chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Headache, Laboratory test
Clinical narrative: After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Dizziness, Chills, Body Aches, Headache- Began 9 hours after injection. Lasted approximately 24 hours. Tiredness- Began 18 hours after injection. Lasted one more day.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Wound
Clinical narrative: DAY 1 / a few bumps on my calfs, progressing day by day Day 5 / countless bumps, open sores, unbearably itchy on lower legs and healthcare provider completely baffled / no solution 5 weeks later I still have a terrible rash on my legs and arms // very scary
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Dermatitis
Clinical narrative: Started with eyelid reaction to makeup (eyeliner) that has no turned into eyelid dermatitis x 5 days and then both forearm dermatitis x 3 days. Benadryl (oral and ointment) and Claritin (oral) have been tried with no improvement. Will be trying steroid cream on forearms.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Eye pruritus, Fatigue
Clinical narrative: Headache, chills, low grade fever, muscle and joint pain, sore throat, malaise, tiredness, itching & burning eyes, swelling, redness, pain, itching <5" diameter spread over several days at injection site, hard 'knot' 2" diameter at injection site, swollen lymph node in R armpit of injection arm. Benadryl topical, ice, heat, lymph drainage, ibuprofen to no effect. Symptoms currently lasting 9 days without signs of waning at time of report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Headache, chills, low grade fever, muscle and joint pain, sore throat, malaise, tiredness, itching & burning eyes, swelling, redness, pain, itching <5" diameter spread over several days at injection site, hard 'knot' 2" diameter at injection site, swollen lymph node in R armpit of injection arm. Benadryl topical, ice, heat, lymph drainage, ibuprofen to no effect. Symptoms currently lasting 9 days without signs of waning at time of report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Manual lymphatic drainage, Myalgia
Clinical narrative: Headache, chills, low grade fever, muscle and joint pain, sore throat, malaise, tiredness, itching & burning eyes, swelling, redness, pain, itching <5" diameter spread over several days at injection site, hard 'knot' 2" diameter at injection site, swollen lymph node in R armpit of injection arm. Benadryl topical, ice, heat, lymph drainage, ibuprofen to no effect. Symptoms currently lasting 9 days without signs of waning at time of report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, chills, low grade fever, muscle and joint pain, sore throat, malaise, tiredness, itching & burning eyes, swelling, redness, pain, itching <5" diameter spread over several days at injection site, hard 'knot' 2" diameter at injection site, swollen lymph node in R armpit of injection arm. Benadryl topical, ice, heat, lymph drainage, ibuprofen to no effect. Symptoms currently lasting 9 days without signs of waning at time of report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Heart rate increased
Clinical narrative: 10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tall building, then quick pulses, and then I felt my lungs were full/heavy.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital oedema, Periorbital swelling
Clinical narrative: 15 minutes following COVID vaccine administration pt observed to have periorbital erythema and edema. Pt administered 25mg/10ml diphenhydramine. Erythema and edema improving, increased pt wait time to 30 minutes. Pt left observation area in good condition.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt reports sensation of tongue swelling. Benadryl 25 mg/10ml given. Progressive tingling/numbness reported with mild dyspnea with mild dizziness. No itching reported. Vitals taken and stable. Emergency response contacted; arrived and completed EKG.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt reports sensation of tongue swelling. Benadryl 25 mg/10ml given. Progressive tingling/numbness reported with mild dyspnea with mild dizziness. No itching reported. Vitals taken and stable. Emergency response contacted; arrived and completed EKG.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: PATIENT FELT DIZZY AND FELL DOWN RIGHT AFTER RECEIVING VACCINE
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: received the shot on 2/12/2021 felt ok 2/13/2021 until noon on 2/14/2021 then had a fever achy  headache these symptoms lasted until 2/15/2021 until about 6 pm.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 24 hours. I took Tylenol and am starting to feel better
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anxiety, Asthenia, Blood pressure increased, Confusional state
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depressed mood, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Logorrhoea, Mood altered, Negative thoughts, Suicidal ideation
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tension
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Blood thyroid stimulating hormone, Depression, Full blood count normal
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Logorrhoea, Metabolic function test, Psychomotor hyperactivity
Clinical narrative: Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after injection, injection site swollen, bright red and hot.  Full body hives, intense itching and burning with extreme exhaustion and joint pain still active as of 3/4/2021.  Urgent center visit, given a 6 day pack of steroids, told to monitor symptoms and sent home.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: 2 days after injection, injection site swollen, bright red and hot.  Full body hives, intense itching and burning with extreme exhaustion and joint pain still active as of 3/4/2021.  Urgent center visit, given a 6 day pack of steroids, told to monitor symptoms and sent home.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Migraine, Oropharyngeal pain
Clinical narrative: I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on  a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on  a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: red swollen lesion at injection site.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsey
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Nausea, Seizure
Clinical narrative: 30 second nonepeleptic seizure , loss of blood pressure and extreme dizziness along with nausea
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, hardness and red lesion at injection site. Also very itchy. Symptoms of "COVID Arm."
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "COVID arm", big red bump at injection site, itchy and extremely sore. After redness  and swelling resolved, now (2 weeks later)  a shadow like mark remains where the bump was
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "COVID arm", big red bump at injection site, itchy and extremely sore. After redness  and swelling resolved, now (2 weeks later)  a shadow like mark remains where the bump was
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient witnessed slumped over in chair and unconscious. at approximately 12:52 PM.  Patient aroused with physical stimulation.  Patient immediately  regains  consciousness. Patient oriented to person, time, place and situation. Patient reveals history of syncope to a prior flu vaccine and Gardasil vaccine. Patient then loses consciousness. Patient aroused with verbal and physical stimulation. Patient regains consciousness immediately.  911 had already been activated at this point. Paramedics  assumed care  at approximately  1:00 PM.  Patient refused transport to hospital. Patient advised to have someone drive her home. Patient monitored until transportation arrived. Prior to leaving facility, patient reassessed at approximately 1:30 PM. Blood pressure was 139/102 mmHg and pulse 90 bpm. Patient left facility at approximately 1:35 PM to roommate. Patient escorted to car by paramedic. Patient left facility alert and oriented to person, time, place, and situation with steady gait and unlabored breathing.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vital signs measurement
Clinical narrative: Patient witnessed slumped over in chair and unconscious. at approximately 12:52 PM.  Patient aroused with physical stimulation.  Patient immediately  regains  consciousness. Patient oriented to person, time, place and situation. Patient reveals history of syncope to a prior flu vaccine and Gardasil vaccine. Patient then loses consciousness. Patient aroused with verbal and physical stimulation. Patient regains consciousness immediately.  911 had already been activated at this point. Paramedics  assumed care  at approximately  1:00 PM.  Patient refused transport to hospital. Patient advised to have someone drive her home. Patient monitored until transportation arrived. Prior to leaving facility, patient reassessed at approximately 1:30 PM. Blood pressure was 139/102 mmHg and pulse 90 bpm. Patient left facility at approximately 1:35 PM to roommate. Patient escorted to car by paramedic. Patient left facility alert and oriented to person, time, place, and situation with steady gait and unlabored breathing.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Wheelchair user
Clinical narrative: At approximately 12:45, patient stated she was not feeling well. Paramedic immediately assisted patient into a chair and assessed patient. Patient was fully oriented and able to follow basic commands and answer questions. Patient denied allergies to vaccine, medications, and food. Patient reported not drinking a lot of water today. Patient then stated she felt dizzy and lightheaded and stated she wanted to lay down. Paramedic placed patient into a wheelchair to transport patient to an area in which she would lay down. Patient placed in recovery position and vitals assessed. Blood pressure was 100/56 mmHg and heart rate of 60 beats per minute. Patient symptoms were not resolving. 911 was activated. Fire Department Paramedics arrived and assumed care at approximately 1:00 PM. At approximately 1:08 PM, patient left facility via ambulance and was transported to Hospital for further care.
Sex: F
Vaccine: RAB
Symptoms: Cystitis, Diarrhoea, Immunosuppression, Pelvic pain
Clinical narrative: diarrhoea, immunosuppression, cystitis and pelvic pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial asymmetry, Facial pain, Swelling of eyelid
Clinical narrative: Bell's palsy-left eye upper lid swollen, pain left side of face, asymmetric smile. mild case with no difficulty swallowing, able to close eye. treated with prednisone. onset within 24hrs following moderna vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: I had normal injection site sensitivity after the initial 1st dose, and that cleared within 2 days.  Then on the 6th day post injection, my upper arm started feel hot and taught, hard to the touch and itched.  Not really pain in the muscle but more of a large red skin irritation has increased in symptoms all day.  I have read there is a slight chance of Cutaneous Hypersensitivity, and presume that's what's happening, but thought I should report it.  I have not seen a Dr. at this point.  Will try Benadryl or hydrocortisone cream in the morning if not improving.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Euphoric mood, Feeling abnormal, Hallucination
Clinical narrative: Nothing initially  1-2 hours later,  heart raced for 15-30 second (4 times within that time frame) then stopped  7 hours later- brain fog. Drove short distance and started hallucinating while driving. Saw black wind in street, design on my phone, car behind me appear completely different for few seconds than appear normal, green lights sticking in vision to hold to straight line. Brighter than normal street lights  Right leg started shaking uncontrollably 30 seconds then stopped  Hands started shaking for 15 second then stopped  Arm sore where shot was  No appetite  Once back in apartment, hallucinations stopped but felt high. Wasn?t making lot of sense. Felt weird.  9 hrs later+ low fever 100 10 hours later hallucination started again. Scared me so turned lights on Chills started Tired but couldn?t sleep  11 hrs later trouble sleeping  Appetite returning . Feeling less weird but still brain fog and strange
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Palpitations, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Nothing initially  1-2 hours later,  heart raced for 15-30 second (4 times within that time frame) then stopped  7 hours later- brain fog. Drove short distance and started hallucinating while driving. Saw black wind in street, design on my phone, car behind me appear completely different for few seconds than appear normal, green lights sticking in vision to hold to straight line. Brighter than normal street lights  Right leg started shaking uncontrollably 30 seconds then stopped  Hands started shaking for 15 second then stopped  Arm sore where shot was  No appetite  Once back in apartment, hallucinations stopped but felt high. Wasn?t making lot of sense. Felt weird.  9 hrs later+ low fever 100 10 hours later hallucination started again. Scared me so turned lights on Chills started Tired but couldn?t sleep  11 hrs later trouble sleeping  Appetite returning . Feeling less weird but still brain fog and strange
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tuberculin test
Clinical narrative: Nothing initially  1-2 hours later,  heart raced for 15-30 second (4 times within that time frame) then stopped  7 hours later- brain fog. Drove short distance and started hallucinating while driving. Saw black wind in street, design on my phone, car behind me appear completely different for few seconds than appear normal, green lights sticking in vision to hold to straight line. Brighter than normal street lights  Right leg started shaking uncontrollably 30 seconds then stopped  Hands started shaking for 15 second then stopped  Arm sore where shot was  No appetite  Once back in apartment, hallucinations stopped but felt high. Wasn?t making lot of sense. Felt weird.  9 hrs later+ low fever 100 10 hours later hallucination started again. Scared me so turned lights on Chills started Tired but couldn?t sleep  11 hrs later trouble sleeping  Appetite returning . Feeling less weird but still brain fog and strange
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Intense chills, weakness, headache, lightheaded, muscle aches, very short, but very intense sharp stabbing muscle pains
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast mass, Neck pain, Ultrasound breast
Clinical narrative: Awoke day 4 post inject with  deep aching pain to neck and shoulder and under arm on side where vaccine given. I took 2 OTC Motrin which improved but did not eliminate pain. A few hours later, prior to taking additional NSAIDs, I checked neck and underarm for swollen lymph nodes as that was what the pain/ache reminded me of. I did not feel and lymph nodes in my neck or underarm but I did notice  2 new lumps in my breast on that same side. One was tiny and hard ~1mm, the other was about the size of a pea. Both were located in the upper, outer quadrant @ about10:00.  I called my PCP and got appointment.  By the time of my appointment, I could no longer find the tiny lump. My PCP ordered a breast ultrasound which I had which did not show any new lumps
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Inflammation, Paraesthesia, Pruritus
Clinical narrative: overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Respiratory tract irritation, Throat irritation
Clinical narrative: overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pharyngeal inflammation, Pruritus, Rash, Respiratory rate decreased
Clinical narrative: overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Swelling, rash, itching 8 days after vaccine injection
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hallucination, Panic reaction, Vertigo
Clinical narrative: I was fine during the day .. at about 11 o?clock pm i started feeling like i was falling off the earth .. spinning .. that i was going to jump out my window ... etc !! Like my whole body was out of control. I could not breathe ... i couldn?t realize at the time i was hallucinating terribly !! Like the worst bad acid trip gone wrong .. i am panicked now !!!
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Arthralgia, Biopsy bone marrow, C-reactive protein increased, Full blood count
Clinical narrative: 4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Thrombocytopenia, Weight decreased
Clinical narrative: 4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood test, Full blood count, Inflammatory marker test, Pain
Clinical narrative: 4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: 4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: I received my 2nd dose of Moderna, but have some concerns about where the shot was given on my arm. After I got home, I noticed the injection site was too low. Per my research, this vaccine should be administered as an intramuscular injection in the deltoid muscle. However, here's a photo where I've annotated with a red dot where I got my shot, it's too low (below the armpit line) and a little far back.    I believe the injection was in the tricep (I felt the soreness in the tricep) rather than the deltoid. Since the shot was given at the wrong site, I am reporting this as a vaccination administration error.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nasopharyngitis, Pain in extremity, Sleep disorder
Clinical narrative: chills-cannot seem to get warm,  pain in right arm, headache.  Arm ache started about 6 hours post injection, mild headache soon followed.   Headache intensity increased over night.  Woke me up at 3:30 am.   Took OTC meds (Acetaminophen), which has only slightly decreased the headache.  Arm ache is still the same.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt received 1st dose of Moderna vaccine and shortly afterwards developed a pruritic sensation. No rash was identified and continued for several days. Pt was started on Atarax, pending results. No SOB
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: 100.9 fever, body chills, severe headache
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: On day 4 I experience a severe headache with visual auras in my right eye.  The field defect was the medial field of vision from just my right eye and lasted at least 8 hrs.  I went to sleep with it and woke up to find it resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: About 5 days after vaccine I noticed a bump above  my collar bone. Located on the same side I received the vaccine. I started to have soreness in the same arm again but different location then where the vaccine was given.  Bump is still there as of today. I am monitoring it.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Biopsy kidney abnormal, Blood creatinine increased
Clinical narrative: Acute interstitial nephritis
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Complement factor C3, Complement factor C4, Hepatitis B test negative, Hepatitis C test negative, Red blood cells urine positive
Clinical narrative: Acute interstitial nephritis
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Tubulointerstitial nephritis, Ultrasound kidney normal, Urine analysis abnormal, White blood cells urine positive
Clinical narrative: Acute interstitial nephritis
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune hepatitis
Clinical narrative: painful outbreak of autoimmune hepatitis; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around June 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, in 2017 (reported as within weeks), the pt developed a painful outbreak of autoimmune hepatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of zoster vaccine live (ZOSTAVAX) that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The event painful outbreak of autoimmune hepatitis was considered to be disabling by the lawyer. Upon internal review, the event painful outbreak of autoimmune hepatitis was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: a painful outbreak of shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 05-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, in 2014 (reported as within weeks), the pt developed a painful outbreak of shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered a painful outbreak of shingles to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Oropharyngeal pain, Pruritus, Rash, Vulvovaginal pruritus
Clinical narrative: she had vaginal / itching / Itching is really bad; leg itching / Itching is really bad; throat / pain; right ear pain; rash in different areas (currently on forearms) / moves around; This case was reported by a other health professional and described the occurrence of vaginal itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2020, the patient received Shingrix. On 10th December 2020, 1 days after receiving Shingrix, the patient experienced vaginal itching and itchy legs. In December 2020, the patient experienced throat pain, ear pain and rash. On an unknown date, the outcome of the vaginal itching, itchy legs, throat pain, ear pain and rash were unknown.   It was unknown if the reporter considered the vaginal itching, itchy legs, throat pain, ear pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had vaginal and leg itching. The patient got throat and right ear pain and a rash as well.  The patient went to urgent care and was given medication which seemed to help. However, gets a rash in different areas currently on forearms that moves around.  The itching was bad and had not called since with further issues.  This case linked with US2020AMR252174 and US2020AMR252163, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252174:same reporter US-GLAXOSMITHKLINE-US2020AMR252163:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: The area is red and spreading; Stiff neck; Severe headache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema, stiff neck and headache. On an unknown date, the outcome of the injection site erythema, stiff neck and headache were unknown.   It was unknown if the reporter considered the injection site erythema, stiff neck and headache to be related to Shingles vaccine.  Additional detail were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had 2nd dose of Shingles vaccine and the area was red and spreading with stiff neck and severe headache was that normal. No other information was provided. The information regarding consent to follow up was not reported
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had the first Shingrix dose / contracted mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient stated that he/she received first dose of Shringrix and experienced Shingles before he/she could take second dose.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out with red itchy welt of the injected (left) arm /  similar welt on his right arm; broke out with red itchy welt of the injected (left) arm /  similar welt on his right arm; This case was reported by a consumer via call center representative and described the occurrence of erythema urticarial in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (mild case).   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced erythema urticarial and pruritus. On an unknown date, the outcome of the erythema urticarial was unknown and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the erythema urticarial and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The reporter did not provide lot or expiry date.  A couple of days after the receiving the shot ,the patient broke out with a red itchy welt of the injected(left) arm. The size of the welt started as quarter sized and grew to 3 inches. A couple days after that he developed a similar welt on his right arm which also started as quarter sized and grew to 3 inches. Both areas had resolved, but on 3rd February 2021 after having a blood pressure cuff squeeze his left arm he developed a small welt again. The patient's physician had advised not to get the second Shingrix shot.  The reporter did not consent to follow-up. This case has been linked with US2021029247, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029247:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: redness at injection site/ large red circle and progressed up to the shoulder and down past the elbow; swelling at injection site; injection site area was hot as well; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In June 2019, the patient experienced rash. In June 2019, the outcome of the injection site erythema, injection site swelling, injection site warmth and rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose in the left arm.  The patient experienced redness and swelling at injection site. It was described as a large red circle and progressed up to the shoulder and down past the elbow with a small amount of swelling. The area was hot as well.  The patient went to urgent care for treatment on 16th June 2019 and was provided with medication.  The symptoms resolved within 10 days after vaccination.  The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR030053.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR030053:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Swelling
Clinical narrative: small bump on the right side of her neck where the neck meets the shoulder/ puffiness on right side of neck; bruising under the right armpit; This case was reported by a consumer via call center representative and described the occurrence of neck swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2021, the patient received the 1st dose of Shingrix (intramuscular). In January 2021, an unknown time after receiving Shingrix, the patient experienced neck swelling and contusion. On an unknown date, the outcome of the neck swelling was recovered/resolved and the outcome of the contusion was not recovered/not resolved.   It was unknown if the reporter considered the neck swelling and contusion to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself.  The patient experienced a small bump on the right side of her neck where the neck meets the shoulder, puffiness on the right side of the neck, bruising under the right armpit.  The patient said she would continue to monitor the symptoms.  The reporter did not consent to follow-up and did not give permission to contact the healthcare professional.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: soreness at the injection site; fatigue; general myalgia; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th February 2021 15:00, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and myalgia. On an unknown date, the outcome of the injection site pain and myalgia were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for himself. The patient received 2nd dose of Shingrix in right arm. In the morning of 18th February 2021, after receiving Shingrix, the patient experienced general myalgia, fatigue, soreness at the injection site and no apparent fever.   At the time of reporting, the patient's all symptoms had resolved but still felt a little fatigue. The patient stated he slept well last night from the date of reporting. The reporter consented to follow up with his healthcare professional.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: pain at the injection site; fever of 101 degrees F.; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (receved 1st dose on an unknown date).   On 17th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). In February 2021, 12 hrs after receiving Shingrix, the patient experienced fever, fatigue and headache. On 17th February 2021, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fever, fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Within 1 second after receiving Shingrix, the patient experienced pain at the injection site. On 18th February 2021, about 12 hours after receiving Shingrix, the patient experienced a fever of 101 degrees F, headache and fatigue. The formulation of Shingrix was not known. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: almost the full content of the vial was dropped down, Do not know how much was administered to the patient; needle was not properly attached; A spontaneous report was received from a pharmacist  concerning a 72 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle was not properly attached and so almost the full content of the vial was dropped down, it sprayed out too fast and the amount of vaccine administered to the patient was unknown.  The patient's medical history was not provided. Concomitant product use was unknown.   On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown). On 18-FEB-2021, the patient received his second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  While administering the vaccine, the nurse noticed the needle was not properly attached and so almost the full content of the vial was dropped down. It sprayed out too fast and the nurse did not know how much was administered to the patient.  Action taken with the drug in response to the events is not applicable.  The outcomes of the events were considered resolved.; Reporter's Comments: This report refers to a case of 'needle was not properly attached' and almost the full content of the vial was dropped down, Do not know how much was administered to the patient' for mRNA-1273 (lot# 024M20A) with no associated adverse events.