chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Chills, Contusion, Feeling abnormal, Hyperaesthesia teeth
Clinical narrative: I received my 3rd dose of the Pfizer vaccine on 12/04/2021. My adverse event started on 11/18/2022 around 4:00PM. I have chills and fever. My mouth and jaw was swollen. This was from bacterial infection since my wisdom tooth was growing. I've never been sick like this before. I felt like if I slept I won't be able to wake up again. I had mouth sores. It was bruising all over my body. This continued from 11/18/2022-11/23/2022. On Saturday 11/19/2022 I went to the ER. They prescribed me with oral steroids (magic mouthwash). I don't now the exact name. I tried taking it for 3 days. I stopped using it because I've noticed it wasn't helping. I went to the dentist on 11/21/2022. They prescribed me an anti viral mouthwash along with antibiotics. They recommended me to remove my wisdom tooth out. My teeth was very sensitive for 1 day. I couldn't eat anything for 1 week. It was very painful.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Malaise, Mouth swelling, Pain, Pyrexia
Clinical narrative: I received my 3rd dose of the Pfizer vaccine on 12/04/2021. My adverse event started on 11/18/2022 around 4:00PM. I have chills and fever. My mouth and jaw was swollen. This was from bacterial infection since my wisdom tooth was growing. I've never been sick like this before. I felt like if I slept I won't be able to wake up again. I had mouth sores. It was bruising all over my body. This continued from 11/18/2022-11/23/2022. On Saturday 11/19/2022 I went to the ER. They prescribed me with oral steroids (magic mouthwash). I don't now the exact name. I tried taking it for 3 days. I stopped using it because I've noticed it wasn't helping. I went to the dentist on 11/21/2022. They prescribed me an anti viral mouthwash along with antibiotics. They recommended me to remove my wisdom tooth out. My teeth was very sensitive for 1 day. I couldn't eat anything for 1 week. It was very painful.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Stomatitis, Swelling face, Tooth disorder
Clinical narrative: I received my 3rd dose of the Pfizer vaccine on 12/04/2021. My adverse event started on 11/18/2022 around 4:00PM. I have chills and fever. My mouth and jaw was swollen. This was from bacterial infection since my wisdom tooth was growing. I've never been sick like this before. I felt like if I slept I won't be able to wake up again. I had mouth sores. It was bruising all over my body. This continued from 11/18/2022-11/23/2022. On Saturday 11/19/2022 I went to the ER. They prescribed me with oral steroids (magic mouthwash). I don't now the exact name. I tried taking it for 3 days. I stopped using it because I've noticed it wasn't helping. I went to the dentist on 11/21/2022. They prescribed me an anti viral mouthwash along with antibiotics. They recommended me to remove my wisdom tooth out. My teeth was very sensitive for 1 day. I couldn't eat anything for 1 week. It was very painful.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I mistakenly gave patient Flu-Blok during his visit with me.  He has had no adverse reactions to my knowledge.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arterial catheterisation, Arterial disorder, Arterial haemorrhage, Arteriosclerosis
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Cancer screening, Cardiac monitoring normal, Carotid artery occlusion, Carotid artery thrombosis
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carotid endarterectomy, Cerebral thrombosis, Cerebrovascular accident, Cytogenetic analysis normal, Demyelination
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dystrophic calcification, Eosinophilia, Hyperhidrosis, Hyporesponsive to stimuli
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Movement disorder, Musculoskeletal disorder, Pathology test, Procedural failure
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombectomy, Thrombosis, Vision blurred
Clinical narrative: Initial symptoms of blurry vision, dry sweats, loss of limb right slide function, and unable to speak at 4:00pm on 5/25/21. I was found down on the ground at work and brought to hospital at 4:15pm on 5/25/21. I had difficulty with following commands, unable to move the right side of face and entire right side of my body. Also had expressive aphasia and dysarthria.  I was taken to the operating room where they found a clot in the left side of my brain (LM2 cutoff) via internal carotid artery. TPA was administered and a catheter was inserted via my femoral artery to remove the clot from the left side of my brain. There was apparent loss of grey matter around the area of the clot. They found a larger clot within the left internal carotid artery.  Left-side carotid endarterectomy with use of patch graft was attempted on the morning of 5/26/21 where they removed a 2 cm by 0.5 cm clot. The patch graft procedure failed, and my left internal carotid artery could not be repaired due to the artery having poor tissue quality. After 10 hours in the operating room for a somewhat routine procedure that should have taken 2 hours, they had to sacrifice my left internal carotid artery and rely on the remaining arteries to supply blood/oxygen to my brain.   After I awoke the next day, they confirmed occlusion /sacrifice of the Left cervical ICA origin with no persistent embolic source (cephalad contrast column in ICA) and robust collateral circulation via the PCOM and ACOM. The clot was sent to the pathologist and sections show an organizing hemorrhage/thrombus dissecting between layers of an arterial wall with EVG positive elastin fibers on both sides of the dissection. Adjacent to the intramural hemorrhage/thrombus vascular wall architecture consists of anuclear fibrous or hyalinized eosinophilia rather than the laminated concentric layers of myocytes expected in a tunica media. There is also evidence of atherosclerotic plaque with cholesterol crystal cleft spaces in a faintly basophilic anuclear matrix, intramural foamy vacuolated lipid bearing cells, myointimal spindle cells, and dystrophic calcifications. An adjacent thrombus shows early organization with infiltrating fibroblasts. All follow up blood tests, Ehlers Danlos genetic test, cancer screening, blood clot screening, heart monitoring daily for 2 months were negative. This is being labeled as a cryptogenic stroke. Occurred approximately 9 weeks after second vaccine dose.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Cervix carcinoma, Dizziness, Fatigue, Headache, Infertility
Clinical narrative: Following say I was sick, headaches, dizziness, nausea, and body aches. Developed reoccurring migraines still to this day, have chronic fatigue, infertility, cervical cancer.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Migraine, Nausea, Pain
Clinical narrative: Following say I was sick, headaches, dizziness, nausea, and body aches. Developed reoccurring migraines still to this day, have chronic fatigue, infertility, cervical cancer.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Urticaria
Clinical narrative: First two days was same as the first shot - fatigue, temperature, etc..  The 3rd day after the 2nd vaccination, I broke out in hives and now I am in day 5 after the vaccine with hives all over my body and have to take steroids and additional antihistamines.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, C-reactive protein normal, Electrocardiogram, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient had his bivalent booster dosed for 5-11 year olds one week after turning 5.  He developed a fever the next day, as he did with his initial 2-dose course of the Moderna vaccine for the 6 months -5 year old dose; however, after this recent booster his fever lasted a full 7 days.  He had no other symptoms and no indication of other illness, and tested negative for covid on both an antigen and molecular test.  The pediatrician believes he just had a particularly strong immune response to the vaccine, but no indication of allergic reaction or other issues.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin normal
Clinical narrative: Patient had his bivalent booster dosed for 5-11 year olds one week after turning 5.  He developed a fever the next day, as he did with his initial 2-dose course of the Moderna vaccine for the 6 months -5 year old dose; however, after this recent booster his fever lasted a full 7 days.  He had no other symptoms and no indication of other illness, and tested negative for covid on both an antigen and molecular test.  The pediatrician believes he just had a particularly strong immune response to the vaccine, but no indication of allergic reaction or other issues.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral haemorrhage, Computerised tomogram, Magnetic resonance imaging head abnormal, Peroneal nerve palsy
Clinical narrative: On Friday my foot started dragging in the morning. I went to work, and it wasn't getting better. I went to the ER and they thought it was too severe to be a stroke. They did a CAT scan, and it was all clear, then they did MRI and found bleeding in the brain. I was put in the hospital a couple days later and I am in a acute care program now.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Intensive care, SARS-CoV-2 test positive
Clinical narrative: **case was admitted to ICU 12/03/2022, tested positive for COVID-19 12/04/2022, died 12/06/2022.** Was not able to interview case or POA.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was underdosed at 0.25mcg
Age: 29.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Wrong product administered
Clinical narrative: None reported at this time; received MenQuadFi by mistake (had only asked for MMR)
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: Sinus infection treated by 5-day course of Azithromycin.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cardiac monitoring normal, Distractibility, Disturbance in attention, Electrocardiogram normal
Clinical narrative: On 06/22 after the 2nd dose I had panic attacks symptoms. I would wake up with panic attacks and sleep with panic attacks. My heart was racing. I couldn't focus at all. I was lack of memory. At work I get distracted easily. I had 5 panic attacks each of them lasted for weeks. 2 months later while I was driving the panic attack happened again. I called my doctor he said to track it. After 30 days later I went to a cardiologist after speaking to my doctor. The Cardiologist diagnosed me with Hyper Tachycardia. They did MRI and everything came back as normal. I am a healthy person. I ran marathons, now I can't even run or do the things I used to do regularly. I get tired easily. My hand shakes when I get panic attacks. The second Cardiologist I went to did EKG, and had me on a heart monitor for 24 hours. The result came out good. My doctor said they are keeping an eye on me to see why I kept getting panic attacks out of nowhere.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Palpitations
Clinical narrative: On 06/22 after the 2nd dose I had panic attacks symptoms. I would wake up with panic attacks and sleep with panic attacks. My heart was racing. I couldn't focus at all. I was lack of memory. At work I get distracted easily. I had 5 panic attacks each of them lasted for weeks. 2 months later while I was driving the panic attack happened again. I called my doctor he said to track it. After 30 days later I went to a cardiologist after speaking to my doctor. The Cardiologist diagnosed me with Hyper Tachycardia. They did MRI and everything came back as normal. I am a healthy person. I ran marathons, now I can't even run or do the things I used to do regularly. I get tired easily. My hand shakes when I get panic attacks. The second Cardiologist I went to did EKG, and had me on a heart monitor for 24 hours. The result came out good. My doctor said they are keeping an eye on me to see why I kept getting panic attacks out of nowhere.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, SARS-CoV-2 test negative, Tachycardia, Tremor
Clinical narrative: On 06/22 after the 2nd dose I had panic attacks symptoms. I would wake up with panic attacks and sleep with panic attacks. My heart was racing. I couldn't focus at all. I was lack of memory. At work I get distracted easily. I had 5 panic attacks each of them lasted for weeks. 2 months later while I was driving the panic attack happened again. I called my doctor he said to track it. After 30 days later I went to a cardiologist after speaking to my doctor. The Cardiologist diagnosed me with Hyper Tachycardia. They did MRI and everything came back as normal. I am a healthy person. I ran marathons, now I can't even run or do the things I used to do regularly. I get tired easily. My hand shakes when I get panic attacks. The second Cardiologist I went to did EKG, and had me on a heart monitor for 24 hours. The result came out good. My doctor said they are keeping an eye on me to see why I kept getting panic attacks out of nowhere.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased, Pain
Clinical narrative: Patients daughter reported she was in extreme pain not controlled with Hydrocodone.  She could not lift her arm. (it was not red or inflamed) She was feeling awful. Her whole body hurt.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: No bad reactions luckily. The wrong moderna injection was given. Instead of giving the bivalent the original moderna was administered.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Mobility decreased, Myalgia
Clinical narrative: Injection sit very sore and swollen.  2 days later I felt numbness and tingling in right arm. Next day the pain was moving up on my upper right arm. 4-5 days post shot the sharp pain moved closer to base of neck.  I have loss of range of motion.  The pain still persists.  Goes from sharp pain to dull aching pain.  Arm movement is decreased. Only treatment is Ibuprofen, rest. At writing my right trapezoid area has pain throughout
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Injection sit very sore and swollen.  2 days later I felt numbness and tingling in right arm. Next day the pain was moving up on my upper right arm. 4-5 days post shot the sharp pain moved closer to base of neck.  I have loss of range of motion.  The pain still persists.  Goes from sharp pain to dull aching pain.  Arm movement is decreased. Only treatment is Ibuprofen, rest. At writing my right trapezoid area has pain throughout
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: No symptoms. Pt was given inadequate dose of moderna.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Panic reaction, Pharyngeal paraesthesia, Throat clearing, Throat irritation
Clinical narrative: On 12/7 patient came in for a flu vaccine appointment. Fluarix is currently the only available flu vaccine that we have in stock for her age range so it was chosen for the vaccination. In the vaccination room patient informed me that she had a new egg allergy and that she didn't think it would be an issue. I informed her that the vaccine she was signed up to get was not one of the available egg-free vaccines and that I did not have any egg-free vaccines in stock. I informed patient that with her egg allergy she could still receive the vaccine as studies have shown that a reaction is unlikely however that she may benefit by having the vaccine done at her PCP's office where they have more supplies to treat her in case of a reaction. Patient elected to have the vaccination in store opposed to waiting.  Within minutes of receiving the vaccine she began clearing her throat and coughing. Upon questioning she said that she was experiencing tickling in her throat. As her symptoms progressed over the next minute she began coughing more and wheezing. I asked her if I could administer  an epipen and called emergency services to which she declined and asked for Benadryl stating that it worked to treat her symptoms. I told her that I was unable to give her oral Benadryl but would need to administer it in another shot. At this time patient was still coughing, wheezing, and experiencing tingling in her throat but she stated she was not sure how much of it was the reaction or her panic in response to it. within about 3 minutes of administering 50mg of diphenhydramine patient was calming down and leaving her with just the tickle and cough. Patient remained in our vaccine room for ~15 minutes and then remained in our waiting area for another 15 minutes before stating that she felt good to leave. Roughly two hours later I performed a follow up call with patient to ensure she was feeling better.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: On 12/7 patient came in for a flu vaccine appointment. Fluarix is currently the only available flu vaccine that we have in stock for her age range so it was chosen for the vaccination. In the vaccination room patient informed me that she had a new egg allergy and that she didn't think it would be an issue. I informed her that the vaccine she was signed up to get was not one of the available egg-free vaccines and that I did not have any egg-free vaccines in stock. I informed patient that with her egg allergy she could still receive the vaccine as studies have shown that a reaction is unlikely however that she may benefit by having the vaccine done at her PCP's office where they have more supplies to treat her in case of a reaction. Patient elected to have the vaccination in store opposed to waiting.  Within minutes of receiving the vaccine she began clearing her throat and coughing. Upon questioning she said that she was experiencing tickling in her throat. As her symptoms progressed over the next minute she began coughing more and wheezing. I asked her if I could administer  an epipen and called emergency services to which she declined and asked for Benadryl stating that it worked to treat her symptoms. I told her that I was unable to give her oral Benadryl but would need to administer it in another shot. At this time patient was still coughing, wheezing, and experiencing tingling in her throat but she stated she was not sure how much of it was the reaction or her panic in response to it. within about 3 minutes of administering 50mg of diphenhydramine patient was calming down and leaving her with just the tickle and cough. Patient remained in our vaccine room for ~15 minutes and then remained in our waiting area for another 15 minutes before stating that she felt good to leave. Roughly two hours later I performed a follow up call with patient to ensure she was feeling better.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent booster shot given but patient had not yet received primary vaccine series
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Myocarditis
Clinical narrative: Myocarditis
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient  said at time of injection experienced pain and has been having left arm pain for 1 month
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Palpitations
Clinical narrative: Ever since getting vaccinated with the Pfizer shot I have become easily winded, headaches and have palpations.
Age: 35.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: about 30 seconds after patient received his 2 vaccines, he lost consciousness.  his head slumped toward his chest, his eyes closed.  he remained in his chair.  I applied a cold pack to his neck and about 1 minute later he began regaining consciousness.  He asked for some water, drank about 8 ounces and noticed he was sweating on his forehead.  after about 10 minutes he said he was fine and walked out of the immunization room.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 10/14/21 and 11/12/21. On 11/30/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure due to COVID-19 infection/pneumonia and multifocal PNA. As of today 12/7/22, patient is still admitted in the med/surg unit.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Mechanical urticaria, Sensitive skin
Clinical narrative: Developed dermatographia two weeks after reducing vaccine.   If I touch or scratch my skin it becomes red for approx. 30 minutes.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 2/8/21, 3/8/21, 9/9/21 and Moderna bivalent COVID vaccine on 10/12/22. On 12/1/22, patient admitted to our inpatient facility (med/surg unit) for acute hypoxic respiratory failure due to COVID-19 pneumonia. As of today 12/7/22, patient is still admitted in the med/surg unit.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, COVID-19 pneumonia, Pneumonia bacterial, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 2/24/21, 3/25/21, and 11/11/21. On 12/3/22, patient admitted to our inpatient facility (med/surg unit) with sepsis secondary to COVID-19 pneumonia, superimposed bacterial pneumonia and AKI. As of today 12/7/22, patient is still admitted in the med/surg unit.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Superinfection
Clinical narrative: Patient received Moderna COVID vaccine on 2/24/21, 3/25/21, and 11/11/21. On 12/3/22, patient admitted to our inpatient facility (med/surg unit) with sepsis secondary to COVID-19 pneumonia, superimposed bacterial pneumonia and AKI. As of today 12/7/22, patient is still admitted in the med/surg unit.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: The bivalent Pfizer vaccine was given to the patient instead of the primary series, monovalent, vaccine. Patient did not report any adverse effects and was notified immediately of the error.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to 10-year-old patient on 12/6/22 around 3:00pm. Parents have been informed of the incident around 5:50pm and instructed to monitor for potential adverse effects. As of that discussion, there has been no reported symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: No AE. This is a vaccination error. It was discovered after the fact that patient had never received the initial series of COVID vaccines. He should not have received a booster dose.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Narrative: Patient noticed tingling in left arm then to head and then to tongue after moderna bivalent vaccination. Lef arm tingling and head tingling resolved after 10 min but tongue tingling persists. Patient was advised to go to ED but left.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: MOP asked for a booster dose, but we realized after the shot the primary serie was not completed and it was not Pfizer (021 2022)
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Alopecia
Clinical narrative: Within two weeks after vaccine I started to have major hair loss. It has been diffuse an constant and I have lost over one third of my hair to date.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Alopecia, Blood iron, Blood test
Clinical narrative: Within two weeks after vaccine I started to have major hair loss. It has been diffuse an constant and I have lost over one third of my hair to date.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; patients received expired dose of the monovalent vaccine instead of Bivalent booster; 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 (patients 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 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR7479B) for COVID-19 immunisation.     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 (patients received expired dose of the monovalent vaccine instead of Bivalent booster) and WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients received expired dose of the monovalent vaccine instead of Bivalent booster) and WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster).    No concomitant medication information was 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.  No treatment medication information was reported.   This case was linked to MOD-2022-682304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Significant follow up appended
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Incorrect dose administered, Nausea, Pyrexia
Clinical narrative: Nausea after 3rd Monovalent shot; Dizziness after 3rd Monovalent shot; Fever 99F after 3rd Monovalent shot; /Monovalent (not sure if half dose) on 14AUG2021; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea after 3rd Monovalent shot), DIZZINESS (Dizziness after 3rd Monovalent shot), PYREXIA (Fever 99F after 3rd Monovalent shot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary monovalent dose on 09MAR2021/Monovalent (not sure if half dose) on 14AUG2021) and NO ADVERSE EVENT (No Adverse Event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer since 2019. Concomitant products included RITUXIMAB (RITUXAN) from an unknown date to 27-Apr-2022 for an unknown indication.    On 14-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary monovalent dose on 09MAR2021/Monovalent (not sure if half dose) on 14AUG2021) and NO ADVERSE EVENT (No Adverse Event). On 14-Aug-2021, the patient experienced NAUSEA (Nausea after 3rd Monovalent shot), DIZZINESS (Dizziness after 3rd Monovalent shot) and PYREXIA (Fever 99F after 3rd Monovalent shot). On 17-Aug-2021, NAUSEA (Nausea after 3rd Monovalent shot), DIZZINESS (Dizziness after 3rd Monovalent shot) and PYREXIA (Fever 99F after 3rd Monovalent shot) outcome was unknown. In January 2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary monovalent dose on 09MAR2021/Monovalent (not sure if half dose) on 14AUG2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Antibody tests on MAY2021 & JAN2022 showed no detectable antibody No Treatment Medication were provided by reporter.    This case was linked (Patient Link).
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Viral infection
Clinical narrative: Diarrhea; virus; Initial information was received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA344363(CLUSTER).  This case involves a 80 years old female patient who experienced diarrhea and virus after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Nov-2022, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for immunization.  On an unknown date the patient had diarrhea (diarrhoea) and virus (viral infection) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for the events (Diarrhea, virus).  Outcome: Recovering / Resolving for the events.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AEs; Healthcare worker reported that a patient received an expired PNEUMOVAX; The vaccine also had an temperature excursions prior to the administration; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-OCT-2022, the patient was vaccinated with an expired and improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #t040202, expiration date: 11-SEP-2022, administered for prophylaxis (anatomical location and route of administration were not provided) (expired product administered, product storage error). The suspect vaccine's temperature excursions prior to administration occurred on 14-MAY-2022, at a temperature of 52.7 degrees (deg.) Fahrenheit (F) for a time frame of 1 hour 30 minutes, and on 24-JUL-2022, at a temperature of 51.6 deg. F for a time frame of 50 minutes.  No additional adverse events (AEs) were reported (no adverse event).  This is a non-valid case due to lack of patient identifiers.  Follow-up information has been received on 01-DEC-2022 from an other health professional, referring to a 83-year-old female patient. The patient's concomitant vaccines included influenza vaccine inact split 3v (FLUZONE HIGH DOSE). The patient was administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, first dose (number of previous doses reported as "0"), lot # provided as "T040202 PP", intramuscularly (IM) in right deltoid (RD). It was reported that a staff error occurred: staff data entry error of expiration date into electronic medical records (EMR), and shot giver didn't check syringe expiration date. The reporter indicated that the error occurred at administration, as staff did not check expiration date on syringe and data entry error in EMR was showing expiration date in 2023. No prescription drug treatment was required for the experience. The outcome of staff error regarding the use of an expired vaccine was provided as resolved/recovered with sequelae (considered the outcome of expired product administered, with stop date of ??-???-2022).
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE's; a six month old patient received a third dose of PEDVAX HIB; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender whose concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 08-NOV-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, used as directed to prevent haemophilis influenza b infection (lot number: W002453, which was verified to be valid with an expiration date: 24-JUN-2024; strength and route of administration were not provided) (Inappropriate schedule of vaccine administered).  No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; administered products after they were involved in a temperature excursion.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-NOV-2022 (also reported as today), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W018836, expiration date: 14-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided), after it was involved in a temperature excursion at 7.5 Fahrenheit degrees for 6 hours and 58 minutes (Improper storage of product in use). No previous temperature excursions or additional adverse events were reported.   This is one of two reports received from the same reporter.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional Ae; Nurse reported PEDVAX HIB was administered after multiple temperature excursions to a patient on Nov 15, 2022; This spontaneous report has been received from a nurse, referring to a 3-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications were not provided.  On 15-NOV-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, once, lot number U034518 has been verified to be a valid lot number, expiry date 18-MAR-2024 but updated to 28-MAR-2024 after internal review) (strength, anatomical location, and dose were not reported), the third dose of pneumococcal vaccine conj 13V (crm197) (PREVNAR 13) 0.5 milliliter intramuscularly on the left deltoid, batch number FM5699 (strength, frequency, and expiry date were not reported), and a dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsg  (yeast) (+) pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid  (PEDIARIX) (strengths, doses, frequencies, administration routes, anatomical locations, lot numbers, and expiry dates were not reported) all the vaccines indicated as prophylaxis (product storage error).  The vaccines were stored at a temperature of -0.3 °C (Celsius) for a time frame of 21 minutes,  -1.8 °C for 23 minutes, -2.7 °C for 24 minutes; 0.6 °C for 19 minutes, 0.7 °C for 6 minutes; and 1.2 °C for 14 minutes. There was no previous temperature excursion.  No additional adverse events were reported.