chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site induration, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: The patient reported fever, blister at the site of administration which lasted a week, the site of administration felt hard and hot to the touch, pain in the arm where the vaccine was administered, nausea, vomit, headache and a rash through the body. The patient was prescribed Cefadroxil 500mg.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash, Vomiting
Clinical narrative: The patient reported fever, blister at the site of administration which lasted a week, the site of administration felt hard and hot to the touch, pain in the arm where the vaccine was administered, nausea, vomit, headache and a rash through the body. The patient was prescribed Cefadroxil 500mg.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Ear discomfort, Fatigue, Headache
Clinical narrative: Recieved the 2nd dose of Covid on  1/21/2021 at 8am the symptoms started that night around  9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea  and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Joint swelling, Nausea, Neck pain
Clinical narrative: Recieved the 2nd dose of Covid on  1/21/2021 at 8am the symptoms started that night around  9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea  and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Recieved the 2nd dose of Covid on  1/21/2021 at 8am the symptoms started that night around  9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea  and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: She experienced a migraine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Tight chest, difficulty breathing.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo for 3 hours intermittently, then nausea and mild dizziness from 7am- 5pm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, tenderness, redness, and swelling at the injection site 9 days after 1/15/21 shot after the initial pain had resolved. Several hours after the arm pain, fatigue, mild fever, and chills started.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain, tenderness, redness, and swelling at the injection site 9 days after 1/15/21 shot after the initial pain had resolved. Several hours after the arm pain, fatigue, mild fever, and chills started.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain in extremity
Clinical narrative: Patient woke up om 1/7/2021 and noted lump on middle of left collar bone with pain in left arm
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Red scratchy, watery eyes with some discharge
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Asthenia, Diarrhoea, Dizziness
Clinical narrative: Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work.   Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2.   I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population.   I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flatulence, Impaired work ability, Injection site pain, Injection site swelling
Clinical narrative: Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work.   Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2.   I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population.   I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain of skin, Pyrexia
Clinical narrative: Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work.   Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2.   I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population.   I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work.   Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2.   I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population.   I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy
Clinical narrative: Lymph node swelling in left axilla, pain in lymph node,  left shoulder pain, left scapula pain and still continuing.  This has been going on for 5 days.  At the time of report, still having the same symptoms.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site warmth, Asthenia, Erythema, Fatigue, Pain
Clinical narrative: severe body aches, fever, headache, fatigue and week. Administered spot welped up and was red and warm to touch
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: severe body aches, fever, headache, fatigue and week. Administered spot welped up and was red and warm to touch
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Received vaccine at 4pm.  Woke at 1:30 on 1/23 with headache .  At 4pm aches settled in.  At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills.  Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs.   Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia, Pyrexia, Sensitive skin
Clinical narrative: Received vaccine at 4pm.  Woke at 1:30 on 1/23 with headache .  At 4pm aches settled in.  At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills.  Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs.   Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Nausea
Clinical narrative: 24 hours felt like I was very lethargic and tired. 48 hours felt similar. 60 hours after felt nauseous and light headed
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: Patient is breastfeeding her 5 month old son. Two nights after her 1st Moderna dose, he had violent vomiting, diarrhea, body rash, and hematuria.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue for two days after receiving vaccine, Headache during physical exertion for two days after receiving vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: Fever (101), body aches, mild headache, chills; relieved temporarily with Tylenol, repeated PRN
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash, welts, & itching
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: She ran a fever (101 degrees) with chills Friday night into Saturday. Also had a headache, fatigue, and joint & muscle pain. The fever broke early Saturday morning but the headache, pains & fatigue continued throughout Saturday. She felt better by Sunday, just a little fatigue but attribute that to the poor sleep from Friday & Saturday.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: She ran a fever (101 degrees) with chills Friday night into Saturday. Also had a headache, fatigue, and joint & muscle pain. The fever broke early Saturday morning but the headache, pains & fatigue continued throughout Saturday. She felt better by Sunday, just a little fatigue but attribute that to the poor sleep from Friday & Saturday.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Red bumpy rash with extreme itching and slight swelling for 2 days until I dosed with Benedryl.  After dosing every 4 hours for 2 days, it subsided.   Will call my doctor today!
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Erythema, Peripheral swelling, Psychomotor hyperactivity, Streptococcus test negative, Tourette's disorder
Clinical narrative: Red face, swollen hands, red hands, severe hyperactivity, tourette's type of screaming
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dyspepsia, Hot flush, Impaired driving ability
Clinical narrative: I sat at the hospital for 15 mins after my vaccine shot and was ok. However minutes after I got in my vehicle and started driving, I started to experience hot flashes and a migraine. I had to pull over because I was unable to drive myself. Later in the evening, I continued to have hot flashes and started having chills. My fever became 100.6. I?ve taken Tylenol and ibuprofen as recommended but it hasn?t relieved any of the side effects. After trying to sleep, I woke up with a burning sensation in my stomach. I vomited and have had abdominal pain, aches in muscles and soreness at the injection site.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Migraine, Myalgia, Pyrexia, Vomiting
Clinical narrative: I sat at the hospital for 15 mins after my vaccine shot and was ok. However minutes after I got in my vehicle and started driving, I started to experience hot flashes and a migraine. I had to pull over because I was unable to drive myself. Later in the evening, I continued to have hot flashes and started having chills. My fever became 100.6. I?ve taken Tylenol and ibuprofen as recommended but it hasn?t relieved any of the side effects. After trying to sleep, I woke up with a burning sensation in my stomach. I vomited and have had abdominal pain, aches in muscles and soreness at the injection site.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Muscle spasms
Clinical narrative: severe nausea, chills, sweats, ache in every joint, severe fatique, i have had shingles and the neuropathy started from that was acting , my scalp was sore and couldn't brush hair, muscle cramps. I took ibprofen and didn't go to hospital. it lasted from Friday night til Sunday  and i continue to have some fatique
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain of skin
Clinical narrative: severe nausea, chills, sweats, ache in every joint, severe fatique, i have had shingles and the neuropathy started from that was acting , my scalp was sore and couldn't brush hair, muscle cramps. I took ibprofen and didn't go to hospital. it lasted from Friday night til Sunday  and i continue to have some fatique
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: vomiting, chills, myalgia, fatigue, headache
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm is swollen, hot, red, and itchy.  Very tender and hurts to move.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Left arm is swollen, hot, red, and itchy.  Very tender and hurts to move.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hand-arm vibration syndrome, Impaired work ability, Injection site swelling, Pain
Clinical narrative: Two days after shot had throbbing pains in arm and 4 days later  it got worse and started to travel to left side. through my left arm, spinal cord, left side and shoulder blade.  went on for a little over two and half weeks. so severe i had to miss work.  the last thing i had vibration in left arm like it went to sleep and started to wake up. have been dealing with this since then. it happens randomly through out the day. Still have pain in the upper arm and cant lay on my left arm for more then a few minutes. and it is swollen at the injection site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Two days after shot had throbbing pains in arm and 4 days later  it got worse and started to travel to left side. through my left arm, spinal cord, left side and shoulder blade.  went on for a little over two and half weeks. so severe i had to miss work.  the last thing i had vibration in left arm like it went to sleep and started to wake up. have been dealing with this since then. it happens randomly through out the day. Still have pain in the upper arm and cant lay on my left arm for more then a few minutes. and it is swollen at the injection site
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache, nausea and muscle aches
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Muscular weakness, Pain
Clinical narrative: Inflammed lymph nodes in the arm that it was injected, moderate pain, unable to sleep, weakness in my arm.  Duration 4 days and still unsolved.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dental discomfort, Facial pain, Facial spasm, Fatigue
Clinical narrative: Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Neuralgia, Oral pain, Pain
Clinical narrative: Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Trigeminal neuralgia, X-ray dental, X-ray normal
Clinical narrative: Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood creatine phosphokinase, C-reactive protein, Dizziness
Clinical narrative: Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Groin pain, Headache, Joint range of motion decreased, Micturition urgency
Clinical narrative: Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Neck pain, Pain
Clinical narrative: Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative
Clinical narrative: Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Weight decreased
Clinical narrative: Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Ageusia, Arthralgia, Back pain, Chills, Decreased appetite
Clinical narrative: Runny nose, severe joint aches, headaches, cold/ hot chills, back aches, no taste, no appetite.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Feeling of body temperature change, Headache, Rhinorrhoea
Clinical narrative: Runny nose, severe joint aches, headaches, cold/ hot chills, back aches, no taste, no appetite.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Ear infection, Headache, Myalgia, Nausea
Clinical narrative: Myalgias, nausea, otitis, rigors, chills, subjective fevers, headache began 12 hours after, resolved within an additional 12 hours
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Myalgias, nausea, otitis, rigors, chills, subjective fevers, headache began 12 hours after, resolved within an additional 12 hours
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Hyperhidrosis, Malaise
Clinical narrative: Per MD & RN notes from Emergency Dept Records:  "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls.  Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Spinal compression fracture, Syncope
Clinical narrative: Per MD & RN notes from Emergency Dept Records:  "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls.  Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Headache, Malaise
Clinical narrative: 12h post vaccination: headache, chills, flush/pruritus, malaise, fatigue, arm soreness (acetaminophen, antihistamine, hot shower, sleep) 24h post vaccination: symptoms resolved except malaise and headache (acetaminophen) 48h post vaccination: symptoms resolved ~10 days post vaccination: maculopapular rash on R flank ~14 days post vaccination: maculopapular rash spread to entire torso and bilateral upper extremities
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash maculo-papular
Clinical narrative: 12h post vaccination: headache, chills, flush/pruritus, malaise, fatigue, arm soreness (acetaminophen, antihistamine, hot shower, sleep) 24h post vaccination: symptoms resolved except malaise and headache (acetaminophen) 48h post vaccination: symptoms resolved ~10 days post vaccination: maculopapular rash on R flank ~14 days post vaccination: maculopapular rash spread to entire torso and bilateral upper extremities
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rash, light and no pain
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Oxygen saturation, Vital signs measurement
Clinical narrative: Post COVID vaccine patient complained of light-headedness and fatigue. She was hydrated and her Vitals were taken. She soon felt better
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: ill for 2 months; This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The age group was not reported selected as adult as per vaccine indication. The patient received 1 st dose of shingrix and had been ill for 2 months. The patient stated that side effetcs lasted for 3 months. The information regarding consent to follow up was not reported. No further information was available
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: some of the vaccine leaked down her arm; A spontaneous report was received from a healthcare professional concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  The patient's medical history was not provided. Concomitant product use was not provided.  On 13-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13-Jan-2021, the patient received a partial dose of the vaccine because some of it leaked down the patient's arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, incorrect dose administered, was considered resolved on 13-Jan-2021.; Reporter's Comments: This case concerns a 73 year old female patient who experienced a non-serious unexpected event of  Incorrect dose administered of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age has been vaccinated; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history and relevant concomitant medications were not reported.   On 11 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection.The patient was underage at the time the vaccine was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (vaccine was administrated for 17-years old patient) for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received 1ml as oppose to 0.5 ml of the vaccine; A spontaneous report was received from a health care professional concerning a 60-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that patient received 1 milliliter (ml) of vaccine instead of usual 0.5ml dose.  The patient's medical history included diabetes mellites. Concomitant medications were not reported.  On 12 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in her right arm for prophylaxis of COVID-19 infection.  On 12 JAN 2021, the patient received first dose of vaccine and reported that patient received 1ml of vaccine instead of usual 0.5ml dose.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, patient received 1ml of vaccine instead of usual 0.5ml dose, was considered recovered.; Reporter's Comments: This report refers to a case of incorrect dose administered (patient received 1 milliliter (ml) of vaccine instead of usual 0.5ml dose) for mRNA-1273, lot # 025J20-2A  There were no reported AEs associated with this case of incorrect dose administered. The reported event is unlisted and company causality was assessed s not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: There was a spill and a patient may not have received the full dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, there was a spill and a patient may not have received the full dose.  The patient's medical history was not provided. Concomitant product use was not provided.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, during vaccine administration, there was a spill and the patient did not received the full dose. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, there was a spill and a patient may not have received the full dose, was considered resolved on 12 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a patient who experienced a non-serious event of there was a spill and a patient may not have received the full dose (Incomplete dose administered) for mRNA-1273, lot # unknown), Exp date unknown. There were no reported AEs associated with this case of there was a spill and a patient may not have received the full dose.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Full dose not administered to patient; The needle came loose from the syringe; A spontaneous report was received from a healthcare professional concerning a patient who was participating in the mRNA-1273 Emergency Use Program and experienced the needle came loose from the syringe and the full dose was not administered to the patient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The reporter reported that, the needle came loose from the syringe and the patient did not receive the full dose.  She wanted to know if the patient should receive another dose.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The events, the needle came loose from the syringe and the full dose was not administered, was considered resolved.  The reporter did not provide a causality assessment of the events, the needle came loose from the syringe and the full dose was not administered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting The needle came loose from the syringe and The patient did not receive the full dose without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: She felt something dripping from the spot of injection; A spontaneous report was received from a consumer concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt something dripping from the spot of injection  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, she felt something dripping from the spot of injection. The patient noted it was a clear liquid. The vaccinator placed a bandage on the spot afterwards. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, felt something dripping from the spot of injection, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Not getting full dose; A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and vaccine spilled on her and the dentist's pants and not getting full dose.   The patient's medical history and relevant concomitant medications were not reported.   On 11-Jan-2021, at the same time as the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   When the nurse went to administer the vaccine dose, the needle fell off of the syringe and some vaccine spilled on the patient's pants. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event the needle fell off of the vaccine syringe was resolved.  Reporter causality for the events was not provided.; Reporter's Comments: This report refers to a case of male patient who experienced non-serious unexpected event of the needle fell off of the syringe and some vaccine spilled on the patient's pants. (Incomplete dose administered) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with this case of Incomplete dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Syringe leaking in the vaccination area, he didn't feel anything going in; Syringe leak; A spontaneous report was received from a consumer 78-year-old, male patient concerning a patient who was participating in the mRNA-1273 Emergency Use Program and the syringe leaking in the vaccination area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021, Prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.  During his injection the syringe was leaking at the vaccination area. There was vaccine dripping down his arm and a puddle that formed on his chair.  He reported that he didn't feel anything going in.  No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event incorrect dose administered was unknown.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe leak for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.4 ml dose received; A spontaneous report was received from a healthcare professional concerning an unidentified patient who who was participating in the mRNA-1273 Emergency Use Program and 0.4 ml dose received.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that 30 patients received 0.4ml dose, instead of 0.5ml, all from the same lot number.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 0.4 ml dose received, was considered resolved on 14 Jan 2021.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered.