was diagnosed with COVID 19 and placed in ICU. His kidneys and heart were shutting down and on the 15th, 3 days after the shot, he was placed on hospice.  He died the 19th.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Lymphadenopathy, Rash, Throat tightness
Clinical narrative: The husband reported to me the following:  Soon after the vaccination pt. developed SOB, "bumps" on her skin , swollen lymph nodes and throat tightening.  He called emergency services and she was taken to an emergency room.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Skin warm
Clinical narrative: A large red spot appeared on my arm.  I don't know when it started as I just noticed it last night.  It does not itch, it is not raised and it's slightly warm to the touch.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haemangioma
Clinical narrative: Thousands of tiny to moderate sized cherry angiomas showed up all over my body in the next few days and months. They were located primarily on the tops of my thighs, the tops of my arms, my stomach, my chest and a few tiny ones on my face. Prior to the vaccine, I had only three small cherry angiomas on my body.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema
Clinical narrative: redness developed around the injection area with the size of 3 inch diameter. it got worse as days went on. patient visited ER to get the prescription for antibiotic
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Spinal pain
Clinical narrative: Moderate joint pain in his knees, neck and spine.  The pain was intermittent, occurred most days, and lasted for the next 3 1/2 weeks before resolving.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder, Computerised tomogram normal, Delusion, Feeling abnormal, Magnetic resonance imaging normal
Clinical narrative: "Starting on 10/21/2021, around 17:00, mind and my body started feeling weird. My mind began to have racing thoughts. I felt like I was in a fog/haze. Then on 10/25/2021, I went into a state of psychosis. I went to the ER and had delusions. I was diagnosed Bipolar."
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Tachyphrenia
Clinical narrative: "Starting on 10/21/2021, around 17:00, mind and my body started feeling weird. My mind began to have racing thoughts. I felt like I was in a fog/haze. Then on 10/25/2021, I went into a state of psychosis. I went to the ER and had delusions. I was diagnosed Bipolar."
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Injection site pain, Suicidal ideation
Clinical narrative: Burning sensation with administration Deep depression with suicidal thoughts no attempts were made - resolved severe diarrhea for 5-8 weeks
Age: 27.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event
Clinical narrative: patient was given pfizer bivalent as first time dose, never had covid vaccine before
Age: 27.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was given pfizer bivalent as first time dose, never had covid vaccine before
Age: 29.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Rash, Skin warm
Clinical narrative: At the site of injection, patient developed  redness, swelling and pain.  He went to the doctor on the 3rd day but was told to wait it out to see if it will  resolve. It did not so patient went to urgent care . They gave him antibiotic and prednisone.  Patient also felt numbness on the site.
Age: 29.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: At the site of injection, patient developed  redness, swelling and pain.  He went to the doctor on the 3rd day but was told to wait it out to see if it will  resolve. It did not so patient went to urgent care . They gave him antibiotic and prednisone.  Patient also felt numbness on the site.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: given expired vaccine; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given expired vaccine).    No Concomitant medication was provided by reporter.  There were Individual vials with Vial size 5.5ml and on 29Nov2022 the vial was initially stored in the refrigerator.   No Treatment Drug was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live-Significant Follow-up received with No New Information
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: patient received expired dose of the monovalent vaccine instead of Bivalent booster; No adverse event; patient received expired dose of the monovalent vaccine instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster), WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster), WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   The vial was initially stored in the refrigerator on Nov 29 2022. The vial did not undergo any temperature excursions. HCP realized that the vaccine that was intended to be given was the bivalent booster, but the patient received expired dose of the monovalent vaccine. All other details of the expired dose given was accurate. HCP mentioned 2 adult patents received the expired vaccine.   This case was linked to MOD-2022-682308 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Follow-up  Significant information accepted : Added event and updated narrative
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients that were vaccinated with this vaccine after the excursion; No adverse event; Patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     It was unknown if patient had any acute illness at the time of the vaccination or up to one month before.  It was unknown if any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies were being taken at time of vaccination and/or at the time of the adverse event.  It was unknown if patient was diagnosed or tested positive with COVID-19.  Concurrent medical conditions included Asthma and Depression.    On 05-Oct-2022 at 10:19 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Oct-2022 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients that were vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that were vaccinated with this vaccine after the excursion).    No concomitant medication reported. No treatment medication reported.  The reporter wanted to know the recommendation for the patients. No adverse events were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown.  Concurrent medical conditions included Asthma, Hypertension and Depression.    On 05-Oct-2022 at 10:08 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Oct-2022 at 10:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated with this vaccine after the excursion; No adverse event; Patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Allergy to medication, food or other products: NA Acute illness at the time of vaccination and up to one month before was unknown. It was unknown whether patient has diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Hypertension and Hypothyroidism.    On 06-Oct-2022 at 10:23 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Oct-2022 at 10:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion).    Concomitant medications were not reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Vaccine was not viable. No adverse events were reported.   Treatment information was not provided.