chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Night of injection I had chills around 12 am but next day fine. On the second day I started getting itchy on my right arm, I thought a mosquito had bit me. Went to check and noticed both arms were covered in red blotches. Went to store to get hydrocortisone cream and Benadryl. Got home and noticed more red spots on my legs and lower back. I?m currently on day 3. I have also taken Zyrtec and Claritin.
Age: 58.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Dizziness, Fatigue, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Pain in left arm for 3-4 days, couldn?t lift arm. Hives on torso that lasted 3-4 weeks that created scabby sores with intense itching, lightheaded spells 1-2 after shot, fatigue.
Age: 58.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Scab, Urticaria
Clinical narrative: Pain in left arm for 3-4 days, couldn?t lift arm. Hives on torso that lasted 3-4 weeks that created scabby sores with intense itching, lightheaded spells 1-2 after shot, fatigue.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling cold, Injection site pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: At the time of injection, it was extremely painful and it looked like it was too high on the arm.  My arm has been sore at the injection site for 10 days now. Sometimes I feel tingling and a cold feeling in my arm.  Range of motion is not limited but the pain is lingering and not subsiding. Pain is about 3/10.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Headache, Injection site erythema, Injection site pain, Photophobia
Clinical narrative: Within 24h of vaccination, pt develop fever to max temp of 39.2C as well as significant headache associated with photophobia. Fevers and headache persisting to following day. ~48h after vaccine, pt noted large area of erythema with associated tenderness along lateral L upper arm around injection site.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Within 24h of vaccination, pt develop fever to max temp of 39.2C as well as significant headache associated with photophobia. Fevers and headache persisting to following day. ~48h after vaccine, pt noted large area of erythema with associated tenderness along lateral L upper arm around injection site.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Hives Itching Swollen face
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac monitoring, Dyspnoea, Echocardiogram
Clinical narrative: AFIB, 3 trips to ER due to shortness of breath.  Amiodarone Hydrochloride for heart, Eliquis for blood thinner.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Scan
Clinical narrative: AFIB, 3 trips to ER due to shortness of breath.  Amiodarone Hydrochloride for heart, Eliquis for blood thinner.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: Patient requested her first dose of Moderna primary series. My technician typed up the vaccine correctly and vaccine was processed in the system without any need for verification by the pharmacist. Her consent form was lined up after a string of patients needing the new Moderna- Bivalent vaccines. There was no communication amongst the team that a different Moderna product was requested. I prepared the vaccine for the bivalent booster (which was already open) instead of her first primary doses. Prior to directing her to the consultation room, I asked her if she had her vaccine card to document her vaccine or if she needed a new one - she said she needed a new one. In the consultation room, I asked for her name, birthday, and whether she was expecting the new booster shot. She said yes. After I gave her the vaccine, she asked when she would need a next one and told her this is the only booster dose approved at this time. It was after she left that I took a second look at the consent form and realized the mistake. I immediately called her and let her know of the error and per CDC guidelines, I had the patient come back and gave her the primary dose of the Moderna series. Contributing factors to this error: it happened right as we reopened for lunch and it was very busy - this is uncontrollable. I asked my technicians moving forward to verbalize to me if a patient is needing a different formulation all together - especially if we have both vaccines happening given that the packaging to these vaccines are very similar looking. Patient's confusion to the process did not help with today's situation but shows the importance of verifying name, DOB, and what vaccine they are expecting. Today, was our first day offering this vaccine at a walk-in bases so there were many factors that were contributing to this mistake but a team huddle emphasizing how to mitigate this from happening again will happen tomorrow asap.  As this time, no adverse effects has been reported by the patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest discomfort, Computerised tomogram abnormal, Dizziness, Dyspnoea
Clinical narrative: For a couple of weeks prior to event, I was short of breath and occasionally light headed.  That day I had a very difficult time breathing, pressure in my chest, and too dizzy to walk.  Ambulance took me to emergency room where a scan showed a six inch blood clot across the saddle of my lungs.  A specialist was able to go into my lungs through my groin and suck out the clot.  Three doctors told me I was lucky to be alive.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pulmonary hypertension, Pulmonary thrombosis, SARS-CoV-2 test, Thromboembolectomy
Clinical narrative: For a couple of weeks prior to event, I was short of breath and occasionally light headed.  That day I had a very difficult time breathing, pressure in my chest, and too dizzy to walk.  Ambulance took me to emergency room where a scan showed a six inch blood clot across the saddle of my lungs.  A specialist was able to go into my lungs through my groin and suck out the clot.  Three doctors told me I was lucky to be alive.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: For a couple of weeks prior to event, I was short of breath and occasionally light headed.  That day I had a very difficult time breathing, pressure in my chest, and too dizzy to walk.  Ambulance took me to emergency room where a scan showed a six inch blood clot across the saddle of my lungs.  A specialist was able to go into my lungs through my groin and suck out the clot.  Three doctors told me I was lucky to be alive.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient stated she was coming in for 2nd booster. Staff did not verify that patient had covid vaccine card and gave patient "second booster". Patient presented back to office with card and had received 2nd booster at local pharmacy.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vitiligo
Clinical narrative: Within A month of recieving first 2 vaccines, vitiligo appeared on both hands
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Asthenia, Contusion, Dizziness, Erythema, Fall
Clinical narrative: Pt was sitting in chair after getting his vaccine. The patient then passed onto the floor. He was placed on a cot, pillow under his head, both legs elevated on a chair. He was given water and crackers. A red mark noted on the left side of forehead.   09/6/22 @ 1122 - Client found lying in prone position, unconscious after hearing client falling from chair. RN and LPN assisted client back to chair and client quickly regained consciousness, A&O, speech coherent, able to answer questions that was ask. Skin pallor and red bruising noted on the left forehead, skin intact. Client denied any discomfort. BP @ 1043 sitting position 100/49 pulse 53. Client drinked 1/2 water bottle during observation. Client noted to become weak not as alert. Client c/o of feeling lightheaded. RN and LPN assisted client to lie down, skin noted to become pallor BP 109/75 P 63 RR 20 in lying position @ 1050. MD called regarding situation and she responded that she will send NP to clinic. NP arrived, assessed client. Client was then able to answer all questions. Client sat up on the floor for several minutes before sitting back in chair. Client stated that he felt "fine" and denied any discomfort. A snack was given to client to eat. BP 118/82 pulse 62. Writer witnessed NP encourage client to call someone to have them be aware that client is driving along and that person need f/u. After monitoring client for 30mins, client remain A&OX3, denied any discomfort or needs. Writer escorted client to vehicle and watched him drive out of parking lot.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt was sitting in chair after getting his vaccine. The patient then passed onto the floor. He was placed on a cot, pillow under his head, both legs elevated on a chair. He was given water and crackers. A red mark noted on the left side of forehead.   09/6/22 @ 1122 - Client found lying in prone position, unconscious after hearing client falling from chair. RN and LPN assisted client back to chair and client quickly regained consciousness, A&O, speech coherent, able to answer questions that was ask. Skin pallor and red bruising noted on the left forehead, skin intact. Client denied any discomfort. BP @ 1043 sitting position 100/49 pulse 53. Client drinked 1/2 water bottle during observation. Client noted to become weak not as alert. Client c/o of feeling lightheaded. RN and LPN assisted client to lie down, skin noted to become pallor BP 109/75 P 63 RR 20 in lying position @ 1050. MD called regarding situation and she responded that she will send NP to clinic. NP arrived, assessed client. Client was then able to answer all questions. Client sat up on the floor for several minutes before sitting back in chair. Client stated that he felt "fine" and denied any discomfort. A snack was given to client to eat. BP 118/82 pulse 62. Writer witnessed NP encourage client to call someone to have them be aware that client is driving along and that person need f/u. After monitoring client for 30mins, client remain A&OX3, denied any discomfort or needs. Writer escorted client to vehicle and watched him drive out of parking lot.
Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, Product container issue
Clinical narrative: Jynneos use for MonkeyPox for pediatric use under Emergency Use Authorization (EUA). This occurred while treating a pediatric patient under the EUA along with their parent. When the caps were removed for use, on one vial the cap was difficult to come off and created a very sharp edge where the nurse could have cut themselves (on the right in photo). The other vial (on the left in photo), the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out. This potentially affects the integrity of the products, however, both patients received full dose and experienced no harm. It was confirmed other similar instances have occurred in the same institution.
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Diarrhoea, Dizziness, Mobility decreased, Product preparation issue
Clinical narrative: child got an undiluted dose of Pfizer vaccine, instead of the dialuted dose of the pediatric dose (4 X the amount) Child is Mostly non verbal and Got 1st booster shot>>3rd in series>>5-11 Pfizer. Verified that it was the correct dose. Waited for 15 minutes per the mom, By the time she got to the car>>"she looked woozie", restlessness>>temperature>>tylenol>>Kept hiting herself in the arm, also diarrhea>>Stayed in bed until 2pm the next day... 3rd does of tylenol given>>Very quiet. Member got an undiluted dose, instead of the dialuted dose. (4 X the amount) Child is Mostly non verbal and "is on the spectrum" continues to have a lowgrade temp.
Sex: F
Vaccine: COVID19-2
Symptoms: Restlessness
Clinical narrative: child got an undiluted dose of Pfizer vaccine, instead of the dialuted dose of the pediatric dose (4 X the amount) Child is Mostly non verbal and Got 1st booster shot>>3rd in series>>5-11 Pfizer. Verified that it was the correct dose. Waited for 15 minutes per the mom, By the time she got to the car>>"she looked woozie", restlessness>>temperature>>tylenol>>Kept hiting herself in the arm, also diarrhea>>Stayed in bed until 2pm the next day... 3rd does of tylenol given>>Very quiet. Member got an undiluted dose, instead of the dialuted dose. (4 X the amount) Child is Mostly non verbal and "is on the spectrum" continues to have a lowgrade temp.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: My doctor told me to get the Prevnar 20 injection .5 ML and a flu shot which is 65+ Quad PF 2022-2023 .5. The next day I had terrible Side effects, feeling dizzy, extremely tired and weak, bad headaches, muscle And joint pain, a fever of 101.1. I was pretty sick for two days. The third day was a little better, but still tired and had bad headaches. I had gotten these two shots at a pharmacy store.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: My doctor told me to get the Prevnar 20 injection .5 ML and a flu shot which is 65+ Quad PF 2022-2023 .5. The next day I had terrible Side effects, feeling dizzy, extremely tired and weak, bad headaches, muscle And joint pain, a fever of 101.1. I was pretty sick for two days. The third day was a little better, but still tired and had bad headaches. I had gotten these two shots at a pharmacy store.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Asthenia, Exercise tolerance decreased, Eye inflammation, Eye pain
Clinical narrative: At my annual physical on Tues., 08/16/2022, my primary care physician and I made the decision that I should receive the Prevnar 20 vaccination because I suffer from various autoimmune diseases. Within two hours of receiving the vaccination, I immediately began feeling weak, tired, and general malaise. On Thurs., 08/18 my left eye became inflamed, red and painful. On Fri., 08/19/22, I went to see my eye doctor and was diagnosed with anterior uveitis flare. I was prescribed Prednisolone AC 1% Opthalmic Suspension, USP and instructed to instill one drop in my left eye every hour. I was diagnosed with anterior uveitis in February 2020 but it had been well managed and I was not having any flares until after I received to Prevnar vaccination. On Mon., 08/22/2022 I began experiencing painful joints including my elbows, knees, and right ankle. My sleep was disrupted for several night due to pain in my eye and joints. I was no longer able to do the things that I enjoy including go to work, prepare meals, exercise, and garden. On Sun., 08/28 I began feeling better and was able to resume many of my regular activities.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Impaired work ability, Iridocyclitis, Malaise, Mobility decreased
Clinical narrative: At my annual physical on Tues., 08/16/2022, my primary care physician and I made the decision that I should receive the Prevnar 20 vaccination because I suffer from various autoimmune diseases. Within two hours of receiving the vaccination, I immediately began feeling weak, tired, and general malaise. On Thurs., 08/18 my left eye became inflamed, red and painful. On Fri., 08/19/22, I went to see my eye doctor and was diagnosed with anterior uveitis flare. I was prescribed Prednisolone AC 1% Opthalmic Suspension, USP and instructed to instill one drop in my left eye every hour. I was diagnosed with anterior uveitis in February 2020 but it had been well managed and I was not having any flares until after I received to Prevnar vaccination. On Mon., 08/22/2022 I began experiencing painful joints including my elbows, knees, and right ankle. My sleep was disrupted for several night due to pain in my eye and joints. I was no longer able to do the things that I enjoy including go to work, prepare meals, exercise, and garden. On Sun., 08/28 I began feeling better and was able to resume many of my regular activities.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Ocular hyperaemia, Sleep disorder
Clinical narrative: At my annual physical on Tues., 08/16/2022, my primary care physician and I made the decision that I should receive the Prevnar 20 vaccination because I suffer from various autoimmune diseases. Within two hours of receiving the vaccination, I immediately began feeling weak, tired, and general malaise. On Thurs., 08/18 my left eye became inflamed, red and painful. On Fri., 08/19/22, I went to see my eye doctor and was diagnosed with anterior uveitis flare. I was prescribed Prednisolone AC 1% Opthalmic Suspension, USP and instructed to instill one drop in my left eye every hour. I was diagnosed with anterior uveitis in February 2020 but it had been well managed and I was not having any flares until after I received to Prevnar vaccination. On Mon., 08/22/2022 I began experiencing painful joints including my elbows, knees, and right ankle. My sleep was disrupted for several night due to pain in my eye and joints. I was no longer able to do the things that I enjoy including go to work, prepare meals, exercise, and garden. On Sun., 08/28 I began feeling better and was able to resume many of my regular activities.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: study subject with post dose J&J AD26.COV.2S vaccine on 6/23/2022 in the Protocol was hospitalized 8/15/2022 to 8/20/2022 for covid19. Principal Investigator causality assessment is not study med. related. Study site has requested hospitalization records to hospital of admission.
Age: 5.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna covid vaccine was given to a 5 year-old child with 50mcg dose. The pharmacist notified parents that she discovered her mistake after giving the shot. Reporter's recommendations: 2nd initial verify the dose prior to Pharmacist can bring the vaccine out to the patient. Error reached patient; no patient harm
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: A patient came in and immunizations were pulled in from system, but did not show that she had a pneumococcal vaccine to date, so after confirming with the patient that she didn't have it yet, one was administered in clinic that day, X/X/22. At the end of the day, when the provider got back into her chart, the XXXXX administration date showed up. Pfizer was called and they confirmed that they do not see that there will be any adverse effects to the patient.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Nausea
Clinical narrative: took my tremfya shot and have had flu symptoms since an hour after shot. Nausea chills headache for 36 hours so far. Manageable with Tylenol and Pepto but never had any side effects when took in the past. Been 14 months since last injection. Wondering if reaction could be due to having received Covid vaccine and booster. Only thing different.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administration error
Clinical narrative: An entire moderna multi dose vile 2.5ml/250mcg was given in left deltoid Mother who is a pediatric nurse discovered the error
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Child was scheduled for second Moderna vaccine (first vaccine was June 21). Child was administered Pfizer vaccine instead. Staff brought to my attention (mother) after routine 15 minute waiting period. No explanation beyond them confusing COVID vaccines.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus, Injection site erythema
Clinical narrative: About 24hours after receiving Moderna booster redness at injection site occurred and has lasted 4 days now. In addition, I have diabetes, my blood sugar has been difficult to keep down despite following my routine regimen.
Age: 88.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Cellulitis, Depression, Discomfort, Exercise tolerance decreased
Clinical narrative: Filing of a complaint with FDA concerning the use of Trulicity and the Pfizer vaccine. My age is 88. At the beginning of January 2022, my endocrinologist suggested trying a product called Trulicity. It replaced two pills - Glimepiride and Tradjenta. I used the Trulicity until April 18, 2022 when I voluntarily went back on the pills. My health began to decline from January 2022 until May 2022. Most notable decline was my weight - went from 186 pounds in December to 145 pounds mid May 2022. All of this affected my overall functional ability, decreased endurance during physical skills, poor sleep due to discomfort, fatigue during he day, and just an overall depression. Also notable was increased joint pain - shoulders, wrists, fingers, hips, knees, ankles. Orthopedists tried injecting cortisone even tho there was no evidence of arthritis - left hip, left knee, and right knee. Did provide some temporary relief. Right after the right knee injection I developed an edema and cellulitis below right knee down to the right ankle. My infectious disease doctor immediately put me in hospital. Was there from May 6, 2022, some 12 days before being transferred to a rehab facility for another 18 days and there did receive some PT and OT. After getting out of there a rehab company came to the house for several weeks, I am still battling joint pains, fingers that don't work anymore loss of about 80% of my power in my right hand and about 50% of my power in my left hand. Motor skills are totally limited. Prior to all this, I was fully functional. I was and am my wife's caregiver, (she is 86 and is afflicted with fibromyalgia for the past 5 years and arthritis). I have managed the household needs and was involved in numerous community activities. Was able to drive all around the neighborhood. Need help now just to go shopping for food and supplies. Now what? Did anyone think to test the combination of these products? Were the Pfizer products really that proven? I am at my wits end as to how this can be resolved. I now use a 4 wheel rollator in the house and also have a spare one in the car. Also need a cane to help navigate because of unsure navigation. Someone, please help. This change in medication has ruined a once viable person. I do not know what test date you might want but can provide what I have. The hospital and rehab facility probably can provide additional. What is truly discouraging is the fact that none of my doctors have tried to find the cause, just treating the symptoms.
Age: 88.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Fine motor skill dysfunction, General physical health deterioration, Grip strength decreased, Laboratory test
Clinical narrative: Filing of a complaint with FDA concerning the use of Trulicity and the Pfizer vaccine. My age is 88. At the beginning of January 2022, my endocrinologist suggested trying a product called Trulicity. It replaced two pills - Glimepiride and Tradjenta. I used the Trulicity until April 18, 2022 when I voluntarily went back on the pills. My health began to decline from January 2022 until May 2022. Most notable decline was my weight - went from 186 pounds in December to 145 pounds mid May 2022. All of this affected my overall functional ability, decreased endurance during physical skills, poor sleep due to discomfort, fatigue during he day, and just an overall depression. Also notable was increased joint pain - shoulders, wrists, fingers, hips, knees, ankles. Orthopedists tried injecting cortisone even tho there was no evidence of arthritis - left hip, left knee, and right knee. Did provide some temporary relief. Right after the right knee injection I developed an edema and cellulitis below right knee down to the right ankle. My infectious disease doctor immediately put me in hospital. Was there from May 6, 2022, some 12 days before being transferred to a rehab facility for another 18 days and there did receive some PT and OT. After getting out of there a rehab company came to the house for several weeks, I am still battling joint pains, fingers that don't work anymore loss of about 80% of my power in my right hand and about 50% of my power in my left hand. Motor skills are totally limited. Prior to all this, I was fully functional. I was and am my wife's caregiver, (she is 86 and is afflicted with fibromyalgia for the past 5 years and arthritis). I have managed the household needs and was involved in numerous community activities. Was able to drive all around the neighborhood. Need help now just to go shopping for food and supplies. Now what? Did anyone think to test the combination of these products? Were the Pfizer products really that proven? I am at my wits end as to how this can be resolved. I now use a 4 wheel rollator in the house and also have a spare one in the car. Also need a cane to help navigate because of unsure navigation. Someone, please help. This change in medication has ruined a once viable person. I do not know what test date you might want but can provide what I have. The hospital and rehab facility probably can provide additional. What is truly discouraging is the fact that none of my doctors have tried to find the cause, just treating the symptoms.
Age: 88.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Oedema peripheral, Poor quality sleep, Walking aid user
Clinical narrative: Filing of a complaint with FDA concerning the use of Trulicity and the Pfizer vaccine. My age is 88. At the beginning of January 2022, my endocrinologist suggested trying a product called Trulicity. It replaced two pills - Glimepiride and Tradjenta. I used the Trulicity until April 18, 2022 when I voluntarily went back on the pills. My health began to decline from January 2022 until May 2022. Most notable decline was my weight - went from 186 pounds in December to 145 pounds mid May 2022. All of this affected my overall functional ability, decreased endurance during physical skills, poor sleep due to discomfort, fatigue during he day, and just an overall depression. Also notable was increased joint pain - shoulders, wrists, fingers, hips, knees, ankles. Orthopedists tried injecting cortisone even tho there was no evidence of arthritis - left hip, left knee, and right knee. Did provide some temporary relief. Right after the right knee injection I developed an edema and cellulitis below right knee down to the right ankle. My infectious disease doctor immediately put me in hospital. Was there from May 6, 2022, some 12 days before being transferred to a rehab facility for another 18 days and there did receive some PT and OT. After getting out of there a rehab company came to the house for several weeks, I am still battling joint pains, fingers that don't work anymore loss of about 80% of my power in my right hand and about 50% of my power in my left hand. Motor skills are totally limited. Prior to all this, I was fully functional. I was and am my wife's caregiver, (she is 86 and is afflicted with fibromyalgia for the past 5 years and arthritis). I have managed the household needs and was involved in numerous community activities. Was able to drive all around the neighborhood. Need help now just to go shopping for food and supplies. Now what? Did anyone think to test the combination of these products? Were the Pfizer products really that proven? I am at my wits end as to how this can be resolved. I now use a 4 wheel rollator in the house and also have a spare one in the car. Also need a cane to help navigate because of unsure navigation. Someone, please help. This change in medication has ruined a once viable person. I do not know what test date you might want but can provide what I have. The hospital and rehab facility probably can provide additional. What is truly discouraging is the fact that none of my doctors have tried to find the cause, just treating the symptoms.
Age: 88.0
Sex: M
Vaccine: UNK
Symptoms: Weight decreased, Wheelchair user
Clinical narrative: Filing of a complaint with FDA concerning the use of Trulicity and the Pfizer vaccine. My age is 88. At the beginning of January 2022, my endocrinologist suggested trying a product called Trulicity. It replaced two pills - Glimepiride and Tradjenta. I used the Trulicity until April 18, 2022 when I voluntarily went back on the pills. My health began to decline from January 2022 until May 2022. Most notable decline was my weight - went from 186 pounds in December to 145 pounds mid May 2022. All of this affected my overall functional ability, decreased endurance during physical skills, poor sleep due to discomfort, fatigue during he day, and just an overall depression. Also notable was increased joint pain - shoulders, wrists, fingers, hips, knees, ankles. Orthopedists tried injecting cortisone even tho there was no evidence of arthritis - left hip, left knee, and right knee. Did provide some temporary relief. Right after the right knee injection I developed an edema and cellulitis below right knee down to the right ankle. My infectious disease doctor immediately put me in hospital. Was there from May 6, 2022, some 12 days before being transferred to a rehab facility for another 18 days and there did receive some PT and OT. After getting out of there a rehab company came to the house for several weeks, I am still battling joint pains, fingers that don't work anymore loss of about 80% of my power in my right hand and about 50% of my power in my left hand. Motor skills are totally limited. Prior to all this, I was fully functional. I was and am my wife's caregiver, (she is 86 and is afflicted with fibromyalgia for the past 5 years and arthritis). I have managed the household needs and was involved in numerous community activities. Was able to drive all around the neighborhood. Need help now just to go shopping for food and supplies. Now what? Did anyone think to test the combination of these products? Were the Pfizer products really that proven? I am at my wits end as to how this can be resolved. I now use a 4 wheel rollator in the house and also have a spare one in the car. Also need a cane to help navigate because of unsure navigation. Someone, please help. This change in medication has ruined a once viable person. I do not know what test date you might want but can provide what I have. The hospital and rehab facility probably can provide additional. What is truly discouraging is the fact that none of my doctors have tried to find the cause, just treating the symptoms.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium normal, Blood immunoglobulin G normal, Blood triglycerides normal, Condition aggravated, Lipase increased
Clinical narrative: Patient developed pancreatitis the following day after administration of the vaccine. This was confirmed by elevated lipase. She had had 2 previous episodes of pancreatitis in the prior 6 months. There was no evidence of gallstones (also status-post cholecystectomy) triglycerides were normal, and she had a normal calcium level. Morphology of pancreatic ducts via MRCP was noted to be normal. IgG4 to evaluate for autoimmune pancreatitis was normal. She was hospitalized with supportive care including IV fluids and pain control and was discharged after a few days.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance cholangiopancreatography, Magnetic resonance imaging normal, Pain, Pancreatitis, Ultrasound abdomen normal
Clinical narrative: Patient developed pancreatitis the following day after administration of the vaccine. This was confirmed by elevated lipase. She had had 2 previous episodes of pancreatitis in the prior 6 months. There was no evidence of gallstones (also status-post cholecystectomy) triglycerides were normal, and she had a normal calcium level. Morphology of pancreatic ducts via MRCP was noted to be normal. IgG4 to evaluate for autoimmune pancreatitis was normal. She was hospitalized with supportive care including IV fluids and pain control and was discharged after a few days.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, COVID-19, Discoloured vomit, Dysphagia
Clinical narrative: 59y.o. year old male with significant past medical history of DM, HTN, HLD, CAD s/p CABG, gastric ulcers who presents to Hospital RO EC on 08/20/22 with a chief complaint of hematemesis.  He was apparently well until 2 days back when he started having nausea. This was followed by 2 episodes of vomiting. It was initially yellowish in color and later had blood streaks in them. Later on, he had coffee ground vomiting and had 7-8 episodes of these. He denies melena, blood in stools. He also noticed mild pain in his abdomen around the epigastric region. He does admit to some difficulty in swallowing occasionally. He was taking Prilosec for his symptoms. spoke with and educated patient  on home care services
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Haematemesis, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 59y.o. year old male with significant past medical history of DM, HTN, HLD, CAD s/p CABG, gastric ulcers who presents to Hospital RO EC on 08/20/22 with a chief complaint of hematemesis.  He was apparently well until 2 days back when he started having nausea. This was followed by 2 episodes of vomiting. It was initially yellowish in color and later had blood streaks in them. Later on, he had coffee ground vomiting and had 7-8 episodes of these. He denies melena, blood in stools. He also noticed mild pain in his abdomen around the epigastric region. He does admit to some difficulty in swallowing occasionally. He was taking Prilosec for his symptoms. spoke with and educated patient  on home care services
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood phosphorus, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: Symptoms consistent with near syncope 2 weeks post administration. Symptoms consistent with POTS- tachycardia, hypoxia2-8weeks post administration. Chest pain, extreme fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Full blood count, Hypoxia, Metabolic function test
Clinical narrative: Symptoms consistent with near syncope 2 weeks post administration. Symptoms consistent with POTS- tachycardia, hypoxia2-8weeks post administration. Chest pain, extreme fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Red blood cell sedimentation rate, Tachycardia
Clinical narrative: Symptoms consistent with near syncope 2 weeks post administration. Symptoms consistent with POTS- tachycardia, hypoxia2-8weeks post administration. Chest pain, extreme fatigue.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Severe hives on face, neck, arms, chest and back Severe Itching Asthma flare up Difficulty breathing
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Severe hives on face, neck, arms, chest and back Severe Itching Asthma flare up Difficulty breathing
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, C-reactive protein increased, Conjunctivitis, Electrocardiogram abnormal, Erythema
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Inflammatory marker increased, International normalised ratio normal, Kawasaki's disease, Leukopenia
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mucosal disorder, Multisystem inflammatory syndrome in children, N-terminal prohormone brain natriuretic peptide normal, Peripheral swelling
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Procalcitonin increased, Prothrombin time normal, Pyrexia, Rash
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Serum ferritin increased, Sinus tachycardia, Strawberry tongue, Thrombocytopenia
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, COVID-19, Diarrhoea, Headache
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme increased, Illness, Immunoglobulin therapy, Inflammatory marker increased, Lymphadenopathy
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multisystem inflammatory syndrome in children, Pyrexia, SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Case-patient had first Pfizer vaccine on 8/2/22, acute COVID-19 infection with positive antigen test on 8/8/22, and second Pfizer vaccine on 8/23/22.  Case-patient developed symptoms for Multisystem Inflammatory System (MIS-C) on 8/29/22.  Case met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem involvement (cardiac, hematologic, gastrointestinal, dermatologic). The case experience abdominal pain, diarrhea, elevated liver enzymes, thrombocytopenia, headache, conjunctival injection, shotty cervical lymphadenopathy and various elevated inflammatory markers (see box 19).  Case-patient was treated with IVIG, ASA, and steroids, and survived.
Age: 68.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Underdose
Clinical narrative: Received incorrect dosage of .25ml of Moderna bivalent booster on 9/3 administered by PH. 1891253902. I was contacted on 9/7 by the pharmacist and told the incorrect dosage was given and I needed to have another injection. Returned to pharmacy on 9/8 and received. 5ml dose of Moderna bivalent booster.
Age: 68.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Received incorrect dosage of .25ml of Moderna bivalent booster on 9/3 administered by PH. 1891253902. I was contacted on 9/7 by the pharmacist and told the incorrect dosage was given and I needed to have another injection. Returned to pharmacy on 9/8 and received. 5ml dose of Moderna bivalent booster.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: the three year old patient, was given a 5-11 dose of the COVID-19 vaccine. Her observed symptoms were running nose, low-grade fever, chills, fatigue, and reported soreness. These lasted around 30 hours after the injection. The nurse from the clinic called to inform the mother of the mix-up shortly after the injections.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Incorrect product formulation administered, Pain, Pyrexia
Clinical narrative: the three year old patient, was given a 5-11 dose of the COVID-19 vaccine. Her observed symptoms were running nose, low-grade fever, chills, fatigue, and reported soreness. These lasted around 30 hours after the injection. The nurse from the clinic called to inform the mother of the mix-up shortly after the injections.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea
Clinical narrative: the three year old patient, was given a 5-11 dose of the COVID-19 vaccine. Her observed symptoms were running nose, low-grade fever, chills, fatigue, and reported soreness. These lasted around 30 hours after the injection. The nurse from the clinic called to inform the mother of the mix-up shortly after the injections.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Dyspnoea, Full blood count abnormal, Pain
Clinical narrative: was fine the first few days, woke up three days later with chest and jaw pain and shortness of breath, and body aches. was given aspirin and ketorolac iv as well as some zofran
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Troponin increased
Clinical narrative: was fine the first few days, woke up three days later with chest and jaw pain and shortness of breath, and body aches. was given aspirin and ketorolac iv as well as some zofran
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Condition aggravated, Depressed mood, Derealisation
Clinical narrative: Extreme anxiety and derealization late that Friday afternoon. It disrupted my sleep - lots more sleep panic, tinnitus, noises in my ears, ear pain, facial pain, headache, low mood, low energy, brain fog. I started sleeping longer and later for some reason. Before the vaccine I would usually wake up at 10:30- 11AM. After, I started sleeping until 12-1 PM. The acute symptoms except for sleep continued for 2 months. Sleep is still an issue with delayed sleep schedule. Currently my body needs to sleep until 2 pm most days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial pain, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Extreme anxiety and derealization late that Friday afternoon. It disrupted my sleep - lots more sleep panic, tinnitus, noises in my ears, ear pain, facial pain, headache, low mood, low energy, brain fog. I started sleeping longer and later for some reason. Before the vaccine I would usually wake up at 10:30- 11AM. After, I started sleeping until 12-1 PM. The acute symptoms except for sleep continued for 2 months. Sleep is still an issue with delayed sleep schedule. Currently my body needs to sleep until 2 pm most days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Extreme anxiety and derealization late that Friday afternoon. It disrupted my sleep - lots more sleep panic, tinnitus, noises in my ears, ear pain, facial pain, headache, low mood, low energy, brain fog. I started sleeping longer and later for some reason. Before the vaccine I would usually wake up at 10:30- 11AM. After, I started sleeping until 12-1 PM. The acute symptoms except for sleep continued for 2 months. Sleep is still an issue with delayed sleep schedule. Currently my body needs to sleep until 2 pm most days
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Hypoxia, Inappropriate schedule of product administration, Productive cough, Pyrexia
Clinical narrative: Narrative:  89 year old male admitted on August 11 2022 with chills, productive cough, and fever with mild hypoxia. He had received Moderna vaccine x 4 on January 21 2021, February 17 2021, August 31 2021, May 4 2022. He was treated with remdesivir 200 mg x 1 then 100 mg daily x 3 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and was discharged home on 8/16/2022.